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The SpaTouch is intended for removal of unwanted hair by using a selective photothermal treatment. The device is generally indicated for dermatological use. The SpaTouch is specifically indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional.

The SpaTouch is a Pulsed Light Hair Removal System. With the exception of contact switches added to the handpiece, the SpaTouch is the exact same device as the previously cleared DeLight II device. The only differences between the cleared DeLight II and the SpaTouch are the addition of the contact switches to the handpiece and the expanded indications for use.

The provided text describes the SpaTouch® PhotoEpilation System, but it does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria. The document is a 510(k) summary for a substantial equivalence determination, focusing on comparison to a predicate device.

Here's an analysis based on the information provided, highlighting the limitations in addressing your specific requests:

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

No explicit acceptance criteria or a table of performance metrics are provided in the document. The submission states: "Clinical data demonstrated that the device can be used safely and effectively under the supervision of a health professional." This is a general statement and not a set of measurable acceptance criteria with corresponding performance data.

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

The document mentions "Clinical data" but does not specify the sample size, data provenance (country of origin), or whether the study was retrospective or prospective.

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)

This information is not available in the provided text.

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

This information is not available in the provided text.

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

An MRMC study is not mentioned. The device described is a photoepilation system for hair removal, which typically does not involve "readers" or AI assistance in the context of medical image interpretation.

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

This is not applicable as the device is a physical system for hair removal, not an algorithm. The "human-in-the-loop" aspect is explicit: "under the direction of a physician, after training by a healthcare professional."

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

For a hair removal device, "ground truth" would typically refer to the actual hair reduction observed. However, the document does not specify how this was measured or whether it involved expert assessment, photographic evidence, or patient self-reporting. It broadly states "Clinical data demonstrated that the device can be used safely and effectively."

8. The sample size for the training set

This information is not available in the provided text. The device is a physical device, not an AI algorithm that typically uses "training sets."

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

Not applicable as this is not an AI algorithm.

Summary of what is available and what is missing:

The provided document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device (Radiancy (Israel) Ltd. DeLight II Hair Removal System). The core argument for equivalence hinges on the SpaTouch being "the exact same device" as the DeLight II, with only minor additions (contact switches) and expanded indications for use.

The clinical data mentioned serves to support the general safety and effectiveness for the purpose of substantial equivalence, rather than detailing a rigorous performance study with specific acceptance criteria as might be expected for novel devices or AI/diagnostic applications. The information needed to answer your questions exhaustively is not present in this type of regulatory submission.

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