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The Candela-Inolase Serenity Pro PSF™ (Pneumatic Skin Flattening) System is indicated for the following uses: As an accessory for a compatible legally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration treatment beam through it. Reduction of pain during Laser or Intense Pulse Light System treatment.

The Serenity Pro PSF™ System is a device which has the ability to produce a vacuum at a level of 380-680 mbar. Suction can be delivered through its handpiece. which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PSF system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment erythema.

This device, the Candela-Inolase Serenity Pro PSF™ System, is an accessory for laser/IPL hair removal systems. Its primary claim is to reduce pain during treatment and lessen associated erythema.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not explicitly define "acceptance criteria" with specific numerical thresholds (e.g., "pain reduction must be >X%"). Instead, it states the objectives of the clinical study and presents the findings as confirmation that these objectives were met.

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

• Sample Size: The document does not explicitly state the number of subjects (test set sample size) used in the clinical study. It only mentions that the study "involved normal laser treatment parameters which were typically expected to be painful."
• Data Provenance: The document does not specify the country of origin. The study was a prospective clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the submitted documents. The pain assessment was "recorded utilizing a modified McGill Pain questionnaire," which is a self-reported patient outcome. Erythema was "rated by clinical investigators," but their number and qualifications are not specified.

4. Adjudication Method

The document does not mention any adjudication method specifically. For pain, it was self-reported by subjects. For erythema, clinical investigators rated it (implying subjective assessment, but no details on consensus or single rater).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This study focused on the effectiveness of the Serenity PSF™ system itself on objective patient outcomes (pain and erythema), not on comparing human readers' diagnostic accuracy with and without AI assistance. The device is a physical accessory to a laser, not an imaging or diagnostic AI tool.

6. Standalone (Algorithm Only) Performance

Not applicable. The Serenity Pro PSF™ System is a physical accessory (a handpiece producing negative pressure) that works in conjunction with a laser or IPL system and a human operator. It is not a standalone algorithm.

7. Type of Ground Truth Used

• Pain Reduction: Patient-reported outcomes using a modified McGill Pain questionnaire.
• Erythema Reduction: Clinical investigator ratings immediately and 20 minutes post-treatment.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical/physical accessory, not an AI or machine learning algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. As the device is not an AI/ML algorithm, there is no training set or ground truth establishment relevant to an algorithm.

Ask a specific question about this device

The Serenity Pro PSF™ System is an accessory for a compatible leqally marketed Laser or Intense Pulse Light System for use in hair removal. Its handpiece produces a negative pressure over the skin surface, just prior to the administration of the treatment beam through it.

The Serenity Pro PSF™ System is a device which has the ability to produce a vacuum at a level of 400-700 mbar. Suction can be delivered through its handpiece, which has a sapphire window at its distal end, to be positioned over the skin for laser or IPL treatment. When the PSF system is activated, the negative pressure results in the flattening of the skin of the treatment site. During the time duration of suction, the treatment beam of the laser or IPL is administered through the sapphire window of the handpiece, which is transparent and thermally conductive. The resultant tight mechanical contact produced by the PSF expels blood from the treatment site which enhances the light penetration of the laser or IPL in tissue as well as the removal of its heat from the skin. This can reduce the possibility of post treatment ervthema.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance in the format requested. The document is a 510(k) summary for the Serenity Pro PSF™ System, which describes the device, its intended use, and its substantial equivalence to a predicate device for FDA clearance. It does not detail specific performance metrics, clinical study design, or results in the way you've outlined.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

Ask a specific question about this device