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510(k) Data Aggregation
(668 days)
The Klox Biophotonic LumiHeal™ System is indicated to provide blue light and fluorescent light energy for use on post-surgical incisions for scar management. The System is intended to be used in FST I-IV female patients 22 years and over.
The Klox Biophotonic LumiHeal System is a device which consists of a blue light emitting Multi-LED Light device (KT-L Lamp) with emitted wavelengths of 440-460nm and a topical photoconverter gel (LumiHeal Gel). When the gel is illuminated by the LED device, it will emit fluorescence with blue, green, yellow, and orange wavelengths between 400mm to 625mm. The fluorescence mixed with the excitation blue light is used for scar management (i.e., reducing the appearance of acute post-surgical incisions).
The KT-L Lamp (Figure 1) has a timer and a distance sensor with which the system set the illumination time at 5 min and distance between the lamp and the wound area at 5cm. For the KT-L Lamp interface, press the Distance Verification Button to measure the distance. Display Screen should read approximately 50mm. Press the Time Display Button to return display to Timer Mode. During the illumination, it is possible to toggle between the Timer Mode or Measure Mode by pressing either the Time Display Button or the Distance Verification Button. Time remaining during illumination will be displayed in minutes (min). The lamp comes equipped with a power cable, 2 pairs of protective eyeglasses, and a user manual. The device specification is shown in the Table 1.
The LumiHeal Gel is provided as a two-component gel (Figure 2), specifically Jar A (25g) and Jar B (2.5g). The two components of the LumiHeal Gel are intended to be mixed immediately prior to use. Jar A is the carrier gel and Jar B is the chromophore gel. The LumiHeal Gel is applied just before use and is intended to remain in contact with the surface of wound for 5 minutes during the light exposure and application. After the 5-minute application period, exposure to the KT-L Lamp is discontinued and the LumiHeal Gel is removed.
The purpose of the LumiHeal Gel is to facilitate conversion of the non-coherent blue light wavelength from the KT-L Lamp into blue, green, yellow and orange wavelength light between 400nm to 625mm at the skin surface.
Acceptance Criteria and Device Performance for Klox Biophotonic LumiHeal System
This response synthesizes the acceptance criteria and study findings for the Klox Biophotonic LumiHeal System, as described in the provided regulatory document.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" for effectiveness in a quantitative manner (e.g., "device must achieve X% improvement in Y score"). Instead, it describes general expectations for safety and performance (mitigation of risks) and then reports the study's effectiveness findings. Thus, the acceptance criteria are inferred from the stated benefits and the demonstrated performance.
| Acceptance Criteria (Inferred from Risks & Benefits) | Reported Device Performance |
|---|---|
| Safety: | Safety: |
| 1. Biocompatibility: Patient-contacting components must be biocompatible (prevent adverse tissue reactions). | Biocompatibility assessment was adequate for both light-exposed and non-exposed photoconverter gel. Conclusion: "risk of a clinically significant biocompatibility concern is low." (Section: BIOCOMPATIBILITY/MATERIALS) |
| 2. Sterility: Patient-contacting components must be sterile to prevent infection. | LumiHeal Gel Jar B is terminally sterilized via autoclaving. Preservative effectiveness testing per USP <51> for real-time aged Jar A and packaging integrity testing were performed. "The test gels met the acceptance criteria for each test." (Section: SHELF LIFE/STERILITY) |
| 3. Shelf Life: Photoconverter gel must maintain sterility and functional performance over its shelf life. | Shelf life testing performed (preservative effectiveness, packaging integrity); "The test gels met the acceptance criteria for each test." (Section: SHELF LIFE/STERILITY) Performance after simulated 5 years of service life met specifications. (Section: PERFORMANCE TESTING - BENCH, last bullet point) |
| 4. Electrical & Thermal Safety: Device must be electrically/thermally safe and electromagnetically compatible. | The KT-L lamp passed all relevant portions of IEC 60601-1 and IEC 60601-1-2 testing. (Section: ELECTROMAGNETIC CAPABILITY & ELECTROMAGNETIC SAFETY) Evaluation of heat dissipation showed skin temperatures remained "within a safe temperature range (<43ºC) throughout the illumination for the indicated skin types (up to Type IV on the Fitzpatrick skin scale)". (Section: PERFORMANCE TESTING - BENCH, first bullet point) |
| 5. Software Safety: Software errors should not cause injury. | Software is considered a "minor level of concern." All elements of software information provided for minor LOC devices were found to contain sufficient detail to provide reasonable assurance of proper operation. (Section: SOFTWARE) |
| 6. Use Error: Labeling and design should mitigate use errors. | Usability testing performed, leading to modifications of labeling and lamp design to enable intended operation by users. (Section: HUMAN FACTORS/USABILITY TESTING) |
| 7. Device Performance (Bench): Device must perform as intended under anticipated conditions of use (e.g., light spectrum, power intensity, heat dissipation, gel properties, mechanical functions). | Numerous bench tests were conducted, demonstrating: verification and validation of spectrum/power intensity, heat dissipation within safe limits, biophotonic properties of the gel (absorbance, fluorescence, photobleaching), photonic parameters (peak wavelength, power density), radiant fluence delivered, gel viscosity, complete gel removal, and mechanical functions. Performance after simulated 5 years of service life met specifications. Packaging integrity also verified. (Section: PERFORMANCE TESTING - BENCH) |
| Effectiveness: | Effectiveness: |
