Search Results

Flash N Go is an over the counter device intended for the removal of unwanted hair. Flash N Go is also intended for permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime.

The Flash N Go hair removal system is a pulsed light system composed of a base unit and hand held applicator.

The provided text describes the 510(k) summary for the Silk'n Flash N Go hair removal device. However, it does not contain the specific details required to answer your request regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, or specific study results.

The document only states:

• "Clinical data was collected in a prospective multisite clinical study."
• The intended use includes "permanent reduction in hair regrowth defined as a long-term, stable reduction in hair counts following a treatment regime."
• The device complies with "21CRF § 1040.10 & 1040.11" (performance standards for light-emitting products).

The requested information (acceptance criteria table, sample sizes, ground truth details, MRMC study, standalone performance) is not available in the provided text. This type of detailed performance data and study design would typically be found in the full 510(k) submission or an associated clinical study report, which is not included here.

Therefore, I cannot fulfill your request with the given input.

Ask a specific question about this device

The Flash N' Go is intended for removal of unwanted hair.
The Flash N' Go is an over the counter device intended for the removal of unwanted hair.

The Flash N' Go hair removal system is composed of a base unit and hand held applicator.

The provided text, K082298 for the Flash N' Go device, is a 510(k) summary and associated FDA correspondence for a light-based hair removal device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance study results for the device itself.

Based on the provided text, I can infer the following about acceptance criteria and studies, but I cannot complete the requested tables and sections due to the limited information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or provide a table of reported device performance metrics like efficacy (e.g., percentage hair reduction) or specific safety endpoints. It broadly states:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided text. The document only states "Clinical safety data was collected in a prospective safety study."
• Data Provenance: The safety study was "prospective." The country of origin for the data is not explicitly stated beyond the submitter's address being in Israel.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not specified. The document does not describe the establishment of a "ground truth" for a test set in the context of efficacy or diagnostic accuracy, as it's a hair removal device. The focus is on safety and substantial equivalence based on technical output and intended use.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not specified. As above, this type of detail is typically for diagnostic/screening devices where interpretation of results requires expert consensus.

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 hair removal system, not a diagnostic imaging or AI-assisted interpretation tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical device for hair removal, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the "clinical safety data," the "ground truth" would likely involve objective measures of skin reactions, adverse events, or hair reduction observed by clinicians or study personnel. However, the specific type and methodology are not detailed in this summary. The primary "ground truth" for 510(k) devices often relies on demonstrating equivalence to an already marketed and deemed safe/effective predicate device, rather than establishing a de novo "ground truth" for efficacy in clinical trials if substantial equivalence can be shown.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

• Not applicable. As above, there is no "training set" for this type of device.

In summary, the provided 510(k) summary for the Flash N' Go device primarily focuses on demonstrating substantial equivalence to predicate devices, compliance with FDA performance standards (21CRF § 1040.10 & 1040.11), and the collection of prospective clinical safety data. It does not provide detailed quantitative acceptance criteria, specific performance metrics, or the methodologies for establishing "ground truth" in the manner typically associated with AI/ML or diagnostic devices.

Ask a specific question about this device