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The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures.

The i-Cut is a single use laparoscopic power morcellator. It is provided sterile.

The i-Cut consists of a rotating cutting tube with a trocar that provides protection against the cutting blade when locked in the "CLOSED" position. The device comes with an obturator for placement into the patient's body and a locking clip that keeps the trocar in the "closed" position during insertion. The activation button must be pressed to cut tissue.

The lumen of the device is designed for use with a standard grasper or Tenaculum forceps with a diameter between 10 to 14 mm. The i-Cut is designed to be used with surgical instruments of diameters between 10 to 14 mm. The lumen is fitted with a silicone valve to prevent gas loss during use of the device.

The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.

This 510(k) clearance letter pertains to the i-Cut, a single-use laparoscopic power morcellator. The provided text details regulatory information, device description, indications for use, and non-clinical performance testing. However, it does not include information about clinical studies with human participants, acceptance criteria tables, sample sizes for test sets (in the context of clinical performance), expert ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.

The document primarily focuses on non-clinical bench testing to demonstrate substantial equivalence to a predicate device (LiNA eXcise, K101458). Therefore, I cannot address most of the requested points related to clinical study acceptance criteria and performance as this information is not present in the provided text.

Here's an analysis of what can be extracted from the provided text, and where gaps exist:

Preamble:

The provided 510(k) clearance letter for the i-Cut device focuses on demonstrating substantial equivalence through non-clinical performance testing (bench testing) rather than clinical trials with human participants. Therefore, many of the requested details pertaining to clinical study design, human reader performance, and expert consensus for ground truth are not present in this document. The "acceptance criteria" and "device performance" discussed here apply to the bench testing conducted, not clinical outcomes in human subjects.

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

Based on the provided non-clinical performance testing section, we can infer some "acceptance criteria" as implied by the successful completion of each test. The "reported device performance" is generally stated as "passed" or "met requirements." No numerical data for specific criteria are provided beyond the stated specifications (e.g., cutting rate, speed).

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

• Sample Size: The document does not specify the sample sizes (e.g., number of devices, number of tests) for each of the non-clinical performance tests. It only states that the tests were performed and passed.
• Data Provenance: The data provenance is from non-clinical bench testing conducted by the manufacturer, A.M.I. Agency for Medical Innovations GmbH. The country of origin of the manufacturer is Austria. This data is inherently prospective as it involves new testing for the device's clearance.

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

Not applicable. This was a non-clinical bench testing study. "Ground truth" in this context pertains to engineering specifications and performance metrics rather than clinical diagnoses established by medical experts. Usability testing involved "surgeons of different experience with laparoscopic morcellators," but it was to assess device compatibility and integrity, not to establish a clinical ground truth for a diagnostic AI.

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

Not applicable. This was a non-clinical bench testing study. Adjudication methods are typically used in clinical studies where multiple human readers interpret data to establish a consensus ground truth.

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. No MRMC comparative effectiveness study was performed or described. The clearance is based on substantial equivalence demonstrated through non-clinical bench testing. The device is a physical surgical tool, not an AI.

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

Not applicable. This device is a physical surgical tool and does not employ a standalone algorithm for diagnostic or interpretative purposes.

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

For non-clinical bench testing, the "ground truth" is defined by engineering specifications, regulatory standards (e.g., ISO, ASTM, IEC), and predefined pass/fail criteria for device performance (e.g., measuring force, checking for wear, verifying electrical safety compliance). There is no "expert consensus" or "pathology" in the medical sense for these tests.

8. The sample size for the training set

Not applicable. This device is a mechanical/electrical surgical tool, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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