The subject devices are single use components, intended for cemented use only. The indications for the use of these tibial trays, in keeping with those of other legally marketed Howmedica Osteonics tibial trays, 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.

Additional Indications for Posterior Stabilized Components:

. Ligmentous instability requiring implant bearing surface geometries with increased constraint.
Absent or non-functioning posterior cruciate ligament.

Device Description

Howmedica Osteonics® Series 7000 AD Tibial Trays are intended for cemented fixation on the prepared proximal tibia and are designed to achieve total reconstructive replacement of the knee joint when used in conjunction with the Howmedica Osteonics® Total Knee Femoral, Patellar and Tibial Insert Components. The metallic tibial tray is manufactured from ASTM F75-92 CoCr alloy. The "pocketless" design of the fixation surface employs a roughened, arc-deposited ASTM F67-95 CP Titanium coating. The keeled stems of the Howmedica Osteonics® Series 7000 AD Tibial Tray employ a satin finish and are not coated with arc-deposited CP Titanium. Screw hole plugs, fabricated from low density polyethylene (LDPE), are located in the tibial tray screw holes.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for a medical device, the Howmedica Osteonics® Series 7000 AD Tibial Tray. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving efficacy or performance through a typical clinical study with acceptance criteria and statistical analysis.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample size for test sets, expert involvement in ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for training.

Instead, the "study" demonstrating the device meets acceptance criteria is actually a comparison to a predicate device. The fundamental acceptance criterion for a 510(k) submission is "substantial equivalence" to a legally marketed predicate device.

Here's how the provided information relates to your request, noting the absence of the specific details you're looking for:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria in the typical sense of a performance study (e.g., sensitivity, specificity, accuracy thresholds) and reported statistical performance values. Instead, the acceptance criterion for regulatory approval is "Substantial Equivalence" to predicate devices.

Acceptance Criterion (for 510(k) Substantial Equivalence)	Reported Device Performance (as presented in 510(k))
Technological Comparison: The device must be equivalent to predicate devices in material, design, indications, shape, and intended use, with any differences not raising new questions of safety or effectiveness.	The subject device (Howmedica Osteonics® Series 7000 AD Tibial Tray) is stated to be "identical to the tibial tray of the predicate Howmedica Osteonics® Series 7000 Total Knee Tibial Components in all material and design aspects, indications, shape and intended use, with the exception of the arc-deposited CP Titanium coating and the absence of a "pocket" on the inferior side of the tray."The arc-deposited CP Titanium coating is stated to be "identical to the AD coating on the predicate Howmedica Osteonics® Omniflex™ AD Hip Stem."The combination of CoCr substrate with CP Titanium coating is "similar to that of the predicate Maxim® Complete Knee System manufactured by Biomet, Inc., which offers a CoCr substrate coated with Titanium alloy."
Material Equivalence: Materials used must be equivalent or have demonstrated equivalent safety and performance.	The device uses ASTM F75-92 CoCr alloy and arc-deposited ASTM F67-95 CP Titanium coating, with keeled stems having a satin finish and screw hole plugs made of low-density polyethylene (LDPE). These materials are implicitly deemed equivalent due to their use in the cited predicate devices or by established medical device material standards.
Intended Use and Indications for Use Equivalence: The intended use and indications must be the same or sufficiently similar to predicate devices.	The document lists indications for use that align with those for total knee components, specifically stating they are "in keeping with those of other legally marketed Howmedica Osteonics tibial trays."
Performance (implicitly, through material and design equivalence): The device must perform as safely and effectively as the predicate devices.	This is demonstrated by the "Coating Characterization Summary" (mentioned but not detailed in the provided text) and the material and design comparisons. The conclusion is that "the substantial equivalence... is demonstrated."

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This type of information is typically found in clinical trial reports or performance studies, which are not part of this 510(k) summary. The "test set" here would conceptually be the device itself being compared to standards and predicates. There is no mention of a patient-based test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. Ground truth establishment by experts is relevant for diagnostic devices or those requiring subjective clinical assessment. This device is a pre-formed orthopedic implant.

4. Adjudication method for the test set

Not applicable/Not provided. No formal adjudication method is mentioned as there isn't a "test set" of observations being interpreted.

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

No. This is a hardware orthopedic implant, not an AI-assisted diagnostic device. MRMC studies are not applicable.

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

Not applicable. This is a hardware orthopedic implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The new device's design, materials, and intended use are compared against these known, approved products. In essence, the "truth" is that the predicate devices are safe and effective, and the new device is "substantially equivalent" to them. A "Coating Characterization Summary" is mentioned, which would involve material property testing and thus likely rely on scientific/engineering standards and measurements, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" in the context of device design approval for a hardware implant. The design process would involve engineering principles, materials science, and testing, but not machine learning training.

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

Not applicable/Not provided. As there's no training set, there's no ground truth established for one. The "truth" in this context is based on engineering specifications and comparison to existing, approved devices.

