(156 days)
Intended for the relaxation of muscles and relief of muscle spasms; temporary relief of minor muscle and joint aches, pains, and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation.
The DPL ™ Therapy System is a compact infrared lamp for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The device is comparable in design, technology, and output to the Dermillume HR 1000 infrared lamp product. The lamps are contained in two panels on a desk stand. The panels are detachable for use individually or as a pair on the body. The product has an automatic 17-minute timed cycle which may be repeated by activating the ON cycle. Device takes 8 minutes to reach target temperature on skin. Total time for treatment is 17 minutes.
The provided 510(k) summary for the DPL™ Therapy System (K081570) describes a medical device, an infrared lamp, and its substantial equivalence to a predicate device. However, this document does not contain the typical "acceptance criteria" or a detailed "study that proves the device meets the acceptance criteria" in the way one would expect for a more complex diagnostic or AI-driven device.
Instead, the submission largely relies on demonstrating substantial equivalence to a predicate device (Dermillume Red HR 1000, 510(k) K051681) and compliance with relevant electrical safety and electromagnetic compatibility standards. The "clinical studies" mentioned are more about verifying the therapeutic heating effect and safety rather than statistical performance against specific diagnostic metrics.
Here's an attempt to extract and interpret the requested information based on the provided text, making it clear where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this device (an infrared lamp for therapeutic heating) and the provided document, the "acceptance criteria" are primarily related to safety, therapeutic effect (skin temperature elevation), and substantial equivalence to a predicate device. Performance is framed in terms of achieving therapeutic heat safely.
| Acceptance Criteria (Interpreted) | Reported Device Performance |
|---|---|
| Safety: Device conforms to electrical safety standards. | Conforms to IEC 60601-1-1:2000. Safe temperatures were maintained for the duration of the treatment time. No adverse effects or complications encountered. |
| Safety: Device conforms to electromagnetic compatibility. | Complies to EN 60601-1-2:2001. |
| Effectiveness: Therapeutic heat is attained. | Clinical studies demonstrate that therapeutic heat is attained for male and female subjects. |
| Performance: Comparable to predicate device. | The DPL™ Therapy System is safe, as effective, and performs comparably to the predicate device (Dermillume Red HR 1000, K051681). It furnishes therapeutic heating comparable to the predicate. Device takes 8 minutes to reach target temperature on skin. |
| Operational: Automatic timed cycle. | Product has an automatic 17-minute timed cycle which may be repeated by activating the ON cycle. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "male and female subjects" for clinical studies but does not provide a specific number for the test set or any breakdown.
- Data Provenance: Not specified. It's listed under "Clinical studies demonstrate," but there's no information about the country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable / Not provided. This device is an infrared lamp for therapeutic heating. The "ground truth" here is not an expert consensus on interpreting images or diagnoses, but rather objective physiological measurements (e.g., skin temperature, absence of burns/adverse events) and patient-reported outcomes (e.g., pain relief, muscle relaxation). The submission does not detail the personnel involved in collecting or assessing this.
4. Adjudication Method for the Test Set
- Not applicable / Not provided. Since there's no expert interpretation of data needing consensus, an adjudication method like 2+1 or 3+1 is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is typically for evaluating diagnostic performance of human readers, sometimes with and without AI assistance. This document describes an infrared therapy device, not a diagnostic tool, and involves no "human readers" in the context of interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an infrared lamp, a physical therapy device, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this product.
7. The Type of Ground Truth Used
- Physiological measurements and safety observations: The "ground truth" seems to be based on objective measurements like skin temperature elevation reaching "therapeutic heat" and the absence of adverse effects or complications. It would also implicitly involve the device successfully delivering infrared light.
- Patient-reported outcomes (implied): While not explicitly stated as "ground truth," the intended use (relaxation, relief of aches/pains) implies that some form of subjective feedback on these outcomes would have been assessed in the "clinical studies."
8. The Sample Size for the Training Set
- Not applicable / Not provided. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable / Not provided. As there's no AI component or training set, this question is not relevant.
§ 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.