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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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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.

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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 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 3 mm working channel.

Here's an analysis of the provided text regarding the MyoSure Hysteroscopic Tissue Removal System, extracting the requested information about acceptance criteria and the supporting study:

The provided text (K120593 Premarket Notification) describes a modification to an existing device, the MyoSure Hysteroscopic Tissue Removal System. The modification specifically concerns the motor within the control unit, which now rotates bidirectionally. The submission aims to demonstrate substantial equivalence to the predicate device (K100559).

Acceptance Criteria and Device Performance

The core of the performance testing is to demonstrate equivalence to the predicate device. The acceptance criteria are implicitly tied to the performance characteristics of the predicate device, K100559. The study's outcome is that the modified device meets or is equivalent to these established characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes (e.g., number of fibroids tested, number of cutting cycles, duration of heat generation tests) used for the performance verification testing.

• Sample Size: Not explicitly stated. The testing methodology used was the same as for the predicate device (K100559), implying similar rigor but not detailing specific numbers.
• Data Provenance: Not explicitly stated, but it would have been generated internally by Hologic, Inc. as part of product development and regulatory submission. The study is described as "Performance verification testing" and "Verification/validation testing," which are typically prospective tests conducted on the modified device under controlled laboratory or simulated conditions. There is no mention of retrospective patient data.

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

This type of information is not applicable to this submission. The tests described are engineering performance tests of a mechanical device (cutting efficacy, durability, heat generation), not clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" here is objective physical measurement or operational equivalence.

4. Adjudication Method for the Test Set:

This is not applicable. As mentioned above, the testing involves objective engineering measurements and comparisons, not subjective interpretations requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on the device's mechanical and functional performance, not the diagnostic or interpretative performance of human readers, with or without AI assistance. The device is a surgical tool, not an AI diagnostic system.

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

Not applicable in the context of AI. This device is hardware with an embedded software controller for its motor. The "standalone" performance here refers to the device operating according to its design specifications. The testing performed is essentially "standalone performance" in the sense that the device's cutting, durability, and heat generation were tested independently to ensure they met the established benchmarks (i.e., equivalence to the predicate).

7. The Type of Ground Truth Used:

The "ground truth" for this engineering study is based on:

• Objective Engineering Measurements: Direct measurements of cutting performance (e.g., speed, efficacy on tissue simulants), durability (e.g., number of cycles before failure), and heat generation (e.g., temperature readings).
• Functional Equivalence to Predicate Device: The established performance characteristics and specifications of the legally marketed predicate device (K100559) serve as the benchmark for comparison.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or AI that would require a "training set" in the conventional sense. The "training" for such a device would be its engineering design and manufacturing processes.

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

Not applicable for the same reason as point 8.

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