Precision AI Surgical Planning System (PAI-SPS)

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January 21, 2025 Precision AI Pty Ltd Sara Baniadam Quality and Regulatory Manager Address Suite 18, 36 Agnes Street Fortitude Valley, Queensland Australia Re: K243955 Trade/Device Name: Precision AI Surgical Planning System (PAI-SPS) Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: QHE, KWS, PHX Dated: December 20, 2024 Received: December 23, 2024 Dear Sara Baniadam: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. 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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. 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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed by Farzana Farzana Sharmin -S Date: 2025.01.21 20:06:29 Sharmin -S -05'00' Farzana Sharmin, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K243955 #### Device Name Precision AI Surgical Planning System (PAI-SPS) ## Indications for Use (Describe) Software The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit presurgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision AI Shoulder Guide and Biomodels. ### Hardware The Precision Al Planning System Guides are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral head resection. The Precision AI Guides and Biomodels are indicated for single use only. The Precision AI Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a delto-pectoral approach only. The Precision Al Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components: ### Enovis: - · AltiVate Anatomic (K162024, K173073, K193226 (CS Edge)) - · AltiVate Anatomic Augmented (K213387, K222592) - · Turon Shoulder System (K111629, K080402, K123982) - · Reverse Shoulder Prosthesis (K051075, K092873, K111629, K100741, K111735, K041066, K141006) - · AltiVate Reverse (K141990, K172351, K190290) - · AltiVate Reverse Glenoid (ARG) (K233481) ### Lima: - · SMR Shoulder System (K161476, K100858, K101263) - · SMR Reverse Shoulder System (K110598) - · SMR 40MM Glenosphere (K142139) - · SMR 3-Pegs Glenoid (K153722, K130642) - · SMR Modular Glenoid (K113254, K143256) - · SMR TT Metal Back Glenoid (K133349) - · SMR Hybrid Glenoid System (K163397) - · SMR Stemless Anatomic (K221758) - · SMR 140° Reverse Humeral Body (K201905) - · SMR TT Augmented Glenoid System (K191746, K200171) - · SMR Lateralized Connectors with screws (K183042) {4}------------------------------------------------ - SMR TT Augmented 360 Baseplate (K220792) - SMR TT Hybrid Glenoid (K220792) - PRIMA Humeral System and SMR Glenosphere Ø42 (K212800) - PRIMA TT Glenoid (K222427) Type of Use (Select one or both, as applicable) | <span> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px; text-align: center;">X</div> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <div style="display:inline-block; border: 1px solid black; width: 10px; height: 10px;"></div> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The target symbol is composed of concentric circles of dots, with horizontal and vertical lines intersecting at the center. # 510(k) Summary #### Applicant Details 1 | Name: | Precision Al Pty Ltd | |----------------------------------|--------------------------------------------------------------| | Address: | Suite 18 36 Agnes Street Fortitude Valley QLD 4006 Australia | | Contact Person / Prepared<br>By: | Sara Baniadam | | | Quality and Regulatory Manager | | | regulatory@precisionai.com.au | | Date Prepared: | 20-Dec-2024 | #### Device Details and Predicate 2 | Device Common Name: | Surgical Planning Software and Patient Specific Surgical Guide | |---------------------------------|---------------------------------------------------------------------------------| | Device Trade Name: | Precision AI Surgical Planning System (PAI-SPS) | | Regulation Number: | 21 CFR 888.3660 | | Regulation Name: | Single/multiple component metallic bone fixation appliances and<br>accessories. | | Regulatory Class: | II | | Panel: | Orthopedic | | Classification Product<br>Code: | QHE, PHX, KWS | | Predicate Devices: | PAI-SPS (K233992) | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Precision AI. The logo consists of a stylized target symbol made of dots and lines, with the words "PRECISION AI" written in a sans-serif font below the symbol. The target symbol is made of four lines that intersect at the center, with a circle of dots around the center point. #### 3 Device Description Summary The Precision AI Surgical Planning System is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific guides and models to transfer the plan to surgery. The subject device is a system composed of the following: - . The Precision Al Surgical Planning System Software will create a 3D construct/render of the patient's shoulder joint for the surgeon to plan the operatively then