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510(k) Data Aggregation
(88 days)
TEPHAFLEX MELTBLOWN CONSTRUCT
TephaFLEX Melt blown Matrix is intended to reinforce soft tissue where weakness exists in patients undergoing surgical procedures that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
The TephaFLEX Meltblown Matrix is a resorbable construct prepared from poly-4-hydroxybutyrate (P4HB) and is provided either non-dyed or dyed with D&C Violet No. 2. It is a porous, fibrous structure composed of thin P4HB fibers that result in a non-woven mesh like fabric. It is provided in single sheets of varying widths, lengths and shapes ranging from 1x1 to 10x14 inches.
This document describes the TephaFLEX® Meltblown Matrix, a resorbable surgical mesh, and its substantial equivalence to predicate devices, rather than an AI-powered device. Therefore, many of the requested categories related to AI device performance are not applicable.
Here's the information that can be extracted and a clear indication of what is not applicable based on the provided text:
Acceptance Criteria and Device Performance for TephaFLEX® Meltblown Matrix
1. A table of acceptance criteria and the reported device performance
The document establishes "substantial equivalence" to predicate devices as the primary acceptance criterion. Performance is evaluated through comparative mechanical testing and in vivo animal testing against these predicates. While specific quantitative acceptance criteria values are not explicitly stated, the conclusion is that the new device is "Substantially Equivalent" to the predicates.
| Characteristic | Acceptance Criterion (Based on Predicate Devices) | Reported Device Performance (TephaFLEX® Meltblown Matrix) |
|---|---|---|
| Suture Pullout Strength | Substantially Equivalent to predicate devices (TephaFLEX® Mesh, Cook Biodesign Surgisis, MAST Biosurgery Surgi-Wrap) | Substantially Equivalent |
| Tensile Strength | Substantially Equivalent to predicate devices (TephaFLEX® Mesh, Cook Biodesign Surgisis, MAST Biosurgery Surgi-Wrap) | Substantially Equivalent |
| Burst Strength | Characterized comparably to predicate devices | Data collected determined product to be substantially equivalent |
| Tear Resistance Strength | Characterized comparably to predicate devices | Data collected determined product to be substantially equivalent |
| In vivo Strength Retention | Characterized via subcutaneous implantation study comparable to predicate devices | Data collected determined product to be substantially equivalent |
| Biocompatibility | In compliance with applicable parts of FDA's Class II Special Controls Guidance Document for Absorbable Poly(hydroxybutyrate) Surgical Suture | Performed and in compliance |
| Absorption Profile | Essentially complete within 12-18 months (similar to TephaFLEX Mesh and MAST Biosurgery's Surgi-Wrap) | Absorption essentially complete within 12-18 months |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Mechanical testing, biocompatibility testing, and in vivo animal testing" were performed. However, specific sample sizes for these tests are not provided. The provenance of the data (country of origin, retrospective/prospective) is also not specified.
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 relates to AI interpretation or expert consensus on clinical data. For this device, "ground truth" would be established through physical and biological testing parameters, likely overseen by engineers, material scientists, and animal study veterinarians. The document does not specify the number or qualifications of individuals involved in generating or interpreting these test results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for evaluating the physical properties of a surgical mesh.
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
Not applicable. This document describes a medical device (surgical mesh), not an AI algorithm. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes a medical device (surgical mesh), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on standardized mechanical property measurements and in vivo animal study observations, compared against the performance of legally marketed predicate devices. This is a scientific and engineering ground truth, not a clinical ground truth established by expert consensus, pathology, or outcomes data in humans.
8. The sample size for the training set
Not applicable. This document describes a medical device, not an AI algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of medical device.
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