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510(k) Data Aggregation
(23 days)
VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW
The VALOR® Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. These include Neuro-osteoarthropathy (Charcot's Foot), Avascular Necrosis of the talus, failed joint replacement, failed ankle fusion, distal tibia fracture nonunions. Osteoarthritis, Rheumatoid Arthritis, and Pseudoarthrosis.
The VALOR® Ankle Fusion Nail System - Extended Screw Lengths are a line extension to the existing VALOR® Ankle Fusion Nail System and will be offered in multiple lengths. The implants will be manufactured from titanium alloy.
This 510(k) summary describes a device (VALOR® Ankle Fusion Nail System - Extended Screw Lengths) that is a line extension of an existing product, and therefore does not include a study proving device performance against acceptance criteria in the same way a novel device might. Instead, it relies on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Fatigue resistance comparable to predicate device | "The results of the test show that the subject VALOR® Ankle Fusion Nail System - Extended Screw Lengths can be expected to perform at least as well as legally marketed predicate devices." | This is a general statement. Specific numerical criteria (e.g., cycles to failure, load limits) are not provided in this summary. |
| Material Compatibility | Same materials as predicate device | "The subject VALOR® Ankle Fusion Nail System - Extended Screw Lengths and the legally marketed predicate VALOR® Ankle Fusion Nail System have the same... materials." (Titanium alloy) | No specific material property tests or acceptance criteria are detailed. |
| Design Characteristics | Substantially equivalent design features to predicate device | "The design features of the VALOR® Ankle Fusion Nail System - Extended Screw Lengths are substantially equivalent to the design features of other devices previously cleared for market." | The only stated difference is overall length. |
| Intended Use | Same indications for use as predicate device | "The VALOR® Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection." (Full list provided in the "Indications for Use" section). | The subject and predicate devices share the same clinical indications. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The study involved "fatigue testing" but the number of samples tested is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data for this 510(k) submission, as no clinical evidence was presented or required. The equivalence was shown through non-clinical (bench) testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This was a non-clinical (bench) study.
4. Adjudication method for the test set
- Not applicable. This was a non-clinical (bench) study.
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 not an AI-powered device, and no clinical or MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI-powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical fatigue testing, the "ground truth" would be the engineering specifications and performance benchmarks established for the predicate device, or industry standards for intramedullary fixation rods. The summary indicates performance "at least as well as legally marketed predicate devices," implying the predicate's performance serves as the benchmark.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of the Study:
The study proving the device meets acceptance criteria was a non-clinical bench test, specifically fatigue testing. The purpose of this testing was to demonstrate substantial equivalence to the predicate VALOR® Ankle Fusion Nail System (K090857).
- Methodology: Fatigue testing was conducted on the subject device (VALOR® Ankle Fusion Nail System - Extended Screw Lengths).
- Acceptance Standard: The acceptance criteria for the fatigue test were implicitly tied to the performance of the legally marketed predicate device. The new device needed to perform "at least as well as" the predicate.
- Results: The fatigue testing results indicated that the subject device "can be expected to perform at least as well as legally marketed predicate devices."
- Conclusion: Based on this non-clinical evidence, along with material and design comparisons, the device was deemed substantially equivalent, meaning it meets the necessary safety and effectiveness standards without requiring clinical studies. The only stated difference between the new device and the predicate was its overall length.
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