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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 Tissue Removal System is indicated for the contained removal of tissue, including contained manual tissue sectioning, during minimally invasive surgical procedures.

The Tissue Removal System is comprised of the Tissue Removal Pouch cleared under K150781 and an additional accessory Sectioning Device. It is provided sterile, and is for single patient use.

The Tissue Removal Pouch of the Tissue Removal System includes a bag with a single large opening held open by a thin, opening ring. During laparoscopic surgery, the bag is placed within the peritoneal space via an existing port site. Tissue that has been resected is placed within the bag for isolation, containment and removal from the patient. The bag opening is exteriorized. Two halves of the Tissue Removal Pouch flip ring are attached to each other and to the bag is rolled around the flip ring by inverting the flip ring, in order to draw the resected tissue toward the port site.

The resected tissue is then removed en bloc (for smaller specimens), or by first dividing the specimen using the accessory Sectioning Device. The Sectioning Device is comprised of a blunt wire, a flexible passer and a handle with a blunt hook. The passer is used to encircle the specimen with the wire. The handle includes a blunt hook that can be used to aid in the advancement of the passer. The specimen is divided by the manual application of a back and forth motion to the wire. Use of the accessory Sectioning Device permits division of the specimen while maintaining the containment effectiveness of the Tissue Removal Pouch

Here's an analysis of the provided text regarding acceptance criteria and the supporting study, structured according to your request:

Unfortunately, the provided document does not contain information related to an AI/ML device. The document is a 510(k) premarket notification for a medical device called "Tissue Removal System," which is a physical device used in surgery to contain and remove tissue.

Therefore, many of your requested points, such as AI-related performance metrics, sample sizes for training or test sets for an algorithm, expert adjudication, or MRMC studies, are not applicable to this document.

However, I can extract the information that is present regarding the non-clinical testing performed for this physical device.

Description of Acceptance Criteria and Supporting Study for the Tissue Removal System

The document describes non-clinical testing performed to demonstrate the safety and effectiveness of the "Tissue Removal System," particularly focusing on the integrity and containment capabilities of the Tissue Removal Pouch when used with its accessory Sectioning Device.

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

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

• Sample Size for Test Set: The document does not specify the sample sizes (e.g., number of pouches, sectioning devices, or test repetitions) used for any of the non-clinical tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, though non-clinical tests are inherently prospective laboratory studies.

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

• Not Applicable. This document describes non-clinical engineering and material integrity tests on a physical device, not an AI/ML diagnostic system requiring expert interpretation or ground truth establishment in the traditional sense. The "ground truth" here is the physical performance of the device against predefined engineering standards (e.g., no leaks, no punctures, no tears).

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

• Not Applicable. As above, this is not an interpretive diagnostic study requiring adjudication. The outcomes are objective measurements of physical integrity (e.g., presence/absence of bubbles, dye penetration, tears, punctures).

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 is not a study involving human readers or AI assistance.

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

• Not Applicable. This document pertains to a physical medical device, not an algorithm.

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

• The "ground truth" in this context refers to the objective performance of the physical device as measured by specific non-clinical test methods. For example, for "Bubble Leak" testing, the ground truth for failure would be the observation of bubbles, and for "Dye Penetration," it would be the observation of dye. These are direct physical observations, not interpretive diagnoses.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/ML model.

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

• Not Applicable. There is no "training set."

Summary of Device and Testing Context:

The Tissue Removal System is a physical device for containing and removing tissue during minimally invasive surgery. Its key innovation over a predicate device is the inclusion of an accessory Sectioning Device that uses a blunt wire for dividing specimens, in contrast to predicate devices that might require sharp instruments.

The non-clinical tests aim to prove that this new Sectioning Device does not compromise the primary function of the Tissue Removal Pouch, which is to maintain containment and integrity. The tests specifically assessed physical characteristics such as leak prevention, puncture resistance, and tear resistance under various conditions, including simulated and extreme use. The "conclusions" state that the device is "as safe and effective as, and performs as well as, or better than, the legally marketed predicate device" based on these non-clinical tests.

