(24 days)
The Isolaz™ is intended to treat benign vascular and pigmented lesions, permanent hair reduction, mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).
The Isolaz™ System is a portable tabletop system used to deliver non-coherent 400-1200nm, 530-12000mm and 580-1200mm intense pulsed light via a delivery handpiece utilizing photpneumatic technology. The system consists of a main console, a treatment handpiece and a footswitch. The desired power and delivery time are set manually by the operator.
The provided text is a 510(k) summary for the Isolaz™ Intense Pulsed Light System. This document focuses on establishing substantial equivalence to a predicate device, rather than detailed clinical study results with acceptance criteria.
Therefore, the document does not contain the information requested to comprehensively describe the acceptance criteria and the study that proves the device meets them, according to your specific points.
Here's a breakdown of what is and isn't present in the provided text:
1. A table of acceptance criteria and the reported device performance:
- Not present. The document states "Product testing was conducted to evaluate conformance to product specification. The results showed the system met specification." However, it does not elaborate on what those specifications or acceptance criteria were, nor does it provide a table of performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not present. This document doesn't detail any clinical test sets or their characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not present. There is no mention of ground truth establishment by experts for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not present.
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:
- The Isolaz™ is an Intense Pulsed Light system, not an AI-powered diagnostic device that would typically involve human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The Isolaz™ is a physical medical device for treatment, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not present.
8. The sample size for the training set:
- Not present. The document does not describe a training set as would be relevant for an AI/ML model.
9. How the ground truth for the training set was established:
- Not present.
In summary:
The provided K083730 510(k) summary is a regulatory filing for a medical device that demonstrates substantial equivalence to a predicate device. It focuses on the device's intended use, basic function, manufacturing methods, and materials, asserting that product testing confirmed conformance to general specifications. It does not include the detailed clinical study data, acceptance criteria, or ground truth establishment methodologies that would be required to answer your specific questions, which are more relevant to diagnostic devices, particularly those involving AI/ML.
§ 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.