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The Myosure Hysteroscopic Tissue Removal System is intended for hysteroscopic intrauterine procedures by a trained gynecologist to resect and remove tissue including submucous myomas and endometrial polyps.

The modified Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the predicate Myosure System: Myosure Control Unit, Myosure Tissue Removal Device, Myosure Foot Pedal. The Myosure Control Unit contains an electric motor and software controller that drives the Myosure Tissue Removal Device. The Control Unit motor is activated by the Myosure Foot Pedal. The Myosure Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The morcellator's cutter blade is controlled by a drive system that enables simultaneous rotation and reciprocation of the cutter. The cutter is also connected to a vacuum source which aspirates resected tissue through a side-facing cutting window in the device's outer tube. Distension fluid and resected tissue are transported from the Myosure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The Myosure Hysteroscopic Tissue Removal System is compatible with commercially available fluid management systems and may be used with hysteroscopes that have a straight 3 mm working channel.

This document describes a 510(k) summary for a modified MyoSure Tissue Removal Device. This is not a device that uses AI or machine learning. The performance testing described is for a physical medical device, specifically its cutting functionality and heat generation, compared to a predicate device. Therefore, many of the requested criteria related to AI/ML model evaluation (such as sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission.

Here's the information that can be extracted from the provided text, focusing on the mechanical and functional aspects of the device comparison:

Acceptance Criteria and Device Performance (for a Mechanical Medical Device)

Study Details (as applicable to a physical device modification)

• Sample size used for the test set and the data provenance: Not explicitly stated as a number of subjects or samples. The testing methodology was "the same methodology as was used in support of the predicate Myosure System 510(k) submission (K100559)". This implies in-vitro or bench testing, comparing the performance characteristics of the modified device against the predicate.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this would be established through objective measurements (e.g., cutting efficiency metrics, temperature readings, durability cycles) rather than expert interpretation of images or data.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As this is mechanical performance testing, there's no "adjudication" in the sense of reconciling subjective expert opinions.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. MRMC studies are used for evaluating the impact of diagnostic aids on human readers' performance, typically in imaging. This is a surgical tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical, user-operated device, not an algorithm. The "standalone" performance here refers to the device's inherent mechanical capabilities.
• The type of ground truth used: For cutting performance, it would be quantitative metrics of tissue resection rate or efficiency. For durability, it would be the number of cycles to failure or maintenance of performance over a specified number of uses. For heat generation, it would be temperature measurements at specific points. These are objective engineering measurements.
• The sample size for the training set: Not applicable. This is a physical device, not an AI/ML model that requires training data.
• How the ground truth for the training set was established: Not applicable. As above, no training set for an AI/ML model.

Summary of the Study:
The study was a performance verification testing comparing a modified MyoSure Hysteroscopic Tissue Removal System to its predicate device (K100559). The "study" focused on mechanical performance characteristics such as tissue cutting, cutter durability, and heat generation. The primary goal was to demonstrate equivalence between the modified device and the previously cleared predicate device, rather than establishing absolute performance benchmarks. The testing methodology was identical to that used for the predicate, suggesting a rigorous engineering evaluation rather than a clinical trial or AI model validation.

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