(90 days)
To emit energy in the infrared spectrum to provide topical temperature. Intended to use for the temporary relief of minor muscle and joint stiffness, temporary increase in local circulation where applied, and the relaxation of muscles.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Sacred Crane TDP Lamp". This type of document does not contain details about acceptance criteria, device performance studies, or clinical trial methodologies as typically found in a clinical study report or a premarket approval (PMA) application.
A 510(k) clearance is based on demonstrating substantial equivalence to a predicate device, not on proving safety and effectiveness through extensive clinical trials for a new device type. Therefore, most of the information requested in your prompt is not available in this document.
Here's what can be extracted based on the information provided in the 510(k) letter:
1. A table of acceptance criteria and the reported device performance
- Not Available: This document does not specify acceptance criteria or report detailed device performance metrics. Its clearance is based on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available: This document does not describe a clinical study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Available: This document does not describe a clinical study with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Available: This document does not describe a clinical study with an adjudication method.
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 is a physical device (TDP Lamp) and does not involve AI or human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical device (TDP Lamp) and does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Available: This document does not describe a clinical study or the establishment of ground truth. The clearance is based on substantial equivalence.
8. The sample size for the training set
- Not Available: This document does not describe a training set as it's not an AI/algorithm-based device and doesn't detail clinical study specifics for training.
9. How the ground truth for the training set was established
- Not Available: This document does not describe a training set or how ground truth for such a set would be established.
In summary: The provided document is a regulatory approval letter based on substantial equivalence, not a detailed clinical study report. Therefore, it does not contain the specifics about clinical trial design, acceptance criteria, sample sizes, or ground truth establishment that you are looking for. Such information would typically be found in a separate 510(k) submission summary or a full study report, which is not part of this letter.
§ 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.