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The Quasar Calypso C100 is an Over-The-Counter handheld device intended to emit energy in the red/IR spectrum, specifically indicated for use in the treatment of periorbital wrinkles.

The Quasar C100 Wrinkle Reduction Device is intended to emit energy in the red and IR region of the spectrum, specifically indicated for the treatment of periorbital wrinkles.

The Silver Bay, Quasar Calypso, C100 Anti-Wrinkle device consists of a collection of red and near infrared diodes (LEDs), packaged in a compact hand held device. The device has a head containing the LED array and an on/off switch.

The device is made of ABS plastic with clear polycarbonate lenses covering the LED light source. The Quasar Calypso C100 uses a 12 volt wall mount power supply.

The C100 light delivery system used for applying therapy for the use in the treatment of periorbital wrinkles, by emitting at least 65 mW/cm² of red and near infrared (610nm to 850nm) light via an electic light emitting diodes [LEDs] energy source. There are 20 red LEDs and 20 infrared LEDs in the head. The device is not intended for ocular applications or direct eye exposure.

Here's an analysis of the acceptance criteria and study information for the Quasar Calypso C100 Wrinkle Reduction Device based on the provided text:

Important Note: The provided document is a 510(k) summary for a substantial equivalence determination. As such, it focuses on comparing the new device to a predicate device and demonstrating that it does not raise new safety or effectiveness issues. It is not a detailed clinical study report designed to prove efficacy in the same way a PMA (Premarket Approval) submission would. Therefore, many of the requested details about specific clinical study methodologies, such as sample size for the test set, expert qualifications, and adjudication methods, are not present in this type of regulatory document.

Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for this 510(k) submission is the demonstration of substantial equivalence to a previously cleared predicate device. This means showing that the Quasar Calypso C100 has the same intended use, similar technological characteristics, and does not raise new safety or effectiveness issues compared to the predicate.

Here’s a table summarizing the comparison, which serves as the "performance" data in this context:

Study Information & Limitations

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

   • Not explicitly stated for clinical efficacy. This is a substantial equivalence submission, which primarily relies on technological comparison to a legally marketed predicate. Clinical data proving the efficacy of this specific device for wrinkle reduction is not detailed in this summary. The comparison is based on the predicate's known performance.
   • Data Provenance: The document does not describe a new clinical study. The "provenance" is the previous clearance of the predicate device (K101190 - Light for Wrinkles).

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

   • Not applicable / Not explicitly stated. Since a new clinical study with a "test set" and "ground truth" derived from expert consensus for this specific device's efficacy is not described, this information is not provided. The ground truth for the predicate's effectiveness would have been established during its own clearance process.

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

   • Not applicable / Not stated. No such clinical adjudication method is described for this submission.

4. 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:

   • No. This device is a light therapy system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant and was not performed.

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

   • Not applicable. This is a physical device that delivers light therapy, not a standalone algorithm.

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

   • Implicitly from the predicate device's clearance. The "ground truth" for the effectiveness of light therapy for periorbital wrinkles is implicitly accepted through the prior clearance of the predicate device. The current submission demonstrates that the Quasar Calypso C100 operates on the same principles and largely with the same specifications, and therefore should achieve similar outcomes. No specific "ground truth" for this device's efficacy is established in this document.

7. The sample size for the training set:

   • Not applicable. This section does not describe a machine learning algorithm that requires a "training set."

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

   • Not applicable. (See point 7).

Summary of the Study/Evidence:

The "study" that proves the device meets the acceptance criteria is primarily a comparison of technological characteristics and intended use to a predicate device (Light for Wrinkles, K101190), alongside demonstrating compliance with relevant electrical safety and biocompatibility standards. The submission asserts that because the Quasar Calypso C100 is substantially equivalent in its design, energy output, wavelengths, and treatment parameters to a legally marketed device with the same intended use, it does not raise new questions of safety or effectiveness. No new large-scale clinical efficacy trials are presented in this 510(k) summary.

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The Quasar Calypso C50 is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.

