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The Insightra Freedom Ventral Hernia Repair System is intended for use in the open repair of ventral hernias.

The Insightra Ventral Hernia Repair System is composed of a polypropylene woven mesh implant and a disposable Strap Passer accessory that is used during the surgical implantation. The mesh implant is an oval shape with 8 straps that extend radially from the oval portion. The straps are used to secure the mesh to the implantation site, similar to traditional methods such as suturing or stapling. During the implantation procedure, the straps are then trimmed below the skin and become incorporated in the muscle tissue.

The provided text describes the Insightra Freedom Ventral Hernia Repair System, a surgical mesh device. However, it does not include detailed "acceptance criteria" for the device's performance in terms of specific metrics (like sensitivity, specificity, accuracy, or recurrence rates with statistical targets) nor does it delineate a formal study with a methodology typically associated with establishing such criteria.

Instead, the document highlights biocompatibility testing and bench testing, as well as a "simulated use" animal study, to demonstrate safety and effectiveness in support of a 510(k) submission, confirming substantial equivalence to predicate devices.

Therefore, many of the requested sections regarding acceptance criteria, performance tables, sample sizes for test/training sets, expert qualifications, and adjudication methods cannot be fully answered from the provided text.

Here's a breakdown of what can be extracted and what is missing:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size:
  • For biocompatibility testing, the sample size is not specified.
  • For bench testing, the sample size is not specified.
  • For the in vivo simulated use animal test, the sample size (number of animals) is not specified.
• Data Provenance: Not specified, but the animal testing was performed "per GLP requirements."

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 as this is a medical device for surgical repair, not an AI/diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical performance and biological response of the mesh based on engineering and biological tests.

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

• Not applicable for this type of device and testing. The evaluation relies on standardized test methods and observations of physical and biological outcomes.

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, this is not an AI-assisted diagnostic device. The document does not describe any MRMC studies or AI assistance.

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

• Not applicable as this is a surgical mesh device, not an algorithm or AI system.

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

• The "ground truth" for this device's evaluation is primarily established through:
  • Biocompatibility Standards: Adherence to ISO 10993-1.
  • Engineering Specifications: Meeting predefined product specifications derived from design requirements.
  • Simulated Use Observations: Performance observed in in vivo simulated use experiments (animal study) to assess physical attributes like deployment, securement, and general surgical utility.
  • Comparative Analysis: Demonstrating substantial equivalence to predicate devices, implying similar safety and effectiveness profiles as established by the predicate devices' historical performance.
  • Clinical Observations (implied): Phrases like "effective in terms of recurrence rates, lack of migration and acute pain rates" suggest a general understanding of desired clinical outcomes, though no specific clinical study data is provided in this summary.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI-driven device that requires a training set.

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

• Not applicable.

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