(28 days)
The TriGen Straight Humeral Nail System is indicated for proximal and/or diaphyseal fractures of the humerus, non-unions, malalignments, pathological humeral fractures, and impending pathological humeral fractures. The TriGen Straight Humeral Nail System is for single use only.
Intramedullary Nail
The provided document describes the "TriGen Straight Humeral Nail System" by Smith & Nephew, Inc. However, it does not contain information about acceptance criteria for a device's performance that is typically measured against specific metrics (e.g., sensitivity, specificity, accuracy) nor does it detail a study proving the device meets such criteria.
Instead, the document is a 510(k) premarket notification summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to existing legally marketed predicate devices.
Here's how the information provided relates to your request:
1. A table of acceptance criteria and the reported device performance
- No specific acceptance criteria or performance metrics (like sensitivity, specificity, or accuracy) are provided in the document for the TriGen Straight Humeral Nail System.
- The document states: "A review of the mechanical test data indicated that the TriGen Straight Humeral Nail System is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure." This is a general statement about mechanical equivalence and capability, not a set of quantitative acceptance criteria or detailed performance results.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "mechanical test data," but it does not specify the sample size used for these tests, the type of data (e.g., patient data, in vitro data), or its provenance.
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)
- This information is not applicable or provided in the context of this 510(k) submission. The evaluation is based on mechanical testing and comparison to predicates, not a clinical study involving expert interpretation of data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable or provided.
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 performed or is mentioned. This device is an intramedullary nail, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the mechanical testing, the "ground truth" would implicitly be engineering standards and successful in vivo performance of the predicate devices. However, this is not explicitly defined as "ground truth" in the document.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable.
Summary based on the provided text:
The TriGen Straight Humeral Nail System received FDA clearance based on its substantial equivalence to previously marketed predicate devices (Smith & Nephew's Titanium Nail System K981529, Smith & Nephew's Intramedullary Nail System K983942, and Acumed's Polarus nails K951740).
The primary evidence for equivalence cited is:
- Similarities in indications for use.
- Similar design features, operational principles, and material composition.
- Mechanical test data indicating it is "equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure."
The document does not provide detailed quantitative performance metrics or the specifics of the mechanical testing (e.g., sample sizes, exact nature of tests, pass/fail criteria). It relies on a general statement of equivalence based on those tests.
§ 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.