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The Spectra Hair Removal Laser is intended for temporary hair removal.

The Spectra Hair Removal Laser is a semiconductor diode laser system that delivers infrared light at a wavelength of nominally 800 nm.

The provided text states, "Performance Data: None. The specifications and indications for use of the Spectra Hair Removal Laser are substantially equivalent to those claimed in the clearance for the above-listed predicate devices. Thus performance data were not required."

Therefore, based on the input:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states "None" for performance data because it claims substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable. No performance study was conducted for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance study was conducted.
4. Adjudication method for the test set: Not applicable. No performance study was conducted.
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 performance study was conducted.
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 performance study was conducted.
8. The sample size for the training set: Not applicable. No performance study was conducted.
9. How the ground truth for the training set was established: Not applicable. No performance study was conducted.

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