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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 TX1 Tissue Removal System is intended for use as an Ultrasonic Surgical Aspirator of soft tissue.

The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

The TX 1 Tissue Removal System is an ultrasonic surgical aspirator that emulsifies and removes soft tissue. The system consists of a console, ultrasonic handpiece, and foot pedal. The console provides control over the four user functions including irrigation, aspiration, cutting, and coagulation. It has a large, color LCD and employs a touch-screen for selection of required settings. The console provides audible tones for confirmation of selections. The console also houses the irrigation and aspiration pumps, thereby eliminating the need for a dedicated service cart or suction/waste source within the operating room. The console provides a connection for a commercially available cautery pencil or forceps. Two USB ports and one Ethernet port are available for loading software upgrades.

The ultrasonic handpiece connects to the console for power, as well as for delivering irrigation fluid directly to the surgical site and for removing emulsified tissue by way of integrated tubing set. The handpiece is constructed from various polymers and metals, while the tubing is made of biomedical grade PVC. The handpiece and tubing are provided sterile. The handpiece is a single use disposable component of the system.

Irrigation fluid is delivered under pressure to the surgical site by operation of an air pump residing in the console. The regulated output of the air pump pressurizes a cuff that is fitted around the irrigating fluid bag, thus providing irrigation at a fixed pressure regardless of the height of the fluid bag.

The foot pedal is used to control each of the four functions (irrigation, aspiration, ultrasonic fragmentation/emulsification, coagulation) of the system. It offers on/off functionality and is rated IPX5 (by the supplier) for protection against liquids.

This document covers the 510(k) summary for the Tenex Health TX1 Tissue Removal System, an ultrasonic surgical aspirator. The submission focuses on demonstrating substantial equivalence to a predicate device (K101561 TX1 Tissue Removal System) rather than presenting a de novo study with specific acceptance criteria for performance as would be expected for a novel device or AI/ML product.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly concerning human readers, AI assistance, ground truth, and training data, is not directly applicable to this 510(k) submission. This submission primarily relies on comparing technological characteristics and non-clinical performance tests to a predicate device.

However, I can extract information related to the non-clinical performance and the basis for the FDA's clearance.

1. Table of "Acceptance Criteria" and Reported Device Performance (interpreted from non-clinical tests for equivalence):

Since this is a 510(k) submission for an ultrasonic surgical aspirator, the "acceptance criteria" are not reported as numerical thresholds like accuracy or precision for an AI/ML device. Instead, the acceptance criteria are implicitly that the device performs functionally as intended and meets relevant safety and biocompatibility standards, demonstrating equivalence to the predicate device. The reported "performance" is whether these tests were passed.

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

• This submission describes non-clinical performance tests for a physical medical device (ultrasonic surgical aspirator), not a software or AI/ML device relying on diagnostic images or patient data.
• Therefore, there is no "test set" in the context of clinical data, images, or patient cohorts. The "test set" refers to the device units and components undergoing the specified engineering, electrical, and biocompatibility tests.
• The document does not specify the number of units or components tested for each non-clinical test, nor does it specify data provenance (country of origin, retrospective/prospective) as these are not relevant for these types of engineering and safety tests.

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

• This is not applicable. "Ground truth" in the context of expert review of data is irrelevant for the non-clinical performance tests of a physical surgical device. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified standards (e.g., electrical resistance, mechanical strength, chemical reactivity).

4. Adjudication method for the test set:

• This is not applicable. Test results for engineering and safety standards are typically determined by objective measurements against predefined criteria, not by expert adjudication.

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:

• This is not applicable. The device is an ultrasonic surgical aspirator, not an AI/ML diagnostic aid or image processing tool. No MRMC study was performed, nor is there any AI component to assess human reader improvement.

