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K Number
K243955
Device Name
Precision AI Surgical Planning System (PAI-SPS)
Manufacturer
Precision AI Pty Ltd
Date Cleared
2025-01-21

(29 days)

Product Code
QHEKWSPHX
Regulation Number
888.3660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 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 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 AI Surgical Planning System is indicated for total and reverse shoulder arthroplasty using the following implant systems and their compatible components: Enovis and Lima.
Device Description
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 AI 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 AI 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. Patient-specific guide and models will be manufactured if the surgeon requests patient-specific guides to transfer the plan to surgery.
More Information

K233992

K162024, K173073, K193226, K213387, K222592, K111629, K080402, K123982, K051075, K092873, K100741, K111735, K041066, K141006, K141990, K172351, K190290, K233481, K161476, K100858, K101263, K110598, K142139, K153722, K130642, K113254, K143256, K133349, K163397, K221758, K201905, K191746, K200171, K183042, K220792, K212800, K222427, K111061

Yes
The device description explicitly states that CT scan images are "auto segmented via a locked, or static, artificial intelligence algorithm."

No.
The device is a pre-surgical planner and patient-specific surgical instruments (guides and biomodels) designed to assist surgeons in the accurate positioning of shoulder implant components during arthroplasty, rather than treating a disease or condition itself.

No

Explanation: The device is a pre-surgical planner and surgical guide system used to assist in the positioning of shoulder components during surgery. It does not provide a diagnosis.

No

The device description explicitly states that the system is composed of both software and hardware components (patient-specific guides and models manufactured using 3D printing).

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this system is used for pre-surgical planning and creating patient-specific surgical guides and models based on CT scans of the patient's shoulder joint. It does not involve the analysis of biological samples like blood, urine, or tissue.
  • The purpose is surgical planning and guidance, not diagnosis. The software assists in visualizing, measuring, and planning the placement of implants during shoulder arthroplasty. The hardware (guides and biomodels) are used intraoperatively to assist in positioning components. This is a surgical tool, not a diagnostic test.

The device falls under the category of surgical planning software and patient-specific surgical instruments, which are regulated as medical devices but not as IVDs.

No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

Intended Use / 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 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 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.

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:

Lima:

Product codes (comma separated list FDA assigned to the subject device)

QHE, KWS, PHX

Device Description

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.

Mentions image processing

The Precision Al Planning 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.

Mentions AI, DNN, or ML

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.

Input Imaging Modality

CT-imaging scans, CT scan images

Anatomical Site

shoulder joint

Indicated Patient Age Range

adult patients

Intended User / Care Setting

qualified surgeon, surgical interventions

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

PAI-SPS (K233992)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K162024, K173073, K193226, K213387, K222592, K111629, K080402, K123982, K051075, K092873, K100741, K111735, K041066, K141006, K141990, K172351, K190290, K233481, K161476, K100858, K101263, K110598, K142139, K153722, K130642, K113254, K143256, K133349, K163397, K221758, K201905, K191746, K200171, K183042, K220792, K212800, K222427, K111061

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.”

0

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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. Please note that regardless of whether a change requires premarket review, the QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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:

Lima:

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)

X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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5

K243955 Page 1 of 6

Image /page/5/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 simple sans-serif font below the symbol. 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
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
accessories.
Regulatory Class:II
Panel:Orthopedic
Classification Product
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:

Lima:

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:

Lima:

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:

Lima:

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.