(168 days)
LightStim for Acne/LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.
LightStim for Acne / LightStim for Acne Mini, model: LS4A/LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm and 630nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.
The provided text describes a 510(k) premarket notification for the "LightStim for Acne/ LightStim for Acne Mini" device. However, it does not provide the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria in the way requested (e.g., acceptance criteria for an AI/ML device, details about ground truth establishment by experts, MRMC studies, training set details).
This document is a regulatory submission for a light therapy device, not an AI/ML diagnostic or prognostic tool. Therefore, the "study" mentioned is a usability study, not a performance study comparing the device's output against a medical ground truth established by experts.
Based on the provided text, here's what can be extracted and what cannot:
What can be extracted:
- Device Name: LightStim for Acne / LightStim for Acne Mini
- Intended Use: Treatment of mild to moderate acne (Over-The-Counter use).
- Type of "Study" mentioned: A usability study.
- Sample size for the "study": 40 participants.
- Purpose of the "study": To show that participants adequately decided whether or not to use the device for their level of acne, and comprehended risks, warnings, cautions, precautions, and proper use from the Instruction Manual.
What CANNOT be extracted (because the document does not contain this information, as it's not a study proving device performance against medical acceptance criteria in the AI/ML context):
- A table of acceptance criteria and the reported device performance: The document mentions a usability study, not a performance study with quantitative clinical outcomes like sensitivity, specificity, accuracy, etc., for a diagnostic or AI/ML device. The "performance" described is user comprehension and appropriate self-selection for device use, not clinical efficacy or diagnostic accuracy.
- Sample size used for the test set and the data provenance: A "test set" in the context of AI/ML performance is not described. The 40 participants were for a usability study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment by experts is not applicable to a usability study for a light therapy device.
- Adjudication method for the test set: Not applicable.
- 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, as this is not an AI/ML diagnostic or assistance device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth in the sense of a medical diagnosis or outcome is not mentioned for the usability study. The "ground truth" was whether users understood the instructions and self-assessed their acne appropriately.
- The sample size for the training set: Not applicable, as this is not a machine learning device.
- How the ground truth for the training set was established: Not applicable.
In summary: The provided document is a 510(k) clearance letter and summary for a light therapy device. It discusses a usability study to demonstrate that users can safely operate the device and understand its appropriate use based on the instructions. It does not contain information about acceptance criteria or performance studies relevant to AI/ML devices or diagnostic accuracy, which would typically involve expert-adjudicated ground truth, sensitivity/specificity metrics, or MRMC studies.
§ 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.