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The SW-180 is indicated for use in applying therapeutic deep heat in body tissues for the treatment of selected medical conditions, including relief of pain, muscle spasms, and joint contractures.

The SW-180 Shortwave Therapy Unit consists of a main unit and a standard applicator. Several other types of applicators are available as options. The device may be operated in continuous or pulsed modes. The SW-180 has an output power of 80 W and operates at 27.12 ± .16 MHz. The device has an LED screen that serves as the interface with the user to specify options, provide messages, and display parameters. The SW-180 Shortwave Therapy Unit device is a prescription device and the prescription statement is contained in the labeling as required.

The provided text describes a 510(k) premarket notification for the SW-180 Shortwave Therapy Unit. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for an AI-powered diagnostic device.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert involvement, and ground truth establishment is not available in the provided text.

Here's an attempt to answer the questions based on the available information, noting where data is absent:

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

   • Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a diagnostic outcome. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate device, which involved performance testing on general device characteristics.
   • Reported Device Performance:

     Characteristic	Performance
     Electrical Safety	Testing conducted, assumed to meet predicate standards.
     Electromagnetic Compatibility	Testing conducted, assumed to meet predicate standards.
     Heating Patterns	Testing conducted, assumed to be similar to predicate.
     Various Integrity Checks	Testing conducted, assumed to meet predicate standards.

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

   • Not applicable as this is a physical therapy device, not a diagnostic AI. The "testing" mentioned refers to engineering performance validation, not clinical studies with patient data.

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)

   • Not applicable. Ground truth as typically defined for AI/diagnostic studies is not relevant here. The ground truth for the engineering performance tests would be established through industry standards and internal specifications.

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

   • Not applicable.

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 not an AI-powered diagnostic device, and no MRMC study was mentioned.

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

   • Not applicable.

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

   • Not applicable in the context of diagnostic AI. For the engineering tests, the "ground truth" would be the established engineering specifications and benchmarks for electrical safety, EMC, heating patterns, and integrity.

8. The sample size for the training set

   • Not applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not applicable.

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