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The Medigus Ultrasonic Surgical Endostapler (MUSE™) System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.

The Medigus Ultrasonic Surgical Endostapler (MUSE™) System enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories.

The endoscopic stapler is a single use, sterile device (EtO) which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the shaft of the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile (EtO) and contains standard, 4.8 mm titanium surgical staples. Each application of the device fires five staples in 3 staggered rows. A new cartridge is loaded for each application.

The control console includes the insufflation, light and camera electronics.

The associated accessories include:

• Irrigation bottle with liquids for irrigation of the camera lens
• Silicon tubes for connecting the console and other accessories to the stapler
• Standard overtube for protecting patient's pharynx
• Tweezers to remove and replace staple cartridge
• Staple cartridges

The provided text describes a 510(k) premarket notification for the Medigus Ultrasonic Surgical Endostapler (MUSE™) System. The document focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a new diagnostic or AI-driven device.

Based on the information provided, here's an analysis:

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

The document does not explicitly list acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or clinical outcomes for the MUSE system itself. Instead, it relies on comparison to a predicate device.

The "acceptance criteria" here are fundamentally about demonstrating that the modified device (which has a different overtube) is as safe and effective as the predicate device (which is K143634 Medigus SRS Endoscopic Stapling System (Trade Name MUSE)).

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 does not detail specific "test set" sample sizes, data provenance, or study types (retrospective/prospective) in the context of comprehensive clinical or performance studies for the MUSE system's effectiveness. The "performance data" mentioned (dimensional, mechanical, biocompatibility) are likely engineering tests and not clinical studies with patient sample sizes.

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 type of submission described. The submission focuses on substantial equivalence based on engineering and bench testing, not on interpreting data where expert consensus would establish ground truth (e.g., for diagnostic imaging).

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

This information is not applicable to the type of submission described.

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

An MRMC study is not mentioned because this device (an endoscopic stapler) is a surgical tool, not an AI-assisted diagnostic or interpretation system that would involve "human readers" or AI assistance.

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

This information is not applicable. The MUSE system is an operative device, not a standalone algorithm.

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

The concept of "ground truth" as typically used in diagnostic or AI studies is not directly applicable here. For the engineering tests mentioned (dimensional, mechanical, biocompatibility), the ground truth would be established by validated test methods, reference standards, and laboratory measurements. For substantial equivalence, the "ground truth" is that the predicate device is already legally marketed and presumed safe and effective.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not applicable. There is no mention of a "training set."

Summary of what the document focuses on:

The provided document is an FDA 510(k) clearance letter for a modified medical device. The "study" described is a demonstration of substantial equivalence to a previously cleared predicate device (K143634 Medigus SRS Endoscopic Stapling System).

The primary evidence given to support substantial equivalence are:

• Dimensional comparisons: Showing that the modified device's measurements are consistent with the predicate.
• Mechanical Testing: Demonstrating that the modified device's functional and structural integrity match the predicate.
• Biocompatibility Testing: Ensuring that the materials of the modified device are safe for human contact, likely conforming to ISO standards.

The key point is that the only difference between the predicate and the subject device is the manufacturer of the overtube. The FDA concluded that these minor differences do not raise any new or different questions of safety or effectiveness, and that the performance data demonstrates comparable performance to the predicate. Therefore, the acceptance criteria are met by proving the new device is essentially the same, with no negative impact on safety or efficacy, as the already-approved predicate device.

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The MUSE System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy

The MUSE system enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories. The endoscopic stapler is a single use, sterile device (EtO) which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the shaft of the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile (EtO) and contains standard, 4.8 mm titanium surgical staples. Each application of the device fires five staples in 3 staggered rows. A new cartridge is loaded for each application. The control console includes the insufflation, light and camera electronics. The associated accessories include: Irrigation bottle with liquids for irrigation of the camera lens, Silicon tubes for connecting the console and other accessories to the stapler, Standard overtube for protecting patient's pharynx, Tweezers to remove and replace staple cartridge, Staple cartridges.

The provided text is a 510(k) summary for the Medigus Ultrasonic Surgical Endostapler (MUSE) System. It describes the device, its intended use, and its comparison to a predicate device, as well as performance data provided to support substantial equivalence.

However, the document does not contain acceptance criteria or a study that directly proves the device meets specific acceptance criteria in the format requested. The "Performance Data" section lists types of tests conducted (e.g., electrical safety, software verification, mechanical testing, animal model validation) but does not provide details on specific acceptance criteria for these tests, nor does it present the results in a comparative table with reported device performance against those criteria.

The document details that the modified MUSE System's substantial equivalence is determined by its similarity to a predicate device (K132151 Medigus SRS Endoscopic Stapling System) in intended use, indications, principles of operation, and fundamental technology, with minor differences not raising new safety or effectiveness concerns.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study that proves the device meets them, as this specific information (especially in the structured format requested) is not present in the provided text.

Based on the information available, I can extract the following, but it does not directly answer the core request about acceptance criteria and their proof:

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

• Not provided in the document. The document lists types of tests (Electrical safety and electromagnetic compatibility (EMC), Software verification and validation testing, Mechanical Testing, Animal Model Validation) but does not specify individual acceptance criteria or reported performance values against those criteria.

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

• Not provided in the document. The document mentions "Animal Model Validation" but does not detail the number of animals used or other test sets, nor their provenance (country of origin, retrospective/prospective).

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

• Not provided in the document. The types of studies listed (electrical safety, software, mechanical, animal) do not inherently involve "experts to establish ground truth" in the way clinical studies for AI/diagnostic devices would.

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

• Not provided in the document. This applies more to clinical trials or diagnostic accuracy studies, which are not detailed here.

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/Not provided. This device is an endoscopic stapler, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

• Not applicable/Not provided. This device does not feature an algorithm for standalone diagnostic performance.

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

• Not provided in the document for the performance data mentioned. For mechanical testing, the "ground truth" would be engineering specifications; for software, it would be functional requirements; for animal models, it would be physiological responses/outcomes observed by a veterinarian. Specifics are not given.

8. The sample size for the training set:

• Not applicable/Not provided. As this is a medical device (endoscopic stapler) and not an AI/ML algorithm that requires a "training set," this information is not relevant to the document.

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

• Not applicable/Not provided. (See point 8).

In summary, the provided document is a regulatory submission for a medical device that establishes substantial equivalence, but it does not contain the detailed clinical study data, particularly acceptance criteria and performance against those criteria, that your request outlines for AI/diagnostic devices.

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