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The Optical Integrity General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, cystoscopes, cystoscopes, gastroscopes, and colonoscopes, or for contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue.

The Optical Integrity GS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT, General and Vascular Surgery, Lithotripsy, Arthroscopy, Podiatry, Orthopedics and Neurosurgery.

The Optical Integrity General Shaped (GS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the GS fiber may be used for a wide variety of surgical procedures.

The provided text for K022338 describes a medical device, the Optical Integrity General Shaped (GS) Fiber, and its intended use. However, it does not contain detailed information regarding acceptance criteria, specific study designs, sample sizes, expert qualifications, or ground truth establishment.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive clinical study report with detailed performance metrics against predefined acceptance criteria.

Based only on the provided text, I can infer the following about how the device meets its claims:

1. Acceptance Criteria and Reported Device Performance: This information is not
   explicitly stated in the provided document. The document states "Bench testing was performed to demonstrate that the device will perform as intended," but it does not specify what those "intentions" (i.e., acceptance criteria) were, nor does it list specific performance results like accuracy, sensitivity, specificity, etc., that would typically be found in a performance table. The focus of the 510(k) is on the technological characteristics and comparison to predicate devices, not on quantitative performance metrics against specific criteria.

2. Sample Size and Data Provenance for Test Set: This information is not provided in the document. The text mentions "Bench testing," which implies laboratory-based tests, but no details on the number of samples used or if any human-derived data was involved. Given it's "bench testing," it's likely physical or engineering tests on the fiber itself, not a clinical test set with patient data.

3. Number of Experts and Qualifications: This information is not provided. Bench testing typically involves engineers or technicians, not medical experts in the way clinical studies do for ground truth establishment.

4. Adjudication Method: This information is not applicable or provided. Adjudication methods like 2+1 or 3+1 are used in clinical trials involving human readers/interpreters to establish ground truth from discrepancies. Bench testing does not involve this type of adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: An MRMC comparative effectiveness study was not mentioned in the document. This type of study would be relevant for evaluating the impact of AI on human reader performance, which is not the focus of this 510(k) for a laser delivery fiber.

6. Standalone Performance Study (Algorithm Only): A standalone performance study was not mentioned. This device is a physical fiber optic laser delivery system, not an algorithm.

7. Type of Ground Truth Used: For "bench testing," the "ground truth" would be engineering specifications, physical measurements, and performance benchmarks relevant to the fiber's function (e.g., optical power transmission, durability, beam profile, heat dissipation). The document does not specify the exact type of ground truth used for these bench tests.

8. Sample Size for Training Set: This information is not applicable or provided. The device is a physical product, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set was Established: This information is not applicable or provided for the reasons mentioned above.

Summary based on available information:

The 510(k) summary (K022338) for the Optical Integrity General Shaped Fiber primarily focuses on establishing substantial equivalence to existing predicate devices through technological characteristic comparison and general bench testing, rather than presenting detailed clinical performance data against specific acceptance criteria.

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