(56 days)
LiteCure Therapy System, Model LTS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
LiteCure Therapy System, Model LTS-1500 is a compact medical laser system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight handpiece. Activation occurs when the operator enables the laser and presses the foot/finger switch. Depending on laser system configuration, the foot/finger switch can function as on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
This 510(k) summary focuses on the LiteCure Therapy System, Model LTS-1500, which is an infrared lamp device. The documentation provided does not contain information about software performance or an AI/ML-driven device, so many of the requested categories about acceptance criteria, study design, and AI model performance will be not applicable or not mentioned based on the provided text.
Specifically, this submission is for a medical device that emits infrared energy for topical heating and pain relief, and its substantial equivalence is based on its physical characteristics and intended use, not on diagnostic accuracy or algorithmic performance.
Here's a breakdown of the requested information based on the provided 510(k) summary:
Acceptance Criteria and Device Performance for LiteCure Therapy System, Model LTS-1500
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Expected Performance) | Reported Device Performance (as stated in document) |
|---|---|---|
| Safety and Effectiveness | Substantially equivalent to predicate devices (K070400, K091497) in terms of safety and effectiveness, and raises no new issues of safety or effectiveness. | "The LiteCure Therapy System, Model LTS-1500 is as safe and effective as the predicate devices." "The minor technological differences between the LiteCure Therapy System, Model LTS-1500 and its predicate devices raise no new issues of safety or effectiveness." |
| Intended Use | Aligns with the intended use of predicate devices: "emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation." | "LiteCure Therapy System, Model LTS-1500 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation." |
| Technological Characteristics | Similar technological characteristics to predicate devices (e.g., wavelength, laser safety class, principles of operation). | "The LiteCure Therapy System, Model LTS-1500 has the same intended uses and similar indications, technological characteristics (such as wavelength, laser safety class, etc), and principles of operation as its predicate device." |
| Standard Compliance | Compliance with relevant medical device safety and electromagnetic compatibility standards. | "The device is subject to the following voluntary consensus standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1." |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable / Not mentioned. This submission describes a physical medical laser device, not an AI/ML device that requires a test set for performance evaluation in the context of diagnostic or predictive accuracy. The substantial equivalence relies on comparison to predicate devices, compliance with standards, and demonstration of similar physical and operational characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable / Not mentioned. As this is for a physical therapy device and not a diagnostic AI system, there is no "ground truth" to establish in the context of expert consensus on image interpretation or disease diagnosis.
4. Adjudication Method for the Test Set
- Not applicable / Not mentioned. There is no test set or adjudication method described for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, Effect Size
- Not applicable / Not mentioned. An MRMC study is relevant for diagnostic imaging interpretation devices, which this infrared therapy device is not.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable / Not mentioned. This device does not involve an algorithm for standalone performance.
7. The Type of Ground Truth Used
- Not applicable / Not mentioned. The concept of "ground truth" (e.g., pathology, outcomes data) as it applies to diagnostic or prognostic AI systems is not relevant to this infrared lamp device. The "truth" here relates to the device's physical output specifications, safety, and therapeutic effects, none of which are typically established by expert consensus on cases or pathology reports in this context.
8. The Sample Size for the Training Set
- Not applicable / Not mentioned. This device does not have a "training set" in the context of an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not mentioned. Correspondingly, there is no training set ground truth to establish for this type of medical device.
§ 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.