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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, processed into monofilament fiber, and then knitted into a surgical mesh. Phasix™ Mesh is packaged individually as a sterile, single, flat mesh available in a wide range of shapes and sizes. Phasix™ Mesh provides immediate short-term support, and 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 is essentially complete within 12 to 18 months.

The provided document is a 510(k) Premarket Notification for a medical device called Phasix™ Mesh. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing detailed acceptance criteria and a study to prove a device meets those criteria from scratch.

Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training data, etc., is not available within this type of regulatory submission. This document highlights that the proposed device is so similar to an already approved device that extensive new studies are not required.

Here's how to interpret the document in the context of your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The "acceptance criteria" here are implicitly that the proposed Phasix™ Mesh performs similarly or equivalently to the predicate Phasix™ Mesh (K142818) across various physical and biological characteristics. The FDA's substantial equivalence determination means they accepted that the proposed device is just as safe and effective as the predicate.
• Reported Device Performance: The document states that "The proposed Phasix™ Mesh demonstrated equivalent performance in comparison to the predicate device" for the following non-clinical tests:
  • Mesh thickness
  • Mesh knit construction
  • Mesh pore size
  • Mesh density
  • Tensile strength
  • Device stiffness
  • Suture pullout strength
  • Burst strength
  • Tear resistance
• Specific performance values are NOT provided. The document only states "equivalent performance," implying that the results fell within acceptable ranges or were statistically comparable to the predicate.

2. Sample size used for the test set and the data provenance

• Test Set (Bench Testing): The specific sample sizes for the bench tests listed above are not reported in this summary.
• Data Provenance: The bench testing was conducted by the manufacturer, C.R. Bard, Inc. (Davol Inc. is the submitter). The country of origin for the data is not specified but would typically be the location of the manufacturing and testing facilities. These appear to be retrospective tests designed to compare the proposed device to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. For this type of physical/mechanical performance testing, "ground truth" is established through standardized engineering and materials science methods, not expert consensus in the clinical sense.

4. Adjudication method for the test set

• Not applicable. Adjudication is typically for clinical or interpretative tasks, not for objective physical measurements.

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 MRMC study was done. This device is a surgical mesh, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a surgical mesh, not an algorithm.

7. The type of ground truth used

• For the bench tests, the "ground truth" is the objective measurement (e.g., actual mesh thickness, measured tensile strength) derived from standardized test methods.
• For biocompatibility and in-vivo studies, the "ground truth" is established through the results of standardized biological and animal tests. In this case, previous studies for the predicate device (K142818) were adopted because the proposed device uses the same materials and knit characteristics. These previous studies would have established biocompatibility based on ISO 10993-1 and characterized mechanical strength and resorption profiles in animal models.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that would require a "training set."

9. How the ground truth for the training set was established

• Not applicable.

In summary: This document is a regulatory submission for a device seeking substantial equivalence to a predicate. It relies heavily on the fact that the proposed device uses almost identical technology and materials as an already-approved device, therefore adopting prior testing results rather than generating entirely new, extensive clinical or comparative effectiveness data. The "acceptance criteria" are effectively that the new device's physical and biological properties are equivalent to the predicate, as demonstrated through bench testing and by leveraging prior biocompatibility and animal study data.

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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

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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