1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
1. Correction of varus, valgus or posttraumatic deformity
1. Corrections or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
  This device is for Cemented Use Only

Device Description

The Ascent Knee Revision Stems are similar to the previously cleared Performance Posterior Stabilized (PS) Total Knee System (K936274) used to ensure component placement and stability. The modifications made add a larger and smaller diameter size, decrease the slot width, and change the stem material. The distal diameter on stems sized 10 - 16 were also increased. Minor modifications were also made to the femoral locking screw.
There are sixteen new wrought titanium alloy (Ti-6Al-4v) Ascent Revision Stems available. Twelve of these sixteen have the same diameter and length as the previously cleared Performance PS Total Knee System (K936274). The larger diameter revision stem has been added to fit within larger canals. The smaller diameter revision stem has been added to fit within smaller canals.

AI/ML Overview

This document discusses a 510(k) premarket notification for the "Ascent Knee Revision Femoral Stem." Due to the nature of 510(k) submissions, the data provided focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific study with acceptance criteria and performance metrics in the way one might find for a novel device with clinical trial data.

Based on the provided text, a direct table of acceptance criteria and reported device performance, or a detailed study proving the device meets specific acceptance criteria, is not present. The submission relies on demonstrating substantial equivalence to an existing, legally marketed device.

Here's an analysis of the provided information in the context of your request:

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

Not Applicable in this context. The document is a 510(k) summary, which is a premarket notification aiming to demonstrate "substantial equivalence" to a predicate device rather than fulfilling specific, pre-defined acceptance criteria through a novel clinical study. The "performance" described is in comparison to the predicate, and detailed success/failure rates or specific outcome metrics against pre-set thresholds are not typically part of this type of submission.
Implied "Acceptance Criteria": The implicit acceptance criterion for a 510(k) is that the new device is "as safe and effective" as a legally marketed predicate device. This is primarily demonstrated by showing that the new device has the same intended use, similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.

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/Provided. Since this is a 510(k) submission focused on substantial equivalence, there is no mention of a "test set" in the context of a prospective clinical study involving patients. The "test" is more about comparing the device's design, materials, and intended use to the predicate. The document describes modifications to an existing device (Performance P/S Knee femoral stem) and states the new stems "have the same diameter and length" or represent "larger and smaller diameter size" modifications. This implies engineering analysis and possibly bench testing, but not 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 (e.g., radiologist with 10 years of experience)

Not Applicable/Provided. As there is no clinical test set with patient data being evaluated for "ground truth," there is no mention of experts establishing such a truth. The regulatory review process involves FDA experts evaluating the submission.

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

Not Applicable/Provided. No clinical test set with patient data is described, so no adjudication method is 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. The device is a knee revision femoral stem, a physical implant, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not Applicable. The device is a physical implant. This question relates to AI/software performance, which is not relevant for this medical device.

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

Not Applicable in the traditional sense. For a 510(k) for a physical implant, "ground truth" often refers to well-established engineering principles, material science data, and performance characteristics (e.g., wear, fatigue strength) compared to the predicate device, which has a proven track record of safety and effectiveness (its "ground truth" being its historical clinical outcomes). The clinical performance data of the predicate device (Performance P/S Knee femoral stem - K936274) serves as the "ground truth" that the new device is being compared against for substantial equivalence in safety and effectiveness.

8. The sample size for the training set

Not Applicable/Provided. There is no "training set" in the context of machine learning or a clinical trial for this type of device submission.

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

Not Applicable/Provided. As there's no training set, this question is irrelevant.

In summary:

The provided document is a 510(k) notification for a knee revision femoral stem. This regulatory pathway primarily involves demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing detailed clinical study results against specific acceptance criteria. The information you're asking for (acceptance criteria table, study sample sizes, expert ground truth, MRMC studies, etc.) is typically found in submissions for novel devices requiring clinical trials (e.g., PMA applications) or for AI/software as a medical device (SaMD). For this device, the "study" is the comparison against the predicate device through engineering analysis, material testing, and confirmation of similar intended use.

Summary

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SUMMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR: Biomet, Inc. Airport Industrial Park P. O. Box 587 Warsaw IN 46580 -0587

CONTACT PERSON: Tina Lakin (219) 267-6639 ext. 1816

DEVICE NAME: Ascent Knee Revision Femoral Stem

CLASSIFACTION NAME: Knee joint patello-femorotibial polymer/metal/polymer semi-constrained cemented prosthesis (CFR 888.3560).

INDICATIONS FOR USE: Ascent Knee Revision Femoral Stem is indicated for use in:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
1. Correction of varus, valgus or posttraumatic deformity
1. Corrections or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is for Cemented Use Only

DEVICE DESCRIPTION: The Ascent Knee Revision Stems are similar to the previously cleared Performance Posterior Stabilized (PS) Total Knee System (K936274) used to ensure component placement and stability. The modifications made add a larger and smaller diameter size, decrease the slot width, and change the stem material. The distal diameter on stems sized 10 - 16 were also increased. Minor modifications were also made to the femoral locking screw.

There are sixteen new wrought titanium alloy (Ti-6Al-4v) Ascent Revision Stems available. Twelve of these sixteen have the same diameter and length as the previously cleared Performance PS Total Knee System (K936274). The larger diameter revision stem has been added to fit within larger canals. The smaller diameter revision stem has been added to fit within smaller canals.

POTENTIAL RISKS: The potential risks with this device are the same with any other joint replacement device. These include, but are not limited to:

Reaction to bone cement Fracture of component Cardiovascular disorders Blood vessel damaqe Deformity of the joint Delayed wound healing
Fracture of bone cement Metal sensitivity Implant loosening/migration Soft tissue loosening Tissue growth failure Dislocation
Hematoma Nerve damage Infection Bone fracture
00038

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SUBSTANTIAL EQUIVALENCE: The Ascent Knee Revision femoral stem is modified from the Performance P/S Knee femoral stem (Biomet - K936274).

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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 a stylized image of three human profiles facing right, arranged in a way that suggests a bird in flight. The profiles are connected and form a single, flowing shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2000

Ms. Tina Lakin Regulatory Specialist Biomet, Inc. P.O. Box 587 Airport Industrial Park Warsaw, Indiana 46581-0587

Re: K001010

Trade Name: Ascent Knee Revision Femoral Stems Regulatory Class: II Product Code: JWH Dated: March 28, 2000 Received: March 29, 2000

Dear Ms. Lakin:

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 (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 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. Tina Lakin

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,

Donna R Lochner

Image /page/3/Picture/4 description: The image shows the name and title of Celia M. Witten, Ph.D., M.D., who is the Director of the Division of General, Restorative and Neurological Devices. The image also indicates that this division is part of the Office of Device Evaluation, which is under the Center for Devices and Radiological Health. The text is arranged in a hierarchical manner, with the name and title at the top, followed by the division, office, and center.

Enclosure

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510(k) NUMBER (if KNOWN):_____________________________________________________________________________________________________________________________________________________

DEVICE NAME: Ascent Knee Revision Femoral Stems

INDICATIONS FOR USE:

The Ascent Knee Revision Femoral Stem is indicated for:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
1. Correction of varus, valgus or posttraumatic deformity
1. Corrections or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is a single use implant

This device is for cemented use only

(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)

Over-The-Counter-Use (Optional Format 1-2-96)

Dunn R. Lochner.

(Division Sign-Off) (Division Sign-Off)
Division of General Restorative Devices
Division of General Restorative Collect C) Division of General Roolo TO

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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.