| 1. Reduction in Appearance of Acute Post-Surgical Incisions: The device should show an improvement in scar appearance. | Blinded expert review of photographs using POSAS Observer scale showed "at least a 1 point improvement in each sub-category (Vascularity, Pigmentation, Thickness, Relief and Surface area)" for the LumiHeal system. (Section: Effectiveness - POSAS- Blinded Evaluators Using Photographs) The mean 1 point improvement was also seen in the control, Silicone group, indicating improvement comparable to an existing scar management method. (Section: BENEFIT-RISK DETERMINATION) Patients' POSAS scores and overall opinion also showed a trend toward improvement. (Section: POSAS- Patient - Total Score and Overall Opinion) |
| 2. Comparable or superior to standard of care (implicitly suggested by comparative study design). | The study compared the LumiHeal System to Silicone sheets (Cica-Care® Silicone Sheeting). The POSAS Observer sub-categories' evolution was considered similar between LumiHeal and Silicone, except for pigmentation which showed a trend to be lower in the Silicone group. This suggests comparable effectiveness for most evaluated scar characteristics. No explicit superiority criteria were stated, but comparability to a known effective modality serves as a benchmark. Patient satisfaction with LumiHeal was demonstrated. (Section: Patient Perspectives) |
2. Sample Sizes and Data Provenance
- The document states "102 subjects were enrolled and evaluated in the study, with [Tost] to follow-up by the study completion." (Section: Effectiveness - POSAS- Blinded Evaluators Using Photographs). However, a preceding section states, "A total of [number] subjects were enrolled and [number] patients completed the study." and later, "J (patients (92.9%) received all applications as planned in the protocol." This indicates the number of subjects who completed the study is slightly less than the initial enrollment. The exact number of patients who were analyzed for effectiveness from the 102 subjects mentioned is not explicitly stated as a separate "test set" size after follow-up.
- Data Provenance: The study was conducted at a "single center in two locations" (Section: SUMMARY OF CLINICAL INFORMATION). The demographics table (Table 3) indicates that the majority of participants (93.0%) were White, suggesting the data is likely from a Western country, possibly Canada given the sponsor information. It was a prospective clinical study.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: For the blinded review of photographs, the document refers to "experts" in the plural, but does not specify the exact number.
- Qualifications of Experts: The document refers to them as "experts" (Section: Effectiveness - POSAS- Blinded Evaluators Using Photographs). It does not provide specific qualifications (e.g., "radiologist with 10 years of experience" or "board-certified plastic surgeon"). However, the nature of the assessment (POSAS on surgical scars) implies they would be clinicians with relevant experience, likely dermatologists or plastic surgeons.
4. Adjudication Method for the Test Set
- The document states, "a blinded review by experts was performed." (Section: Effectiveness - POSAS- Blinded Evaluators Using Photographs). It describes that for each image, "the blinded experts had to score each criterion of the POSAS Observer scale." It does not specify an adjudication method such as 2+1 or 3+1 if there were multiple experts. It implies that their individual scores were aggregated, possibly averaged, or simply reported without adjudication if a single expert scored each case.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Yes, a comparative study was done, though it's structured as a within-subject comparison against a control rather than a pure MRMC study of "human readers with vs. without AI." Patients served as their own controls, with one breast receiving LumiHeal and the other receiving Silicone sheets.
- Effect Size of Human Readers Improve with AI vs. without AI assistance: This specific type of MRMC study (human reader with/without AI assistance) was not performed. The study compared the device (LumiHeal) directly against a standard of care (Silicone sheets) for scar management. The "AI" component is the LumiHeal system itself, providing therapeutic light, not an AI assisting human interpretation. The experts were involved in assessing the outcome of the treatment, not in making diagnoses or interpretations assisted by AI.
- Improvement: The study found that both LumiHeal and Silicone groups showed "at least a 1 point improvement in each sub-category" of the POSAS Observer scale. The evolution of sub-categories was "similar in all sub-groups combined analysis, except for the pigmentation which showed a trend to be lower in the Silicone group." This indicates the device achieved comparable effectiveness to the control.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- No, a standalone study (in the context of an AI algorithm reading medical images) was not done. The Klox Biophotonic LumiHeal System is a therapeutic device that applies light energy. Its "performance" is its effect on the human body, not its ability to analyze data independently. Human experts were used to assess the outcome of the device's application.
7. Type of Ground Truth Used
- Expert Consensus (Blinded Evaluators using Photographs): The primary effectiveness ground truth was established by "blinded experts" (clinicians) who scored photographs of the scars using the Physician Observer Scar Assessment Scale (POSAS). This is a well-established subjective clinical assessment tool.
- Patient Self-Assessment: Patient-reported outcomes (Patient POSAS, Patient's Overall ease of use and satisfaction questionnaire) also contributed to the assessment of effectiveness and benefit, reflecting patient perspective on scar appearance and treatment experience.
8. Sample Size for the Training Set
- Not applicable. The Klox Biophotonic LumiHeal System is a physical light therapy device, not an AI algorithm that learns from data. Therefore, there is no "training set" in the context of machine learning. The clinical study described is for validation and effectiveness assessment, not for training a model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a physical device, there is no "training set" or "ground truth for a training set" for this product in the typical machine learning sense. The device is designed based on known biophotonic principles, and its safety and effectiveness are then validated through non-clinical and clinical studies.
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