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The Myosure Hysteroscopic Tissue Removal System and Myosure 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
• 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 does not contain information about acceptance criteria and a study proving a device meets them in the typical sense of a clinical or performance study that quantifies sensitivity, specificity, or other performance metrics.

Instead, this document is a 510(k) summary for a modified medical device, the Myosure Hysteroscopic Tissue Removal System. The "acceptance criteria" discussed here refer to the regulatory requirements and internal design verification/validation criteria for the changes made to an already cleared device, not to establishing performance for a new, unproven device against a clinical benchmark.

Here's an analysis of the provided text in relation to your request:

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

The document does not provide a table with quantitative performance metrics (like sensitivity, specificity, accuracy) for the device's clinical function. The "acceptance criteria" mentioned are related to:

• Biocompatibility: The modified cleaning process was tested to ensure it does not negatively impact the biocompatibility.
  • Acceptance Criteria Implied: Biocompatibility test results must fall within acceptable limits according to ISO 10993 standards and FDA guidance.
  • Reported Performance: "Results from this testing demonstrated that the modified cleaning process does not negatively impact the biocompatibility of the device for the specified use conditions."
• Performance Verification (Cutting Performance):
  • Acceptance Criteria Implied: The change in manufacturing (laser cutting vs. EDM) should not impact the cutting performance of the device.
  • Reported Performance: "An engineering assessment of the cutting method determined there was no impact to the cutting performance of the device as a result of the change in manufacturing process."
• Overall Design Verification and Validation:
  • Acceptance Criteria Implied: The device must meet all specified design verification and validation criteria, applicable standards, guidance, test protocols, and customer inputs.
  • Reported Performance: "The proposed Myosure Tissue Removal System met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Biocompatibility Testing: The text says "Testing was completed using the same methodology as was used in support of the predicate MyoSure Hysteroscopic Tissue Removal System 510(k) submission". This type of testing typically involves in vitro or in vivo animal studies (e.g., cytotoxicity on cell cultures, systemic toxicity in mice, intracutaneous reactivity and sensitization on guinea pigs/rabbits). Specific sample sizes for these tests are not provided in this summary.
• Performance Verification Testing (Cutting): "An engineering assessment" was performed. This implies bench testing or simulation. No sample size is specified.
• Data Provenance: Not explicitly stated, but standard regulatory submissions generally involve studies conducted in controlled laboratory environments, not necessarily tied to specific "countries of origin" for clinical data. These are typically preclinical/lab-based studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the studies described. The biocompatibility and engineering assessments described a preclinical, non-human-in-the-loop evaluation of manufacturing changes, not a clinical study involving expert interpretation of results or establishment of ground truth in a diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set for which adjudication would be required.

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 instrument for tissue removal, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is a hardware device.

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

For biocompatibility, the ground truth is established by standardized biological responses to the materials as defined by ISO 10993. For the engineering assessment of cutting performance, the ground truth would be based on established engineering principles and possibly comparative bench testing data against the predicate. This is not "ground truth" in the clinical sense of a diagnostic outcome.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. No training set was used.

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

Not applicable. No training set was used.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence for minor manufacturing changes to an already cleared hysteroscopic tissue removal system. The "studies" mentioned are largely preclinical biocompatibility tests and engineering assessments to confirm that these manufacturing changes do not negatively impact the safety (biocompatibility) or performance (cutting) of the device, rather than a clinical performance study with human subjects.

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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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The Myosure Hysteroscopic Tissue Removal System and Myosure 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 predicate TRUCLEAR Morcellator System:

• Tissue Removal Drive System
• Tissue Removal Device

The Myosure Hysteroscopic Tissue Removal System uses mechanical resection to remove endometrial polyps and submucous myomas 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. There have been no major changes in design or materials in the subject Myosure System or its associated tissue removal devices since their market clearance.

This document is a 510(k) Summary for the Myosure Hysteroscopic Tissue Removal System. It describes a medical device and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device for the purpose of market clearance for an electromechanical medical device, not on evaluating the performance of an AI system against specific metrics.

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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 O
• MyoSure Tissue Removal Device o
• MyoSure Foot Pedal o

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 MyoSure Tissue Removal Device features a rotating/reciprocating (2.5 mm OD) cutter blade encased in a (3 mm OD) outer tube (i.e. morcellator). 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.

1. Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria in a table format. However, it indicates that the modified device's performance was evaluated against the predicate device. The conclusion states:

The study essentially aimed to prove equivalence to the predicate device (MyoSure Hysteroscopic Tissue Removal System, K091100) across these categories, rather than meeting specific numerical thresholds.

2. Sample Size for Test Set and Data Provenance:

The document describes "in-vitro testing" for performance evaluation. It does not specify the sample size of the test set used for this in-vitro testing. Furthermore, there is no information regarding the data provenance (e.g., country of origin of the data, retrospective, or prospective), as this was an in-vitro study, not a clinical trial with human data.

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

Not applicable. This was an in-vitro study comparing a modified device to a predicate device. Ground truth, in the sense of expert human assessment of medical images or conditions, was not established for this type of test. The performance was likely measured against objective physical or mechanical parameters relevant to tissue removal.

4. Adjudication Method for the Test Set:

Not applicable, as there were no human readers or expert panels involved in establishing ground truth for a test set in the traditional sense. The evaluation was based on in-vitro measurements and comparisons.

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

No, an MRMC comparative effectiveness study was not done. The document describes an in-vitro study focused on demonstrating equivalence to a predicate device, not a comparative study involving human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device described, the MyoSure™ Hysteroscopic Tissue Removal System, is a mechanical medical device for tissue removal, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant to this submission. The performance assessment focused on the device's mechanical and material characteristics.

7. Type of Ground Truth Used:

The "ground truth" for the in-vitro performance testing would have been objective measurements of physical parameters relevant to the device's function (e.g., cutting efficacy, tissue morcellation efficiency, fluid dynamics, material integrity under stress, etc.) compared against the performance of the predicate device under the same conditions. It was not based on expert consensus, pathology, or outcomes data in the context of human patients.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical system, not an AI/machine learning model that requires a "training set."

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

Not applicable, as there was no training set for an AI/machine learning model.

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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 MyoSURE Hysteroscopic Tissue Removal System consists of the following procedural components: 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 MyoSURE Tissue Removal Device features a rotating/reciprocating (2mm OD) cutter blade encased in a (3 mm OD) outer tube (i.e. morcellator). 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 sidefacing 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.

The provided text describes the MyoSURE™ Hysteroscopic Tissue Removal System and its comparison to a predicate device for 510(k) clearance. However, the document does not contain specific acceptance criteria, a detailed study protocol for performance evaluation against these criteria, or information about sample sizes (beyond "in-vitro testing"), expert involvement, or adjudication methods in the way a typical AI/software device submission would.

This submission is for a physical medical device, not a software or AI-driven diagnostic device. Therefore, the concepts of "acceptance criteria," "test set," "ground truth," "MRMC study," and "training set" as they relate to AI performance metrics are not applicable in this context. The performance testing described focuses on safety, biocompatibility, and functional equivalence to a predicate device.

Here's an attempt to structure the available information based on your request, even though it doesn't fit neatly into an AI device framework:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical device and not an AI/software product, the "acceptance criteria" are not framed as performance metrics (e.g., sensitivity, specificity) but rather as compliance with standards and equivalence to a predicate device.

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

• Sample Size: The document mentions "in-vitro testing" but does not specify the sample size (e.g., number of devices tested, number of tissue samples processed).
• Data Provenance: The testing was "in-vitro," meaning it was conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms typically apply to clinical studies with human or patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This concept is not applicable. The "ground truth" for a physical device in this context would be its ability to safely and effectively resect tissue. This is evaluated through engineering testing (e.g., material properties, electrical safety, mechanical function) and functional in-vitro tests, not by expert consensus on diagnoses or images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations (e.g., reading images). This is not relevant for the type of testing described for this physical device.

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

Not applicable. MRMC studies are used to assess the impact of AI on human reader performance, typically in diagnostic tasks. This device is a surgical tool, not a diagnostic imaging AI, and such a study would not be relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established standards and the performance of the predicate device. For example:

• Electrical Safety: Standards like IEC 60601 (implied by "EMC standards").
• Biocompatibility: ISO 10993-1.
• Functional Performance: Direct comparison to the established performance of the predicate Interlace Morcellator in an in-vitro setting. This would likely involve measuring tissue resection rates, cutting efficiency, or other mechanical aspects.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML system that requires a "training set."

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

Not applicable. As there's no training set, there's no ground truth to be established for it.

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