(111 days)
The Shaser Skin Beauty Intense Pulsed Light System Family for Acne is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Shaser Skin Beauty Intense Pulsed Light System Family For Acne is an Over-The-Counter, Light-Based Acne Clearing Device. Emission activation is by finger switch. Device includes a limited life treatment head and battery charger/AC cord. Electrical requirement is 115 VAC, 15A, 50-60 Hz, single phase. The Principle of Operation is both photochemical and photothermal. The Mechanism of Action is to stimulate oxygen production which attacks p.acne and to reduce inflammation due to acne.
The Shaser Skin Beauty Intense Pulsed Light System Family for Acne (K150282) is an over-the-counter home use device intended to provide phototherapeutic light to the body, specifically for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., a specific reduction percentage in acne). Instead, the clinical performance data focuses on label comprehension and usability to ensure safe and appropriate use of the device by consumers in a home setting.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on stated successful outcomes) | Reported Device Performance (Summary from submission) |
|---|---|---|
| Label Comprehension | Consumers can understand the instructions for use. | Confirmed sufficient label comprehension. |
| Device Usability | Consumers can safely and appropriately use the device in a simulated home-use environment. | Confirmed safe and appropriate use of the device. |
| Nonclinical Performance | Device meets performance verification and electrical safety testing standards. | Bench testing for performance verification and electrical safety testing was conducted successfully. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 84 study subjects were tested for label comprehension and usability.
- Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a "simulated home-use environment," implying a prospective study design for the usability and comprehension aspects.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not describe the use of experts to establish a "ground truth" for the test set in the traditional sense of medical image analysis or disease diagnosis. The assessments were focused on consumer understanding and ability to use the device, rather than expert diagnostic accuracy. Therefore, information on the number and qualifications of experts for ground truth is not applicable in this context.
4. Adjudication Method (Test Set)
No adjudication method is described, as the studies conducted focused on label comprehension and usability by the subjects themselves, rather than expert assessment of an outcome requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study focused on consumer (user) performance in understanding and operating the device, not on diagnostic accuracy or comparison of human readers with and without AI assistance for acne diagnosis.
6. Standalone Performance (Algorithm Only)
The device is an Intense Pulsed Light (IPL) system, not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to its physical operation and user interaction.
7. Type of Ground Truth Used (Test Set)
For the clinical performance data presented (label comprehension and usability), the "ground truth" was established by observing and evaluating the subjects' ability to understand the instructions and use the device correctly and safely. This is an assessment of human behavior and understanding in relation to the device, rather than a medical ground truth (e.g., pathology, clinical outcomes, expert consensus on disease state).
8. Sample Size for Training Set
The document describes a medical device study for 510(k) clearance, which typically involves demonstrating substantial equivalence to a predicate device and verifying safety and effectiveness through non-clinical and clinical performance testing. This is not a machine learning or AI algorithm submission that would have a distinct "training set." Therefore, information on the sample size for a training set is not applicable.
9. How Ground Truth for Training Set was Established
As there is no "training set" in the context of an AI algorithm, this question is not applicable.
§ 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.