Search Results

TephaFLEX mesh is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

The TephaFLEX mesh is a resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB). The mesh is prepared from non-dyed or dyed (D&C Violet #2) monofilament P4HB fiber that is knitted into a surgical mesh. It is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application.

This is a medical device submission (K113723) for TephaFLEX® Mesh, which is a surgical mesh. The provided document does not describe an AI/ML powered device, but rather a traditional medical device that undergoes mechanical and biological testing for safety and performance. Therefore, many of the requested fields related to AI/ML device studies will not be applicable.

Here's the breakdown of the information as it relates to the provided document:

Acceptance Criteria and Device Performance

The "Safety and Performance" section states that "Mechanical testing, in vivo animal testing, and biocompatibility testing, were performed based on recommendations identified in the FDA surgical mesh guidance document." The conclusion is that the mesh was determined to be "substantially equivalent to the predicate devices."

The specific acceptance criteria are not explicitly detailed in quantifiable targets within the provided summary, but rather by comparison to predicate devices and established guidance. The reported performance is that the device met these comparative standards.

Study Details (as applicable)

Since this is a traditional medical device and not an AI/ML device, many of the requested fields are not applicable.

1. Sample sizes used for the test set and the data provenance:

   • The document mentions "in vivo animal testing" (subcutaneous implantation study) and "mechanical testing." Specific sample sizes for these tests are not provided in this summary.
   • Data provenance (e.g., country of origin, retrospective/prospective) is not specified.

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

   • Not applicable as this is not an AI/ML device relying on expert-established ground truth from images or data. The testing involves physical and biological evaluations.

3. Adjudication method for the test set:

   • Not applicable. The testing methods for mechanical and in vivo studies would follow standard scientific protocols for data collection and analysis, not expert adjudication in the context of diagnostic interpretation.

4. 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 is not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device.

6. The type of ground truth used:

   • For mechanical testing: The "ground truth" would be the direct physical measurement of properties like burst strength, tensile strength, etc., compared against specified benchmarks or predicate device performance.
   • For in vivo animal testing: The "ground truth" would be the observed biological response and strength retention in the animal model, again compared to expected outcomes or predicate device performance.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that uses a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device that uses a training set.

Ask a specific question about this device

The TephaFLEX® mesh is intended to reinforce soft tissue where weakness exists in patients undergoing plastic and reconstructive surgery, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desire surgical result.

The TephaFLEX mesh is a resorbable mesh prepared from poly-4- hydroxybutyrate (P4HB). The mesh is prepared from undyed, size 5-0 monofilament P4HB fiber that is knitted into a surgical mesh. It is provided in single sheets of varying widths and lengths and may be cut to the shape or size desired for a specific application.

Here's a breakdown of the acceptance criteria and study information for the TephaFLEX® Mesh, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in numerical or precise terms. Instead, it relies on a comparison to predicate devices and general performance characteristics. The study aimed to demonstrate "substantial equivalence" to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• The document does not specify the sample size for any of the mechanical or in vivo tests.
• The data provenance is also not specified (e.g., country of origin, retrospective or prospective). The in vivo study is explicitly an animal study (subcutaneous implantation study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• This information is not applicable as the studies are primarily mechanical and in vivo animal studies, not human clinical trials requiring expert ground truth for interpretation of images or patient outcomes. The "ground truth" for these tests would be the measurement results themselves against scientific standards or predicate device results.

4. Adjudication Method for the Test Set

• This information is not applicable for the type of tests described (mechanical and animal in vivo studies). Adjudication methods are typically used in clinical studies for ambiguous cases, which is not the context here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, an MRMC comparative effectiveness study was not done. The document describes mechanical testing and an in vivo animal study, not human reader studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable as the device is a physical surgical mesh, not an algorithm or AI-powered diagnostic tool. The performance described is that of the physical device itself.

7. The Type of Ground Truth Used

• For mechanical properties, the ground truth appears to be direct physical measurements (e.g., burst strength, tensile strength, suture pull-out force, tear resistance). These measurements would be compared against values obtained from predicate devices to establish substantial equivalence.
• For in vivo strength retention, the ground truth was derived from the results of a subcutaneous implantation animal study. This would involve measuring the mesh's integrity and strength after a period of implantation in animals.

8. The Sample Size for the Training Set

• This information is not applicable as the device is a physical surgical mesh and does not involve AI or machine learning algorithms that require training sets.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable as there is no training set for this type of device.

In summary: The provided documentation describes a 510(k) submission for a surgical mesh. The "studies" involve mechanical characterization and an in vivo animal study to demonstrate substantial equivalence to legally marketed predicate devices, rather than human clinical trials or AI performance evaluations. Therefore, many of the requested categories related to AI and human reader studies are not relevant to this specific document.

Ask a specific question about this device