The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement for one of the following:

Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
Correction of varus, valgus or post traumatic deformity
Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement
Ligament deficiencies
Tumor resections
Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
Revision of previously failed total joint arthroplasty
Trauma
This device is a single use implant.

Device Description

The OSS Les Proximal Femoral Component is designed for use with Biomet's Oncology Salvage System. It may be used either for proximal femoral replacement with a diaphyseal segments and intramedullary stem or as part of a total femur replacement with a segmental distal femur component and the appropriate hinged knee components.
The OSS Les Proximal Femeral Component combines features of the three styles of Proximal Femoral Components contained in 510(k) K002757.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (OSS Les Proximal Femoral Component) and a letter of substantial equivalence from the FDA. This type of document focuses on establishing equivalence to existing devices and does not typically include an acceptance criteria table, detailed study results for performance metrics, or information on AI/standalone algorithms, MRMC studies, or detailed ground truth methodologies that would be found in a clinical trial report or a performance study for novel devices.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's an analysis based on the available information:

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

Not applicable / Not provided. The document states "Engineering analysis has shown the modified device to have similar characteristics to predicate devices and no new risks are envisioned." This suggests that the acceptance criteria are implicitly met by demonstrating "similar characteristics" to legally marketed predicate devices, rather than specific performance metrics against a predefined threshold. No specific performance metrics or acceptance criteria are listed.

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. No clinical or non-clinical test set data is described in a way that would allow for sample size determination or data provenance information.

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. No test set or ground truth establishment by experts is described.

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

Not applicable / Not provided. No test set or adjudication method is described.

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 document pertains to a mechanical orthopedic implant, not an AI or imaging device. No MRMC study or AI assistance is mentioned.

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

Not applicable. This document pertains to a mechanical orthopedic implant, not an AI or algorithm-based device. No standalone algorithm performance is mentioned.

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

Not applicable / Not provided. As no dedicated clinical study is described for the device, there is no mention of ground truth types for performance evaluation. The basis for clearance is "substantial equivalence" to predicate devices, which implies that the predicate devices' established safety and effectiveness serve as an indirect "ground truth" for the new device's acceptable performance.

8. The sample size for the training set

Not applicable / Not provided. No training set for an algorithm is relevant or mentioned.

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

Not applicable / Not provided. No training set or ground truth establishment for it is relevant or mentioned.

Summary derived from the document:

The document explicitly states: "Clinical Testing: None provided". It also mentions "Non-Clinical Testing: Engineering analysis has shown the modified device to have similar characteristics to predicate devices and no new risks are envisioned."

This indicates that the device's acceptance was based on a demonstration of substantial equivalence to previously cleared predicate devices (K002757) through engineering analysis, rather than through a new clinical study with specific acceptance criteria and performance outcomes. The "acceptance criterion" in this context is that the device is "substantially equivalent" to predicate devices in terms of materials, surface finishes, processing, and intended use, and that "no new risks are envisioned."

Summary

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MAY 2 8 2002

Image /page/0/Picture/1 description: The image shows the logo for Biomet Corporate Headquarters. The logo consists of the word "BIOMET" in a stylized font, with the letters connected to each other. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, sans-serif font. The text is centered below the logo.

K0d21380
page 1 of 2

Summary of Safety and Effectiveness

Applicant/Sponsor:	Biomet Orthopedics, Inc.P.O. Box 587Warsaw, Indiana 46581-0587
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Contact Person: Patricia Sandborn Beres Biomet Orthopedics, Inc. 56 Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 Phone: (574) 267-6639 extension 1278 Fax: (574) 372-1790
Proprietary Name: OSS Les Proximal Femoral Component

Classification Name: Prosthesis, Hip, semi-constrained, metal/polymer, cemented (888.3350) and Prosthesis, Hip, semi-constrained, metal/polymer, uncemented (888.3358) - when used as proximal femoral

Legally Marketed devices to Which Substantial Equivalence is Claimed: Proximal Femoral Components previously cleared in 510(k) K002757 for the Oncology Salvage System.

Device Description: The OSS Les Proximal Femoral Component is designed for use with Biomet's Oncology Salvage System. It may be used either for proximal femoral replacement with a diaphyseal segments and intramedullary stem or as part of a total femur replacement with a segmental distal femur component and the appropriate hinged knee components.

The OSS Les Proximal Femoral Component combines features of the three styles of Proximal Femoral Components contained in 510(k) K002757.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

FAX 219.267.8137

E-MAIL biomet@biomet.com

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021380
page 2 of 2

Indications For Use: The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement for one of the following:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
1. Correction of varus, valgus or post traumatic deformity
1. Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement
1. Ligament deficiencies
1. Tumor resections
1. Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
1. Revision of previously failed total joint arthroplasty
1. Trauma

Summary of Technologies: The materials, surface finishes, and processing of the OSS Les Proximal Femoral Component are similar to the predicate devices.

Non-Clinical Testing: Engineering analysis has shown the modified device to have similar characteristics to predicate devices and no new risks are envisioned.

Clinical Testing: None provided

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2002

Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet. Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K021380

Trade Name: OSS Les Proximal Femoral Component Regulation Number: 21 CFR 888.3350 and 888.3358 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

Regulatory Class: Class II Product Code: JDI and LPH Dated: April 24, 2002 Received: May 1, 2002

Dear Ms. Sandborn Beres:

We have reviewed your Section 510(k) premarket 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 May 20, 1970, the enabilities and of the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, (Treefore, market the device, subject to the general controls provisions of the Act. The general thereofs, maintons 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 11 your device 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 r load be actived a determination that your device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or uny 1 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.

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Page 2 - Ms. Patricia Sandborn Beres

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 premated predicated 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

R. Mark N. Mdlkess

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): ├од 1380

Device Name: OSS Les Proximal Femoral Component

Indications For Use:

The OSS Les Proximal Femoral Component is indicated for treatment of patients that require proximal femoral, or total femur replacement.

Indications:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
1. Correction of varus, valgus or post traumatic deformity
1. Correction of revision of unsuccessful ostoetomy, arthrosis, or previous joint replacement
1. Ligament deficiencies
1. Tumor resections
1. Treatment of non-unions, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
1. Revision of previously failed total joint arthroplasty
1. Trauma

This device is a single use implant.

(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)

eral. Restorative and Neurological Devices

Over-The-Counter Use

(Optional Format 1-2-96)

510(k) Number K091380

Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 an acetabular resurfacing 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.