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Vertessa™ Lite may be used for the repair of uterine or vaginal vault prolapse that require support material. It may be used in open or lagaroscopic abdominal procedures.

Vertessa™ Lite devices are designed to be used in women suffering from uterine or vaginal vault prolapse and are implanted or affixed using suture of the surgeon's choice. Vertessa™ Lite devices are provided sterile and are comprised of macroporous monofilament polypropylene warp knit blue mesh. Vertessa™ Lite will be available in a two rectangular flat sheet mesh designs.

The provided text is a 510(k) summary for the Vertessa™ Lite surgical mesh. It describes the device, its intended use, technological characteristics, and demonstrates substantial equivalence to a predicate device through performance testing. However, it does not describe a study involving an AI/CADe device or any sort of "device performance" in terms of clinical outcomes, diagnostic accuracy, or human reader improvement with AI.

Therefore, I cannot directly answer your prompt's specific questions regarding acceptance criteria and a study proving device performance in the context of an AI/CADe device. The document is for a medical device (surgical mesh), not an AI system.

However, I can extract the information related to the acceptance criteria and performance summary for the surgical mesh itself, as described in the 510(k) summary. I will present this information in a way that aligns with your prompt structure, while noting the difference in device type.

Device Type: Surgical Mesh (Vertessa™ Lite) - NOT an AI/CADe device.
Premarket Submission Number: K123337

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vertessa™ Lite surgical mesh were based on demonstrating substantial equivalence to its predicate device, Vertessa™ (K120327). This was achieved by assessing various mesh characteristics against established standards and guidelines.

Study Proving Device Meets Acceptance Criteria:

The study referenced is a series of "mechanical bench and validation testing" and other compliance tests (biocompatibility, sterility, accelerated aging) conducted on the Vertessa™ Lite device. This testing was performed to demonstrate "function equivalence based upon key device characteristics and its intended use to the predicate device, Vertessa™."

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

• Sample Size: Not explicitly stated in terms of a specific number of units for each test. The summary indicates "results from testing," implying that a sufficient number of samples were tested to demonstrate equivalence.
• Data Provenance: The tests were conducted by Caldera Medical, Inc. (the manufacturer). This is internal testing data. The country of origin of the data is implicitly the United States, as Caldera Medical, Inc. is located in Agoura Hills, CA. The nature of the data is prospective, as it involves newly manufactured devices undergoing specific tests.

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

• Not Applicable: This is a physical medical device (surgical mesh), not a diagnostic or AI device that requires expert ground truth for its performance assessment. The "ground truth" for these tests is based on objective measurements against established engineering standards and regulations, and comparison to the predicate device.

4. Adjudication method for the test set

• Not Applicable: As this is primarily bench testing against objective physical/chemical properties and regulatory standards, an adjudication method for a "test set" (in the sense of a clinical or image-based study) is not relevant.

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 is not an AI-assisted diagnostic device. Therefore, no MRMC study, human reader improvement with AI, or effect size is relevant or mentioned.

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

• Not Applicable: This device is a surgical mesh; it does not involve algorithms or AI.

7. The type of ground truth used

• The "ground truth" for the performance evaluation of the surgical mesh was based on:
  • Objective physical and mechanical properties: Measured values (e.g., tensile strength, pore size, thickness) compared against the predicate device and potentially industry standards.
  • Regulatory standards and guidance: Compliance with FDA guidance for surgical mesh characteristics, biocompatibility (ISO-10993), sterility (FDA Guidance K90-1), and accelerated aging (ASTM F-1980-07).
  • Predicate device characteristics: The characteristics of the legally marketed predicate device, Vertessa™ (K120327), served as the benchmark for demonstrating "substantial equivalence."

8. The sample size for the training set

• Not Applicable: This is not an AI/ML device where a "training set" in the computational sense would be used.

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

• Not Applicable: See point 8.

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