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510(k) Data Aggregation
(183 days)
The Phasix™ Mesh is indicated to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery. or for use in procedures involving soft tissue repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
The proposed Phasix™ Mesh utilizes a fully resorbable poly-4-hydroxybutyrate (P4HB) polymer material. The P4HB is produced from a naturally occurring monomer and is processed into monofilament fiber then knitted into a surgical mesh. The Phasix™ Mesh is packaged individually as a sterile, single flat mesh available in several rectangular sizes and one small circle. Phasix™ Mesh provides immediate short term support and provides a scaffold that enables tissue in-growth over time while the mesh predictably and gradually degrades via hydrolysis and a hydrolytic enzymatic digestive process. Preclinical implantation studies indicate that Phasix™ Mesh retains approximately 70% of its strength at 12 weeks. Absorption of the mesh material will be essentially complete within 12 to 18 months.
This document describes the premarket notification for the Phasix™ Mesh, a surgical mesh, and its comparison to a predicate device, the TephaFLEX® Mesh. The submission focuses on demonstrating substantial equivalence rather than presenting an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and study design are not applicable to this document.
Here's an attempt to answer the questions based on the provided text, noting where information is not available due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Phasix™ Mesh) |
|---|---|
| Mesh weave characteristics comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Mesh pore size comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Mesh density comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Mesh thickness comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Device stiffness comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Burst strength comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Tear resistance comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Suture pullout strength comparable to predicate TephaFLEX® Mesh | Same as predicate TephaFLEX® Mesh |
| Cytotoxicity met acceptance criteria | Passing results |
| Biocompatibility (Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Genotoxicity, Chronic Toxicity, Implantation, Haemocompatibility) met acceptance criteria | All met acceptance criteria (leveraged from predicate) |
| Resorption profile (retains approx. 70% strength at 12 weeks, complete within 12-18 months) | Same as predicate TephaFLEX® Mesh (leveraged from predicate) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Testing: The document does not specify the exact sample sizes for each bench test. It states "Bench testing was performed to compare the proposed Phasix™ Mesh to the predicate TephaFLEX® Mesh."
- Biocompatibility/Animal Studies: The data was largely leveraged from the predicate device (TephaFLEX® Mesh), which was FDA cleared. Specific sample sizes for these studies are not detailed in this document. The provenance is implied through FDA clearance and adherence to international and FDA guidance documents. These were likely prospective studies conducted for the predicate.
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)
This is not applicable as the device is a surgical mesh, not an AI/ML diagnostic tool. Ground truth in this context would refer to objective material properties and biological responses, measured through standardized tests, rather than expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the device is a surgical mesh and no expert adjudication for a test set is mentioned or relevant to its evaluation for substantial equivalence.
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
This is not applicable as the device is a surgical mesh and not an AI-assisted diagnostic or intervention system. No human readers or AI assistance are involved in its primary function or evaluation for this premarket notification.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a surgical mesh and not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's evaluation is based on:
- Objective Material Properties: Measurements of mesh weave characteristics, pore size, density, thickness, stiffness, burst strength, tear resistance, and suture pullout strength.
- Biocompatibility Standards: Results demonstrating adherence to ISO 10993 standards for various biological responses (cytotoxicity, sensitization, systemic toxicity, etc.).
- In vivo Animal Study Data: Characterization of mechanical strength retention and resorption profile.
- Comparison to Predicate: Demonstrating equivalence to a legally marketed predicate device (TephaFLEX® Mesh) with an established safety and effectiveness profile.
8. The sample size for the training set
This is not applicable as there is no "training set" in the context of an AI/ML powered device. The evaluation is based on in vitro and in vivo testing of the physical device.
9. How the ground truth for the training set was established
This is not applicable as there is no "training set." The ground truth for the evaluation was established through standardized testing procedures, leveraging data from the predicate device that had undergone similar rigorous testing and obtained FDA clearance.
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(88 days)
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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