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

• This is not applicable. As noted, the device is a physical surgical tool, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is defined by the objective engineering and safety standards (e.g., IEC 60601 series, ISO 10993 series). The device's performance against these standards determines if it "passes" or "fails."

8. The sample size for the training set:

• This is not applicable. There is no "training set" as this is not an AI/ML device.

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

• This is not applicable.

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The SurgiSure™ Tissue Removal System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited.

The SurgiSure™ Hysteroscopic Tissue Removal System consists of the following procedural components:

• SurgiSure™ Tissue Removal Device
• SurgiSure™ Control Unit
• SurgiSure™ Foot Pedal
  The SurgiSure™ Control Unit contains an electric motor and firmware motor controller that drives the SurgiSure Tissue Removal Device. The Control Unit motor is activated and deactivated by the SurgiSure Foot Pedal. The SurgiSure Tissue Removal Device is a tissue morcellator that is connected to the Control Unit via a flexible drive cable. The SurgiSure Tissue Removal Device features a rotating/reciprocating (2mm OD) cutter blade encased in a (3 mm OD) outer tube. The device's cutter blade is controlled by a drive system that enables simultaneous rotation and reciprocation of 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 SurgiSure Tissue Removal Device to a tissue trap and vacuum canister via a tube protruding from the proximal end of the Tissue Removal Device. The SurgiSure Tissue Removal System is compatible with commercially available fluid management systems and may be used with endoscopes that have a straight ≥3 mm working channel.

The provided document is a 510(k) summary for the SurgiSure™ Tissue Removal System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

However, based on the information provided, we can extrapolate and infer some aspects related to acceptance criteria and the "study" (performance testing) that supports it.

Here's a breakdown of the requested information:

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

Since specific numerical acceptance criteria (e.g., minimum tissue removal rate, maximum power consumption) and direct reported performance values are not explicitly stated in the document, we must infer the criteria based on the comparison to predicate devices and the general safety and performance claims. The acceptance criterion is essentially "equivalent to or performs similarly to the predicate devices" in the specified aspects.

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

The document mentions "in-vitro testing" for tissue cutting rate. It does not specify the sample size, data provenance (country of origin), or whether it was retrospective or prospective. It is highly likely to be prospective data generated specifically for this submission.

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 is not applicable as the performance testing described is "in-vitro" and does not involve human readers/experts evaluating device output. The ground truth for functional performance like tissue cutting rate would be established by objective measurements (e.g., mass of tissue removed per unit time) during the in-vitro tests, rather than expert evaluation.

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

Not applicable. As described in point 3, the testing is objective and in-vitro, not relying on subjective expert judgment or adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a submission for a tissue removal system, which is a physical surgical device, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance.

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

Yes, a form of standalone performance testing was done. The "in-vitro testing" for tissue cutting rate, electrical safety, and biocompatibility are all standalone tests performed on the device itself without human intervention in the performance measurement. The device's motor, firmware, and mechanical components are assessed directly.

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

For the in-vitro tests:

• Electrical Safety & EMC: Ground truth is defined by the objective pass/fail criteria of the relevant international standards (e.g., IEC 60601 series).
• Biocompatibility: Ground truth is defined by the objective pass/fail criteria of ISO 10993-1.
• Tissue Cutting Rate: Ground truth would be objective measurements of tissue mass removed over time, or a similar quantitative metric, compared against the predicate device's measured performance.

8. The sample size for the training set

This is not applicable. The SurgiSure™ Tissue Removal System is a mechanical device, not a machine learning or AI algorithm that requires a training set.

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

This is not applicable, as there is no training set for this type of device.

