(53 days)
The PRO-TOE™ VO Hammertoe Implant system is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
The subject implants are modified from the previously cleared Pro-Toe™ VO Hammertoe Implant System. They offer additional size ranges as well as additional material.
The provided document is a 510(k) summary for the Pro-Toe™ VO Hammertoe Implant System - Line Addition. This is a premarket notification for a medical device that claims substantial equivalence to a predicate device, rather than a clinical study establishing new performance criteria. Therefore, much of the requested information, such as detailed acceptance criteria, specific device performance metrics, sample sizes for test and training sets, expert qualifications, and study designs for AI or human readers, is not applicable in this context.
Here's a breakdown of the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The primary "acceptance criteria" for a 510(k) submission like this is demonstrating substantial equivalence to a previously cleared predicate device. This is achieved through non-clinical performance testing and engineering analysis to show that the design changes (new sizes, new material) do not introduce new safety or effectiveness concerns.
- Reported Device Performance: The document states: "Performance testing and engineering analysis supports the equivalence of the new sizes and shows that no new worst-case implants are introduced in this system." And, "Performance testing and engineering analysis shows that no new worst-case design is introduced in this system."
- No specific numerical performance metrics (e.g., tensile strength values, fatigue life cycles) are provided in the summary. The "performance" is described in terms of structural integrity and equivalence.
| Criteria | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence (Non-Clinical) | Performance testing and engineering analysis supports equivalence of new sizes. No new worst-case implants or designs introduced. ASTM standards address new Titanium material. |
2. Sample size used for the test set and the data provenance:
- N/A. This is not a clinical study involving a "test set" of patient data in the typical sense. The "test set" would refer to the implants themselves undergoing non-clinical mechanical testing, but no sample sizes or specific test details are provided.
- Data Provenance: N/A, as it's not patient data. The non-clinical testing would have been conducted by the manufacturer (Wright Medical Technology, Inc.) in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This information is relevant for studies involving human interpretation or clinical data. The "ground truth" here is based on engineering principles, materials science, and mechanical testing results compared against established standards and predicate device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are used in clinical studies for reconciling differences in expert opinions. This is a mechanical/material equivalence assessment.
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:
- N/A. This device is a hammertoe implant system, not a diagnostic AI system or an imaging modality requiring human reader interpretation. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" would be established engineering standards (e.g., ASTM standards referenced for Titanium) and the validated performance characteristics of the predicate device. The performance of the new implants is compared against these established benchmarks.
8. The sample size for the training set:
- N/A. This device is not an AI algorithm requiring a training set. The "training data" for the engineering design would encompass material properties, biomechanical principles, and predicate device design specifications that informed the new design.
9. How the ground truth for the training set was established:
- N/A. As above, it's not an AI training set. The "ground truth" for the design process would be based on well-established engineering principles, biomechanical data related to hammertoe correction, and the performance history of the predicate device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.