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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

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