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The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

The TX1 Tissue Removal System is an ultrasonic surgical aspirator that emulsifies and removes soft tissue. The system consists of a console, ultrasonic handpiece, tube set, and foot pedal: The system has been designed to work with commercially available accessories and consumables including cautery pencils and forceps, ultrasonic handpiece tips, and silicone sleeves. The console provides control over the four modes of operation including irrigation, aspiration, cutting, and coagulation. It has a large, color LCD and employs a touch-screen for selection of required settings. The console also provides audible tones for confirmation of selections. The console also houses the irrigation and aspiration pumps, thereby eliminating the need for a dedicated service cart or suction/waste source within the operating room. Two USB ports are available for loading software upgrades. An Ethernet port is also available for future system expandability. The ultrasonic handpiece connects to the console for power. and to the tube set for both delivering irrigation fluid directly to the surgical site and for removing emulsified tissue. The handpiece is constructed from both 316L stainless steel and TiAl6V4 Titanium Alloy components, and can be sterilized by steam and reused multiple times. The tube set employs an external tubing cartridge design that can be easily installed or removed in a single step. The tubing is made of biomedical grade silicone. The tube set can be sterilized by steam and reused multiple times. Irrigation fluid is delivered under pressure to ensure adequate cooling of the ultrasonic tip, as well as adequate flushing of the surgical site, by operation of an air pump residing in the console. The regulated output of the air pump pressurizes a cuff that is fitted around the irrigating fluid bag, thus providing irrigation at a fixed pressure regardless of the height of the fluid bag. The foot pedal is used to control each of the four functions of the system. Simple in design, it offers on/off functionality and is rated IPX5 for protection against liquids.

The provided text describes a 510(k) submission for a medical device, the TX1 Tissue Removal System, and focuses on demonstrating its substantial equivalence to a predicate device. This type of submission relies on comparisons to existing devices rather than a standalone clinical study to establish acceptance criteria based on performance. As such, the information you've requested regarding specific acceptance criteria metrics (like sensitivity, specificity), sample sizes, expert ground truth establishment, MRMC studies, or training set details is not present in the provided document.

The document states: "Independent, 3rd party electrical safety testing, adherence to U.S. FDA design control guidance, as well as thorough in-house, non-clinical (bench) testing and software validation provide reasonable assurance that the TX1 Tissue Removal System is safe and effective, and is, with respect to intended use and technological characteristics, substantially equivalent to the predicate device." This indicates that the "study" proving the device meets acceptance criteria was primarily focused on bench testing, software validation, and compliance with electrical safety standards and design control guidance, rather than a clinical trial with performance metrics.

Here's a breakdown of what can be extracted based on your request, with the understanding that many fields will be "Not Applicable" or "Not Provided" given the nature of a 510(k) substantial equivalence submission:

1. Table of acceptance criteria and the reported device performance

For a 510(k) submission, the "acceptance criteria" are typically related to demonstrating comparable technological characteristics and intended use to a predicate device, along with adherence to relevant safety standards. "Reported device performance" would thus be a comparison of these characteristics.

Note on Acceptance Criteria: The acceptance criteria for a 510(k) are implicitly met if the new device demonstrates "substantial equivalence" to the predicate, meaning it has the same intended use and similar technological characteristics, or if differences do not raise new questions of safety or effectiveness. The table above summarizes how the device compares to the predicate on these characteristics.

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

• Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission. No clinical "test set" (e.g., patient cases for diagnostic accuracy) is mentioned. The "testing" involved bench testing, software validation, and electrical safety testing. Details of these tests (e.g., number of units tested, duration of tests) are not provided in this summary.
• Data Provenance: Not applicable. The "study" was primarily engineering and regulatory compliance testing rather than clinical data collection from a specific country or retrospective/prospective design.

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

• Number of Experts: Not applicable. Ground truth for a diagnostic test set is not established here. The assessment is based on engineering specifications and performance against those specifications.
• Qualifications of Experts: The document mentions "Independent, 3rd party electrical safety testing" and "in-house, non-clinical (bench) testing and software validation." This implies qualified engineers and testers conducted these evaluations, but specific qualifications are not detailed.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There was no diagnostic test set requiring expert adjudication.

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

• MRMC Study: No. This is not an AI-based device, nor is a clinical comparative effectiveness study described in this 510(k) summary.

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

• Standalone Performance: Not applicable. This device is an ultrasonic surgical aspirator, not an algorithm. Its "standalone" performance would be its functional operation in a surgical setting, which is inferred as equivalent to the predicate device through bench testing and design comparisons.

7. The type of ground truth used

• Type of Ground Truth: For the engineering and performance evaluations, the "ground truth" would be the established engineering specifications, performance parameters (e.g., maximum tip amplitude, vacuum levels), and electrical safety standards (e.g., IEC 60601-1). The device was tested to ensure it met these predefined technical requirements and performed comparably to the predicate on relevant parameters.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not involve machine learning or an "AI" component that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for a 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 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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The Mentor Contour Genesis System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications. It is also indicated for the liquefication and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

The Mentor Contour Genesis System consists of the following components: ultrasonic generator, infiltrator, aspirator, ultrasonic handpiece, foot pedal(s), cannulae and cannulae sheaths, system cart, irrigation tubing set, infiltration tubing set, and aspiration tubing set.

The provided text describes a 510(k) premarket notification for the Mentor® Contour Genesis System, a device for ultrasound-assisted lipoplasty. It references a clinical study conducted to demonstrate substantial equivalence to a predicate device. However, the document does not present specific acceptance criteria in a table format with reported device performance against those criteria. It also doesn't detail the study information in the structured way requested.

Based on the information provided, here's what can be extracted and inferred, along with the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative or tabular format. Instead, it compares the new device (UAL) to a predicate device (SAL) based on safety and effectiveness measures.

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

• Sample Size for Test Set:
  • Total subjects enrolled: 366
  • UAL patients (test group): 180
  • SAL patients (control group): 186
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a clinical study comparing two treatments for a 510(k) submission, it is highly likely to be a prospective study. The country of origin is not specified, but typically for FDA submissions, studies are often conducted in the US or follow international clinical trial standards.

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

• The document mentions "a masked reviewer" assessed body contour measurements.
• It does not specify the number of experts (beyond "a masked reviewer"), their qualifications (e.g., radiologist with X years of experience), or how they established the 'ground truth' for other measures like satisfaction or self-esteem (which are patient-reported outcomes).

4. Adjudication Method for the Test Set:

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For patient-reported outcomes like satisfaction and self-esteem, adjudication is typically not applicable as the patient's report is the primary data. For body contour measurements, "a masked reviewer" implies a single assessment, not a consensus or adjudication process.

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

• This study was a clinical comparative effectiveness study, but specifically comparing device performance (UAL vs. SAL lipoplasty), not a multi-reader multi-case study comparing human readers with and without AI assistance.
• Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable to this document as it's not an AI device.

6. Standalone (Algorithm Only) Performance:

• This is not an AI device, so standalone algorithm performance is not applicable. The study evaluates the performance of a medical device (Mentor® Contour Genesis System) used by a surgeon.

7. Type of Ground Truth Used:

• Primary Safety Measures: Adverse events (patient-reported and/or clinician-observed).
• Secondary Effectiveness Measures:
  • Patient-reported overall satisfaction.
  • Patient-reported feelings towards each body area treated.
  • Patient-reported self-esteem (using Rosenberg Self-Esteem scale and Body Esteem scale).
  • Body contour measurements as assessed by a masked reviewer.

8. Sample Size for the Training Set:

• The document describes a clinical study to compare the device, which serves as the test set for demonstrating equivalence. It does not mention a separate training set for the device itself. This device is a physical medical system (ultrasonic generator, handpiece, etc.), not a machine learning algorithm that requires a training set.

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

• As this is not an AI/ML device, a separate training set and its associated ground truth establishment are not applicable.

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