The Precision Al Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder ioint 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 Al Planning System Guides and Biomodels are intended to be used as patientspecific 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.

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 deltopectoral approach only.

The Precision Al Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following Enovis implant systems and their compatible components:

AltiVate Anatomic Shoulder System (K162024)
AltiVate Anatomic Augmented Glenoid (K213387)
Turon Shoulder System (K111629)
Reverse Shoulder Prosthesis (K051075, K092873, K111629)

Device Description

Precision Al Surgical Planning System (PAI-SPS) 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 guide and models to transfer the surgical plan to surgery.

The device is a system composed of the following:

a software component, Precision Al Surgical Planning Software which will create a 3D construct of the patient's joint for the surgeon to plan the operatively. The surgeon will be able to visualise the movement of the diseased joint and determine mechanical failings. They will then be able to place the virtual shoulder replacement in different positions and decide which position gives the patient the best result. Once the surgeon has decided on the best position, the software will generate a CAD file for a Patient Specific Guide.
Precision Al Surgical Guides, which are patient-specific guides and models will be manufactured if the surgeon requests patient-specific guides to transfer the surgical plan to surgery. Once the CAD model is generated from the planning software, the model is sent to a 3D printer which will then print the guide out of a biocompatible medical grade Nylon material for sintering (Polyamide-12) which has an established usage for similar application. The specific design of the guide will be customised to the individual patient as well as depending on the particular anatomy it will be applied to. Precision Al Patient Specific Guides are intended for single use only.

AI/ML Overview

The Precision AI Surgical Planning System (PAI-SPS) is a patient-specific medical device comprised of software and physical surgical guides, designed to assist in the placement of shoulder components during shoulder replacement surgery.

Here's an analysis of its acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state a table of acceptance criteria with specific numerical targets. However, based on the Performance Data section, the overall acceptance criterion is that the device is "as safe, as effective, and performs as well as the predicate device." The performance reported primarily focuses on the successful completion of various non-clinical and a clinical study.

Feature/Metric	Acceptance Criterion (Implicit)	Reported Device Performance
Overall	As safe, as effective, and performs as well as predicate device	Non-clinical and clinical performance testing indicates this.
Biocompatibility	Meets biocompatibility standards	Biocompatibility Evaluation performed.
Dimensional Stability	Maintains dimensions after cleaning & sterilization	Dimensional Stability Testing Post Cleaning and Sterilisation performed.
Packaging & Transport	Integrity maintained during packaging & transport	Packaging and Transportation Testing performed.
Durability (Impact)	Withstands impact without failure	Drop (Impact) Testing performed.
Durability (Compression)	Withstands compression without failure	Compression Testing performed.
Wear (Debris)	Minimal wear and debris generation	Wear (Debris) Testing performed.
Software Functionality	Verified and validated software performance	Software Verification and Validation Testing performed.
Guide Performance (Lab)	Effective on composite bone models	Composite Bone Model Testing performed.
Guide Performance (Cadaver)	Effective in cadaveric settings	Cadaveric Testing performed.
Measurement Accuracy (Clinical)	Accurate measurements compared to post-operative CT	Clinical case series of 35 subjects evaluated measurement accuracy via post-operative CT.

2. Sample Size Used for the Test Set and Data Provenance

For the clinical study, the sample size used was 35 subjects.
The data provenance for this clinical study was Australia, and it was a post-market evaluation of a clinical case series, implying retrospective data collection or analysis, though the exact nature (e.g., only post-operative CT analysis from existing records versus a direct follow-up) isn't specified beyond "post-market evaluation." The study was conducted under ethics committee approval and according to GCP.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used to establish ground truth for the clinical test set or their qualifications. It only states that the measurement accuracy was evaluated "via post-operative CT." Assuming post-operative CT scans were the ground truth, their interpretation would typically involve radiologists or orthopedic surgeons, but this is not detailed.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the clinical test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance. The clinical study focused on the measurement accuracy of the device itself.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance assessment was done for the software component of the PAI-SPS. The Performance Data section mentions "Software Verification and Validation Testing." Additionally, the clinical study evaluating "measurement accuracy of the subject device via post-operative CT" implicitly assesses the standalone accuracy of the planning output (which is generated by the software) as compared to the actual outcome. The software generates "a pre-surgical plan data file" and "[allows] the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data." The accuracy of these measurements would be a standalone performance metric.

7. The Type of Ground Truth Used

For the clinical study, the ground truth used for evaluating measurement accuracy was post-operative CT scans. For the non-clinical tests (e.g., biocompatibility, dimensional stability), established laboratory test standards and methods define the ground truth.

8. The Sample Size for the Training Set

The document does not provide the sample size for the training set used for the "non-adaptive machine or deep learning algorithms trained for the purpose of semi-automatic segmentation and landmark identification of image scans."

9. How the Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established for the machine/deep learning algorithms. It only states that the algorithms are trained for "semi-automatic segmentation and landmark identification." Typically, this would involve expert annotation of images, but this detail is not provided.

Summary

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August 5, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Precision AI Pty Ltd Sara Baniadam Quality and Regulatory Manager Suite 18, 36 Agnes Street Fortitude Valley, Queensland Australia

Re: K233992

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, PHX, KWS Dated: July 5, 2024 Received: July 5, 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.

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).

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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. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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.

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-regulatoryassistance/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,

Image /page/1/Picture/7 description: The image contains the text "Farzana" and "Sharmin -S" stacked on top of each other. The text is written in a simple, sans-serif font and is black. The background is white, and there is a faint watermark in the background.

