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The MultiClearXL Multiwavelength Targeted Phototherapy System ("MultiClearXL") is intended to provide phototherapeutic light to the body. The MultiClearXL is generally indicated to treat dermatological conditions. The MultiClearXL's specific indication is for use in UVB phototherapy and PUVA photochemistry to treat psoriasis, vitiligo, atopic dermatitis, and leukoderma and for the use of visible blue/violet light to treat moderate inflammatory acne vulgaris.

The MultiClearXL is a computer controlled, high-intensity lamp intended for treatment of dermatological disorders by emitting a homogenous UV light dose in the UVB, UVA, and visible blue/violet light ranges. The desired dose of UVA or UVB or blue/violet light is selected using controls on the system front panel. The system consists of a console trolley, control console, illumination assembly, an extension arm (light guide and hand piece) and protective eyewear for the operator and patient.

This 510(k) premarket notification for the MultiClearXL Multiwavelength Targeted Phototherapy System does not contain the information requested in your prompt regarding acceptance criteria, study details, and performance data.

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting detailed clinical study results or acceptance criteria based on performance metrics. It primarily discusses the device's intended use, technological characteristics, and comparison to existing devices.

Therefore, I cannot populate the table or provide the requested study details. The document states:

• "The MultiClearXL has the same intended use and indications and similar principles of operation and technological characteristics as a combination of the predicate devices. The MultiClearXL's specific indications are specific indications for at least one of the predicate devices. Any minor differences between the MultiClearXL and its predicate devices raise no new issues of safety or effectiveness. Thus, the MultiClearXL is substantially equivalent to the predicate devices."

This indicates that the basis for approval is substantial equivalence to existing devices, not a new clinical study demonstrating specific performance against predefined acceptance criteria for the MultiClearXL itself.

Summary of missing information:

• Acceptance Criteria Table: No acceptance criteria or reported device performance metrics are provided.
• Sample size and data provenance for test set: Not mentioned.
• Number and qualifications of experts for ground truth: Not mentioned.
• Adjudication method for test set: Not mentioned.
• MRMC comparative effectiveness study: Not mentioned.
• Standalone algorithm performance: Not applicable, as this is a phototherapy system, not an AI algorithm.
• Type of ground truth: Not applicable in the context provided.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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The Clear100™ Phototherapy System (" Clear100™ ") is intended to provide phototherapeutic light to the body. The Clear100 ™ is indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris and infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

The Clear100™ Therapy System is a high intensity lamp emitting visible light in the violet-blue range (405 nm to 420 nm) and in the near infrared range (850-890nm) with a fluency of light ranging between 50-200 mW/cm2. The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and near infrared range with an optical system for controlling spectra and beam parameters of the light source. It also includes a mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area, and a timer unit to indicate the duration of light treatment.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria.

The 510(k) submission for the CureLight Clear100 Phototherapy System focuses on demonstrating substantial equivalence to a predicate device (CureLight ReClear). It primarily describes:

• Intended Use: What the Clear100 is designed to do (provide phototherapeutic light for moderate inflammatory acne vulgaris and infrared light energy for temporary relief of aches, pains, stiffness, and muscle relaxation).
• Technological Characteristics: Specifications of the device (light wavelengths, fluency, components like light source, optical system, mechanical fixture, and timer).
• Substantial Equivalence Argument: An assertion that due to similar intended use, indications, and technological characteristics (with minor differences not raising new safety/effectiveness questions), the Clear100 is substantially equivalent to the ReClear.

There is no mention of:

• Specific performance acceptance criteria (e.g., a certain percentage reduction in acne lesions or pain scores).
• A clinical study or any study data showing the device's performance against such criteria.
• Sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any study.
• MRMC studies or standalone algorithm performance.

The FDA's letter (K041569) confirms that the device has been found substantially equivalent based on the provided information, allowing it to be marketed, but does not detail a performance study.

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The ReClear™ Phototherapy System ("ReClear™") is intended to provide phototherapeutic light to the body. The ReClear™ is specifically indicated to emit visible blue/violet light for treatment of moderate inflammatory acne vulgaris. It also emits infrared light energy for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.

The ReClear emits in the range of visible blue/violet light (405-420nm) and infrared light (850 nm to 900 nm) with a fluency of light up to 200mW/cm². The system also includes an optical system for controlling spectra and beam parameters of the light source, a mechanical fixture for holding the light source at an adjustable distance and direction in relation to the skin treatment area, and a timer unit to control the duration of the emitted radiation.

The provided text is a 510(k) summary for the CureLight ReClear™ Phototherapy System. It details the device's intended use and technological characteristics but does not contain any information about acceptance criteria, device performance results, sample sizes, expert involvement, or any specific studies proving the device meets acceptance criteria.

The document relies on demonstrating substantial equivalence to previously cleared predicate devices (K030338, K001179, K020017, and K020851) rather than presenting new performance data from a specific study for the ReClear™ itself.

Therefore, I cannot populate the requested table or answer most of the questions based on the provided text.

Here is what can be inferred from the document regarding the device and its predicate:

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

• Acceptance Criteria: Not explicitly stated in the document. The basis for clearance is "substantial equivalence" to predicate devices, implying that the ReClear™'s specifications and intended uses are similar enough to already approved devices.
• Reported Device Performance: Not reported for the ReClear™ explicitly. The document states its technological characteristics, which are the basis for substantial equivalence.

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

• Not applicable as no new specific performance study is detailed for the ReClear™ device in this 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 applicable as no new specific performance study is detailed for the ReClear™ device in this document.

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

• Not applicable as no new specific performance study is detailed for the ReClear™ device in this 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 applicable. This device is a phototherapy system, not an AI diagnostic tool, and no MRMC study or AI component is mentioned.

