(578 days)
The SW Ultrasound Line is intended for use in applying therapeutic deep heat for selected medical conditions.
Ultrasound therapy is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies (21 CFR 890.5300)
IS A THERAPEUTICAL ULTRASONIC DIATHERMY DEVICE FOR ION THEFULL LONSE TO APPLY THERAPEUTIC DEEP HEAT FOR SELECTED MEDICAL CONDITIONS.
The SW Ultrasound Line is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.
The provided document outlines the 510(k) premarket notification for the "SW ULTRASOUND" device. This is a notification for substantial equivalence to a legally marketed predicate device, rather than a de novo approval requiring extensive clinical efficacy studies against specific performance criteria.
Therefore, the information you've requested regarding acceptance criteria and performance studies, particularly in the context of diagnostic accuracy, human reader effectiveness with AI, and standalone algorithm performance, is not present in these documents. The focus here is on demonstrating that the new device is as safe and effective as an existing device, primarily through technological comparison and basic safety testing.
Here's an breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, accuracy) because it is for an ultrasonic diathermy device (therapeutic, not diagnostic). The substantial equivalence is based on:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | Identical to predicate device (therapeutic deep heat for selected medical conditions like pain, muscle spasms, joint contractures, excluding malignancies). |
| Technological Characteristics | "The technological characteristics of the SW Ultrasound device are the same as those of the predicate device." |
| Electrical Safety | Testing carried out and presumably met relevant standards (though specific results are not detailed). |
| Electromagnetic Compatibility (EMC) | Testing carried out and presumably met relevant standards. |
| Temperature Rise in Phantom | Testing carried out to compare temperature rise during SW Ultrasound procedures with that of the predicate device, implying similar thermal effects. |
| Compliance with 21 CFR 1050.1 | Testing carried out to demonstrate compliance. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of this 510(k). The "testing" referred to are physical and electrical performance tests on the device itself, not a clinical test set of patient data.
- Data Provenance: Not applicable. The testing was conducted by Starbene on its own device and a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the sense of expert adjudicated patient data is not relevant for this type of device submission. The "ground truth" for the engineering tests would be the established scientific principles and regulatory standards for electrical safety, EMC, and thermal effects.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" of patient data 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 a therapeutic ultrasound, not an AI-driven diagnostic imaging system. There are no "human readers" or "AI assistance" involved in its stated function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests performed (electrical safety, EMC, temperature rise, 21 CFR 1050.1 compliance) is based on established engineering standards and regulatory requirements, not clinical outcomes or pathology.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
§ 890.5300 Ultrasonic diathermy.
(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.