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The PhoTex15 Diode Laser Series is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including; gastroenterology, general surgery, plastic surgery, genitourinary (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT) head and neck, orthopedics, ophthalmology, pulmonology, and thoracic surgery.

The PhoTexys Diode Laser Series are diode lasers emitting radiation in either a continuous-wave (CW) or pulsed-mode in the infrared range at one of the following wavelengths: 980nm, 810nm, and 940nm. The PhoTexis Diode Laser Series provides a means for cutting, coagulation, and vaporization of tissue using a compatible fiber optic delivery accessory. The laser is compatible with any fiber optic delivery accessory terminated with a standard SMA905 connector whose core fiber diameter is 400 micron or larger with a numerical aperture of at least .37.

This document is a 510(k) summary for the BioTex PhoTex₁₅ Diode Laser Series, seeking substantial equivalence to predicate devices. It does not describe a study involving acceptance criteria and device performance in the context of AI/ML or diagnostic accuracy.

Instead, it pertains to a traditional medical device (a laser) and its compliance with FDA standards and comparison to existing similar devices. Therefore, I cannot extract information related to AI/ML specific criteria such as sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies.

Here's an analysis based on the provided text, focusing on the traditional device context:

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

The document does not explicitly state acceptance criteria in a quantitative table format that would be typical for performance studies to determine accuracy or sensitivity/specificity. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on design, technological features, device performance (in a general sense), and indications for use.

The "performance" described is that the lasers:

• "functioned and performed in a manner similar to the predicate device when used in accordance with the labeled directions for use and specified indications."
• "are in compliance with FDA standards 21CFR1040,10 and 21CFR1040.11."

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

Not applicable. This is not a study involving a "test set" of patient data for evaluating a diagnostic or AI/ML device. The evaluation was based on "Engineering studies" and comparison of technical specifications.

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. There was no "ground truth" derived from expert review of a test set in the context of diagnostic performance.

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

Not applicable for the same reasons as above.

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 is not a diagnostic device involving human readers or AI assistance.

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

Not applicable. This is a physical surgical laser, not an algorithm.

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

Not applicable. The "ground truth" here is compliance with established safety and performance standards for laser devices and the technical specifications of predicate devices.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not applicable.

Summary of the traditional device evaluation:

• Acceptance Criteria (Implied): Substantial equivalence to predicate devices (SLT Thermalite Diode Laser Series and PhotoMedex LaserPro Diode Laser Systems) in terms of:
  • Technological features
  • Device performance (general functionality and safety)
  • Indications for use
  • Compliance with FDA standards 21CFR1040,10 and 21CFR1040.11.
• Reported Device Performance: The PhoTex₁₅ Diode Laser Series "functioned and performed in a manner similar to the predicate device" and is "in compliance with FDA standards."
• Study Proving Compliance: "Engineering studies have demonstrated the substantial equivalence" to the predicate device. These studies concluded that "no significant differences exist" and "differences were determined to be minor and are each within the specifications listed by the predicate device."
• Study Type: Non-clinical (benched-based) engineering tests and comparison of specifications to predicate devices.

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