The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are intended to articulate with any commercially available Osteonics® Scorpio™ Total Knee Femoral Component, any commercially available Osteonics® Series 7000 Total Knee Femoral Component, and any commercially available Osteonics® Omnifit® Total Knee Femoral Component. The subject patellar components are single use devices, intended for cemented application onto the surgically prepared posterior patella. These components replace the patellar articulating surface of the knee joint and simulate the natural function of the indications for the use of the Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components in conjunction with a total knee replacement. in keeping with those of other legally marketed Class II patellar components, are as follows:

Indications:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis.
. Post-traumatic loss of knee joint configuration and function.
. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Revision of previous unsuccessful knee replacement or other procedure. .

Device Description

The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are fabricated from ultra-high molecular weight polyethylene (UHMWPE). The articular geometry is designed with a round dome topography. The overall geometry essentially consists of a circular patellar button configuration with three fixation pegs on the anterior surface of the component. The anterior surface of the components also features circular grooves and pockets for cement interdigitation. Each patellar component is available in 8mm and 10mm dome thicknesses.

AI/ML Overview

This document, K972967, is a 510(k) Premarket Notification for the Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components. It is a submission to the FDA for market clearance, not an independent study report with detailed device performance data against acceptance criteria. Therefore, the information requested cannot be fully provided from this document.

Specifically, this document does not include:

A table of acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy, etc., which are common for AI/diagnostic devices). This product is a physical medical device (knee implant components), and its "performance" is typically assessed through mechanical testing and comparison to predicate devices, not through statistical metrics derived from AI model outputs.
Sample sizes for test sets, training sets, or data provenance in the context of an AI study.
Information on experts used to establish ground truth or adjudication methods, as these are related to clinical study design for diagnostics, not mechanical component equivalence.
Details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or standalone algorithm performance.
Specific ground truth types (pathology, outcomes data, etc.) for an AI model.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for a 510(k) submission.

Here's what can be inferred or directly stated from the provided text, related to the nature of this submission:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) for a physical medical device (knee implant components), the "acceptance criteria" are implicitly regulatory requirements for demonstrating substantial equivalence to predicate devices, rather than performance metrics for an AI algorithm. The document states:

Criterion	Reported Performance / Statement
Predicate Device Identification	The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are substantially equivalent to other legally marketed, Class II, patellar components, including the Osteonics® Scorpio™ Total Knee All-Polyethylene Patellar Components - concentric dome design, and the Johnson and Johnson® P.F.C.® Cruciate Sacrificing Patellar Component.
Materials	Shares the same materials (ultra-high molecular weight polyethylene (UHMWPE)) as predicate devices.
Intended Use	Shares the same intended use as predicate devices: to articulate with specific Osteonics femoral components; single-use, cemented application; replaces patellar articulating surface; simulates natural knee function.
Basic Surgical Techniques	Shares basic surgical techniques with predicate devices.
Basic Design Features	Shares basic design features (circular patellar button, three fixation pegs, circular grooves/pockets for cement interdigitation) with predicate devices.
Performance Testing	"Applicable performance testing demonstrates that the subject devices perform at least as well as, if not better than, commercially available designs." (Specific test results are not detailed in this summary, but would have been part of the full 510(k) submission).
Indications for Use	Indications for use are consistent with those of other legally marketed Class II patellar components (e.g., painful disabling joint disease, post-traumatic loss of function, moderate deformity, revision surgery).
Specific FDA Limitations	Device may not be labeled or promoted for non-cemented use. Labeling must prominently state intended for cemented use only. Non-cemented fixation is considered investigational.

2. Sample sized used for the test set and the data provenance:
Not applicable in the context of an AI-specific "test set." The "test" for this device involved mechanical performance testing and comparison to predicate devices, not evaluation of an AI model. The document does not specify sample sizes for mechanical testing, nor does it refer to data provenance in the context of an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device clearance, not an AI diagnostic study requiring expert ground truth establishment for an algorithm's output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device submission.

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:
Not applicable. This device is a physical knee implant component, and therefore an MRMC study comparing human readers with AI assistance is irrelevant to its purpose.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical knee implant component, not an AI algorithm.

