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The Starlite 2006 will be used with the following lasers for the excision, ablation, vaporization and hemostasis of soft tissue.

Diolase ST produced by American Dental Technologies (810 Nm operating wavelength) Twilight produced by Biolase (810 Nm operating wavelength) Diodent produced by Hoya Con Bio (810 Nm operating wavelength) Softlase produced by Zap Lasers (810 Nm operating wavelength) Aurora produced by Premier Lasers (810 Nm operating wavelength)

indications of use summary statement: The StarLite laser fiber optic can be used for all the of the lasers cited above as well as other diode soft tissue lasers operating using the same wavelengths.

The StarLite will become an intergral part of the laser system and by default be cleared for the same exact indications and procedures as the laser it is deployed on.

The starLite 2065 is an "after-market" accessory for use with an existing surgical laser system. The device is used as a complete system (optical fiber and connector) The StarLite 2006 IS used as a direct replacement for the laser optical fiber supplied as original equipment or the original equipment laser optical fiber.

One of the primary considerations when using a fiber-optically delivered surgical laser system is that the fiber is capable of delivering the maximum amount of energy the laser is set for minus a small connector loss.

Most fiber based laser systems include a handpiece that clasps or grips the laser fiber on its protective jacket. For this reason the laser fiber must have an outside coating capable of protecting the inner core.

Many procedures call for the use or application of a "bare fiber" to the operative tissue; the so called "contact mode" of operation.

The StarLice is designed using industry standard connectors and optical fiber. The components of this fiber optic assembly are the same as what is currently being used on cleared existing lasers cited above. The protective outside buffer or jacket is compatible with all handpieces designed for this fiber type.

The starLite laser fiber optic is intended for use with lasers that do various surgical procedures. The StarLite is universal in nature and is intended to be used on currently FDA cleared soft tissue lasers. The StarLite assembly is designed to accommodate hard clad faser fibers including 200, 300, 400 and 600 micron diameters.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria in terms of specific performance metrics (like accuracy, sensitivity, specificity, etc.) for the StarLite 2006. Instead, the primary "acceptance criterion" appears to be substantial equivalence to legally marketed predicate devices, meaning it functions in the same way and uses the same materials and principles.

Therefore, the table will reflect this qualitative assessment of equivalence, rather than specific performance numbers.

Here's an analysis of the study related information, based on the provided text:

1. Sample size used for the test set and the data provenance:

   • The document does not describe a test set, a specific study with a sample size, or data provenance in the context of typical device performance evaluation (e.g., clinical trials, bench testing with a defined set of samples).
   • The focus is on demonstrating "substantial equivalence" through descriptive comparisons to predicate devices and adherence to design principles rather than empirical performance testing against a specific dataset.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There is no mention of a test set, ground truth, or experts establishing such ground truth.

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

   • Not applicable. No test set or adjudication method is described.

4. 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. The device is a laser optical fiber, not an AI or diagnostic imaging device. No MRMC study was performed or mentioned.

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

   • Not applicable. The device is a physical component (laser fiber), not an algorithm.

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

   • Not applicable. No ground truth is mentioned in the context of device performance evaluation. The "ground truth" for this submission is implicitly the established functionality and safety of the predicate devices and general industry standards for laser fiber optics.

7. The sample size for the training set:

   • Not applicable. The device is a physical component, not a learning algorithm or AI. There is no concept of a "training set" for this product submission.

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set, this question is not relevant.

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