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The Reprocessed MyoSure Tissue Removal Device (Model # 10-401/10-403) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.

The Reprocessed MyoSure REACH Tissue Removal Device (Model # 10-401FC/10-403FC) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.

The Reprocessed MyoSure LITE Tissue Removal Device (Model # 30-401LITE) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.

The Reprocessed MyoSure XL Tissue Removal Device (Model # 50-501XL/50-503XL) is indicated for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retain products of conception.

The Reprocessed MyoSure XL Tissue Removal Device for Fluent (Model # 50-601XL/50-603XL) is indicated for intrauterine use by trained gynecologically resect and remove tissue such as: submucous myomas. endometrial polyps, and retain products of conception.

The Reprocessed MyoSure Tissue Removal Devices are sterile, disposable, hand-held tissue removal devices that are used to hysteroscopically remove intrauterine tissue. The devices are connected via a 6-foot (1.8-meter) flexible drive shaft to a motorized control unit. A foot pedal allows the user to control the cutting action of the tissue removal device by turning the motor in the control unit on and off. The proximal end of the 10-foot (3-meter) vacuum tubing is connected to a collection canister. The devices use mechanical resection by drawing the tissue through the cutting window under suction, while the inner blade simultaneously rotates and reciprocates to cut the tissue.

The provided text describes the regulatory clearance for reprocessed MyoSure Tissue Removal Devices (K201756). The clearance is based on demonstrating substantial equivalence to predicate devices, supported by performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative, pass/fail format. Instead, it lists general categories of performance testing and states that the devices comply or demonstrate effectiveness without providing specific numerical thresholds or outcomes for each test.

However, based on the listed "Functional Performance" tests, we can infer general performance areas. The reported device performance is broadly stated as: "The results of the evaluations demonstrate that the Reprocessed MyoSure Tissue Removal Devices effectively cut and resect tissue in accordance with the intended use." and "The results of bench testing and laboratory evaluations demonstrate that the Reprocessed MyoSure Tissue Removal Devices are at least as safe and effective and perform as well as the identified legally marketed predicate devices as described herein."

Here's an inferred table based on the functional performance tests and general statements:

Important Note: The document does not provide specific numerical acceptance thresholds (e.g., "Shaft deflection must be < X mm") nor quantitative results ("Shaft deflection observed was Y mm"). It only states that the device meets criteria "in accordance with" or "demonstrates effective" performance.

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

The document does not specify the sample size for any of the tests conducted. It refers to "bench and laboratory testing" but provides no numerical count of devices tested.

The data provenance is implied to be from laboratory and bench testing conducted by Stryker Sustainability Solutions. Specific details regarding the country of origin of the data or whether it was retrospective or prospective are not mentioned, though "bench and laboratory testing" typically implies controlled, prospective testing in a lab environment.

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

This information is not provided in the document. The studies described are primarily bench and laboratory performance tests, not clinical studies involving human patients or expert review of clinical data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or clinical diagnosis doesn't apply directly here. The "ground truth" for these engineering tests would be derived from the physical properties and performance metrics of the devices themselves, measured against engineering specifications.

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

The document does not mention any adjudication method. This is expected as the studies are engineering/bench tests rather than clinical studies requiring expert consensus on subjective 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 MRMC comparative effectiveness study was done or mentioned. This device is a reprocessed tissue removal device, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this product.

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

This question is not applicable as the device is a physical medical instrument, not an algorithm or AI. The tests conducted are "standalone" in the sense that they evaluate the device's intrinsic mechanical, material, and functional properties.

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

For the "Functional Performance" tests (e.g., shaft deflection, torque, tissue cutting and removal), the ground truth is based on engineering specifications, physical measurements, and the device's ability to mechanically perform its indicated function (i.e., effectively cut and resect tissue). For biocompatibility, sterilization, and electrical safety, the ground truth is compliance with recognized international and national standards and guidance documents (e.g., ISO 10993-1, ANSI/AAMI/ISO 11135-1, IEC 60601-1).

8. The sample size for the training set

The document does not refer to a training set as this is not an AI/machine learning device.

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

This question is not applicable as there is no training set for this device.

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