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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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