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

• Not applicable. This device is a phototherapy system, not an algorithm.

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

• Not applicable as no new specific performance study is detailed for the ReClear™ device in this document. The "ground truth" for substantial equivalence is the FDA's prior clearance of the predicate devices based on their safety and effectiveness data.

8. The sample size for the training set

• Not applicable as no training set for an algorithm is mentioned.

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

• Not applicable as no training set for an algorithm is mentioned.

Summary of what the document DOES provide:

• Intended Use:
  • Visible blue/violet light (405-420nm): Treatment of moderate inflammatory acne vulgaris.
  • Infrared light (850-900nm): Temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
• Technological Characteristics:
  • Emits visible blue/violet light (405-420nm) and infrared light (850-900nm).
  • Fluency of light up to 200mW/cm².
  • Includes an optical system, mechanical fixture, and timer unit.
• Substantial Equivalence Basis:
  • Blue/violet light mode: Substantially equivalent to CureLight's iClear (K030338).
  • Infrared light mode: Substantially equivalent to Light Force Therapy's Acubeam (K001179), MedX Health Corp.'s MedX 1000 series (K020017), and C&H International Inc.'s TDP lamp (K020851).
• Regulatory Clearance Date: April 15, 2004
• Applicant: CureLight Ltd.

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The iClear Phototherapy System is intended to provide phototherapeutic light to the body. The iClear is generally indicated to treat dermatological conditions. The iClear is specifically indicated to treat moderate inflammatory acne vulgaris.

The iClear Therapy System is a high intensity lamp intended for the therapy of dermatological disorders such as moderate inflammatory acne vulgaris by emitting visible light in the violet-blue range with fluency of light ranging between 50-200 mW/cm². The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and an optical system for controlling spectra and beam parameters of the light source. It also includes a mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area, and an timer unit to indicate the duration of light treatment.

I am sorry, but the provided text is a 510(k) summary and not a study report. The document describes a medical device seeking clearance (iClear Phototherapy System) and states its substantial equivalence to a predicate device (CureLight ClearLight).

However, it does not contain any information regarding clinical studies, acceptance criteria, or performance data for the iClear device. Therefore, I cannot extract the requested information such as a table of acceptance criteria and reported performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document focuses on the device's intended use and technological characteristics to demonstrate its similarity to an already cleared product, rather than providing evidence of its own clinical effectiveness through performance metrics.

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The ClearLight Phototherapy System is intended to provide phototherapeutic light to the body. The ClearLight is generally indicated to treat dermatological conditions. The ClearLight is specifically indicated to treat moderate inflammatory acne vulgaris.

The ClearLight Therapy System is a high intensity lamp intended for the therapy of dermatological disorders such as acne vulgaris by emitting visible light in the violet-blue range with fluency of light ranging between 50-200 mW/cm². The system includes a spectral band light source with spectral emittance concentrated in the violet/blue spectral band and an optical system for controlling spectra and beam parameters of the light source. It also includes a mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area, an electronic unit to control the duration, and power of the emitted radiation and to capture and store patient data via a touch screen (i.e., control console), and a camera for capturing digital images.

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, there are no explicitly stated numerical acceptance criteria or quantitative performance metrics for the ClearLight Phototherapy device. The substantial equivalence determination is made against predicate devices, which suggests that the "acceptance criteria" here are qualitative and focused on safety and effectiveness being similar to already marketed devices for the stated indication.

However, we can infer the primary performance goal: Demonstrate safety and effectiveness for treating moderate inflammatory acne vulgaris.

• Clinical data: "Clinical data from the trial of the ClearLight device for the treatment of dermatological conditions supports substantial equivalence and demonstrates that the ClearLight device is safe and effective for the treatment of acne vulgaris." |
  | Substantial Equivalence: Comparable to predicate devices in intended use, indications for use, and technological characteristics without raising new safety/efficacy questions. | Stated to be substantially equivalent to listed predicate devices (Phototherapeutix, Derma-Wand, XTrac Excimer Laser System, Wallaby 3 Phototherapy System) based on similar intended use, general indications, and principles of operation. Differences in technological characteristics "do not raise new questions of safety or efficacy." |

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

• Sample Size for the Test Set: Not mentioned. The document only references "Clinical data from the trial of the ClearLight device." The specific number of patients or cases in this clinical trial is not provided.
• Data Provenance: Not explicitly stated, but the submitter (CureLight Ltd.) is located in Or Akiva, Israel. The study likely originated from Israel, but this is an assumption. The document does not specify if it was retrospective or prospective.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not mentioned.

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:

• MRMC Study: No, this is not an AI-assisted diagnostic device, but rather a phototherapy system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.

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

• Standalone Performance: Not applicable. This is a phototherapy device, not an algorithm. The "performance" refers to its physical therapeutic effects rather than algorithmic output.

7. The Type of Ground Truth Used:

• Ground Truth: The document states that "Clinical data from the trial... demonstrates that the ClearLight device is safe and effective for the treatment of acne vulgaris." This implies that the ground truth for effectiveness was likely based on clinical outcomes observed in patients (e.g., reduction in lesion count, physician global assessment of acne severity, or patient-reported outcomes for acne treatment). The "in vitro testing" provided biological evidence (eradication of P. acnes) which supports the mechanism of action but isn't the primary clinical ground truth.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not a machine learning device that requires a training set in the conventional sense. The "training" here would be the development and testing of the physical phototherapy system itself (e.g., optimizing light parameters), rather than training an algorithm on a dataset.

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

• How Ground Truth for Training Set Was Established: Not applicable, as it's not an AI/ML device requiring a training set with established ground truth.

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