(163 days)
The VERTEX Nitinol Staple System is indicated for bone fragments and osteotomy fixation and joint arthrodesis of the hand or foot.
The VERTEX Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The VERTEX bone staples are made from superelastic nitinol that does not require cold storage or heating.
This document is a 510(k) summary for the VERTEX Nitinol Staple System. It describes non-clinical testing performed to establish substantial equivalence to predicate devices. This type of document refers to the regulatory clearance process for medical devices and does not typically include information about clinical studies or AI-related performance.
Here's a breakdown based on your request, highlighting what's not available in this specific document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (as described in the document) |
|---|---|
| Static Bending, Bending Fatigue, and Pullout (per ASTM F564) | Tested to demonstrate safety. Results indicate substantial equivalence to predicate devices. (Specific quantitative results or pass/fail criteria are not provided in this summary) |
| Cyclic Potentiodynamic Polarization Testing (per ASTM F2129) | Tested to demonstrate safety. Results indicate substantial equivalence to predicate devices. (Specific quantitative results or pass/fail criteria are not provided in this summary) |
| Bend and Free Recovery (BFR) Testing (per ASTM F2082) | Tested to demonstrate safety. Results indicate substantial equivalence to predicate devices. (Specific quantitative results or pass/fail criteria are not provided in this summary) |
Note: The document states, "No FDA performance standards have been established for the VERTEX Nitinol Staple System." Therefore, the acceptance criteria are based on recognized consensus standards and current industry practice for demonstrating safety and substantial equivalence to predicate devices. The document only states that the device "meets" these criteria in a general sense, not providing specific pass/fail thresholds or quantitative results of the tests.
2. Sample Size Used for the Test Set and Data Provenance
This document describes non-clinical bench testing rather than a clinical study with a "test set" of patients.
- Sample size for test set: Not applicable (non-clinical bench testing). The sample size would refer to the number of physical staples tested for each benchmark. This specific detail is not provided in the summary.
- Data provenance: Not applicable. The data is generated from laboratory bench tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth, in the context of clinical or AI studies, typically refers to expert labels or diagnoses. This document concerns a physical medical device and its mechanical/material properties, evaluated through non-clinical testing.
4. Adjudication method for the test set
Not applicable, as this is non-clinical bench testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This document does not mention any MRMC comparative effectiveness study. This type of study is for evaluating human performance, often with and without AI assistance, which is not relevant to the non-clinical testing described for this device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for a physical medical device (nitinol staples), not an algorithm or AI system.
7. The type of ground truth used
For the non-clinical testing described, the "ground truth" would be established by:
- Physical measurements and material properties: Conforming to the specifications outlined in the respective ASTM standards (F564, F2129, F2082).
- Engineering analysis: Comparing the design, dimensions, and materials to the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/algorithm study that involves a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.