create a physical Patient Specific Instrument (or Guide), using 3D printing by selective laser sintering. The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm. The surgeon can visualise the deformity of the diseased joint, on this 3D render and CT scan images, and determine the inherent deformity of the joint. They are then able to virtually place the artificial implants in an optimal position to correct the measured deformity for that specific patient. - The Precision Al Guides, which are a patient-specific guide and models that are based on a . pre-surgical plan. This pre-surgical plan is generated using the software component. Patientspecific guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery. #### Intended Use and Indications for Use 4 ### Software The Precision Al Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which can be used as input data to design the Precision Al Shoulder Guide and Biomodels. ### Hardware The Precision AI Planning System Guides and Biomodels are intended to be used as patient-specific surgical instruments to assist in the intraoperative positioning of shoulder implant components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-imaging scans. The Glenoid Guide is used to place the k-wire and the Humeral Guide is used to place humeral pins for humeral head resection. The Precision Al Guides and Biomodels are indicated for single use only. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Precision AI. The logo consists of a stylized target symbol made of concentric circles of dots, with a crosshair intersecting at the center. Below the symbol, the words "PRECISION AI" are written in a modern, sans-serif font, with the letters spaced apart. The Precision Al Surgical Planning System is indicated for use on adult patients that have been consented for shoulder joint arthroplasty. Both humeral and glenoid guides are suitable for a deltopectoral approach only. The Precision Al Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components: Enovis: - AltiVate Anatomic (K162024, K173073, K193226 (CS Edge)) - AltiVate Anatomic Augmented (K213387, K222592) ● - Turon Shoulder System (K111629, K080402, K123982) - Reverse Shoulder Prosthesis (K051075, K092873, K111629, K100741, K111061, K111735, K041066, K141006) - AltiVate Reverse (K141990, K172351, K190290) - AltiVate Reverse Glenoid (ARG) (K233481) ● Lima: - SMR Shoulder System (K161476, K100858, K101263) - SMR Reverse Shoulder System (K110598) - SMR 40MM Glenosphere (K142139) ● - SMR 3-Pegs Glenoid (K153722, K130642) ● - SMR Modular Glenoid (K113254, K143256) - SMR TT Metal Back Glenoid (K133349) - SMR Hybrid Glenoid System (K163397) - SMR Stemless Anatomic (K221758) - SMR 140° Reverse Humeral Body (K201905) - SMR TT Augmented Glenoid System (K191746, K200171) ● - SMR Lateralized Connectors with screws (K183042) - SMR TT Augmented 360 Baseplate (K220792) ● - SMR TT Hybrid Glenoid (K220792) - PRIMA Humeral System and SMR Glenosphere Ø42 (K212800) ● - PRIMA TT Glenoid (K222427) #### Functioning of the Device ഗ The PAI-SPS generates a pre-surgical plan based on medical imaging data using the PAI-SPS Software. The software allows a qualified surgeon to visualize, measure, reconstruct, annotate, edit and approve pre-surgical plan data, which leads to the generation of a case planning report. The PAI-SPS Software allows for the creation of a glenoid and/or humeral pre-operative plan. If requested by the surgeon, PAI-SPS Guides and Models are designed and manufactured based on the approved glenoid pre-surgical plan. PAI-SPS Guide and Models are patient specific templates which transfer the pre- {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for Precision AI. The logo consists of a circular target symbol made of dots, with two intersecting lines passing through the center. Below the symbol, the words "PRECISION AI" are written in a simple, sans-serif font. operatively determined pin positioning to the patient intraoperatively assisting the surgeon in positioning glenoid/humeral components used with total and reverse shoulder arthroplasty procedures. #### Comparison of Technological Characteristics 6 The Precision AI Surgical Planning System has an equivalent intended use and the same fundamental scientific technology as the predicate device. The subject device's is intended for positioning shoulder components, i.e. glenoid components and humeral components (same as the predicate device). ### Software The subject software device employs similar fundamental technologies as the predicate software device. Technological similarities include: - Device functionality: The planning functionality, including visualization, measurement, . reconstruction, annotation, and editing of pre-surgical plan data, is the same in the subject and predicate device. - . Software technology: