Search Results

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 and deactivated 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 4 mm working channel.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The provided text does not specify the exact sample sizes used for the performance testing. It states that the testing "evaluated cutting functionality and heat generation over the test interval" but does not give numerical values for the number of tests performed or the duration.

The data provenance is not explicitly stated as "country of origin," but given that Hologic, Inc. is based in Marlborough, MA, USA, and the submission is to the FDA, it is highly probable that the testing, or at least the data collection, occurred in the United States. The study is retrospective in the sense that it compares the modified device to a previously cleared predicate device (K100559) and uses the same methodology as the prior submission.

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

This type of information (number of experts, their qualifications, and their role in establishing ground truth) is not applicable to this submission. The device is a medical instrument (tissue removal system), and its performance testing focuses on objective, measurable physical characteristics (cutting performance, durability, heat generation) rather than diagnostic accuracy or interpretation, which would typically involve expert ground truth establishment.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. Adjudication methods are relevant for studies where subjective assessments (e.g., image interpretation) are made by multiple readers and a consensus or tie-breaking process is needed to establish "ground truth." This is a performance verification study for a physical device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as per the provided information. This type of study is typically performed for diagnostic imaging algorithms or tools that involve human interpretation, to assess the impact of AI assistance on human reader performance. The MyoSure XL is a surgical tissue removal device, not an AI-powered diagnostic tool.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The "Performance Testing" section states: "Performance verification testing of the modified MyoSure Hysteroscopic Tissue Removal System was completed... The testing evaluated cutting functionality and heat generation over the test interval for the modified MyoSure System." This indicates that the device's performance was assessed independently to ensure it met certain criteria, even if those criteria were based on equivalence to a predicate device. The comparison to the predicate device was done using the results of these standalone tests for both the modified and predicate systems.

7. Type of Ground Truth Used

The "ground truth" for this performance study was based on objective physical measurements and functional performance criteria. Instead of expert consensus, pathology, or outcomes data, the ground truth here is the established and verified performance of the predicate device (K100559) against which the modified device's performance was compared for equivalence in:

• Tissue cutting performance
• Cutter durability over time
• Heat generation over time

8. Sample Size for the Training Set

This information is not applicable. The MyoSure XL Tissue Removal Device is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train an algorithm. Its performance is based on its engineering design and manufacturing, tested through physical performance verification.

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

This information is not applicable for the same reasons as #8. There is no training set for a physical device.

Ask a specific question about this device