(111 days)
The Quasar MD21 infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
The Quasar MD21 consists of a collection of both infrared and red diodes [LEDs], packaged in a compact plastic head. The system emits pulsed light in the infrared spectrum to provide topical heating. The red diodes [LEDs], provide a visible indication that the unit is in operation. For operation turn on LEDs for a time period of twenty-five (25) minutes prior to use.
The provided document K032379 is a 510(k) summary for an infrared heat lamp, the Quasar MD21. This type of filing is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific clinical performance criteria from a clinical study. The document states that testing included "functional performance testing and electrical safety testing," but it does not describe a clinical study with acceptance criteria, sample sizes, ground truth establishment, or expert reviews for clinical effectiveness.
Therefore, many of the requested details about a study and acceptance criteria related to clinical performance cannot be extracted from this document, as such a study was not presented or required for this 510(k) submission.
Here's a breakdown of what can be inferred or explicitly stated from the document regarding the acceptance criteria and the "study" (referring to the testing mentioned):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance: | |
| Emit energy in infrared spectrum for topical heating. | The Quasar MD21 emits pulsed light in the infrared spectrum. |
| Provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. | This is the stated intended use based on equivalence to predicate devices; no specific performance metrics or clinical trial results are provided to prove this relief. |
| Temporarily increase local blood circulation. | This is the stated intended use based on equivalence to predicate devices; no specific performance metrics or clinical trial results are provided to prove this increase. |
| Promote relaxation of muscle tissue. | This is the stated intended use based on equivalence to predicate devices; no specific performance metrics or clinical trial results are provided to prove this relaxation. |
| Achieve temperatures similar to predicate devices. | The document states "The temperatures achieved by these devices are the same, using a similar number of diodes [LEDs], over a similar coverage area" when compared to predicate devices. |
| Electrical Safety: | |
| Comply with relevant electrical safety standards. | "Electrical safety testing" was performed. No specific standards or results are detailed in this summary. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable/Not provided. The "testing" mentioned refers to functional and electrical safety assessments of the device itself, not a clinical test set on human subjects.
- Data Provenance: Not applicable/Not provided in relation to clinical data. The device itself was manufactured by Quantum Skincare, Inc. in Ringgold, LA, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not provided. Ground truth in the context of clinical performance review by experts was not established since a clinical study on effectiveness was not described.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/None mentioned. This concept applies to the resolution of discrepant readings in clinical studies, which were not conducted.
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
- MRMC Study: No. This device is an infrared heat lamp, not an AI-powered diagnostic imaging device. An MRMC study is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This refers to AI algorithm performance, which is not relevant to an infrared heat lamp.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable. For the functional and electrical safety testing, the "ground truth" would be established engineering specifications and industry standards for electrical safety and infrared emission. No clinical ground truth (e.g., pathology, patient outcomes) was established or used for the purpose of this 510(k) submission's stated "testing."
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This concept applies to machine learning models, which are not involved in this device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable.
In summary: The K032379 submission is for a medical device (infrared heat lamp) that achieves market clearance through substantial equivalence to predicate devices, rather than through extensive clinical trials demonstrating specific performance against rigorous acceptance criteria. The "testing" referred to in the document focuses on functional (e.g., infrared emission, temperature) and electrical safety aspects of the device itself, not on clinical effectiveness in human subjects in a manner that would generate the kind of data typically found in clinical studies for diagnostic or therapeutic devices requiring such evidence.
§ 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.