(24 days)
The PanaLight-BLU™ Illuminator, Model 4175 is intended to provide phototherapeutic light to the body. The PanaLight-BLU™ is generally indicated to treat dermatological indications. The PanaLight-BLU™ is specifically indicated to treat moderate inflammatory acne vulgaris.
The PanaLight-BLU™ is a compact light source that delivers a uniform distribution of narrowband blue light to the body with a spectral output at a peak wavelength of 417 +/- 5 nm. The principal parts of the system include the light unit head and floor stand with timer.
The provided text is a 510(k) Summary of Safety and Effectiveness for the DUSA PanaLight-BLU™ Illuminator, Model 4175. It explicitly states that no performance data is required for this Class II device, nor has it been requested by the Food and Drug Administration (Office of Device Evaluation).
Therefore, the study does not include acceptance criteria, specific device performance metrics, or details typically found in studies designed to prove a device meets performance criteria. The basis for clearance is substantial equivalence to predicate devices.
Given this information, a table of acceptance criteria and device performance, and details about a study proving these criteria, cannot be extracted from the provided document.
However, I can address the other points based on the document's content:
1. A table of acceptance criteria and the reported device performance:
Not applicable. The document states: "No performance data is required for this Class II device nor has it been requested by the Food and Drug Administration (Office of Device Evaluation)."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No performance study, test set, or data provenance is mentioned as no performance data was required.
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 applicable. No ground truth establishment for a test set is discussed as no performance study was required.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a test set is discussed as no performance study was required.
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 device is a blue light illuminator for phototherapy, not an AI-assisted diagnostic tool involving human readers. No MRMC study was conducted or referenced.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical light source, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No performance study requiring ground truth was conducted for this device's 510(k) clearance.
8. The sample size for the training set:
Not applicable. The device is a physical light source, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set or ground truth for it is relevant to this device's 510(k) submission.
Summary based on the provided document:
The DUSA PanaLight-BLU™ Illuminator, Model 4175, received 510(k) clearance based on substantial equivalence to predicate devices (BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170, and ClearLight™ Phototherapy Device, Model CL-420), rather than on specific performance data from a clinical study. The submission explicitly states that "No performance data is required for this Class II device nor has it been requested by the Food and Drug Administration (Office of Device Evaluation)." The rationale is that the PanaLight-BLU™ has the same spectral output, mode of operation, treatment area, general operating principles, and same intended use and indications for use as the predicate devices, leading to the conclusion that no significant differences exist and therefore it raises no new questions of safety or efficacy.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.