Search Results

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.

Ask a specific question about this device