(197 days)
The ReClear™ Phototherapy System ("ReClear™") is intended to provide phototherapeutic light to the body. The ReClear™ is specifically indicated to emit visible blue/violet light for treatment of moderate inflammatory acne vulgaris. It also emits infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
The ReClear emits in the range of visible blue/violet light (405-420nm) and infrared light (850 nm to 900 nm) with a fluency of light up to 200mW/cm². The system also includes an optical system for controlling spectra and beam parameters of the light source, a mechanical fixture for holding the light source at an adjustable distance and direction in relation to the skin treatment area, and a timer unit to control the duration of the emitted radiation.
The provided text is a 510(k) summary for the CureLight ReClear™ Phototherapy System. It details the device's intended use and technological characteristics but does not contain any information about acceptance criteria, device performance results, sample sizes, expert involvement, or any specific studies proving the device meets acceptance criteria.
The document relies on demonstrating substantial equivalence to previously cleared predicate devices (K030338, K001179, K020017, and K020851) rather than presenting new performance data from a specific study for the ReClear™ itself.
Therefore, I cannot populate the requested table or answer most of the questions based on the provided text.
Here is what can be inferred from the document regarding the device and its predicate:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document. The basis for clearance is "substantial equivalence" to predicate devices, implying that the ReClear™'s specifications and intended uses are similar enough to already approved devices.
- Reported Device Performance: Not reported for the ReClear™ explicitly. The document states its technological characteristics, which are the basis for substantial equivalence.
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 as no new specific performance study is detailed for the ReClear™ device in this document.
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 as no new specific performance study is detailed for the ReClear™ device in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no new specific performance study is detailed for the ReClear™ device in this document.
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 device is a phototherapy system, not an AI diagnostic tool, and no MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a phototherapy system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable as no new specific performance study is detailed for the ReClear™ device in this document. The "ground truth" for substantial equivalence is the FDA's prior clearance of the predicate devices based on their safety and effectiveness data.
8. The sample size for the training set
- Not applicable as no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established
- Not applicable as no training set for an algorithm is mentioned.
Summary of what the document DOES provide:
- Intended Use:
- Visible blue/violet light (405-420nm): Treatment of moderate inflammatory acne vulgaris.
- Infrared light (850-900nm): Temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
- Technological Characteristics:
- Emits visible blue/violet light (405-420nm) and infrared light (850-900nm).
- Fluency of light up to 200mW/cm².
- Includes an optical system, mechanical fixture, and timer unit.
- Substantial Equivalence Basis:
- Regulatory Clearance Date: April 15, 2004
- Applicant: CureLight Ltd.
§ 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.