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The Model SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System is intended for use as a fiber optic delivery system in conjunction with any Ho:YAG (holmium) surgical laser with SMA 905 compatible connector. The MegaBeam SideFiber Fiber Optic Delivery System is indicated for hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.

The SF-2100-H MegaBeam SideFiber Fiber Optic Delivery System consists of quartz fiber core and a coaxially mounted protective sheath with a metal tin at the distal end.

The provided document is a 510(k) summary for the Biolitec MegaBeam® SideFiber® Fiber Optic Delivery System, which is a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with acceptance criteria for device performance as would be seen for new, high-risk devices.

Therefore, the document does not contain information about specific acceptance criteria or a study proving that the device meets those criteria in terms of clinical performance metrics like sensitivity, specificity, or reader improvement with AI.

Instead, the submission relies on bench test data and the demonstration of substantial equivalence to legally marketed predicate devices.

Here's a breakdown of what can be extracted from the document based on your request, and what cannot:

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

• Cannot be provided. The document states "Bench test data was provided in support of the 510(k) notice." However, the specific acceptance criteria and the quantitative results of these bench tests are not included in this public summary. The summary concludes that the device is "as safe and effective" as its predicate based on these tests and other characteristics, but doesn't quantify this performance against explicit acceptance criteria.

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

• Cannot be provided. The document refers to "bench test data," which implies laboratory testing rather than human subject data or a clinical "test set." No sample sizes or data provenance (country, retrospective/prospective) are mentioned for any testing.

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)

• Cannot be provided. Since no clinical test set or human subject data is described, there's no mention of experts establishing a ground truth.

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

• Cannot be provided. No clinical test set means no adjudication method.

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

• Cannot be provided. This device is a fiber optic delivery system, not an AI diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or mentioned.

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

• Cannot be provided. This question is relevant for AI algorithms. The device is a physical medical instrument, not an algorithm.

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

• Cannot be provided. Given the nature of a fiber optic delivery system and the reliance on bench testing for a 510(k), ground truth in the sense of clinical diagnostic accuracy (e.g., pathology) is not applicable. The "ground truth" for bench tests would relate to engineering specifications and physical measurements (e.g., power output, fiber integrity, heat dissipation) compared to specified design parameters or predicate device performance. These specifics are not detailed in the summary.

8. The sample size for the training set

• Cannot be provided. This question is relevant for AI algorithms. The device is a physical medical instrument, not an algorithm, and therefore does not have a "training set" in this context.

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

• Cannot be provided. This question is relevant for AI algorithms. Not applicable to this device.

Summary of Device Performance (Based on provided text):

The 510(k) summary primarily asserts "Substantial Equivalence" to predicate devices rather than providing detailed performance metrics against specific acceptance criteria.

Acceptance Criteria & Reported Performance Table (as much as can be inferred):

In conclusion, this document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It does not contain the kind of detailed performance metrics, acceptance criteria, or clinical study data that would be present for a novel diagnostic device or AI algorithm, which typically requires a different regulatory pathway or more extensive clinical evidence.

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