ORTHOPEDIC SALVAGE SYSTEM- OSS by BIOMET, INC.

Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
Correction of varus, valgus, functional or post traumatic deformity
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
Ligament deficiencies
Tumor resections
Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
Trauma
Revision of previously failed total joint arthroplasty

Device Description

The Orthopedic Salvage System- OSS offers a variety of component options for the treatment of patients that require proximal femoral, total femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur. These devices are single use implants. These devices are for cemented use only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Orthopedic Salvage System - OSS. It explicitly states that clinical testing was not required for the predicate device, and therefore, this submission contains no clinical testing.

This means that the type of study described in your request (one that proves the device meets acceptance criteria) was not performed. Instead, the device's substantial equivalence to a legally marketed predicate device (Orthopedic Salvage System- OSS, K002757) was established through non-clinical testing.

Here's a breakdown of the requested information based on the provided text, highlighting where data is unavailable due to the lack of clinical testing:

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

Acceptance Criteria: Not explicitly stated as this was not a clinical performance study. The implied acceptance criterion for this 510(k) submission was "substantial equivalence" to the predicate device based on design, intended use, contraindications, and design specifications.
Reported Device Performance:
- Non-Clinical Testing: An engineering analysis was performed on the modified and predicate devices comparing their profiles.
- Results: "The results indicated that the device was functional within its intended use."

Criteria Type	Acceptance Criteria	Reported Device Performance (from Non-Clinical Testing)
Functional Design	Implied: Similar or identical designs, intended use, contraindications, and design specifications to predicate device (K002757). Functionality within intended use.	Engineering analysis compared profiles of modified and predicate devices. Results indicated the device was functional within its intended use.

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

Sample Size for Test Set: Not applicable. No clinical test set was used. The non-clinical engineering analysis would involve comparing design specifications and potentially physical prototypes/CAD models.
Data Provenance: Not applicable. No clinical data.

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. No clinical test set or ground truth established by experts as part of a performance study.

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

Not applicable. No clinical test set.

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 device is an orthopedic implant, not an AI-assisted diagnostic tool.

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

No. This device is an orthopedic implant.

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

Not applicable. For the non-clinical engineering analysis, "ground truth" would be established by engineering principles and design specifications, rather than clinical outcomes or pathology.

8. The sample size for the training set

Not applicable. No clinical training set.

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

Not applicable. No clinical training set.

Summary based on the provided text:

The submission for the Orthopedic Salvage System - OSS (K052685) did not include any clinical testing to prove it met specific acceptance criteria. Instead, it relied on a non-clinical "engineering analysis" that compared the modified device to a legally marketed predicate device (K002757). The results of this analysis indicated that the device was "functional within its intended use," which supported the claim of substantial equivalence. This approach is common for 510(k) submissions where a device is substantially equivalent to a predicate that also did not require clinical data for its initial clearance.

Summary

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K052685

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510(k) Summary

Applicant/Sponsor:	Biomet Manufacturing Corp.
Contact Person:	Allison Koskey, Regulatory Affairs Specialist
Proprietary Name:	Orthopedic Salvage System - OSS
Common Name:	OSS Bodies
Classification Name:	-Prosthesis, Hip, semi-constrained, metal/polymer, cemented(888.3350, 87 JDI)-Prosthesis, Knee, femorotibial, constrained, cemented, metal/polymer(888.3510, 87 KRO)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Orthopedic Salvage System- OSS (K002757)

Device Description: The Orthopedic Salvage System- OSS offers a variety of component options for the treatment of patients that require proximal femoral, total femoral, total femur, or proximal tibial replacements, as well as, resurfacing components for the proximal tibial and distal femur.

Indications for Use:

1 ) Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
Correction of varus, valgus, functional or post traumatic deformity 2)
Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement 3)
1. Ligament deficiencies
Turnor resections 5)
Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal 6) femur with head involvement, unmanageable using other techniques
1. Trauma
1. Revision of previously failed total joint arthroplasty

These devices are single use implants.

These devices are for cemented use only.

Summary of Technologies: The designs, intended use, contraindications, and design specifications of the subject components are similar or identical to their predicate counterparts. This submission allows for additional sizing options for the OSS bodies.

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Formerly known as the Oncology Salvage System- OSS All trademarks are property of Biomet, Inc.

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Non-Clinical Testing: An engineering analysis was performed on the modified and predicate devices comparing their profiles. The results indicated that the device was functional within its intended use.

Clinical Testing: Clinical testing was not required for the predicate device. Therefore, this submission contains no clinical testing.

Formerly known as the Oncology Salvage System- OSS All trademarks are property of Biomet, Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 27 2005

Allison Koskey Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K052685

Trade/Device Name: Orthopedic Salvage System - OSS Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Codes: KRO, JDI Dated: September 26, 2005 Received: September 28, 2005

Dear Ms. Koskey:

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 for ass saled in the exerces, 1976, the enactment date of the Medical Device Amendments, or 10 conniner 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). and Cosmetic Free (110) has the device, subject to the general controls provisions of the Act. The rou may a controls provisions of the Act include requirements for annual registration, listing of general obtable provinciting practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it rr your device is elaborned toontrols. Existing major regulations affecting your device can be found in the Codc 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 I rease be advisou that I bristian that your device complies with other requirements of the Act that + Dr Has Intactions and regulations administered by other Federal agencies. You must or any I edetal statuated and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N 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. Allison Koskey

This letter will allow you to begin marketing your device as described in your Section 510(k) This icher will anow your to organ finding of substantial equivalence of your device to a legally premits tourication. The PPF midning of 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 11 you desire specific acriously 3 at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Computance in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet and odress http://www.fda.gov/cdrh/industry/support/index.html.

Sincercly yours,

Mark N. Melkerson

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_KO526 85

Device Name: Orthopedic Salvage System - OSS

Indications For Use: The OSS bodies are indicated for cemented use only in cases of:

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

Prescription use __X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use 1 CFR 807 Subpart C)

(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, and Neurological Devices

510(k) Number X052685

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Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.