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The PK Morcellator is intended for cutting, and extracting tissue in laparoscopic gynecologic procedures. It is recommended to use the PK Morcellator in containment device (WA90500US) for removal of uterine tissue.

The proposed PK Morcellator is configured in an ergonomically friendly pistol grip configuration, and includes an axially oriented hollow shaft. The pistol grip integrates the electrical connection cable that allows bipolar RF energy to be supplied by the electrosurgical generator to the tissue site located at the distal end of the hollow shaft. The design of the pistol grip body is such that a clinician mav utilize a "ski-pole" grip on the Morcellator body, if that is their preference. The proposed PK Morcellator incorporates an improved smoke evacuation system to provide improved visibility during procedures. Smoke management can alternate between intermittent or constant by activating a trigger lock on the handle.

The hollow shaft of the Morcellator has an operative length of approximately 15 cm, extending distally from the pistol grip body. The surface of the Morcellator shaft is smooth, allowing the device to be introduced to the operative site through a trocar cannula seal, or with the use of the optional obturator, through an abdominal port. To facilitate optimal placement of the device during laparoscopic procedures, a depth stop normally located at the distal end of the pistol grip (at the junction of the pistol grip and Morcellator shaft), may be moved distally along the Morcellator shaft. The shaft has a nominal outer diameter of 15 mm. and a nominal inner diameter of 12 mm. The proximal end of the shaft also includes an elastomeric reducer that permits the passage of a grasper to the operative site and removal of tissue from the operative site, while preventing loss of pnuemoperitoneum.

The provided text describes the Gyrus ACMI, Inc. PK Morcellator (K161038) and its substantial equivalence to a predicate device. The information details non-clinical testing performed to demonstrate the device's safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

The provided document lists numerous non-clinical bench tests with objectives that serve as acceptance criteria. The text then states, "Performance testing summarized above demonstrates that the proposed PK Morcellator is substantially equivalent to the predicate device," implying that the device met these criteria. However, explicit numerical results for each test against the criteria are generally not provided in this 510(k) summary, which typically focuses on demonstrating equivalence rather than detailed pass/fail reports for every single test.

Below is a table summarizing some of the listed objectives as acceptance criteria. Since specific performance data (e.g., exact force values, flow rates) are not explicitly reported in the summary but rather affirmed as met, the "Reported Device Performance" column reflects this general confirmation of meeting the objectives.

Additional Requested Information:

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

• Sample Size for Test Set: Not explicitly stated as a numerical count for each test in human-related terms. For bench testing, the "samples" would typically refer to the number of devices tested for each condition. The document mentions "bovine tongue was selected as the tissue model for the PK Morcellator representing normal uterine tissue along with porcine/bovine blood" and "a porcine model" for usability/containment testing. No specific number of tissue samples or animals tested is provided.
• Data Provenance: The document implies the tests were conducted by Gyrus Medical Ltd. (Cardiff, United Kingdom) and Gyrus ACMI, Inc. (Southborough, MA, USA), as these are the entities associated with the device. The data is prospective, generated specifically for this 510(k) submission.

2. 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)

• The document mentions "Usability evaluation included surgeons with varying levels of experience" for user feedback and "trained laparoscopists with a range of experience" for containment system compatibility testing. However, it does not specify the number of experts, their qualifications (e.g., years of experience, specific board certifications), or how they established a "ground truth" in the traditional sense of diagnostic accuracy. Their input was more related to device usability and functional performance in a simulated clinical setting.

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

• This is not applicable as the studies described are primarily non-clinical bench and usability tests, not diagnostic accuracy studies requiring expert adjudication methods like 2+1 or 3+1 for ground truth establishment. Expert feedback was used for usability, but not in a formal adjudication process for diagnostic ground truth.

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

• No MRMC comparative effectiveness study was done. This document is for a medical device (morcellator), not an AI diagnostic algorithm, so such a study design is not relevant.

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

• Not applicable. This is for a medical device, not an algorithm.

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

• For the bench testing, the "ground truth" or reference for performance was based on engineering specifications and acceptable functional parameters (e.g., maximum temperature, minimum force, maximum leakage).
• For usability and compatibility, the "ground truth" was expert feedback and visual/functional assessment against predetermined acceptance criteria related to ease of use, deployment, and performance within a containment system. There was no pathological or outcomes "ground truth" in the diagnostic sense.

7. The sample size for the training set

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

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

• Not applicable as there is no training set for an AI/machine learning algorithm.

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