The Silver Bay Quasar Calypso C50 is a visible light and/or heat source with high spectral purity. The device is made of ABS plastic with clear polycarbonate lenses covering the LED light sources. The device is two-sided with one side emitting narrow band blue light at 405 to 420 nm. The opposite side of the device emits red light at 628 nm +- 10 nm. The device is operated by a momentary switch, which allows the operator to select either the blue or red operation. The device does not allow the operator to select the red and blue light simultaneously.

The Quasar Calypso C50 uses a 12 volt wall mount power supply.

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, explicit performance acceptance criteria and corresponding reported device performance for treating acne vulgaris are not provided. The document focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and safety standards, rather than direct clinical performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. No clinical studies were conducted or submitted.
• Data Provenance: Not applicable. No clinical data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable. No clinical studies were conducted, and therefore, no expert-established ground truth for a test set was required.

4. Adjudication Method for the Test Set

• Not applicable. No clinical studies were conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was NOT done.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as no such study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone performance study was NOT done. The device is a physical light therapy device, not an algorithm.

7. The Type of Ground Truth Used

• Not applicable. No clinical efficacy data was submitted, and thus no ground truth for clinical performance was established in the context of this submission. The "ground truth" for the submission's purpose was the established safety and efficacy of the predicate devices and compliance with relevant safety standards.

8. The Sample Size for the Training Set

• Not applicable. This is a medical device (light therapy) submission, not an AI/machine learning algorithm. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set mentioned, there is no ground truth established for a training set.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The provided 510(k) summary explicitly states: "No Clinical Data is submitted with this application."

Instead of conducting clinical studies to prove direct efficacy for treating mild to moderate acne vulgaris, the submission relies on demonstrating substantial equivalence to existing predicate devices already on the market. The "proof" that the device meets its implicitly accepted performance (i.e., effectiveness for its intended use) and safety criteria is based on the following:

• Technological Equivalence: The device shares the "same technological characteristics, design, material, chemical composition, and energy source" as the identified predicate devices (K093963 Quasar Blue Light Therapy System, K060792 Illumimed, K083183 Aklarus, K081307 Omnilux Clear-U). This implies that if the predicates are safe and effective, and the new device is technologically similar, it is also assumed to be safe and effective for the same indications.
• Compliance with Recognized Standards: The device's compliance with established performance standards under Section 878 of the Federal Food, Drug, and Cosmetics Act, and electrical and safety standards like IEC/EN 60601-1-2000 and IEC/EN 60601-1-2. This addresses the safety aspect of the device.
• Biocompatibility of Materials: The use of polycarbonate plastic for patient contact, a material already "well known and accepted" and used in predicate devices, addresses biocompatibility concerns.

In essence, the "study" proving the device meets the acceptance criteria is a comparative analysis against predicate devices and adherence to relevant safety and performance engineering standards, rather than a clinical trial demonstrating efficacy in patients.

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This is a hand held device intended to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

The Baby Quasar consists of a collection of red and near infrared diodes [LEDs], packaged in a compact handheld device. The device has a head containing the led array, momentary switch, and indicator light.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Baby Quasar Infrared Lamp:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence to a predicate device rather than setting specific quantitative acceptance criteria or reporting detailed clinical performance metrics like wrinkle reduction percentages or photographic evidence. The "reported device performance" is largely framed by its similarity to the predicate device.

2. Sample Size Used for the Test Set and the Data Provenance

The provided document does not mention any clinical test set involving human subjects for evaluating the effectiveness of the Baby Quasar device. The testing described primarily covers functional performance, electrical safety, and EMC of the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

As there's no mention of a clinical test set with human subjects, there's no information about experts used to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set using human subjects 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. This device is an infrared lamp for wrinkle reduction, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or AI-related metrics are relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For the device's functional and safety testing, the ground truth would be based on established engineering and safety standards (e.g., power level specifications, electrical safety criteria, EMC standards).

For the intended effect (wrinkle reduction), the document states an equivalence to predicate devices, which would have historically demonstrated effectiveness. However, no specific clinical ground truth (e.g., expert consensus on wrinkle severity, photographic analysis) is described for the Baby Quasar itself in this submission.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product that utilizes a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned.

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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.

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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.

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