(495 days)
The MiMedx HydroFix™ Surgical Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The surgical sheet minimizes tissue attachment to the device in case of direct contact with the tissues.
The HydroFix™ Surgical Sheet is a flexible sheet of 30 Wt.% polyvinyl alcohol (PVA) material with dimensions 60 ±6 mm X 50 ±5 mm and 60 ±6 mm X 100 ±10 mm with a thickness of 1.0 ±0.2 mm. The comers of the sheet are rounded. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated in saline solution.
The HydroFix™ Surgical Sheet will be provided in other shapes and sizes as needed for particular surgical procedures.
This document describes the 510(k) submission for the HydroFix™ Surgical Sheet, which aims to demonstrate its substantial equivalence to previously cleared devices. It primarily focuses on comparing the new device's performance and characteristics to those of predicate devices rather than establishing specific acceptance criteria for standalone performance.
Here's an analysis of the provided information based on your requested points:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria with pass/fail thresholds for the HydroFix™ Surgical Sheet. Instead, it states that the device's performance was judged as "comparable to the predicate devices."
| Performance Criterion | Reported Device Performance (vs. Predicate) |
|---|---|
| In Vitro Testing | |
| Suture Pull out | Comparable |
| Tensile Strength | Comparable |
| Burst Strength | Comparable |
| Tear resistance | Comparable |
| In Vivo Testing | |
| Tissue attachment | Comparable |
| Ability to suture to tissue | Comparable |
| Ability to cut the sheet | Comparable |
| Ability to secure to tissue | Comparable |
| Ability to manage and protect tendon injuries | Comparable |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified for in vitro tests. For in vivo tests, it mentions studies conducted in "both sheep and rabbit models," implying a sample size of at least two different animal types, but the number of individual animals within each model is not provided.
- Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, in vivo studies typically imply prospective animal studies conducted in a controlled environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document refers to "in vitro" and "in vivo" testing, implying laboratory and animal model evaluations, not expert-based ground truth for interpretation as might be found in diagnostic imaging studies.
4. Adjudication method for the test set
This information is not provided, as the evaluation type doesn't involve human interpretation that would require an adjudication method.
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, an MRMC comparative effectiveness study was not done. This device is a surgical sheet, not an AI-assisted diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable. The device is a surgical sheet, not an algorithm. The testing performed was to evaluate the physical and biological characteristics of the sheet.
7. The type of ground truth used
- For In Vitro Testing: The ground truth is inherent in the physical properties and mechanical measurements themselves (e.g., actual tensile strength, burst strength, etc., measured according to established material testing standards).
- For In Vivo Testing: The ground truth is the observed biological response and mechanical performance within the animal models as assessed by researchers (e.g., visual assessment of tissue attachment, successful suturing, etc.). This would likely involve histological examination and gross observations post-sacrifice.
8. The sample size for the training set
This concept is not applicable. The device is a physical product (surgical sheet), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This concept is not applicable, as there is no training set for a physical surgical sheet.
§ 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.