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The GYNECARE Morcellex Tissue Morcellator is intended for gynecologic, urologic and general surgical endoscopic use by trained professionals in hospital environments and ambulatory surgery centers.
The GYNECARE MORCELLEX Tissue Morcellator is indicated for cutting, coring and extracting tissue during operative laparoscopy, including laparoscopic general surgical procedures, laparoscopic urologic procedures, and laparoscopic gynecologic procedures.

The GYNECARE Morcellex Tissue Morcellator is a singlepatient-use device. The device is inserted into the patient with the use of the provided single-patient-use Obturator. The device allows tissue to be grasped with a standard grasping instrument extended through its central lumen. The tissue can be drawn up inside the device's central lumen into the inner stationary sheath as the exposed blade cuts the tissue. The physician can activate the GYNECARE Morcellex Tissue Morcellator via a foot pedal or via the dual-function Blade Guard/Activation Trigger on the device's Detachable Handle. The device can operate in either coring or peeling mode based on the degree of exposure of the blade and placement of the rotatable Coreguard. The device is packaged with a single-patient-use reducer cap to allow the optional use of a 5mm instrument.
The variable-speed, reversible GYNECARE Motor Drive Unit (MDU) drives the rotation of the blade of the GYNECARE Morcellex Tissue Morcellator at a controlled speed and torque after connection of the device to the MDU via the Flexible Drive Cable. An operating room staff member outside of the sterile field controls the direction and speed of rotation on the MDU.

The provided text is a 510(k) summary for the GYNECARE MORCELLEX Tissue Morcellator. It contains information about the device's technical characteristics and intended use, as well as a statement about performance data. However, it does not provide specific acceptance criteria or an in-depth study report with the level of detail requested for AI/medical device performance evaluation.

Here’s a breakdown of why this information is not available in the provided text, and what can be extracted:

• Type of Device: The GYNECARE MORCELLEX Tissue Morcellator is a mechanical surgical device for cutting and extracting tissue, not an AI or diagnostic imaging device. Therefore, the typical metrics and study designs (like sensitivity, specificity, MRMC studies, training/test sets, ground truth establishment by experts, etc.) that apply to AI-based medical devices are not relevant or described here.

• Nature of "Performance Data": The document states: "The bench testing provided in this 510(k) shows that there is less force required to pull simulated tissue through the Morcellex device than is required for the existing device." This is a very high-level summary of a bench test comparing the new device to a predicate device based on a mechanical performance characteristic (force required to pull simulated tissue). It's not a clinical performance study with human subjects, diagnostic accuracy metrics, or AI algorithm evaluation.

Given the limitations of the provided document, I cannot create the table or answer most of the questions as they pertain to AI/diagnostic device performance. However, I can extract the following information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not explicitly state numerical acceptance criteria. The claim is comparative: the new device requires "less force" than the predicate. This implies that "less force" was the performance goal, and achieving it was considered sufficient for substantial equivalence in this aspect.

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

• Sample Size: Not specified. (The term "simulated tissue" suggests a lab/bench test, not clinical data from patients).
• Data Provenance: Bench testing, likely conducted internally by the manufacturer (Ethicon, Inc.). No country of origin for clinical data is applicable as it was simulated tissue.

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

• Not applicable. The "ground truth" for a mechanical force measurement is typically objective, measured by instruments, not established by expert consensus.

4. Adjudication method for the test set:

• Not applicable. This is not a study requiring adjudication of expert opinions.

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 device or a diagnostic device involving human readers.

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

• Not applicable. This is a mechanical surgical device.

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

• Objective measurement of force using simulated tissue, likely defined by engineering specifications.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

Summary of what the document does convey:

• Device: GYNECARE MORCELLEX Tissue Morcellator.
• Predicate Device: GYNECARE X-TRACT Tissue Morcellator.
• Intended Use: Gynecologic, urologic, and general surgical endoscopic use.
• Indications for Use: Cutting, coring, and extracting tissue during operative laparoscopy.
• Technological Characteristics: The modified device has the same technological characteristics as the predicate device (form, fit, function, method of operation are similar).
• Performance Claim: Bench testing showed "less force required to pull simulated tissue through the Morcellex device than is required for the existing device."
• Conclusion: The device is substantially equivalent to the predicate.

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