(41 days)
The TRIGEN META-TAN Trochanteric Antegrade Nail is indicated for fixation of fractures that occur in and between the proximal third and distal fourth of the femur including simple long bone fractures, severely comminuted, spiral, and segmental fractures, and supracondylar fractures.
In addition, TRIGEN META-TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; and intracapsular fractures.
The device in scope of this submission is the TRIGEN META-TAN Trochanteric Antegrade Nail.
TRIGEN META-TAN Trochanteric Antegrade Nails are intended to be used as aids to normal fracture healing of the femur. They are made from Ti-6Al-4V material and available in a nail size range of 30 to 50 cm in 2 cm increments. They are Gamma sterlized and intended for single-use only.
The provided text is a 510(k) summary for the TRIGEN META-TAN Trochanteric Antegrade Nail. This document primarily focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical performance testing. It is not a study that proves the device meets specific performance acceptance criteria related to AI/ML or diagnostic accuracy.
Therefore, many of the requested fields cannot be filled from the provided text, as they pertain to clinical studies, human reader performance, or AI/ML algorithm evaluation, which are not present in this regulatory document.
However, based on the information available, I can extract the following:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the context of clinical outcomes or AI/ML algorithm metrics. Instead, it refers to non-clinical bench tests demonstrating acceptable outcomes for design, materials, and technological characteristics to establish substantial equivalence.
| Acceptance Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Test (MR Compatibility) | Compliance with standards (ASTM F2182-19e2, ASTM F2052-15, ASTM F2213-2017, and ASTM F2119-07(2013)) | "met the required criteria" |
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. The document explicitly states: "No clinical tests were performed to support safety and efficacy of the subject device." The testing mentioned is non-clinical bench testing.
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 is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method is mentioned.
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 MRMC study was done, as explicitly stated: "No clinical tests were performed to support safety and efficacy of the subject device." This device is a physical intramedullary nail, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. Ground truth, in the context of clinical or diagnostic performance, is not discussed as "No clinical tests were performed." The device's "acceptance" is based on meeting non-clinical engineering and material specifications.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device.
§ 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.