7. The type of ground truth used:
For this type of device, the "ground truth" implicitly refers to established engineering standards, biomechanical principles, and the safety and effectiveness of the predicate devices. The "study" proving it meets criteria largely involves mechanical testing and engineering analysis to ensure it performs comparably (or better) than existing devices in terms of mechanical properties, wear, and fixation, consistent with its intended use.

8. The sample size for the training set:
Not applicable, as this is not an AI algorithm.

9. How the ground truth for the training set was established:
Not applicable, as this is not an AI algorithm.

Summary

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Osteonics" Scorpio™ Total Knee Universal Dome and Recessed Patellar Components

K972967

510(k) Premarket Notification

510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS

IAN 6 1998

Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components

Submission Information Name and Address of the Sponsor of the 510(k) Submission:

Osteonics Corporation 59 Route 17 Allendale, NJ 07401-1677 201-825-4900

Donna S. Wilson Regulatory Affairs Specialist

Date Summary Prepared:

Device Identification Proprietary Name:

Contact Person:

August 8. 1997

Osteonics® Scorpio™ Total Knee Universal Dome Patellar Component; Osteonics® Scorpio™ Total Knee Recessed Patellar Component

Common Name:

Classification Name and Reference:

Knee Prosthesis

Knee Joint, Patellofemorotibial, Polymer/Metal/Polymer, Semi-Constrained, Cemented Prosthesis 21 CFR §888.3560

Predicate Device Identification

The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are substantially equivalent to other legally marketed, Class II, patellar components, including the Osteonics® Scorpio™ Total Knee All-Polyethylene Patellar Components - concentric dome design, and the Johnson and Johnson® P.F.C.® Cruciate Sacrificing Patellar Component.

Device Description

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patellar button configuration with three fixation pegs on the anterior surface of the component. The anterior surface of the components also features circular grooves and pockets for cement interdigitation. Each patellar component is available in 8mm and 10mm dome thicknesses.

Intended Use

The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components are intended to articulate with any commercially available Osteonics® Scorpio™ Total Knee Femoral Component, any commercially available Osteonics® Series 7000 Total Knee Femoral Component, and any commercially available Osteonics® Omnifit® Total Knee Fernoral Component. The subject patellar components are single use devices, intended for cemented application onto the surgically prepared posterior patella. These components replace the patellar articulating surface of the knee joint and simulate the natural function of the knee.

Statement of Technological Comparison

The Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components share the same materials, intended use, basic surgical techniques, and basic design features of their predicate devices. Applicable performance testing demonstrates that the subject devices perform at least as well as, if not better than, commercially available designs.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized caduceus with three figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 16 1998

Robert A. Koch, J.D. · Director, Regulatory/Legal Affairs Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K972967 Re: Osteonics® Scorpio™ Total Knee Universal Trade Name: Dome and Recessed Patellar Components Requlatory Class: II Product Code: JWH Dated: November 13, 1997 November 14, 1997 Received:

Dear Mr. Koch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (Act). This decision is based on this device being equivalent only to similar devices labeled and intended to be fixed within bone with acrylic "bone cement." You may, therefore, market your device subject to the general controls provisions of the Act and the following limitations:

This device may not be labeled or promoted for non-1. cemented use.
All labeling for this device, including package label 2. and labeling included within the package, must- -----------prominently state that the device is intended for cemented use only.
Any non-cemented fixation of this device is considered 3. investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulation under 21 CFR, Part 812. All users of the device for noncemented fixation must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) to conduct the investigation.

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Page 2 - Robert A. Koch, J.D.

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general -

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information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Cecelia M. Whitten, Ph.D.

a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 91 - 2967

Device Name: Osteonics® Scorpio™ Total Knee Universal Dome and Recessed Patellar Components

Indications For Use:

Indications:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis.
. Post-traumatic loss of knee joint configuration and function.
. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Revision of previous unsuccessful knee replacement or other procedure. .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use × (Per 21 CFR 801.109) OR

Over-The-Counter Use

_
(Division Sign-Off)

(Optional Format 1.2.96

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. R972967

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.