(77 days)
The indications for the use of the Osteo IC Femoral and Tibial Nails in Titanium Alloy are as follows:
- . Closed and open femoral and tibial shaft fractures
- Pseudarthrosis and correction osteotomies in the shaft area ●
- Pathological fractures and tumor resections of the shaft area .
- . Change of procedure following external fixation.
The subject Osteo IC Femoral and Tibial Nails are similar to the predicate Osteo IC Femoral and Tibial Nails. The major difference is that the subject devices are made from Titanium Alloy, while the predicate devices were made from Stainless Steel. The subject Osteo IC Femoral and Tibial Nails in Titanium share the same basic design as the Osteo IC Femoral and Tibial Nails in Stainless Steel, except that they feature an additional groove and come in some additional sizes.
The provided text describes a 510(k) submission for the Osteo IC Femoral and Tibial Nails in Titanium Alloy. However, it does not contain information regarding acceptance criteria, specific performance data, or a detailed study of the device's performance against such criteria.
The document states:
"The subject devices are so similar to the predicate devices cited in terms of design, materials, intended use, and size range, that additional testing was not thought necessary to demonstrate their Substantial Equivalence."
This indicates that the manufacturer relied on substantial equivalence to predicate devices rather than conducting a new performance study with specific acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document explicitly states that "additional testing was not thought necessary." There are no reported acceptance criteria or device performance data for this specific device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No new test set was used for this 510(k) submission, as no new testing was deemed necessary.
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)
- Cannot be provided. No new test set with ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No new test set was used.
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
- Cannot be provided. This device is an intramedullary nail, not an AI or imaging device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is an intramedullary nail, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No new ground truth was established for this device, as no new performance testing was conducted. The equivalence is based on the previously established performance and safety of the predicate devices.
8. The sample size for the training set
- Cannot be provided. There is no mention of a training set as this is not an AI/algorithm device.
9. How the ground truth for the training set was established
- Cannot be provided. There is no mention of a training set or ground truth establishment relevant to this device.
Summary of what is available from the document:
- Rationale for demonstrating equivalence: The subject Osteo IC Femoral and Tibial Nails in Titanium Alloy are considered "so similar" to predicate devices (Osteo IC Femoral and Tibial Nails in Stainless Steel and Howmedica Alta Femoral and Tibial Rod System in Titanium Alloy) in terms of design, materials, intended use, and size range, that additional testing was not deemed necessary.
This document serves as a 510(k) summary relying on substantial equivalence, which bypasses the need for new performance studies and acceptance criteria for the specific device under review.
§ 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.