(17 days)
The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Dyax 8 and Gamma® Nails. The product is intended for use in stabilizing various types of intertrochanteric fractures of the femur.
This Special 510(k) submission is a line extension to the Trochanteric Dyax® and Gamma® Nail Systems. This line extension is intended to address a material modification and design modifications to the predicate Trochanteric Dyax® and Gamma® Nail Systems. Both the subject and predicate systems offer trochanteric nails, and offer various accessories such as lag screws, locking screws, and end caps. The Trochanteric Gamma 3 Nail in the Gamma 3 Nail System also has the same basic design concepts as the currently available Trochanteric Dyax and Gamma® Nail Systems.
This is a 510(k) premarket notification for a medical device (Gamma 3 Nail System), not a study evaluating an AI device, therefore the requested information fields are not applicable in this context. The document describes a "line extension" meaning minor changes to a previously approved device. The "study" mentioned in the document is a "mechanical testing" to show that the new device has comparable mechanical properties to the predicate device.
Here's why most of your requested fields are not applicable:
- No AI component: This document is about an intramedullary nail system, a physical implant for fracture stabilization. There is no mention of any AI or software component.
- No diagnostic or prognostic claims: The device is a treatment system, not a diagnostic tool. Therefore, there are no claims related to diagnostic accuracy (like sensitivity, specificity, or AUC) that would require a test set, ground truth established by experts, or MRMC studies.
- Predicate Device Comparison (510(k) pathway): The FDA 510(k) pathway relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials for every iteration. The "study" in this context refers to engineering or bench testing to ensure the modified device performs similarly to the predicate.
Given these points, I cannot fill out the requested table and sections as they are designed for performance evaluation of AI-powered diagnostic/prognostic devices.
However, I can extract information related to the device and its assessment within the context of this 510(k) submission:
1. Acceptance Criteria and Reported Device Performance (as inferred from the document):
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred) |
|---|---|
| Mechanical properties are comparable to legally marketed predicate (Trochanteric Dyax® and Gamma® Nail Systems). | "Mechanical testing demonstrated comparable mechanical properties to the predicate components." |
| Intended use is identical to the predicate device. | "The intended use of the subject Trochanteric Gamma 3 Nail is identical to that of the predicate Trochanteric Dyax® and Gamma® Nails. The device is intended for use in stabilizing various types of intertrochanteric fractures of the femur." |
| Basic design concepts are the same as the predicate device. | "The Trochanteric Gamma 3 Nail in the Gamma 3 Nail System also has the same basic design concepts as the currently available Trochanteric Dyax and Gamma® Nail Systems." |
2. Sample size used for the test set and the data provenance: Not applicable. This document refers to "mechanical testing" which typically involves laboratory-based tests on device samples, not patient data. The "test set" in an AI context (e.g., patient images or clinical data) is not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI, relates to the correct diagnosis or outcome. For a physical device undergoing mechanical testing, the "ground truth" is established by engineering specifications and physical measurements, not expert clinical consensus.
4. Adjudication method for the test set: Not applicable.
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 is not an MRMC study. This device is a surgical implant, not an AI diagnostic tool that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used: For mechanical testing, the "ground truth" would be the measured physical properties (e.g., strength, durability, fatigue life) against established engineering standards or the properties of the predicate device. The document only generally states "comparable mechanical properties."
8. The sample size for the training set: Not applicable for a physical device undergoing mechanical testing.
9. How the ground truth for the training set was established: Not applicable.
§ 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.