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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.

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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.

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