(110 days)
The Nirvana device is indicated for hair removal and permanent hair reduction.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The NIRVANA is a diode laser device indicated for hair removal and permanent hair reduction. The device is provided with two different handpieces that deliver the laser energy to the patient. The NIRVANA electrical specifications are: 100-115V~, 50/60Hz, 1600VA.
The provided document is a 510(k) premarket notification for a medical device called "Nirvana," a diode laser indicated for hair removal and permanent hair reduction. It details the device's characteristics, its comparison to predicate devices, and non-clinical performance data.
However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in a clinical performance context. Specifically, there is no mention of:
- Clinical performance data: The document explicitly states "Clinical Performance Data: None."
- Acceptance criteria for device performance: There is no table or description of specific metrics (e.g., accuracy, sensitivity, specificity, reduction percentage) that the device must achieve to be considered effective or safe, especially in terms of hair reduction.
- Study design for clinical evaluation: No information on sample size, data provenance, ground truth establishment, expert involvement, or statistical analysis for clinical effectiveness is provided.
- AI/Algorithm performance metrics: This device is a laser hair removal system, not an AI-driven diagnostic or assistive device. Therefore, metrics like MRMC studies, standalone algorithm performance, or human-in-the-loop improvement with AI assistance are not applicable.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use/Indications: The Nirvana device's indications for use are a subset of or identical to the predicate and reference devices.
- Technical Specifications: Comparison of wavelengths, spot sizes, fluence, pulse duration, and power to predicate devices.
- Non-Clinical Performance Data: Electrical safety, EMC, and software validation testing to relevant standards.
Therefore, I cannot fulfill your request for: "A table of acceptance criteria and the reported device performance" (clinical performance), "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established" because this information is not present in the provided 510(k) summary.
The manufacturer has demonstrated substantial equivalence through non-clinical means and comparison to legally marketed predicate devices, rather than through a new clinical performance study. This is a common pathway for 510(k) clearances when a device is sufficiently similar to existing ones.
§ 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.