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The MED flash II Intense Pulsed Light System is indicated for use in:

• Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction
• Treatment of inflammatory acne (acne vulgaris)
• Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and café-au-lait
• Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins
• The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.

The MED flash II Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. The system is based on a quick power discharge of capacitors in a Xenon lamp, mounted on a handpiece. This generates a rapid and Intense Pulsed Light.
The Med flash II system contains five principal components:

• Charge system of the capacitors .
• Electronic control system .
• Control panel .
• Handpiece with exchangeable lamp box ●
• Handpiece cooling system .

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the MED flash II Intense Pulsed Light System:

1. Table of Acceptance Criteria and Reported Device Performance

• Treatment of inflammatory acne (acne vulgaris)
• Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and café-au-lait
• Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins
• Integrated cooling handpiece intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications. | The device is deemed acceptable for these indications based on its substantial equivalence to predicate devices that have similar indications and technological characteristics. |
  | Technical Specifications (Implicit Acceptance for Equivalence) | - Emitting light radiation in the range from 590 nm to 1200 nm.
• Based on quick power discharge of capacitors in a Xenon lamp.
• Handpiece with exchangeable lamp box.
• Handpiece cooling system. | These technical specifications are presented in the device description, implying that they align with or are sufficiently similar to the predicate devices to support substantial equivalence. |

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states "None presented" under the "Performance Data" section. This indicates that no specific test set data, sample size, or information on data provenance (country of origin, retrospective/prospective) was provided or required for this 510(k) submission. The approval was based on demonstrating substantial equivalence to predicate devices, not on new clinical performance data from a specific test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. Since no specific performance data or test set was presented, there was no ground truth to be established by experts in the context of this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. As no test set data was presented, no adjudication method was mentioned or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "None presented" for performance data. There is no mention of an MRMC study, or any comparative effectiveness study with or without AI assistance. This type of study would typically be part of a robust performance data section, which is absent here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/No. This device is an Intense Pulsed Light System, a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance without human interaction is not relevant to its type. The 510(k) summary does not mention any software or AI components that would require such a study.

7. The Type of Ground Truth Used

No specific ground truth type was used or reported in the context of a new performance study. The basis for clearance is substantial equivalence to predicate devices. This implies that the safety and effectiveness of the device are inferred from the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. As the approval is based on substantial equivalence to existing predicate devices and no new performance study data was presented, there are no references to a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. Since no training set was mentioned in this 510(k) summary, there is no information on how a ground truth for a training set would have been established.

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