The Osteonics® Series 7000 Total Knee Augmented Femoral Component is intended to replace the articulating surface of the distal femur in a total knee arthroplasty. This posteriorly stabilized femoral component is utilized when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present. This device is a single use component intended for cemented fixation. The indications for use are:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis, complicated by the presence of bone loss.
. 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, accompanied by . bone loss.
Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
Absent or non-functioning posterior cruciate ligament. .

Device Description

The Osteonics® Series 7000 Total Knee Augmented Femoral Component features a posterior stabilizing housing, intercondylar cam, fixed intramedullary stem, waffled interior surface pattern, optional nitrogen ion implanted bearing surface treatment (LFIT™), and a distal and posterior build-up on the interior of the component to compensate for femoral bone loss.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device: the Osteonics® Series 7000 Total Knee Augmented Femoral Component. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies to prove performance against specific acceptance criteria.

The information requested in the prompt (acceptance criteria, specific study details, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth types, training set details) is typically associated with a Premarket Approval (PMA) application or a de novo classification, where a novel device's safety and effectiveness are established through rigorous clinical trials and performance testing.

Given this context, the provided document does not contain the specific information required to complete the table or answer the detailed questions about acceptance criteria and a study demonstrating the device meets those criteria. The 510(k) process relies on demonstrating that the new device is "as safe and effective as, and performs as well as" a legally marketed predicate device. This is achieved by comparing technological characteristics, intended use, and materials.

However, based on the provided text, I can infer the "acceptance criteria" through the lens of substantial equivalence and how the "study" (the comparison process) addresses them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as demonstrated by comparison)
Safety: Device materials and design are safe for human implantation and fixation.	The Osteonics® Series 7000 Total Knee Augmented Femoral Component uses the same materials as the predicate device (Osteonics® Series 7000 Total Knee Posteriorly Stabilized Long Stem Femoral Component). This implies established safety profiles for these materials.
Effectiveness/Performance: The device effectively replaces the articulating surface of the distal femur and addresses specified conditions (non-functioning PCL, femoral bone loss).	The device shares basic design features with the predicate device, which is already marketed and presumed safe and effective for similar indications. The "applicable performance testing" demonstrates "no significant difference exists between this component and the predicate designs," suggesting comparable functional performance.
Intended Use: The device performs its intended function for the specified indications (e.g., total knee arthroplasty, management of posterior cruciate ligament absence, bone loss).	The device has the same indications and intended use as the predicate devices: replacing the articulating surface of the distal femur when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present.
Biocompatibility: Materials are biocompatible and do not elicit adverse reactions.	(Inferred) As the device uses the same materials (e.g., polymer/metal) as the predicate, it is assumed to share the predicate's established biocompatibility.
Mechanical Integrity/Durability: The component can withstand the stresses of knee articulation.	"Applicable performance testing demonstrates that no significant difference exists between this component and the predicate designs." While specific tests aren't detailed, this refers to mechanical and fatigue testing demonstrating comparable durability and structural integrity to the predicate. This would involve tests for aspects like wear, fatigue, and fixation strength.
Fixation Method: Compatibility with cemented fixation.	The device is explicitly designed for cemented fixation, matching the established method of the predicate and explicitly stated in the FDA letter.

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 / Not Provided. This document is a 510(k) submission, not a report on a clinical trial with a "test set" in the context of an AI/diagnostic device. The "performance testing" mentioned likely refers to bench testing (mechanical, material properties) rather than human subject data. There is no mention of a test set size, data provenance, or retrospective/prospective nature of data for clinical evaluation.

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 / Not Provided. This information is not relevant to a 510(k) submission for a knee implant, which focuses on engineering comparisons to a predicate device, not clinical performance against ground truth established by experts.

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

Not Applicable / Not Provided. See answer for point 3.

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 / Not Provided. This is a medical implant, not an AI-assisted diagnostic tool.

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

Not Applicable / Not Provided. This is a medical implant, not a standalone AI algorithm.

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

Not Applicable / Not Provided. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily the established safety and effectiveness profile of the predicate device, supported by technical specifications, materials data, and bench test results (e.g., mechanical testing, wear testing) which are compared to the predicate's known performance. Clinical outcomes data or pathology for "ground truthing" a new implant's performance would typically be part of a more extensive clinical trial, not usually required for a 510(k).

8. The sample size for the training set

Not Applicable / Not Provided. There is no "training set" in the context of this 510(k) device submission.

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

Not Applicable / Not Provided. There is no "training set" in the context of this 510(k) device submission.

Summary

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K973406

Osteonics" Series 7000 Total Knee Augmented Femoral Component

510(k) Premarket Notification

510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS

DEC - 8 1997

OSTEONICS® SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT

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

Regulatory Affairs Specialist

Contact Person:

Date Summary Prepared:

Device Identification Proprietary Name:

Common Name:

Classification Name and Reference:

September 8, 1997

Donna S. Wilson

Osteonics® Series 7000 Total Knee Augmented Femoral Component

Knee Prosthesis

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

Predicate Device Identification

The Osteonics® Series 7000 Total Knee Augmented Femoral Component is substantially equivalent to the Osteonics® Series 7000 Total Knee Posteriorly Stabilized Long Stem Femoral Component.

Device Description

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Intended Use

Statement of Technological Comparison

The Osteonics® Series 7000 Total Knee Augmented Femoral Component shares the same materials, indications and intended use, and basic design features of the predicate devices. Applicable performance testing demonstrates that no significant difference exists between this component and the predicate designs.

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Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a bold, sans-serif font. The text is black and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 8 1997

Ms. Donna S. Wilson Requlatory Affairs Specialist Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

K973406 Re : Osteonics Series 7000 Total Knee Augmented Femoral Component Requlatory Class: II Product Code: ਹੈਕਸ September 8, 1997 Dated: Received: September 9, 1997

Dear Ms. Wilson:

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:

1. This device may not be labeled or promoted for noncemented use.
1. All labeling for this device, including package label and labeling included within the package, must prominently state that the device is intended for cemented use only.
1. Any non-cemented fixation of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) requlation 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 - Ms. Donna S. Wilson

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 regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other genera Other general information on your responsibilities under the Act may be

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Page 3 - Ms. Donna S. Wilson

obtained from the Division of Small Manufacturers Assistance obtained from the Division of Small March (301) 443-6597 or at
at its toll-free number (800) 638-2041 or (301) 443-6597 or at at its toll-free number (600) 656-2041 Of (600) do 100 homemain.itml".
its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia 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): K973406

Device Name: Osteonics® Series 7000 Total Knee Augmented Femoral Component

Intended Use:

Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis, complicated by the presence of bone loss.
. 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, accompanied by . bone loss.
Ligamentous 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)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K973406
Prescription Use (Per 21 CFR 801.109)	X
	OR
Over-The-Counter Use	_

(Optional Format 1-2-96)

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.