(162 days)
Biomet's MAK OSS Femoral Knee Components are intended for use in conjunction with the OSS System for total knee replacement procedures. Specific indications for the OSS System are:
- Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
- Correction of varus, valgus or post-traumatic deformity.
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Ligament deficiencies.
- Tumor resections.
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. *
- Revision of previously failed total joint arthroplasty.
- Trauma.
These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).
- Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Tumor resections.
- Revision of previously failed total joint arthroplasty.
- Trauma.
The MAK OSS Femoral Knee Components are intended to be used as an optional femoral knee component for use in coniunction with the cleared Orthopedic Salvage System. The MAK OSS Femoral Knee Components include either resurfacing or segmental femoral components that utilize the yoke and axle of the OSS System but limit extension of the knee to limit or prevent hyperextension.
This document is a 510(k) premarket notification for a medical device called "MAK OSS Femoral Knee Components." It focuses on design modifications to a locking pin within the existing device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Locking pin easy insertion | Testing demonstrated that the locking pins could be easily inserted. |
| Adequate extraction force | Testing demonstrated that the locking pins still maintained adequate extraction force. |
| Design modification does not adversely affect insertion. | Verified through non-clinical testing. |
| Design modification does not adversely affect extraction. | Verified through non-clinical testing. |
| Intended Use and Indications for Use remain identical to predicate systems. | Stated in the "Technological Characteristics" section and confirmed by FDA's substantial equivalence determination. |
| Made from same wrought Co-Cr-Mo alloy conforming to ASTM F-1537. | Stated in the "Technological Characteristics" section. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the test set used in the non-clinical testing. It only states that "Verification testing was conducted."
The data provenance is not explicitly mentioned (e.g., country of origin). Since this is a 510(k) submission to the FDA, it can be inferred that the testing and data generation occurred within a context relevant to US regulatory standards, likely in the US or by a US-based or affiliated entity. The testing was non-clinical, involving mechanical tests, not human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes non-clinical, mechanical testing. Therefore, there were no human experts establishing a "ground truth" in the clinical sense (e.g., diagnosis, outcome assessment). The "ground truth" for this engineering verification would be the objective measurements of insertion and extraction forces against predefined engineering specifications or benchmarks for the predicate device. The experts involved would be biomechanical engineers or test technicians, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable. This was non-clinical testing against engineering specifications, not a study involving human interpretation or subjective assessments that would require adjudication.
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 is a 510(k) submission for a mechanical medical device (femoral knee components) and does not involve AI, human readers, or image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a mechanical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical testing was based on objective engineering measurements of insertion and extraction forces, compared against predefined specifications or performance of the predicate device.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device. The term "training set" is generally used in the context of supervised learning, where an algorithm learns from labeled data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this mechanical device.
§ 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.