(267 days)
Heat Lamp Therapy Feature: The StimLase 2000 System is intended to be used for topical heating of tissue for the purpose of temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasms. The unit may be used for temporary increase in local blood circulation and/or the temporary relaxation of muscles. Electrotherapy Feature: The StimLase 2000 System is intended to be used for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
The StimLase 2000 System is a therapeutic heating device with the capability to provide simultaneous or separate electrotherapy. The system consists of a console with selector settings, a footpedal control, and a laser wand. The unit can also accommodate two disposable OEM carbon electrodes for electrical stimulation therapy.
The provided text describes a 510(k) summary for the StimLase 2000 System, a therapeutic heating device with electrotherapy capabilities. It focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study with specific acceptance criteria and performance metrics for a novel AI/software device.
Therefore, many of the requested categories for AI/software device studies are not applicable to this document.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This document is a 510(k) summary based on substantial equivalence to predicate devices. It does not present a de novo study with explicit acceptance criteria and corresponding performance metrics from such a study. The "performance" discussed relates to meeting regulatory and technical standards (e.g., IEC 60601, IEC 60825) and having similar technical features to predicate devices.
2. Sample size used for the test set and the data provenance
Not applicable. There is no mention of a clinical "test set" in the context of an AI/software performance study. The submission relies on demonstrating similarity to existing, legally marketed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is discussed.
4. Adjudication method 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 document does not concern an AI/software device or an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software algorithm.
7. The type of ground truth used
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of Relevant Information from the Provided Text:
- Device Name: StimLase 2000 System
- Regulatory Pathway: 510(k) Premarket Notification
- Basis for Clearance: Substantial Equivalence to predicate devices.
- Predicate Devices:
- Technological Characteristics Comparison: The StimLase 2000 System has similar technical features to the predicate devices, including a console, footpedal, laser wand, and capability for electrotherapy with disposable electrodes. Specific power output (0-550 mW) and laser type (gallium arsenide semiconductor laser diode) are mentioned.
- Standards Met: The device meets requirements in 21 CFR §1040.10, 21 CFR §1040.11, and 21 CFR §1010, and has been tested to comply with IEC 60601 and IEC 60825.
- Conclusion on Equivalence: The submission concludes that the StimLase 2000 System shares similar indications, technology, and application with the predicate devices, and is equivalent in key performance areas affecting safety and effectiveness.
In essence, the "study" proving the device meets the acceptance criteria is the 510(k) submission itself demonstrating substantial equivalence based on technical comparison and adherence to standards, rather than a clinical performance study with specific quantitative acceptance criteria.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.