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The 1300 XSBP - 300 WATT XENON Illuminator is intended for use as a high intensity light to be used with fiberoptic cables. Applications include endoscopes, surgical headlights and other tools that contain fiberoptic bundles. Illumination from this device is intended to be used for observation of body cavities, hollow organs and other surgical sites. Specific areas of application include arthroscopy, laproscopy, gynecology, broncoscopy, urology and vascular endoscopy. The device is also intended for use as a light source for surgical headlights used in various open surgical procedures.

Isolux America has engineered the 1300 XSBP - 300 Watt Xenon to provide a high intensity white light source for fiber optic cables. The system consists of a single cabinet containing a power supply, a Xenon lamp with focusing optics, a variable attenuator, a turret selector for four standard fiber optic cable connectors and a forced air cooling system consisting of two fans.

The provided text describes a 510(k) summary for the Xenon Fiberoptic Light Source, Model 1300 XSBP. It explicitly states that no performance data was required for this Class II device, nor was it requested by the FDA for its 510(k) clearance process.

Therefore, the following information about acceptance criteria and a study proving the device meets them cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable, as performance data beyond basic specifications was not required for regulatory clearance.
2. Sample size used for the test set and the data provenance: Not applicable, as no formal test set was used for a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is an illumination device, not an AI-based diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

However, the text does provide "Performance Data" for the lamp and power supply in an attachment (Attachment 4), and states the "Effectiveness" of the device:

"Performance Data" (as presented in the document, not a formal study):

• Acceptance Criteria/Performance Goal (Implied by Predicate Equivalence): The device is substantially equivalent to legally marketed predicate devices (Karl Storz Cold Light Fountain Xenon 300, Maxenon, Brite Lite III) in use, design, and function. The overall goal is to provide sufficient illumination for specified medical procedures.
• Reported Device Performance:
  • Light Output: Provides up to 600,000 Lux of white light at the output of an eight-foot long, 5.0 mm diameter fiber bundle.
  • Sufficient Illumination: This level of light output is stated to be "sufficient for all presently known endoscopic illumination tasks."
  • Temperature Control: Internal forced air cooled turret design maintains temperature control of the fiber bundle termination.
  • Predicate Equivalence: Similar in use, design, and function to its predicates.

Study/Evidence that Proves the Device Meets the Criteria (Based on information provided):

The primary "study" or evidence for regulatory clearance was a 510(k) Substantial Equivalence Comparison. This is not a performance study in the traditional sense, but rather a demonstration that the new device is as safe and effective as a legally marketed predicate device.

• Comparison Basis: The Isolux America 1300 XSBP - 300 Watt Xenon was compared to predicate devices:
  • Karl Storz Cold Light Fountain Xenon 300
  • Maxenon (BFW)
  • Brite Lite III (Applied Fiberoptics)
• Demonstration: The manufacturer asserted, and the FDA agreed, that the Isolux America 1300 XSBP - 300 Watt Xenon is "substantially equivalent" to these predicates. This equivalence is based on:
  • Intended Use: Identical or very similar intended use (high intensity white light source for fiber optic cables in various endoscopic and surgical procedures).
  • Technological Characteristics: Similar use, design, and function. While specific detailed performance metrics for the predicates are not listed in this summary, the assumption of substantial equivalence implies that the Isolux device's performance is comparable and adequate for its intended use.
  • Effectiveness Claim: The claim of 600,000 Lux being "sufficient for all presently known endoscopic illumination tasks" implies that this level of output is at least equivalent to, or (if higher) exceeds, the output of the predicate devices deemed safe and effective.
  • Safety: A database search, performed to evaluate any adverse effects of currently marketed devices (Attachment 5), would have contributed to the safety assessment, demonstrating no new significant safety concerns compared to predicates.

In summary, for this particular device and its 510(k) clearance, the "proof" that it meets acceptance criteria primarily relies on demonstrating substantial equivalence to predicate devices rather than on a standalone clinical or performance study with defined acceptance criteria and statistical analysis of device performance. The FDA explicitly stated that "No performance data is required for this Class II device nor requested by the Food and Drug Administration".

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