(386 days)
The Lustre PRO light system is indicated for the treatment of mild to moderate acne.
The Lustre PRO light system is a small portable non-invasive device, comprising of a rechargeable controller and therapy heads containing light emitting diodes, emitting blue light at a peak wavelength of 415nm, and a Full Width Half Maximum (FWHM) of 15nm.
The therapy heads are designed to be attached to the site of the acne using a disposable polyethylene film impregnated with a medical-grade adhesive. The controller comprises of an LCD graphical user interface, 3 control buttons, a coaxial connector and 3 mini USB connectors. The controller switches the therapy heads on and off and includes a programmable timer, allowing modification of treatment time and indicators for battery level, therapy head status and treatment time remaining. The device contains sensors which monitor the therapy heads and emit audible and visible alarms relating to overheating and disconnection of the therapy heads.
The provided document is a 510(k) premarket notification for the Ambicare Health Lustre PRO Light System. It describes the device, its intended use, and provides a summary of non-clinical performance and safety data to demonstrate substantial equivalence to a predicate device.
Unfortunately, the document does not contain a detailed study with acceptance criteria and device performance results in the format requested. The document primarily focuses on non-clinical performance and safety to establish substantial equivalence, rather than presenting a clinical study with specific acceptance criteria and detailed performance metrics.
Specifically, the document states: "A self-selection and usability study of 71 subjects demonstrated that the labelling and user guide for the Lustre PRO system exceeded comprehension levels determined a priori and demonstrated that the device could be used safely and effectively by lay persons." However, it does not provide the specific "acceptance criteria" or "reported device performance" in terms of how well the device treats acne, which is its stated indication for use.
Therefore, I cannot populate the requested table or answer the specific questions about sample size of test/training sets, ground truth establishment, expert qualifications, or MRMC studies for device efficacy. The information provided is about usability and safety, not clinical effectiveness in treating acne.
Here's what I can extract regarding the usability study, though it doesn't fit neatly into the requested format for clinical efficacy:
1. Table of Acceptance Criteria and Reported Device Performance (for Usability, as clinical efficacy data is not provided):
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Usability/Comprehension | Labelling and User Guide comprehension levels determined a priori (specific levels not stated). | Exceeded comprehension levels determined a priori. |
| Safe Use by Lay Persons | Device could be used safely by lay persons (specific metrics not stated). | Demonstrated that the device could be used safely by lay persons. |
| Effective Use by Lay Persons | Device could be used effectively by lay persons (specific metrics not stated). | Demonstrated that the device could be used effectively by lay persons. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: 71 subjects (for the self-selection and usability study).
- Data Provenance: The document does not specify the country of origin for this usability study. It is a retrospective or prospective study, although the document does not explicitly state it, usability studies are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for a usability study as described. "Ground truth" in this context would likely refer to objective measures of comprehension and safe/effective use, not expert clinical assessment of acne.
4. Adjudication method for the test set:
- Not applicable for a usability study as 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:
- No, an MRMC comparative effectiveness study was not mentioned. The device is a direct treatment system, not an AI-assisted diagnostic or interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a physical light therapy system for direct patient use, not an algorithm.
7. The type of ground truth used:
- For the usability study, the ground truth was likely based on objective assessments of user comprehension and observed performance/interaction with the device by lay persons.
8. The sample size for the training set:
- Not applicable. The document describes a usability study, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device Efficacy Studies (or lack thereof, as per the document):
The document relies on the "substantial equivalence" principle, stating: "Data generated from post market clinical experience does not generate any significant doubts to the similarity of the Lustre acne system to other commercial and clinically tested Blue LED light systems. The data presented is suitable to justify safety and performance of the device in relation to predicate devices with similar technology."
This suggests that no new clinical efficacy study with specific acceptance criteria was performed for the Lustre PRO Light System itself within this 510(k) submission to demonstrate its effectiveness in treating acne. Instead, the approval is based on its similarity to existing, clinically tested blue LED light systems and an assessment of its safety and usability.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.