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The LitePort@LP100 Surgical Illuminator provides supplemental illumination in surgical procedures in the thoracic and abdominal cavities.

The LitePort® LP100 illumination device is a tubular fully self contained, sterile, disposable surgical illuminator powered by batteries.

The provided document describes the predicate comparison for the LitePort® LP100 Surgical Illuminator for its 510(k) submission (K041621), not a study proving its acceptance criteria against specific performance metrics for the device itself. Therefore, many of the requested categories cannot be answered directly from the provided text as it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results for the LitePort® LP100.

However, I can extract the information that is present and indicate where information is not available.

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

Note: The document states that the device "complies with voluntary Performance Standards applicable to all existing surgical lamps" and that "Food and Drug Administration mandated Performance standards are not in effect" for this device type. Specific numerical acceptance criteria are not provided in this document. The "Reported Device Performance" is a summary statement that "The devices perform according to predetermined performance requirements, providing evidence of their ability to operate within their specified environment. Product performance specifications were validated using an appropriate methodology."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified. This appears to be non-clinical testing performed by the manufacturer, Medical Vision Industries, Inc., in Modesto, CA, USA. The document doesn't indicate if any data was sourced from other countries or if it was retrospective or prospective.

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 as this is non-clinical testing on device performance (illumination, sterility, etc.), not a diagnostic or clinical study requiring expert ground truth for interpretation.

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

• Not applicable, as this is non-clinical testing.

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, as this is a surgical illuminator, not an AI-assisted diagnostic device.

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

• Not applicable, as this is a surgical illuminator, not an algorithm. The testing described is "standalone" in the sense that it's the device's inherent performance.

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

• For the non-clinical performance testing (illumination levels, duration, sterility, packaging), the "ground truth" would be established by engineering specifications, standardized test methods (e.g., ISO/EN protocols), and validated internal performance requirements. The document mentions "predetermined performance requirements" and "design specifications."

8. The sample size for the training set

• Not applicable, as this is not a machine learning model.

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

• Not applicable, as this is not a machine learning model.

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