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510(k) Data Aggregation
(50 days)
LUMACARE LC-122M NON-COHERENT LIGHT SOURCE
The LumaCare LC-122M Non-coherent Light Source is intended to provide therapeutic light to the body. The LumaCare LC-122M Non-coherent Light Source is generally indicated to treat dermatological conditions. The LumaCare LC-122M Non-coherent Light Source is specifically indicated to treat moderate inflammatory acne vulgaris.
The LumaCare LC-122M Non-coherent Light Source is a high intensity lamp intended for the therapy of dermatological disorders such as moderate inflammatory acne vulgaris by emitting visible light in the wavelength range 400-440nm (blue) with fluences of order 10-100mW/cm². The principle parts of the system comprise of a desktop base unit and a Fibre Optic Probe (FOP) delivery system. The base unit contains a mains supplied power supply unit which powers a 250W halogen bulb, the duration of the illumination being controlled by a timing pcb with user-accessible controls. The FOP delivery system comprises of a ruggedised fibre bundle assembly and (crucially) an optical filter which selectively transmits only the therapeutic blue light. A mechanical fixture is also optionally available for holding the output of the FOP delivery system at an adjustable distance and direction relative to the skin treatment area.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the LumaCare LC-122M Non-coherent Light Source:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed results of a clinical study demonstrating the device's performance against such criteria for treating acne vulgaris. Instead, the document focuses on demonstrating substantial equivalence to a predicate device.
The "device performance" in this context refers to the characteristics that allow it to be considered substantially equivalent to the predicate, rather than measured effectiveness in a clinical trial.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and EMC Standards Compliance | The pre-clinical testing includes Electrical Performance Data: Safety and EMC testing meeting the requirements of IEC 60601-1:1988/A1/A2 and IEC 60601-1-2:2002. |
| Intended Use Equivalence | The LumaCare LC-122M has the same intended use: "to provide therapeutic light to the body." |
| General and Specific Indications for Use Equivalence | The LumaCare LC-122M has the same general indication ("to treat dermatological conditions") and the same specific indication ("to treat moderate inflammatory acne vulgaris") as the BLU-U predicate device. |
| Spectral Output Equivalence | The spectral output (visible light in the wavelength range 400-440nm (blue)) of the LumaCare LC-122M is "similar to or the same as" the BLU-U. Fluences are of order 10-100mW/cm². |
| Mode of Operation Equivalence | The mode of operation is "similar to or the same as" the BLU-U. |
| General Operating Principles Equivalence | The general operating principles are "similar to or the same as" the BLU-U. Both are light devices that expose the skin surface to light at precise wavelengths. |
| No New Questions of Safety or Efficacy (due to differences) | "Although there are some differences in method by which each device produces light and is delivered to the treatment area, these differences do not raise new questions of safety or efficacy." This is a key acceptance criterion for substantial equivalence, inferring that the device is safe and effective because it is similar to an already cleared device and its differences do not negatively impact this. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a clinical study or a 'test set' in the context of evaluating the device's efficacy for treating acne vulgaris. The assessments mentioned are pre-clinical (safety and EMC testing) and a comparison to a predicate device.
Therefore, information regarding sample size and data provenance for an efficacy "test set" is not available in these documents.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable as the document does not describe a clinical study that required expert-established ground truth for an efficacy evaluation. The "ground truth" for the device's clearance is its substantial equivalence to the predicate, supported by technical and safety comparisons.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe a clinical study requiring an adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No MRMC comparative effectiveness study is mentioned in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new effectiveness study with human readers (or in this case, direct efficacy comparison).
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This device is a physical light therapy device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable.
7. The Type of Ground Truth Used
The "ground truth" used for the LumaCare LC-122M's clearance is substantial equivalence to a legally marketed predicate device (BLU-U Blue Light Photodynamic Therapy Illuminator Model 4170). This "ground truth" is established by comparing the new device's intended use, indications for use, technological characteristics (spectral output, mode of operation, operating principles), and safety profile to that of the predicate. The FDA concluded that its differences did not raise new questions of safety or efficacy.
8. The Sample Size for the Training Set
This concept is not applicable as the document does not describe the development or evaluation of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as the document does not describe the development or evaluation of an AI algorithm.
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