Search Results

The no!no! Skin™ is intended to provide phototherapeutic light and heat to the body and is generally indicated to treat dermatological conditions. It is specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

The no!no! Skin™ device is an over the counter device employing LHE® (Light & Heat Energy) phototherapy as a part of its fundamental characteristics to treat acne. It is a small, light, hand-held, portable, battery powered devices designed to treat individual acne pimples. The no!no! Skin™ device consist of an enclosure, a rechargeable battery, an electronic circuit and a low voltage halogen lamp. The treatment tip diameter of 8 mm covers an area of 0.5 cm². The energy delivered to the lesion is a combination of focused light emitted from the halogen lamp together and the heat accumulated in the tip placed over the acne lesion.

The provided document is a 510(k) summary for the Radiancy Ltd. no!no! Skin™ device. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines technical specifications and intended use. Crucially, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria through performance data.

Instead, the document states:

• "A series of safety and performance testing were performed to demonstrate that the modified no!no! Skin™ did not raise any new questions of safety and efficacy."
• These tests included: "Electrical Safety testing" and "Temperature Evaluation test."
• "Based on the risk analysis performed and these tests results, Radiancy Ltd. believes that the modified no!no! Skin™ device is substantially equivalent to the cleared no!no! Skin™ device and does not raise any new safety and/or effectiveness issues."

This indicates that the submission relies on demonstrating that changes made to an already cleared device (K082423) did not negatively impact its safety and effectiveness, rather than providing a de novo study with acceptance criteria and performance results for the device's clinical efficacy.

Therefore, for most of the requested points, the information is not available in the provided text.

Here's a breakdown of what can be answered and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not available. The document states safety and performance tests were done (electrical safety, temperature evaluation) but does not provide specific acceptance criteria or reported performance results in a table format for these tests, nor for clinical efficacy. The submission focuses on substantial equivalence based on not raising new questions of safety and efficacy with changes made to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available. The document does not describe a clinical study with a test set of human subjects, therefore, sample size and data provenance are not mentioned in this context. The "tests" mentioned are technical safety and performance tests of the device itself.

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/Not available. Since there is no described clinical study involving a test set of patients or medical images requiring ground truth establishment by experts, this information is not present.

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

• Not applicable/Not available. No clinical study with a test set requiring adjudication is described.

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/Not available. The device is not an AI-assisted diagnostic tool or an imaging device. It's a phototherapy device for acne. Therefore, an MRMC study is irrelevant in this context and none was performed or described.

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

• Not applicable/Not available. Again, this is a physical medical device, not an algorithm. Its performance is inherent in its operation and effect on the user/patient.

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

• Not applicable/Not available. No clinical efficacy study with ground truth for patient outcomes is described. The "tests" were likely engineering or bench tests for electrical and thermal safety.

8. The sample size for the training set

• Not applicable/Not available. As this is not an AI/machine learning device, there is no concept of a "training set."

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

• Not applicable/Not available. As above, no training set exists for this device.

Ask a specific question about this device

No! No! Skin is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.

Not Found

The provided text describes the FDA's decision to deem the "No! No! Skin™" device substantially equivalent for the treatment of mild to moderate acne based on a clinical trial. However, it does not explicitly state acceptance criteria in a quantitative table or the specific reported device performance values. It focuses more on the type of study and its outcome rather than numerical criteria and results.

Based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

• Note: The document does not provide specific numerical thresholds for "statistically and clinically significant improvement" or the exact performance metrics (e.g., mean time to resolution in days). It focuses on the conclusion drawn from the study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated. The document mentions "data from a randomized, sham-controlled, double-blinded, clinical trial," but the number of participants is not provided.
• Data Provenance:
  • Country of Origin: Radiancy (Israel) LTD. is the applicant, suggesting the study could have been conducted in Israel or elsewhere, but the document does not explicitly state the study's location.
  • Retrospective or Prospective: The study was a "randomized, sham-controlled, double-blinded, clinical trial," which by its nature is a prospective study.

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)

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The assessment was carried out by "blinded investigators." Their specific qualifications (e.g., dermatologists, medical professionals) are not detailed, but their role as "investigators" implies medical expertise in evaluating acne.

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

• The document mentions "blinded investigators" assessed the improvement and resolution of acne. The specific adjudication method (e.g., consensus, single reader, majority vote) is not specified.

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

• This device is not an AI-assisted diagnostic tool. It is a device for treating acne. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed. The study described is a clinical trial comparing the device's effectiveness to sham treatment.

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

• This question is not applicable as the device is a physical treatment device, not an algorithm. The "performance" in this context refers to its clinical efficacy in treating acne when used by individuals, not an algorithmic assessment.

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

• The ground truth was established by clinical assessment / outcomes data by blinded investigators. They assessed the "time to improvement and time to resolution of mild to moderate acne." This implies a subjective or semi-objective clinical evaluation of acne severity and progression by trained medical professionals.

8. The sample size for the training set

• The concept of a "training set" is not applicable here as this is a physical medical device undergoing a clinical trial for efficacy, not a machine learning algorithm that requires training data.

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

• As the concept of a "training set" is not applicable, this question is also not applicable.

Ask a specific question about this device