The subject Tibial Tray Screw Hole Plugs are intended to occlude all tibial tray screw holes not occupied by bone screws. The Tibial Tray Screw Hole Plugs are factory assembled to the tibial tray screw holes. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. By occluding the tibial tray screw holes, the Tibial Tray Screw Hole Plugs help prevent intrusion of bone cement onto the tibial tray.

Device Description

The subject Tibial Tray Screw Hole Plugs are a line extension to the existing Howmedica Osteonics Tibial Tray Screw Hole plugs found substantially equivalent in premarket notification K970779. The predicate Tibial Tray Screw Hole Plugs are fabricated from low-density polyethylene, and are circular in design. The subject Tibial Tray Screw Hole Plugs are manufactured from ultra high molecular weight polyethylene, and incorporate a tapered design, with a flat bottom with a lip, tapering to a flat top surface.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving the device meets these criteria in the typical sense of performance metrics for AI/ML devices. This document is a 510(k) submission for a medical device that is a "Line Extension to Howmedica Osteonics Tibial Tray Screw Hole Plugs."

Here's why the requested information cannot be fully provided based on the given text:

Device Type: The device described is a physical implant component (tibial tray screw hole plugs) for knee replacement surgery, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the concept of "acceptance criteria" and "study performance" as typically applied to AI/ML would not be relevant in the same way.
510(k) Process: This is a premarket notification for substantial equivalence (510(k)). The primary goal of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to meet specific performance criteria on a test dataset using AI/ML methodology.
Content of Document: The document focuses on:
- Description and technological comparison to a predicate device.
- Intended use, which is identical to the predicate device.
- Regulatory classification.
- The FDA's determination of substantial equivalence.

Given this, I will address the parts of your request that can be inferred or explained in the context of this specific regulatory submission for a physical medical device.

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

This information is not explicitly stated in the document as performance metrics common for AI/ML products (e.g., sensitivity, specificity, AUC). For this type of device (a physical implant component), "acceptance criteria" would typically relate to material properties, dimensions, mechanical integrity, biocompatibility, and sterilization, along with functional equivalence to the predicate device. The document states that the intended use is the same as the predicate and describes technological differences (material and design). The FDA's finding of "substantial equivalence" implies that these underlying performance aspects have been deemed acceptable compared to the predicate device.

Acceptance Criteria (Inferred for this type of device)	Reported Device Performance (Inferred from "Substantial Equivalence")
Functional Equivalence: Ability to occlude tibial tray screw holes and prevent cement intrusion.	The intended use is the same as the predicate device (K970779), and the FDA found it substantially equivalent. This implies functional equivalence.
Material Compatibility: Using ultra high molecular weight polyethylene (UHMWPE) which is a well-established biocompatible material for implants.	The device is manufactured from UHMWPE, a common and accepted material for orthopedic implants, suggesting acceptable material compatibility.
Mechanical Integrity/Fit: Proper fit within tibial tray screw holes.	The document describes a "tapered design, with a flat bottom with a lip, tapering to a flat top surface," suggesting design considerations for proper fit, which would have been assessed to achieve substantial equivalence.
Safety: No new safety concerns compared to the predicate device.	The FDA's substantial equivalence determination inherently means no new safety concerns were identified that would preclude market approval.

Important Note: The document does not provide specific test results or data for these inferred criteria; rather, the basis for approval is substantial equivalence to a predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a physical device submission, not an AI/ML study. There is no concept of a "test set" or data provenance in the context of evaluating an algorithm. The evaluation for substantial equivalence would involve engineering tests, material characterization, and potentially bench testing, rather than a clinical dataset in the manner of an AI/ML product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical device submission. "Ground truth" as applied to expert interpretation for AI/ML algorithms is not relevant here. Decisions are made based on engineering principles, materials science, and regulatory precedent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a physical device submission. Adjudication methods are used for resolving disagreements among human readers or experts establishing ground truth for AI/ML performance evaluation. This concept is not relevant here.

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 is a physical device submission. MRMC studies are used to evaluate diagnostic imaging systems or AI/ML algorithms in a clinical context. This device is a component of a knee prosthesis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device submission. There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the AI/ML sense. The "truth" for this device's efficacy and safety is established through:

Its design specifications.
Material properties (UHMWPE is a known and accepted biomaterial).
Bench testing (mechanical, fit, etc. - though details aren't in this summary).
Clinical history and performance of the substantially equivalent predicate device (K970779).
Compliance with relevant standards.

8. The sample size for the training set

Not applicable. This is a physical device submission. There is no training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable. This is a physical device submission.

Summary

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K032479

Line Extension to Howmedica Osteonics Tibial Tray Screw Hole Plugs

Special 510(k) Premarket Notification

Special 510(k) Summary

Proprietary Name:

Common Name:

Classification Name and Reference:

Proposed Regulatory Class: Device Product Code:

Predicate Proprietary Name: Predicate Regulatory Class: Predicate Product Code:

For Information contact:

Howmedica Osteonics Tibial Tray Screw Hole Plugs Tibial Tray Screw Hole Plugs

Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis 21 CFR §888.3560 and Cement Obturator

Class II 87 JWH and LZN

Osteonics Tibial Tray Screw Hole Plugs Class II 87 JWH and LZN

Margaret F. Crowe Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677 Phone: (201) 831-5580 Fax: (201) 831-6038

Description/Technological Comparison

Page 3

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K032479

Line Extension to Howmedica Osteonics Tibial Tray Screw Hole Plugs

Page 4

Intended Use

The intended use of the new Tibial Tray Screw Hole Plug is the same as that of the predicate device described in premarket notification K970779 -- to occlude all tibial tray screw holes not occupied by bone screws. The Tibial Tray Screw Hole Plugs are factory assembled to the tibial tray screw holes. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. By occluding the tibial tray screw holes, the Tibial Tray Screw Hole Plugs helps prevent intrusion of bone cement onto the tibial tray.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret F. Crowe Regulatory Affairs Consultant Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677

Re: K032479

Trade/Device Name: Line Extension - Howmedica Osteonics Tibial Tray Screw Hole Plugs Regulation Number: 21 CFR 888.3560

Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis and cement obturator

Regulatory Class: II Product Code: JWH, LZN Dated: August 8, 2003 Received: August 12, 2003

Dear Ms. Crowe:

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 (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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

SEP = 4 2003

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Page 2 - Ms. Margaret F. Crowe

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mach n Milbersen

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

Enclosure

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510(k) Number (if known): _K032479

Device Name: Line Extension - Howmedica Osteonics Tibial Tray Screw Hole Plugs

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use (Pcr 21 CFR 801.109) (Optional Format 1-2-96)

Mark N Millican

Division of General, Restorative and Neurological Devices

510(k) Number K032479

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.