(19 days)
The TriGen Hindfoot Fusion Nail (HFN) is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot; tibiocalcaneal arthrodesis; combined arthrodesis of the ankle and sub-talar joints; avascular necrosis of the ankle and sub-talar joints; failed total ankle replacement with sub-talar intrusion; failed ankle arthrodesis with insufficient talar body; rheumatoid arthritis; severe deformity secondary to untreated talipes equinovarus or neuromuscular disease; and severe pilon fractures with trauma to the subtalar joints. The TriGen HFN is for single use only.
The TriGen Hindfoot Fusion Nail (HFN) is an intramedullary nail used for fixation of the ankle and hind foot. The TriGen HFN nails are made from titanium alloy conforming to ASTM F 1472 and are used with existing bone screws.
This document is a 510(k) premarket notification for a medical device called the "TriGen Hindfoot Fusion Nail." This type of submission is for demonstrating "substantial equivalence" to a predicate device, not for proving effectiveness through comprehensive clinical studies with acceptance criteria in the way a PMA (Premarket Approval) submission would.
Therefore, much of the requested information regarding acceptance criteria, specific study design details, ground truth establishment, sample sizes for training/test sets, expert involvement, and comparative performance metrics (like MRMC studies or standalone algorithm performance) is not applicable or available in this type of regulatory document.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Equivalence to Predicate Devices | "A review of the mechanical test data indicated that the TriGen HFN is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure." |
| Substantial Equivalence (Overall Regulatory) | The FDA determined the device is "substantially equivalent...to legally marketed predicate devices" based on similarities in indications for use, design features, operational principles, and material composition. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission relies on demonstrating substantial equivalence to predicate devices and mechanical testing, not a clinical study on a "test set" of patients with specific outcomes.
- The "test set" here refers to the mechanical tests conducted. No sample size for a patient test set is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no mention of "ground truth" establishment by experts in the context of a patient test set for performance evaluation. The "ground truth" for substantial equivalence is based on the characteristics of the predicate devices.
4. Adjudication method for the test set
- Not Applicable. No clinical trial or patient test set requiring adjudication is described.
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 physical orthopedic implant; AI assistance for readers is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical orthopedic implant; there is no "algorithm only" performance to evaluate.
7. The type of ground truth used
- For regulatory substantial equivalence: The "ground truth" is established by the safety and effectiveness profile of the predicate devices (Smith & Nephew, Inc. Tibia-Talus-Calcaneus Nail K950394 and Encore Orthopedics UltiMax Ankle Fusion Rod System K991790). The new device is compared against these already-marketed devices.
- For mechanical testing: The "ground truth" for mechanical integrity is likely derived from established engineering standards and performance of reference devices under simulated physiological loading conditions.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of device performance in this type of submission. If "training set" refers to data used to design or refine the device, that is not explicitly detailed here.
9. How the ground truth for the training set was established
- Not Applicable. (See #8)
§ 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.