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The Affirm DO Diode laser device is indicated for use in general surgery and dermatology for the coagulation of soft tissue. It is also indicated for the treatment of perioral wrinkles, and pigmented lesions.

Affirm DO is a diode laser. It is a laser with a wavelength of 1440 nm. Laser activation is by footswitch. Overall weight of the laser is 15 Kg, and the size is 25 x 9 x 18 cm (HxWxD). Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase.

The provided document does not describe acceptance criteria or a study that proves a device meets such criteria.

Instead, it is a 510(k) summary for the "Affirm DO Diode Laser" and the corresponding FDA clearance letter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Here's why the requested information cannot be extracted and what the document does state:

• No Acceptance Criteria or Performance Data: The "Nonclinical Performance Data" and "Clinical Performance Data" sections explicitly state "none." This means no studies were submitted to demonstrate performance against pre-defined criteria.
• Substantial Equivalence: The basis for clearance is "comparison" to a predicate device (Cynosure YAG MIR Family Laser) based on having "the same indication for uses, the same principle of operation, the same wavelength and similar pulse energy range."

Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided text.

Specifically, for each point requested:

1. A table of acceptance criteria and the reported device performance: Not available. No acceptance criteria or performance data are reported.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or clinical data was used for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established as no clinical data was used.
4. Adjudication method for the test set: Not applicable. No adjudication was performed as no clinical data was used.
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 a laser device, not an AI diagnostic tool, and no MRMC study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laser device, not an algorithm.
7. The type of ground truth used: Not applicable. No ground truth was used.
8. The sample size for the training set: Not applicable. No training set was used.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for it was established.

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