(377 days)
The Vilex eZ-Staple (Superelastic Bone Fixation Staple) is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
The Vilex memory bone fixation staples (eZ-Staple) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
The Vilex eZ-Staple Superelastic Bone Fixation Staple is a single-use bone fixation appliance intended to be permanently implanted. Super Elastic staples are compression staples made of shape memory nickel titanium alloy, Nitinol. Vilex will offer Monocortical Staples ranging in width from 10mm to 20mm with leg lengths ranging from 10mm to 20mm and Biocortical Staples ranging in width from 10mm to 18mm with leg lengths from 15x13 to 19x17.
The provided text describes a 510(k) summary for the Vilex eZ-Staple Superelastic Bone Fixation Staple. This document outlines the device's characteristics, intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. It does not contain information about clinical studies, acceptance criteria for device performance based on human reader studies, or details about ground truth establishment with expert consensus.
Therefore, I cannot provide a table of acceptance criteria and device performance as no such criteria or clinical performance data are presented in the document.
Based on the provided text, here's what can be inferred and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Non-Clinical Test Data: |
| • Cytotoxicity (MEM Elution) - No specific performance metrics provided, but expected to be within acceptable limits for biocompatibility. | |
| • Genotoxicity (Ames Assay) - No specific performance metrics provided, but expected to be within acceptable limits for biocompatibility. | |
| • Intracutaneous Reactivity - No specific performance metrics provided, but expected to be within acceptable limits for biocompatibility. | |
| • Acute Systemic Toxicity - No specific performance metrics provided, but expected to be within acceptable limits for biocompatibility. | |
| • Material-Mediated Pyrogenicity - No specific performance metrics provided, but expected to be within acceptable limits for biocompatibility. | |
| • Corrosion Susceptibility - Tested against predicate device, implied comparable performance. | |
| • Auger Electron Spectroscopy of Oxide Layer - Tested against predicate device, implied comparable characteristics. | |
| • Pullout Strength - Tested against predicate device, implied comparable performance. | |
| • Static Bending Stiffness - Tested against predicate device, implied comparable performance. | |
| • Dynamic Bending Fatigue Life - Tested against predicate device, implied comparable performance. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. The provided document details non-clinical laboratory testing, not clinical trials with "test sets" in the context of diagnostic or AI performance.
- Data Provenance: Not applicable for clinical data. The non-clinical tests were performed on "samples of the Vilex eZ-Staple." The country of origin of the data is not specified beyond being part of a U.S. FDA 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is a bone fixation staple, not a diagnostic or AI device requiring expert-established ground truth for performance evaluation in the context of clinical images or data.
4. Adjudication Method for the Test Set:
- Not applicable. There is no mention of a test set requiring adjudication in the context of clinical evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. The document describes non-clinical testing of a bone fixation staple, not an AI or diagnostic device that would typically undergo an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This is a medical implant, not an algorithm or AI device.
7. The Type of Ground Truth Used:
- Not applicable in the context of clinical ground truth. For the physical and material properties, the "ground truth" would be established by validated ASTM and ISO standards for material properties and predicate device performance for comparative testing.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI or machine learning device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is not an AI or machine learning device.
In summary, the provided document details a 510(k) submission for a medical implant (bone fixation staple), which primarily relies on non-clinical engineering and material compatibility testing to demonstrate substantial equivalence to a predicate device. It does not involve AI, diagnostic imaging, or human reader studies, and therefore, most of the requested information regarding acceptance criteria and studies in that context is not present.
§ 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.