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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.

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The device is intended to be used in surgical, aesthetic applications in the medical specialties of general and plastic surgery and dermatology, including:

• Treatment of benign vascular lesions

• Hair removal

• Permanent* hair reduction

• permanent hair reduction defined as reduced hair growth without maintenance when measured at 6, 9 and 12 months.

The laser device Echo is a 160 W diode laser emitting at 808 nm laser wavelength. The device is a therapeutic and aesthetic medical laser system for professional use only.

For the release of laser radiation to the patient, the device uses, as delivery system, a fiber with a handpiece plugged on its end.

Echo is a transportable mobile electrical equipment with a graphical user interface (GUI) for user-device interaction.

Laser radiation is delivered through optical fibers connected to handpieces having fix spot dimension.

The device is equipped with an integrated skin cooler. In this case, a specific housing called Skin Cooler handpiece is provided to provide skin cooling and housing the laser handpiece at the same time.

Laser emission can be activated by the footswitch or by a finger-switch placed on Skin Cooler handpieces.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample size, ground truth establishment, or multi-reader multi-case studies. The document is an FDA 510(k) clearance letter and summary for a laser device, primarily focusing on its equivalence to predicate devices based on technical specifications and non-clinical testing for safety and effectiveness according to established standards. It does not include the detailed clinical study information you requested.

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