(90 days)
VersaWrap is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.
VersaWrap® is an absorbable implant (device), designed to serve as an interface between the target tissues and surrounding tissues to provide a non-constricting, protective encasement. Versa Wrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan (GAG). VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. 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. The Solution, comprised of aqueous citrate, is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.
This document is a 510(k) summary for the VersaWrap device, which is a resubmission (K203600) based on a previously cleared device (K200311). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided from the given document.
Here's what can be extracted and inferred based on the nature of a 510(k) submission for a device that is "identical to the predicate device" with "differences in the indication for use" that "do not affect the safety and effectiveness":
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" for performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this 510(k) submission. This is because it's a re-submission of an "identical" device. The acceptance criteria for this submission would have been demonstrating:
- Substantial Equivalence: That the device is as safe and effective as a legally marketed predicate device.
- Safety and Effectiveness for Modified Indications: That the modified indications for use still fall within the demonstrated safety and effectiveness profile of the original device and its predicate.
| Acceptance Criteria (Implied for 510(k) Resubmission) | Reported Device Performance (Implied from Summary) |
|---|---|
| Device is identical to predicate K200311. | Confirmed: "VersaWrap is identical to the predicate device." |
| Differences in Indications do not affect safety/effectiveness. | Confirmed: "Differences in the indication for use are not critical to the intended therapeutic... because the differences do not affect the safety and effectiveness of the device when used as labeled." |
| Non-clinical testing supports modified indications. | Confirmed: "The prior non-clinical testing and animal model studies were used to support the modified indications." |
| Device is as safe and effective as legally marketed predicate. | Confirmed: "Conclusion(s) drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the identified legally marketed device." |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable for this 510(k) submission, as it relies on previous testing of the identical predicate device. No new test set data is presented.
- Data Provenance: No new data provenance information is provided as the submission relies on "prior non-clinical testing and animal model studies" for the predicate device. The document does not specify the country of origin or whether these prior studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no new test set requiring new ground truth establishment is detailed in this 510(k) summary. The summary refers to existing non-clinical and animal model studies, but does not provide details on how ground truth was established within those studies.
4. Adjudication method for the test set:
- Not applicable, as no new test set or clinical study requiring adjudication is detailed in this 510(k) summary.
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:
- No. The VersaWrap device is a surgical mesh/implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- No. This device is a physical surgical implant, not an algorithm or software. Standalone algorithm performance is not applicable.
7. The type of ground truth used:
- For the original predicate device (K200311), the ground truth for safety and effectiveness would have been established through a combination of:
- Non-clinical testing: (e.g., mechanical properties, biocompatibility, degradation profiles).
- Animal model studies: (e.g., observation of healing, adhesion formation, tissue response in vivo).
- Literature review and comparison to existing similar devices.
- This 510(k) summary (K203600) states that "The prior non-clinical testing and animal model studies were used to support the modified indications." This implies the same types of ground truth from the predicate were leveraged.
8. The sample size for the training set:
- Not applicable. This device is not an AI model, so there is no concept of a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of medical device.
In summary: This 510(k) submission (K203600) is for a physical surgical implant (VersaWrap) that is identical to an already cleared predicate device (K200311), with minor modifications to the Indications for Use that do not impact its fundamental safety or effectiveness. Therefore, the submission primarily focuses on demonstrating this equivalence and does not present new clinical study data, detailed acceptance criteria, or performance metrics in the way an innovative diagnostic or AI device might. The "study" proving the device meets the (implicit) acceptance criteria is the demonstration of substantial equivalence through comparison to the predicate and leveraging its existing non-clinical and animal model data.
§ 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.