(57 days)
The LUMINA Systems are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
The LUMINA 1600, 3300 and 6600 Systems are easy to use, non-invasive therapeutic device that provides continuous heat therapy. The Systems consist of a Console that houses the electronics and controls and a treatment probe applicators that deliver the infrared energy to the target area.
The provided document is a 510(k) Premarket Notification Summary for the LUMINA Infrared Heat Lamp Therapy Systems. This type of submission is a regulatory pathway to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the document does not contain the detailed study information typically associated with establishing acceptance criteria and proving performance through a clinical trial with human subjects.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Device provides continuous heat therapy. | The LUMINA Systems are described as "easy to use, non-invasive therapeutic devices that provide continuous heat therapy." |
| Emits energy in the infrared spectrum. | Explicitly stated that the systems "emit energy in the infrared spectrum." | |
| Elevates tissue temperature for therapeutic purposes. | The systems are designed to "produce a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration" for the stated indications. | |
| Electrical Safety | Complies with applicable electrical safety standards for medical devices. | Electrical safety testing was conducted "in accordance with all applicable standards for this type medical device." |
| Intended Use Equivalence | Intended uses are substantially equivalent to predicate devices. | The LUMINA Systems have "the same intended uses" as the predicate devices. |
| Technical Characteristic Equivalence | Similar functional and performance characteristics to predicate devices. | The LUMINA Systems have "similar functional and performance characteristics" to the predicate devices. |
Explanation: The acceptance criteria here are primarily based on demonstrating substantial equivalence to predicate devices, focusing on functional performance, safety, and intended use, rather than specific quantitative clinical efficacy thresholds. The "reported device performance" reflects the general claims made about the device's capabilities and its alignment with predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes a 510(k) submission, which relies on demonstrating substantial equivalence to existing devices rather than a clinical study with a "test set" in the traditional sense. The testing mentioned (functional performance and electrical safety) is laboratory-based and doesn't involve human subjects as a "test set" for clinical efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This information is relevant for clinical studies where expert review is used to establish ground truth for a diagnostic or predictive device. This 510(k) premarket notification does not describe such a study.
4. Adjudication Method for the Test Set
Not applicable. (See explanation for point 3).
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. The LUMINA Systems are infrared heat lamps, not AI-powered diagnostic or assistive devices that would involve human readers or an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The LUMINA Systems are therapeutic devices that physically deliver infrared energy, not standalone algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for clinical efficacy. The "ground truth" for the 510(k) submission primarily revolved around:
- Regulatory Standards: Compliance with 21 CFR 890.5500 for infrared lamps.
- Literature: The device's ability to produce "a level of tissue temperature reported in literature and accepted by the Federal Food and Drug Administration" for the indications. This implies that existing scientific and medical literature on infrared therapy serves as the basis for what constitutes an effective tissue temperature.
- Predicate Device Characteristics: The functional and performance characteristics of legally marketed predicate devices served as a de facto "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-driven device requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. (See explanation for point 8).
Summary of the Study and Device Proof:
The "study" in this context is the 510(k) premarket notification process, not a clinical trial. The device, LUMINA Infrared Heat Lamp Therapy Systems, meets acceptance criteria by demonstrating substantial equivalence to already legally marketed predicate devices.
The proof relies on:
- Functional Performance Testing: Confirming the device operates as intended (e.g., emits infrared energy, provides continuous heat).
- Electrical Safety Testing: Ensuring compliance with all applicable safety standards.
- Comparison to Predicate Devices: Explicitly stating that the LUMINA Systems have the "same intended uses, with similar functional and performance characteristics" as the predicate devices (Avicenna Laser Therapy, Inc. ALT Laser Model VTR 75, Light Force Therapy, Inc. Super Nova and Acubeam Systems, and Meditech International, Inc. BioFlex Professional Therapy System).
- Compliance with Literature and FDA Acceptance: The systems are designed to produce tissue temperatures known to be therapeutically effective, as supported by existing literature and prior FDA acceptances for similar devices.
There is no mention of a human test set, experts establishing ground truth for a clinical study, or any form of AI involvement. The focus is on regulatory compliance and equivalence to established technology.
§ 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.