The subject device has the same code base as the predicate device and uses the same methods for design verification and validation as the predicate device. Following technological differences exist between the subject device software and the predicate device software: The main difference between the subject device and previously cleared predicate device K233992 is the addition of the following Enovis' and Lima's implant system components in the software component of the subject device for the surgeon to select during the planning stage: Enovis: - AltiVate Anatomic (K173073, K193226 (CS Edge)) - AltiVate Anatomic Augmented (K222592) ● - Turon Shoulder System (K080402, K123982) - Reverse Shoulder Prosthesis (K100741, K111061, K111735, K041066, K141006) ● - AltiVate Reverse (K141990, K172351, K190290) ● - AltiVate Reverse Glenoid (ARG) (K233481) ● Lima: - SMR Shoulder System (K161476, K100858, K101263) ● - SMR Reverse Shoulder System (K110598) ● - SMR 40MM Glenosphere (K142139) ● - SMR 3-Pegs Glenoid (K153722, K130642) ● - SMR Modular Glenoid (K113254, K143256) {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for Precision AI. The logo consists of a stylized target symbol made of dots and lines. Below the symbol, the words "PRECISION AI" are written in a sans-serif font. - SMR TT Metal Back Glenoid (K133349) ● - SMR Hybrid Glenoid System (K163397) ● - SMR Stemless Anatomic (K221758) ● - SMR 140° Reverse Humeral Body (K201905) . - SMR TT Augmented Glenoid System (K191746, K200171) - SMR Lateralized Connectors with screws (K183042) - SMR TT Augmented 360 Baseplate (K220792) - SMR TT Hybrid Glenoid (K220792) ● - . PRIMA Humeral System and SMR Glenosphere Ø42 (K212800) - PRIMA TT Glenoid (K222427) . The non-clinical performance data has demonstrated that the subject software technological differences between the subject and predicate device do not raise any different questions of safety and effectiveness. ### Hardware The subject device's hardware is substantially equivalent in intended use, design, functionality, operating principles, materials and performance characteristics compared with the predicate device. The main difference between the subject device hardware and the predicate device is the extension of compatibility of the Precision Al Guides and Models with additional Enovis' and Lima's implant systems and their compatible components: Enovis: - AltiVate Anatomic (K173073, K193226 (CS Edge)) - AltiVate Anatomic Augmented (K222592) ● - Turon Shoulder System (K080402, K123982) - Reverse Shoulder Prosthesis (K100741, K111061, K111735, K041066, K141006) ● - AltiVate Reverse (K141990, K172351, K190290) ● - AltiVate Reverse Glenoid (ARG) (K233481) #### Lima: - SMR Shoulder System (K161476, K100858, K101263) - SMR Reverse Shoulder System (K110598) - SMR 40MM Glenosphere (K142139) - SMR 3-Pegs Glenoid (K153722, K130642) - SMR Modular Glenoid (K113254, K143256) - SMR TT Metal Back Glenoid (K133349) ● - . SMR Hybrid Glenoid System (K163397) - SMR Stemless Anatomic (K221758) ● - SMR 140° Reverse Humeral Body (K201905) ● - SMR TT Augmented Glenoid System (K191746, K200171) {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for Precision AI. The logo consists of a stylized target symbol above the words "PRECISION AI". The target symbol is made up of concentric circles of dots and lines that intersect at the center. - . SMR Lateralized Connectors with screws (K183042) - SMR TT Augmented 360 Baseplate (K220792) ● - . SMR TT Hybrid Glenoid (K220792) - PRIMA Humeral System and SMR Glenosphere Ø42 (K212800) ● - PRIMA TT Glenoid (K222427) #### Performance Data (non-clinical) 7 ### Hardware: Previous testing for biocompatibility, sterility, cleaning, debris, dimensional stability and packaging are applicable to the subject device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. The stability of the device placement, surgical technique, intended use and functional elements of the subject device are the same as that of the predicate device of Precision Al Surgical Planning System (K233992) and therefore previous cadaver testing and composite bone model testing on the previously cleared device are considered applicable to the subject device. ### Software Software verification and validation were performed, and documentation was provided following the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." This includes verification against defined requirements and validation against user needs. Design verification and validation testing demonstrated that the PAI-SPS meets all design requirements and is as safe and effective as its predicate device (K233992). #### Conclusion 8 Data presented in this submission demonstrates the PAI-SPS is substantially equivalent to the previously cleared PAI-SPS (K233992). Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations.