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The SRS Endoscopic Stapling 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 SRS is an Endoscopic Surgical Stapling System. The system enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, 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 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 stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile 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

Differences between the predicate device and subject device are summarized as follows:

• The subject device has a single console whereas the predicate had two consoles.
• The subject device has an improved user interface and software controls . compared to the predicate.
• . The subject device uses an electric motor to power staple ejection, whereas the predicate device manually ejected staples.
• . The subject device contains an alignment pin mechanism to allow accurate alignment of the stapling anvil and cartridge.
• The subject devices uses an LED for illumination, whereas the predicate . contained a Xenon lamp.
• . The subject device contains a CMOS camera, whereas the predicate contained a CCD camera.

The provided text describes a medical device, the Medigus SRS Endoscopic Stapling System, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in a clinical or AI-related context.

The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a previously cleared device. This type of submission typically relies on non-clinical performance data (e.g., biocompatibility, electrical safety, mechanical testing) and comparison of technical characteristics to the predicate, rather than a clinical trial with acceptance criteria for device performance against ground truth.

Therefore, most of the requested information cannot be extracted from the provided text.

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

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

• Not found. The document does not specify quantitative clinical acceptance criteria or report device performance against such metrics. It lists non-clinical performance data categories that were submitted (Biocompatibility, Electrical safety, Software validation, Sterilization validation, Mechanical and acoustic testing, LED photobiological and thermal safety testing, Camera/optics characterization testing) but does not provide specific criteria or results for these.

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

• Not found. This information would typically come from a clinical trial or a specific performance study, which is not detailed in this 510(k) summary. The listed performance data are non-clinical.

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)

• Not found. Ground truth establishment by experts is relevant for clinical or diagnostic AI studies. This document concerns a surgical stapling system for which this type of ground truth is not applicable in the context of this 510(k) submission.

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

• Not found. N/A, as no expert-adjudicated test set is 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

• Not found. N/A, as this device is a surgical tool, not an AI-assisted diagnostic or interpretation system that would involve human readers.

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

• Not found. N/A, as this is a surgical device, not an AI algorithm. Its "standalone" performance would refer to its mechanical and functional operation, which is covered by the non-clinical tests mentioned.

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

• Not found. N/A. For a surgical device, "ground truth" often relates to successful surgical outcomes or objective measurements from mechanical tests. The document implies that the device's function was verified through mechanical and other non-clinical tests rather than by comparison to clinical ground truth derived from patient outcomes or pathology in a study specific to this submission.

8. The sample size for the training set

• Not found. N/A, as this is not an AI/ML device that requires a training set in the conventional sense.

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

• Not found. N/A, as this is not an AI/ML device.

Summary regarding the provided text:

The document describes the Medigus SRS Endoscopic Stapling System and focuses on demonstrating its substantial equivalence to an existing predicate device (K120299 Medigus SRS Endoscopic Stapling System) for a 510(k) clearance.

• Intended Use/Indications for Use: The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach to create an anterior partial fundoplication for treating symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.
• Differences from Predicate Device: The document highlights several technical differences in the subject device, such as a single console, improved user interface, electric motor for staple ejection (vs. manual), an alignment pin mechanism, LED illumination (vs. Xenon lamp), and a CMOS camera (vs. CCD camera).
• Performance Data (Non-clinical): The substantial equivalence determination was supported by non-clinical performance data, including:
  • Biocompatibility testing
  • Electrical safety and electromagnetic compatibility
  • Software validation
  • Sterilization validation
  • Mechanical and acoustic testing
  • LED photobiological and thermal safety testing
  • Camera/optics characterization testing
• Conclusion: The device has the same intended use and indications, and similar principles of operation and technological characteristics as the predicate. The minor differences do not raise new questions of safety or effectiveness, and the performance data supports its equivalence.

In conclusion, this 510(k) summary demonstrates that the Medigus SRS Endoscopic Stapling System is substantially equivalent to its predicate based on non-clinical performance and technological comparison, rather than a clinical study with specific acceptance criteria as you've outlined for AI or diagnostic devices.

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The SRS Endoscopic Stapling 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 (GERD) in patients who require and respond to pharmacological therapy.

