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The MyoSure MANUAL Tissue Removal Device is intended for intrauterine use by a trained gynecologist to hysteroscopically resect and remove tissue, including focal lesions such as endometrial polyps and retained products of conception.

The MyoSure MANUAL Tissue Removal Device is a single-use device that is intended for the resection and removal of tissue under hysteroscopic visualization. It is sterile, non-powered, and hand-actuated. It is compatible with the MyoSure hysteroscope and can be used in either an office or an operating room setting. The MyoSure MANUAL Tissue Removal Device is packaged with an accessory inflow tube to facilitate delivery of distention media. The inflow tube contains a bag spike, a tube and a luer connection to the hysteroscope. The MyoSure MANUAL Tissue Removal Device incorporates a rotating outer tube with a side facing cutting window and inner reciprocating cutting blade. A removable in-line tissue trap collects the excised tissue. An Outflow tube transfers and directs the waste fluid into a buttock drape.

The provided text describes a 510(k) summary for the MyoSure MANUAL Tissue Removal Device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and specific performance metrics in the way a clinical trial report would.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, MRMC study, training set details) are not explicitly provided or are not applicable to this type of regulatory submission.

However, I can extract the information available regarding acceptance criteria and performance testing for design verification and validation.

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

The document states that "All testing met the acceptance criteria" for a list of performance tests. However, the specific numerical acceptance criteria for each test are not explicitly stated in this summary. Instead, it lists the types of tests performed.

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

The document mentions "Usability and human factors were addressed through Voice of Customer (VOC) studies and design validation."

• Sample size for test set: 15 active physicians.
• Data provenance: Not explicitly stated, but the VOC studies and design validation were conducted within the context of product development and regulatory submission, likely at the manufacturer's location (Marlborough, MA, USA) or through contracted facilities. It's a prospective design validation study.

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

• Number of experts: 15 physicians.
• Qualifications of experts: The document states "15 physicians with a range of experience." Specific specializations or years of experience are not detailed, but given the device's indication for use, they would be gynecologists.

4. Adjudication method for the test set

The document describes "Usability and human factors" testing with physicians using a simulated uterine model. This type of testing typically involves direct observation of device use and participant feedback, rather than a formal adjudication method for ground truth in the sense of comparing multiple expert interpretations to establish a single "correct" answer. Since the goal was to demonstrate usability and that the device meets user needs, the "ground truth" would be the direct experience and feedback from each of the 15 participating physicians. There is no mention of a formal adjudication process.

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

There is no mention of an MRMC study or any AI component in this device. The MyoSure MANUAL Tissue Removal Device is a physical, hand-actuated surgical instrument, not an imaging or diagnostic AI device.

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, hand-actuated manual surgical instrument, not an algorithm or AI product.

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

For the performance testing: The "ground truth" for the engineering performance tests (e.g., dimensions, tensile strength, cutting rate, fluid usage, tissue trap efficiency) would be established by engineering specifications and validated measurement methods. The document states that a simulated uterine model with pieces of chicken breast was used to simulate target tissue for the usability testing. The "ground truth" for the usability aspects was the direct experience and feedback from the 15 physicians regarding device performance and user needs.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such a device would refer to its design and development iterations, not a data-driven training set.

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

This question is not applicable for the same reason as above.

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The MyoSure Tissue Removal System and Tissue Removal Devices are intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as:

Submucous myomas
Endometrial Polyps
Retained products of conception

The Myosure Hysteroscopic Tissue Removal System consists of the following procedural components which are identical to those found in the sponsor's previously cleared device:

• Tissue Removal Drive System
• Tissue Removal Device (TRD)
• Foot Pedal

The Myosure Hysteroscopic Tissue Removal System uses mechanical resection to remove endometrial polyps, submucous myomas, and retained products of conception hysteroscopically from the uterus. Mechanical resection allows the surgeon to have precise control of the locations and extent of tissue resected by drawing the targeted tissue into the cutting window under suction while the inner blade cuts the tissue.

The provided text describes a 510(k) submission for a medical device called the Myosure Hysteroscopic Tissue Removal System. This submission is for a modification to an existing device, and therefore, the testing focuses on demonstrating equivalence to the predicate device, rather than establishing de novo performance criteria against a disease.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the modified device was tested against the predicate device to demonstrate equivalence in key performance areas.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document mentions that "each device was tested for a 30 minute duration test interval" for tissue cutting, cutter durability, and heat generation. It does not specify the number of devices or repetitions within this test, nor the total "sample size" of beef tongue tissue used.
• Data Provenance: The testing was conducted by Hologic, Inc. (the manufacturer) as part of their 510(k) submission. The data is internal performance testing data. The source material for the testing (beef tongue) is not described by country of origin, and the tests are prospective bench tests, not retrospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a bench test demonstrating equivalence of an electromechanical device, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. As this is a bench test, there's no adjudication method for human interpretation. The "adjudication" is based on direct measurement and comparison to the predicate device's performance.

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 device is a surgical tool for tissue removal, not an AI-powered diagnostic tool, and therefore, an MRMC study is not relevant.

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

Not applicable. This is a physical hysteroscopic tissue removal system, not an algorithm. The "standalone" testing described is the bench performance testing of the device itself.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance testing was based on direct physical measurements and observations of the device's function, specifically:

• Tissue Cutting Performance: Likely measured by comparing the efficiency or effectiveness of cutting beef tongue tissue.
• Cutter Durability: Assessed by the device's ability to maintain cutting function over a specified duration (30 minutes).
• Heat Generation: Measured against the thermal safety requirements of IEC 60601-1.

8. The Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, there is no ground truth for a training set.

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