Digitally signed by Farzana Sharmin -S Date: 2024.08.05 20:01:43 -04'00

Farzana Sharmin, PhD 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

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Indications for Use

Submission Number (if known)

K233992

Device Name

Precision AI Surgical Planning System (PAI-SPS)

Indications for Use (Describe)

Software

Hardware

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.

The Precision Al Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following Enovis implant systems and their compatible components:

AltiVate Anatomic Shoulder System (K162024)
AltiVate Anatomic Augmented Glenoid (K213387)
Turon Shoulder System (K111629)
Reverse Shoulder Prosthesis (K051075, K092873, K111629)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for Precision AI. The logo consists of a circular target-like design made of dots, with horizontal and vertical lines intersecting at the center. Below the design, the words "PRECISION AI" are written in a simple, sans-serif font.

1. Submitter

510(k) Sponsor	Precision Al Pty Ltd
Address	Suite 18, 36 Agnes Street, Fortitude Valley, Queensland, 4006, Australia
Correspondence Person	Sara BaniadamQuality and Regulatory Manager
Contact Information	Email: Regulatory@precisionai.com.au
Submission Date	December 18, 2023

2. Subject Device

Proprietary Name	Precision Al Surgical Planning System (PAI-SPS)
Common Name	Surgical Planning Software and Patient Specific Surgical Guide
Classification Name	Single/multiple component metallic bone fixation appliances andaccessories.
Regulation Number	21 CFR 888.3660
Regulation Name	Shoulder joint metal/polymer semi-constrained cemented prosthesis
Product Code	QHE
Additional Product Codes	PHX, KWS
Regulatory Class	II

3. Predicate Devices

Substantial equivalence is therefore claimed to the following devices:

Primary Predicate:
- Materialise Shoulder System (K212569)
Secondary Predicate:
- Medacta MyShoulder Placement Guide (K190738)
A Reference Device:
- Formus Hip (K213272) ●
- . PeekMed Web (K222767)

4. Device Description

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Image /page/4/Picture/1 description: The image shows the logo for Precision AI. The logo consists of a circular pattern of dots arranged in concentric circles, with a crosshair in the center. The text "PRECISION AI" is written in a sans-serif font below the circular pattern.

by the surgeon, by manufacturing a patient-specific guide and models to transfer the surgical plan to surgery.

The device is a system composed of the following:

a software component, Precision Al Surgical Planning Software which will create a 3D construct of the patient's joint for the surgeon to plan the operatively. The surgeon will be able to visualise the movement of the diseased joint and determine mechanical failings. They will then be able to place the virtual shoulder replacement in different positions and decide which position gives the patient the best result. Once the surgeon has decided on the best position, the software will generate a CAD file for a Patient Specific Guide.
Precision Al Surgical Guides, which are patient-specific guides and models will be manufactured if the surgeon requests patient-specific guides to transfer the surgical plan to surgery. Once the CAD model is generated from the planning software, the model is sent to a 3D printer which will then print the guide out of a biocompatible medical grade Nylon material for sintering (Polyamide-12) which has an established usage for similar application. The specific design of the guide will be customised to the individual patient as well as depending on the particular anatomy it will be applied to. Precision Al Patient Specific Guides are intended for single use only.

5. Indications for Use

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 Al 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.

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 delto-pectoral approach only.

The Precision Al Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following Enovis implant systems and their compatible components:

AltiVate Anatomic Shoulder System (K162024)
AltiVate Anatomic Augmented Glenoid (K213387)
Turon Shoulder System (K111629)
Reverse Shoulder Prosthesis (K051075, K092873, K111629)

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Image /page/5/Picture/1 description: The image shows a logo for a company called "PRECISION AI". The logo features a stylized target symbol above the company name. The target symbol is made up of concentric circles of dots, with crosshairs extending from the center.

6. Comparison of Technological Characteristics

The Precision AI Surgical Planning System is comprised of Surgical Planning software and physical patientmatched Surgical Guides. Likewise, the primary predicate, Materialise Shoulder System (K212569), comprises of surgery planning software and physical surgical guides.

The secondary predicate, Medacta MyShoulder Placement Guide (K190738), is a patient-matched Surgical Guide only, similar to Precision Al Surgical Guide.

Precision Al Surgical Guide is substantially equivalent to predicate devices, Materialise Shoulder System (K212569) and Medacta MyShoulder Placement Guide (K190738) for what concerns indications for use and contraindications as well as technological characteristics including materials, manufacturing process, device usage, packaging, labelling, and shelf-life.

Precision Al Surgical Planning Software incorporates non-adaptive machine or deep learning algorithms trained for the purpose of semi-automatic segmentation and landmark identification of image scans similar to the listed reference devices.

7. Performance Data

The following non-clinical performance studies have been conducted on the subject devices:

Characterization tests:

Biocompatibility Evaluation
Dimensional Stability Testing Post Cleaning and Sterilisation
Packaging and Transportation Testing
Drop (Impact) Testing ●
Compression Testing
Wear (Debris) Testing
Software Verification and Validation Testing

Performance testing

Composite Bone Model Testing
Cadaveric Testing ●

In addition, a post-market evaluation of a clinical case series of 35 subjects was conducted to evaluate the measurement accuracy of the subject device via post-operative CT. The study was performed in Australia under ethics committee approval and according to GCP.

The non-clinical and clinical performance testing indicates that the subject device is as safe, as effective, and performs as well as the predicate device.

8. Conclusion

Based on the above information, the Precision Al Surgical Planning System is substantially equivalent to the identified predicate device.

Substantial equivalence has been demonstrated through a comparison of indication for use, design, and technological characteristics, as well as performance evaluations.

None of the technological characteristics differences raised any new question of safety and effectiveness, therefore the Precision Al Surgical Planning System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”