The Medigus SRS is an Endoscopic Stapling System. The device consists of the following components and accessories:

• . The flexible endoscope combines a video camera, ultrasound sensor (range finder) and a stapler mechanism. The distal end of the endoscope is capable of retroflexion. The system enables creation of an endoluminally anterior partial fundoplication by stapling together the soft tissue of the fundus (upper part of the stomach) and the esophagus.
• The endoscopy suite includes the ISL (Insufflation, Suction and Light) console and the CCU . (Camera Control Unit) console.
• The associated accessories include: .
  • Irrigation bottle with liquids for irrigation of the camera lens l
  • Suction canister for extracting liquids during the procedure .
  • . Silicon tubes for connecting the ISL and other accessories to the endoscope
  • . Disposable air filter of the suction ISL input channel
  • I Overtube for protecting patient's pharynx

The acceptance criteria and study proving the device meets them are detailed below, based on the provided text for the Medigus' SRS Endoscopic Stapling System (K120299).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Pivotal Study Sample Size (Test Set): 72 patients.
• Data Provenance: The document does not explicitly state the country of origin for the clinical studies. Given that Medigus Ltd. is based in Omer, Israel, and animal studies were conducted in Israel and Germany, it is plausible that the clinical studies were conducted in Israel or potentially multi-nationally. The study appears to be prospective, as patients were followed for a period of six months after the procedure.

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

The document does not provide specific details on the number or qualifications of experts used to establish the ground truth for the clinical test set (GERD-HRQL scores, PPI use, pH monitoring, adverse event classification). However:

• The clinical studies involved "a prospective, multi-site clinical trial," implying multiple clinical sites and potentially multiple investigators/clinicians collecting and assessing data.
• The adverse event assessment mentions events being "considered related to the device" or "not related to the device," suggesting clinical judgment by qualified medical professionals.
• Outcomes such as GERD-HRQL scores and pH monitoring are objective or semi-objective measures typically assessed and interpreted by medical professionals involved in GERD treatment.

4. Adjudication Method for the Test Set

The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the clinical test set data, especially for subjective assessments or ambiguous cases. Adverse events were "considered" in terms of relation to the device, which implies an assessment process, but the specific methodology is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this device. This type of study typically involves multiple human readers evaluating medical images or cases, with and without AI assistance, to measure the impact of AI on reader performance. This device is a surgical stapling system for endoscopic procedures, not an imaging or diagnostic AI tool. The clinical study focused on direct patient outcomes and device performance in a clinical setting.

6. If a Standalone Study Was Done

Yes, a standalone study (algorithm only without human-in-the-loop performance) was effectively done for the device's technical aspects:

• Biocompatibility testing: This is a standalone evaluation of the materials of the device.
• Electrical safety and electromagnetic compatibility (EMC): This assesses the device's consoles and endoscope against international standards, independent of human operation.
• Mechanical and acoustic testing: This evaluates the manual operation and mechanical performance of the system itself, as well as the acoustic transducer, in isolation.
• Animal testing: While involving interaction with biological systems, these studies (survival and non-survival, staple longevity) evaluate the device's function and biological response largely in a controlled, non-human clinical setting before human use.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Medigus SRS Endoscopic Stapling System included:

• Clinical Outcomes Data: For efficacy, this included patient-reported outcomes (GERD-HRQL score), objective physiological measurements (pH monitoring to assess acid exposure), and reduction in PPI use.
• Clinical Observations/Adverse Event Monitoring: For safety, this involved documentation and classification of adverse events and serious adverse events during patient follow-up, based on clinical assessments by medical professionals.
• Pathology/Histology: For animal studies, safety and feasibility were evaluated by "macroscopic and histological evaluation of the tissue in the treatment stapled areas."
• Pre-defined Engineering Standards: For technical performance, ground truth was built upon compliance with specific international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and EMC), and internal mechanical/acoustic specifications.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of an AI/ML algorithm is not directly applicable here, as the Medigus SRS Endoscopic Stapling System is a medical device, not an AI product. However, if "training set" is meant to refer to developmental or preliminary studies informing the final design and testing, the document mentions:

• Animal testing: "numerous tests with prototype devices on a porcine model," including survival and non-survival studies and staple longevity up to 13 months. The main GLP animal study used 16 pigs (12 for fundoplication, 4 sham).
• Initial feasibility study: 6 patients.
• Pilot study: 13 patients.

These earlier studies would have provided data to refine the device and study design for the pivotal trial.

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

Similar to point 7, for the "training set" (developmental/preliminary studies):

• Animal Studies: Ground truth was established through macroscopic and histological evaluation of tissues, observation of survival/non-survival, and assessment of staple longevity. These evaluations would be performed by veterinarians, pathologists, and researchers. The GLP study was performed "in conformity with GLP standards by an external subcontractor."
• Initial Feasibility and Pilot Clinical Studies: Ground truth was established through clinical observation, patient symptom reporting (e.g., GERD HRQL score), PPI use, and monitoring for adverse events, similar to the pivotal study but on a smaller scale. These would be assessed by the treating clinicians. The pilot study "main success criterion, improvement in GERD HRQL score by 50% or more at six weeks post-procedure," served as a benchmark.

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