(90 days)
The primary indication for these devices is the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee. Indications include: 1. Treatment of patients who are not candidates for total knee arthroplasty. 2. Irretrievably failed total knee arthroplasty. 3. Limb salvage in oncology surgery. 4. Trauma. 5. Any other condition where there is little soft tissue or bony tissue available for support, and arthrodesis is the treatment of choice. These devices are intended for cemented use only.
The Modular Arthrodesis Nail is a multi-component device designed to provide arthrodesis fixation of the knee. The device has a central locking collar that connects fernoral and tibial adapter segments. The adapter segments are available in two resection lengths (1 cm or 3 cm), each with two body styles (standard or elliptical). All components of the Modular Arthrodesis Nail are manufactured from Ti-6Al-4V titanium alloy conforming to ASTM F-136.
The provided text is a 510(k) Summary for the Biomet Manufacturing Corp.'s Modular Arthrodesis Nail. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical testing. Crucially, it explicitly states that clinical testing was not required for this device to support substantial equivalence.
Therefore, the document does not contain information regarding acceptance criteria, or the details of a study (clinical or standalone AI performance) proving the device meets acceptance criteria.
The 510(k) process in this case relies on demonstrating substantial equivalence to already legally marketed devices through other means (like mechanical testing and material similarity), rather than proving efficacy or performance through clinical trials or specific acceptance criteria.
To answer your request, if this were documentation of an AI/ML device, the following would need to be present but are explicitly absent for this device:
The following information is NOT available in the provided document:
- Table of acceptance criteria and the reported device performance: No acceptance criteria or performance metrics are detailed, as no clinical study was conducted.
- Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned as no clinical or performance study was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical or performance study was conducted.
- Adjudication method for the test set: Not applicable as no clinical or performance study was conducted.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.
- The type of ground truth used: Not applicable as no clinical or performance study was conducted.
- The sample size for the training set: Not applicable as the "device" is a physical medical implant, not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable as the "device" is a physical medical implant, not an AI/ML algorithm.
Summary of Relevant Information from the Provided Text:
- Device Name: Modular Arthrodesis Nail
- Manufacturer: Biomet Manufacturing Corp.
- Basis for Substantial Equivalence: Similar intended use, functional characteristics (rigid fixation), and material (Ti-6Al-4V titanium alloy) as predicate devices.
- Non-Clinical Testing: "Mechanical testing indicated that the Modular Arthrodesis Nails are substantially equivalent to the predicate devices for the uses indicated."
- Clinical Testing: "Clinical testing was not required for these components to support substantial equivalence."
Conclusion Regarding Your Request:
The provided 510(k) summary explicitly states that clinical testing was not required for the Modular Arthrodesis Nail to establish substantial equivalence. Therefore, there are no acceptance criteria, study details, or performance data of the type you are asking for (which are typically associated with clinical trials or AI/ML performance studies) within this document. The device's approval was based on non-clinical mechanical testing and comparison to predicate devices, not on a human clinical study or an AI/ML performance study with specific ground truth and expert adjudication.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.