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FortaGen is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.

FortaGen consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 5 x 5 cm to 12 x 36 cm in sterile double layer peelable packaging.

The provided text describes a medical device called FortaGen™ Surgical Mesh and its clearance by the FDA based on substantial equivalence to predicate devices. However, the information provided does not contain details about specific acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of performance data against specific metrics.

The document states:

• "FortaGen was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests." This is a general statement that tests were conducted and passed, but no specific criteria, results, or study details are provided.
• The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which implies that it meets the safety and efficacy standards demonstrated by those predicates. However, it doesn't detail what specific performance metrics constitute substantial equivalence or how FortaGen™'s performance was directly compared against them in a structured study report.

Therefore, I cannot populate the requested table or answer most of the specific questions about the study design as the information is not present in the provided text.

Based on the available information, here's what can be extracted:

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

   Acceptance Criteria	Reported Device Performance
   Biocompatibility requirements	Device passed all tests
   Integrity requirements	Device passed all tests
   Performance requirements	Device passed all tests
   Substantial Equivalence to predicate devices (GraftPatch (K970561) and Surgisis (K980431))	Determined to be substantially equivalent by FDA

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only states "FortaGen was subjected to a panel of tests."

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

   • Not specified. The document does not describe a process involving experts establishing ground truth for a test set. This type of information is typically relevant for diagnostic devices or AI-assisted systems, which this surgical mesh is not.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. Adjudication methods are typically used in clinical studies with human interpretation, which is not described here for the device's technical assessment.

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 device is a surgical mesh, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with/without AI assistance would not be performed for this product.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the device's performance tests (biocompatibility, integrity, performance), the ground truth would be established by validated test methods and established standards/specifications for medical devices, rather than expert consensus on diagnostic images or pathology. The document does not specify the exact methods or standards used for these tests.

8. The sample size for the training set:

   • Not applicable. This is a physical surgical mesh, not an AI model that requires a training set.

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

   • Not applicable. This is a physical surgical mesh, not an AI model.

In summary, the provided text indicates that the FortaGen™ Surgical Mesh passed a panel of tests for biocompatibility, integrity, and performance and was deemed substantially equivalent to predicate devices by the FDA. However, it does not offer the granular detail requested about specific acceptance criteria values, study designs, sample sizes, or methods for establishing ground truth, which are more typically provided for diagnostic devices or those involving interpretation of data.

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FortaFlex™ Surgical Mesh is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or sutere anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one-time use.

FortaFlex Surgical Mesh consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 5 x 5 cm to 12 x 36 cm in sterile double layer peelable packaging.

The provided text describes the FortaFlex™ Surgical Mesh, a Class II device intended for soft tissue reinforcement. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Performance Data" section merely states: "FortaFlex Surgical Mesh was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests." This is a high-level statement without any specific details of the tests, their acceptance criteria, or the actual results.

The 510(k) process focuses on demonstrating similarity to an already approved device. The FDA's letter confirms substantial equivalence, which means they believe the new device is as safe and effective as the predicate device(s) for the stated indications, based on similar technological characteristics, materials, and intended use as presented in the submission. It does not involve proving the device meets specific new performance acceptance criteria through the kind of study described in the prompt.

Ask a specific question about this device

Ask a specific question about this device