(122 days)
The VersaWrap Tendon Protector is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
VersaWrap is an absorbable implant (device), designed to serve as an interface between the tendon and tendon sheath or the surrounding tissues, which provides a non-constricting, protective encasement for injured tendons. VersaWrap consists of a Sheet and a wetting Solution. The Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for easy placement under, around. or over the injured tendon. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet after the Sheet is positioned onto damaged tissue. The Solution is comprised of aqueous citrate and is provided in a dropper packaged in a double peel pouch. The Solution is sterile, non-pyrogenic, and is intended for single use only.
The provided text is a 510(k) summary for the VersaWrap Tendon Protector. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the way typically expected for an AI/CADe device.
This document is for a medical device (a tendon protector), not an AI/CADe system. Therefore, many of the requested categories (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable or described in the context of this type of device submission.
Here's a breakdown of the information that can be extracted, and what is missing based on the request:
1. Table of acceptance criteria and reported device performance:
The document describes "Functional and Safety Testing" and "Non-Clinical Tests Submitted." However, it presents these as categories of tests performed rather than specific quantitative acceptance criteria with corresponding reported performance values. For instance, it mentions "Puncture strength" but does not provide a target value for puncture strength or the measured value for the VersaWrap.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional & Performance Requirements | Device design met functional and performance requirements (general statement) |
| Visual Inspection | Performed |
| Dimensional & Weight Measurements | Performed |
| Puncture Strength | Performed (no specific value or criteria given) |
| Handling | Performed (no specific criteria given) |
| Tissue Adherence and Conformance | Performed (no specific criteria given) |
| Chicken Flexor Tendon Repair Model | Performed (no specific criteria or results given) |
| Biocompatibility (ISO 10993 standards) | |
| Non-cytotoxic | Demonstrated |
| Non-pyrogenic | Demonstrated |
| Non-irritating | Demonstrated |
| Non-sensitizing | Demonstrated |
| Non-toxic | Demonstrated |
| Non-genotoxic | Demonstrated |
| Subchronic toxicity (13 weeks) | Performed (no specific criteria or results given) |
| Muscle implantation toxicity/irritation | Performed (no specific criteria or results given) |
| Protective Interface Function | Alginate-glycosaminoglycan matrix provides a protective interface to improve mobility of repaired tendons (demonstrated by physical testing and animal studies) |
Missing: Specific, quantifiable acceptance criteria (e.g., "puncture strength > X Newtons") and the direct numerical results demonstrating the device met those criteria.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of this device. The tests mentioned are bench testing and animal studies, not a "test set" of patient data for an algorithm.
- Data Provenance: The document mentions "animal studies" (specifically, a "Chicken flexor tendon repair model"). No country of origin is specified for these studies. The studies are non-clinical, not retrospective or prospective patient data.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable in the context of this device. The ground truth for device performance is established via physical and chemical testing, and observations in animal models, not by expert consensus on clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This concept applies to expert review of clinical cases, not the physical testing of a medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical tendon protector, not an AI or CADe system intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
The ground truth for the performance claims would be:
- Physical properties: Measured values from bench tests (e.g., puncture strength, dimensions).
- Biocompatibility standards: Results against defined ISO 10993 criteria.
- Animal study observations: Outcomes from the "Chicken flexor tendon repair model" (e.g., improved mobility, protective interface functionality).
8. The sample size for the training set:
Not applicable. This device does not have a "training set" in the sense of machine learning.
9. How the ground truth for the training set was established:
Not applicable.
In summary: The provided document is a regulatory submission for a physical medical device. It details functional, safety, and biocompatibility testing designed to demonstrate substantial equivalence to a predicate device. It does not contain the types of information (e.g., quantitative acceptance criteria for image analysis performance, clinical test set details, expert ground truth, AI/CADe study methodologies) typically requested for an AI/CADe device.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.