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The Dornier Medilas R Laser is intended to be used in a non-contact technical medical therapy unit, which is indicated for the dermatological application of epilation. The Medilas R is suitable for the following applications: General Surgery, Plastic Surgery, Cosmetology and Dermatology.

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The provided text is a 510(k) summary for the Dornier Medilas R Laser, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because it describes a different type of regulatory submission.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not found. This 510(k) summary does not define specific acceptance criteria or report device performance against such criteria. The submission is based on substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not found. No test set or clinical study data is presented in this 510(k) summary.

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 applicable / Not found. No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not found. No test set or adjudication process is described.

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

• Not applicable / Not found. This device is a laser for dermatological applications, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not found. This device is a laser, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable / Not found. No ground truth is mentioned as this is a substantial equivalence submission for a laser device.

8. The sample size for the training set

• Not applicable / Not found. No training set is mentioned.

9. How the ground truth for the training set was established

• Not applicable / Not found. No training set or ground truth establishment process is described.

Summary of what the document does provide:

• Predicate Devices:
  • Dornier Medilas H Laser System (K981718)
  • Dornier Medilas E Laser System (K981438)
  • Mehl/Biophile Chromos 694 (K962109)
  • Sharplan EpiTouch Laser System (K972099)
• Intended Use / Indications for Use: The Dornier Medilas R Laser is intended to be used in a non-contact technical medical therapy unit, indicated for the dermatological application of general epilation, General Surgery, Plastic Surgery, Cosmetology, and Dermatology.
• Basis for Approval: Substantial equivalence to the predicate devices based on clinical perspective and design specifications. The submitter states "no significant differences exist" and "minor differences... should not raise any concerns regarding the overall safety or effectiveness."

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