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To provide topical heating for the purpose of elevating tissue temperature for 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 devices have a control unit that can be programmed utilized for the patient parameters. In addition, they are equipped with manual interface, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters. During operation the devices have an applicator instrument attached to the main unit.

This document is a 510(k) Pre-Market Notification from the FDA regarding the Hilthera 4.0 Therapeutical Laser System. It seeks to establish substantial equivalence to a predicate device, the El En HILT Family Laser (K051537).

Based on the provided document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics for the Hilthera 4.0 Therapeutical Laser System in comparison to detailed criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed through non-clinical testing focused on safety and functional specifications, rather than clinical efficacy against defined acceptance thresholds for a specific medical outcome.

The closest comparison of "performance" is in the Comparison of Technological Characteristics (Table 5A), which compares specifications:

Note on Acceptance Criteria: For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering, electrical, and performance testing, rather than direct clinical outcome comparisons with predefined thresholds for efficacy in a novel clinical trial.

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

• Test Set Sample Size: Not applicable in the context of clinical patient data. The non-clinical performance data involved testing of the device hardware and software. The document refers to "test plans" for software and "all testing" for electrical and safety, implying comprehensive unit and integration testing.
• Data Provenance: The testing was carried out by the manufacturer, Jeisys Medical, Inc. The document does not specify the country of origin for the non-clinical testing data beyond the manufacturer's location (Seoul, Korea). The testing is retrospective in the sense that it evaluates the manufactured device against pre-established specifications and standards.

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

Not applicable for this type of submission. The ground truth for the non-clinical tests (hardware, software, electrical safety, EMC) is adherence to engineering specifications, national/international standards, and FDA guidelines. This generally involves standard engineering verification and validation processes and compliance checks, not expert adjudication of medical images or diagnostic outcomes.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple experts where ground truth is subjective or requires consensus (e.g., radiology diagnoses). For this device, verification and validation testing against technical specifications serve as the "ground truth establishment."

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 a laser system for therapeutic purposes (topical heating), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is irrelevant to this submission.

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

Not applicable. This is a physical therapeutic device, not an algorithm. Its performance is inherent in its hardware, software, and physical properties.

7. The type of ground truth used

The ground truth used for the non-clinical performance data (hardware and software testing, electrical safety, EMC) was engineering specifications, established software design specifications, Device Hazard analysis, and national/international voluntary standards (e.g., for Electromagnetic Compatibility and Safety). The device performed as intended based on these specified acceptance criteria.

8. The sample size for the training set

Not applicable. This is a hardware therapeutic device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for a machine learning model in this submission.

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