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The ASA laser SH1 is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

The ASA laser SH1 is a medical laser system equipped with a Nd: Y AG laser source. The Nd:YAG laser radiation has a wavelength of 1064nm and is delivered to the treatment area through a fiber optics and a delivery handpiece connected to its distal end. A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready. Overall weight of the device is 13 kg, and the size is 38 cm x 22 cm x 42 cm (H x W x D). Electrical requirement is 115Vac 50/60Hz, 750VA.

The provided 510(k) summary (K122125) describes the ASA laser SH1, a medical device for topical heating. The study provided focuses on the device's ability to achieve and maintain a specific skin temperature. Here's a breakdown based on your request:

Acceptance Criteria and Reported Device Performance

Study Details

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

• Sample Size: Three live human subjects.
• Data Provenance: Prospective (clinical study performed), country of origin not explicitly stated but the applicant is El.En. S.p.A. from Italy.

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

• Number of Experts: Not applicable. The "ground truth" here is the objective measurement of skin temperature.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable. The study involved objective temperature measurement, not subjective interpretation requiring adjudication.

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 device is not an AI-assisted diagnostic tool and no MRMC study was performed.

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

• Not applicable. This is a medical laser device, not an algorithm, and its performance directly involves human subjects for therapeutic effect, not as an "algorithm-only" assessment.

7. The type of ground truth used:

• Objective Measurement (Skin Temperature): The "ground truth" was the direct measurement of skin temperature achieved and maintained on human subjects.

8. The sample size for the training set:

• Not applicable. This study does not involve an AI algorithm with a training set. The clinical study was a direct performance test on a small cohort of subjects.

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

• Not applicable, as there is no training set for an AI algorithm.

Summary of the Study and its purpose for this 510(k):

The clinical study described was a clinical performance trial involving three human subjects with different skin phototypes. The primary purpose of this study was to demonstrate the device's ability to achieve its intended physiological effect (elevating and maintaining tissue temperature within a specific range). This type of study supports the substantial equivalence claim by showing that the device performs as expected and similarly to its predicate device in terms of its therapeutic mechanism. It is important to note that this is a very small study primarily focused on demonstrating direct physiological action rather than complex diagnostic or intervention outcomes.

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