(14 days)
Treatment of 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® 2 System delivers non-coherent 400-1200 nm and 550-1200 nm intense pulsed light via a delivery handpiece utilizing photopneumatic technology. The system consists of a main console and a treatment handpiece. The desired power and delivery time are set by the operator. The modifications made to the device were to reduce and simplify device settings.
The provided text describes a 510(k) summary for the Isolaz® 2 Intense Pulsed Light System, which is a medical device intended for the treatment of mild to moderate acne. However, the text does not contain specific acceptance criteria or a detailed study plan with performance data in the way you've outlined in your request.
Medical device 510(k) submissions typically focus on demonstrating "substantial equivalence" to a predicate device. This often means showing that the new device has similar technological characteristics and is as safe and effective as a legally marketed device, rather than presenting a novel study against predefined quantitative performance criteria.
Therefore, many of the requested data points (e.g., specific acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) are not available in the provided document.
Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantitative metrics. The overall acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device in terms of safety and effectiveness.
- Reported Device Performance: The document states:
- "Verification and validation data show that the device meets all product specifications."
- "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."
- No specific clinical outcome percentages (e.g., X% reduction in acne lesions) are provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies mentioned ("Laboratory and performance tests") were likely internal engineering and safety tests rather than patient-based clinical trials for performance efficacy in the way a pharmaceutical trial might be.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The summary focuses on engineering and safety compliance rather than clinical validation against expert judgment of acne condition.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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 MRMC study was mentioned. This device is not an AI diagnostic tool that requires human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a light-based therapy device, not a diagnostic algorithm. Performance would relate to its physical output and biological effect, not an algorithmic output requiring standalone evaluation.
7. The type of ground truth used:
- Not applicable in the conventional sense of diagnostic device ground truth. The "ground truth" for this device would be its ability to consistently produce the specified light parameters and its safety in use, rather than a clinical outcome measured against an external standard like pathology. The summary mentions compliance with safety standards (IEC 60601-1, 60601-1-4, 60601-1-2) and biocompatibility (ISO 10993-1).
8. The sample size for the training set:
- Not applicable. This device does not use machine learning algorithms that require a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device Rationale from the Document:
The Isolaz® 2 Intense Pulsed Light System is seeking 510(k) clearance by demonstrating substantial equivalence to its predicate device, the Isolaz® Intense Pulsed Light System (K083730).
Key claims for substantial equivalence:
- Similar Design and Technology: Delivers non-coherent 400-1200 nm and 550-1200 nm intense pulsed light via photopneumatic technology, similar to the predicate.
- Similar Intended Use: Treatment of mild to moderate acne (pustular, comedonal, inflammatory) in all skin types (Fitzpatrick I-VI), identical to the predicate.
- Similar Technological Characteristics: Similar in design specification, output energy, and delivery system.
- Minor Modifications: Modifications to the system console and handpiece hardware and circuitry do "not significantly affect the safety or effectiveness of the device."
- Compliance with Standards: Evaluated and found compliant with IEC 60601-1 and 60601-1-4 for electrical safety, IEC 60601-1-2 for EMI/EMC, and ISO 10993-1 for biocompatibility of treatment tips.
- Performance Data (General Statement): "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."
In essence, the "acceptance criteria" here are that the new Isolaz 2 system has not introduced new safety or effectiveness concerns compared to its predicate and that its modifications are minor, as demonstrated by engineering and safety testing, which allows it to leverage the predicate's established safety and efficacy profile.
§ 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.