Search Results

The "Quasar Blue" Blue Light Therapy System is intended to provide photo therapeutic light to the body. The "Quasar Blue" Blue Light Therapy System is generally indicated to treat dermatological conditions. The "Quasar Blue" Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat mild to moderate inflammatory acne vulgaris.

The "Quasar Blue" Blue Light Therapy System is identical to the company's previously cleared Quasar Blue Light Therapy System (K072767). Only the Operators Manual and the Patient Treatment Protocol have been modified to reflect the home use of the product. These documents have been amended to allow for an Over the Counter use. The Quasar Blue Light Therapy System has similar physical and technical characteristics to the predicate devices.

The provided text describes a 510(k) submission for the "Quasar Blue Light Therapy System." However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications.

The document primarily focuses on:

• Device Identification and Classification: Trade name, common name, classification, product code.
• Predicate Device: Stating that the device is substantially equivalent to a previously cleared device (K072767) with only modifications to the operator's manual and patient treatment protocol for home use.
• Indication for Use: "To emit visible blue/violet light to treat mild to moderate inflammatory acne vulgaris."
• Basis for Substantial Equivalence: Claiming substantial equivalence based on intended use, principle of operation, and overall technological characteristics compared to existing marketed devices.
• FDA Review Outcome: The FDA's letter granting substantial equivalence based on the provided information, emphasizing general controls and other regulatory requirements.

Therefore, I cannot fulfill your request for the specific details outlined, as those are not present in the provided text.

Based on the provided text, the following information is available:

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

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: Not specified in the document. The document states, "All necessary testing has been performed for the Quasar Blue Light Therapy System to assure substantial equivalence to the predicate devices." However, no specific performance data or metrics are provided.

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

• Not specified in the 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 specified in the document.

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

• Not specified in the 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 specified in the document. This is a light therapy system, not an AI diagnostic device, so an MRMC study and AI enhancement would not be applicable.

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

• Not specified in the document. This is a light therapy system, not an algorithm.

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

• Not specified in the document. Given this is a light therapy device, "ground truth" in the context of diagnostic accuracy is not directly applicable. Performance would typically relate to clinical efficacy in treating acne.

8. The sample size for the training set

• Not applicable as this is a medical device, not an AI algorithm requiring a training set.

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

• Not applicable as this is a medical device, not an AI algorithm.

Ask a specific question about this device

The Quasar Blue Light Therapy System is intended to provide photo therapeutic light to the body. The Quasar Blue Light Therapy System is generally indicated to treat dermatological conditions. The Quasar Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for the Quasar Blue Light Therapy System. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information.

However, this document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific details regarding standalone or MRMC studies for this device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

Ask a specific question about this device