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The Silk'n is intended for removal of unwanted hair by using selective photothermal treatment. The device is generally indicated for dermatological use. The Silk'n is specifically indicated for patient removal of unwanted hair by using selective photothremal treatment under the direction of a physician, after training by a healthcare professional.

The Silk'n hair removal system is composed of a base unit and hand held applicator.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Silk'n device, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not explicitly state quantitative acceptance criteria for safety or effectiveness (e.g., "efficacy rate > X%", "adverse event rate < Y%"). Instead, it provides qualitative statements about the device's performance based on the clinical study.

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

• Sample Size for Test Set: Not specified. The document states "Clinical data was collected in a prospective clinical study," but no number of participants is given.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the submitter's address is "Apolo building, POB 533, Yokneam 20692, Israel," suggesting the study may have been conducted there or coordinated from there.
  • Retrospective or Prospective: Prospective clinical study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. (The ground truth for this device likely relates to hair reduction, which might be assessed by clinicians or through objective measurements, but the document doesn't detail this.)

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study Done: No. This type of study is not applicable to a hair removal device; it's typically used for diagnostic imaging devices where human readers interpret results.
• Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: Not applicable. This device is a direct-use physical device, not an AI algorithm. Its performance is inherent in its operation, not in an interpretive algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly detailed. For a hair removal device, ground truth would typically be established by:
  • Direct observation/measurement of hair reduction: This could involve counting hairs in a treated area, photographing the area, or using other objective measures to quantify hair growth before and after treatment.
  • Patient self-assessment or clinician assessment: Subjective reports of hair reduction.
  • Based on "functions as intended," it implies that the device successfully removed unwanted hair as observed or measured.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training set" for device development would be engineering and optimization data, not a patient dataset for algorithm training.

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

• How Ground Truth Was Established: Not applicable. (See explanation for point 8.)

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The device's safety and effectiveness were supported by a prospective clinical study. The study demonstrated that the Silk'n system functions as intended with no adverse events. The specific details regarding the number of participants, exact methodologies for assessing effectiveness (e.g., percentage of hair reduction, duration of effect), or how "no adverse events" was quantified (e.g., monitoring period, specific types of adverse events looked for) are not provided in this summary. The device also complies with specific U.S. Food and Drug Administration performance standards (21CRF § 1040.10 & 1040.11).

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