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Laparoscopes are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments. This includes, but is not limited to such uses as gallbladder and appendix removal, hernia repair, gastric bypass, laparoscopic Nissen and examination of the abdominal cavity, appendix, gallbladder and liver.

Bariatric laparoscopes allow surgeons to perform procedures on morbidly obese segments of their patient population.

The Stryker Bariatric Laparoscope is a reusable rigid endoscopc, packaged in the not-sterile state.

The provided text describes a 510(k) submission for a medical device, the Stryker Bariatric Laparoscope, which is a design modification of an existing laparoscope. The primary goal of the submission is to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device rather than defining new, specific performance acceptance criteria for the modified device in isolation. The acceptance criteria essentially revolve around showing that the modified device performs equivalently to the predicate device in key aspects and introduces no new safety or effectiveness concerns.

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

The document does not specify a sample size for a test set in the traditional sense of clinical or performance testing with a 'test set' of subjects or cases. The evaluation appears to be primarily focused on bench testing and engineering assessments of the device's technical specifications and material properties against established standards or in comparison to the predicate device.

• Data Provenance: The nature of the tests (sterilization cycles, biocompatibility, electrical safety, optical performance, mechanical strength) suggests that the data would be derived from laboratory testing and engineering analyses performed by the manufacturer, Stryker Endoscopy. It is retrospective in the sense that the testing was performed on the manufactured device models to support the submission (i.e., not a prospective clinical trial). There is no mention of country of origin of the data beyond the manufacturer's location in Santa Clara, CA, USA.

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

• Not Applicable in the traditional sense. For a 510(k) submission showing substantial equivalence for a device like a laparoscope, "ground truth" isn't established by expert consensus on clinical cases. Instead, the "ground truth" or reference points are:
  • Established international and national standards (e.g., ISO 10993, IEC 601-2-18).
  • The performance characteristics of the predicate device (K910132).
  • General understanding of expected performance for endoscopes in laparoscopic surgery.
• The individuals who conducted and interpreted these engineering and material tests would be qualified engineers, material scientists, and regulatory specialists employed by Stryker Endoscopy or their contracted testing facilities. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set:

• Not Applicable. Since there isn't a "test set" of patient cases requiring expert review or a "ground truth" established by multiple experts in a clinical context, an adjudication method like 2+1 or 3+1 is not relevant to the information provided. The "adjudication" for this submission would be the FDA's regulatory review process.

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 MRMC study was done. This device is a surgical instrument (laparoscope), not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study evaluating human reader performance with or without AI assistance is not relevant and was not performed.

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

• Not Applicable. This device is a rigid endoscope, which is a hardware instrument. It does not contain an algorithm or AI component to be tested in a standalone fashion.

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

As explained in point 3, the "ground truth" is not patient-specific clinical ground truth. Instead, it relies on:

• Adherence to recognized standards: ISO 10993 for biocompatibility, IEC 601-2-18 for electrical safety.
• Comparison to predicate device specifications: For optical performance, mechanical strength, and rigidity.
• Demonstrated performance against validated test methods: For sterilization efficacy.

8. The sample size for the training set:

• Not Applicable. This device development did not involve a "training set" in the context of machine learning or AI. It's a hardware modification.

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

• Not Applicable. As explained in point 8, there was no training set for this device.

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