Summary

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K983657

Howmedica Osteonics Scries 7000 AD Tibial Tray

510(k) Premarket Notification Summary of Safety and Effectiveness for the Howmedica Osteonics® Series 7000 AD Tibial Tray

Submission Information

Name and Address of the Sponsorof the 510(k) Submission:	Howmedica Osteonics Corp.59 Route 17Allendale, NJ 07401-1677
Contact Person:	Mary-Catherine DillonRegulatory Affairs Specialist
Date of Summary Preparation:March 31, 2000
Device Identification
Proprietary Name:	Howmedica Osteonics® Series 7000AD Tibial Tray
Common Name:	Total Knee Tibial Component
Classification Name and Reference:	Knee Joint FemorotibialMetal/Polymer Semi-Constrained

Predicate Device Identification

The Howmedica Osteonics® Series 7000 AD Tibial Tray is substantially equivalent to the following competitive and/or Howmedica Osteonics devices, which have previously been determined substantially equivalent by FDA:

Cemented Prosthesis 21 CFR 888.3530

Howmedica Osteonics® Series 7000 Total Knee System Tibial Components ●
. Howmedica Osteonics® Omniflex™ AD Hip Stem
. The Maxim® Complete Knee System - Biomet, Inc.

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Device Description

Intended Use:

The Howmedica Osteonics® Series 7000 AD Tibial Tray is intended to be marketed for cemented fixation only and may be used with any of the following UHMWPE tibial bearing inserts, which range in thickness from 8mm to 24mm:

· Howmedica Osteonics Tibial Bearing Insert Series I
Howmedica Osteonics® Tibial Bearing Insert Series II ●
· Howmedica Osteonics® Series 7000 Total Knee Tibial Bearing Insert Series P/S- I
Howmedica Osteonics® Scorpio Total Knee Posteriorly Stabilized Tibial Bearing Insert .
Howmedica Osteonics® Scorpio Total Knee Cruciate Retaining Tibial Bearing Insert .

If supplemental bone screw fixation of the tray is deemed necessary, Howmedica Osteonics® 6.5mm Cancellous Bone Screws may be placed through the tibial tray screw holes.

Indications:

· Painful, disabling joint discase of the knee resulting from: degenerative arthritis, theumatoid 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. ●
Additional Indications for Posterior Stabilized Components:
Ligmentous instability requiring implant bearing surface geometries with increased constraint. .
. Absent or non-functioning posterior cruciate ligament.

Contraindications:

The contraindications for the Howmedica Osteonics® Series 7000 AD Tibial Tray include:

· Any active or suspected latent infection in or about the knee joint.
Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
. Bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.

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. Skeletal immaturity.
· Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
. Obesity. An overweight or obese patient can produce loads on the prosthesis which can lead to failure of the fixation of the device or to failure of the device itself.

Statement of Technological Comparison:

The subject device is identical to the tibial tray of the predicate Howmedica Osteonics® Series 7000 Total Knee Tibial Components in all material and design aspects, indications, shape and intended use, with the exception of the arc-deposited CP Titanium coating and the absence of a "pocket" on the inferior side of the tray. The arc-deposited CP Titamium coating on the inferior side of the tibial tray is identical to the AD coating on the predicate Howmedica Osteonics® Omniflex™ AD Hip Stem.

Howmedica Osteonics' CP Titanium coating is arc-deposited onto the surface of CoCr substrate. The combination of a CoCr substrate with CP Titanium coating on the Howmedica Osteonics® Series 7000 AD Tibial Tray is similar to that of the predicate Maxim® Complete Knee System manufactured by Biomet, Inc., which offers a CoCr substrate coated with Titanium alloy.

Summary

Based on the information presented above in combination with a Coating Characterization Summary, and the fact that the Howmedica Osteonics® Series 7000 AD Tibial Trays employ standard sterilization and packaging methods, the substantial equivalence of the Howmedica Osteonics® Series 7000 AD Tibial Trays to other legally marketed, class II total knee components is demonstrated.

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Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it. The text is written in all capital letters.

APR 6 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary-Catherine Dillon Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, New Jersey 07401-1677

Re: K983657

Trade Name: Howmedica Osteonics® Series 7000 AD Tibial Trav Regulatory Class: II Product Code: HRY and JWH Dated: January 24, 2000 Received: January 28, 2000

Dear Ms. Dillon:

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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Ms. Mary-Catherine Dillon

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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Dune R. Lochner.

Colia 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_983657

Device Name: Howmedica Osteonics® Series 7000 AD Tibial Trav

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.

Additional Indications for Posterior Stabilized Components:

. Ligmentous instability requiring implant bearing surface geometries with increased constraint.
Absent or non-functioning posterior cruciate ligament.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	Dunne R. Vochnes (Division Sign-Off)
	Division of General Restorative Devices
510(k) Number	K983657
Prescription Use X	OR	Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial 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.