(125 days)
HPTM is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes which require the use of reinforcing material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery.
HPTM is intended for single patient, one-time use only.
HP Tissue Matrix is a surgical mesh that is derived from porcine dermis and is processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers. This device is designed to perform as a surgical mesh for soft tissue repair. The device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses and is packaged in a double pouch configuration. The device is considered a single use device which is to be used in a healthcare facility or hospital. It is sterilized via Gamma irradiation.
The provided text describes the 510(k) premarket notification for the HPTM surgical mesh. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against defined acceptance criteria in a clinical context with human readers and ground truth.
Therefore, many of the requested sections about acceptance criteria, clinical study details, expert involvement, and reader performance cannot be extracted directly from this document. The document primarily details bench testing for material characteristics.
Here's an analysis of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document provides a list of bench tests performed but does not explicitly state acceptance criteria or the specific numerical results of the device's performance for each test. It only states that "The results of the tests performed demonstrated that the modifications did not affect safety and efficacy of the device or raise any new questions of safety or efficacy."
| Test or Evaluation | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mesh Thickness | Not specified in document | "did not affect safety and efficacy" |
| Tensile Strength | Not specified in document | "did not affect safety and efficacy" |
| Suture Pullout Strength | Not specified in document | "did not affect safety and efficacy" |
| Tear Strength | Not specified in document (refers to ASTM D5735-95) | "did not affect safety and efficacy" |
| Burst Strength | Not specified in document (refers to ASTM D6797-07(2011)) | "did not affect safety and efficacy" |
| Device Stiffness | Not specified in document | "did not affect safety and efficacy" |
| Biocompatibility | Not specified in document (refers to ISO 10993 -1, ISO 14971:2007) | "did not affect safety and efficacy" |
| Drape | Not specified in document | "did not affect safety and efficacy" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the bench tests.
- Data Provenance: Not applicable as this is bench testing on materials, not human data. There is no mention of country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document describes bench testing of a physical medical device, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human interpretation or adjudication involved in the described bench testing.
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 document explicitly states: "No clinical testing was included in this submission." This is a 510(k) submission for a surgical mesh, not a diagnostic AI device, so such a study would not be expected or relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The "device" is a physical surgical mesh.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the bench tests, the "ground truth" would be the measured physical properties of the material, compared to established material standards (like ASTM or ISO) or the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI or algorithm device requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.