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The Flexiva SF Side-Firing Single-Use Laser Fiber is designed for use with Ho:YAG and Nd:YAG lasers for indications that are cleared for these laser systems, including, but not limited to endoscopic, laparoscopic, and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection, incision of soft and cartilaginous tissue, and fragmentation of urinary and biliary calculi (Ho:YAG wavelength only). The fiber is designed for use with a standard SMA-905 connector that has been cleared for surgical use.

The Flexiva SF Side-Firing Single-Use Laser Fibers (Flexiva SF) are fiber optic laser energy delivery devices consisting of an SMA-905 connector and a coated silica core fiber jacketed with ethylene tetrafluoroethylene (ETFE). The Flexiva SF fibers are equipped with a metal cap with circumferential solid black line guides, an adjustable hand piece and rigid tubing. The laser aperture is located near the tip of the metal cap. Laser energy is delivered at an approximately 70° angle to tissue from the tip of the fiber. The line guides assist with correct positioning of the fiber tip within the endoscope. The adjustable hand piece enables manipulation of the laser fiber tip at the treatment site. The rigid tubing aids in control of the fiber tip. These fibers may be used in a variety of laserbased surgical cases as an integral part of laser systems.

The provided document is a 510(k) summary for a medical device (Flexiva™ SF Side-Firing Single-Use Laser Fiber) and primarily focuses on demonstrating substantial equivalence to predicate devices based on performance testing (bench evaluation), rather than clinical studies involving human patients or complex algorithms requiring ground truth establishment with expert consensus.

Therefore, many of the requested categories in your prompt are not applicable to the information contained within this specific 510(k) summary.

Here's an analysis based on the provided text:

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

The document lists the types of performance testing conducted but does not provide specific acceptance criteria or quantitative reported device performance for each test. Instead, it makes a general statement: "The results of the performance testing demonstrate that the Flexiva SF fiber is considered safe and effective for its intended use."

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 mentions "samples aged at T=0 and T=6 months accelerated aging" for testing. However, it does not specify the sample size for these tests. Data provenance (country of origin, retrospective/prospective) is also not mentioned, as this was a bench evaluation of the device's physical and functional characteristics.

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 applicable. This was a bench evaluation of a physical device, not an algorithm requiring expert-established ground truth.

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

Not applicable. This was a bench evaluation of a physical device.

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. This device is a laser fiber for surgical procedures, not an AI-assisted diagnostic tool or an imaging device that would typically involve MRMC studies.

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

Not applicable. This device is not an algorithm. Performance testing was done on the physical device itself.

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

Not applicable. For bench testing of a physical device, "ground truth" would be established by engineering specifications, material properties, and a controlled test environment to measure performance against those specifications.

8. The sample size for the training set

Not applicable. This device is not an algorithm that requires a training set.

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

Not applicable. This device is not an algorithm that requires a training set.

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