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The Emvera Diolux is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Hair removal by laser or IPL sources can cause increase hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.

Caution: Federal (USA) law restricts this device for use by or on the order of a physician.

This laser operation equipment is a diode laser of 808nm of pulsed diode laser.

This equipment is composed of a main body to operate each function of equipment and a hand piece for irradiation of laser, and is designed to be use in various treatments by effecting the skin by laser beam of 808nm.

Diode laser of 808nm is able to transfer stable and uniform pulses to skin, therefore operator can treat patient safely and effectively using this equipment. This equipment provides direct visual color LCD screen configured with prompts for ease of use for the operator.

The provided text is a 510(k) summary for the Emvera Diolux Surgical Laser. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain any information about a study that proves the device meets specific acceptance criteria through performance evaluation.

The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device (Alma Lasers, Inc. Soprano XL) based on similar product characteristics and indications for use. This regulatory pathway does not typically require the submission of new clinical efficacy studies with predefined acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, for aspects of your request related to acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC, standalone performance), and ground truth establishment for this specific device's 510(k) submission, the provided document does not contain this information.

The document essentially states:

"Based on the comparisons found in the predicate product comparison table no new issues of safety and effectiveness are raised in this original new 510(k). This conclusion is based on the fact that the Emvera Diolux and the Alma Lasers Soprano XL have the same as or similar product characteristics, such as laser type, wave length, flounce, mode, duration, repetition, spot size, cooling and power input."

This indicates that the acceptance criteria are implicitly met by being "substantially equivalent" to a legally marketed predicate device, rather than through a new, independent performance study against defined metrics.

Summary of Information Present/Absent based on your request:

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

   • Absent. The document does not define specific performance acceptance criteria for the Emvera Diolux or report its performance against such criteria. It provides a table comparing technical specifications of the Emvera Diolux and the predicate device.

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

   • Absent. No test set or study data is presented.

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):

   • Absent. No test set or ground truth establishment is described.

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

   • Absent. 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:

   • Absent. This device is a laser surgical instrument, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device and was not conducted.

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

   • Absent. Not applicable to this type of medical device.

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

   • Absent. No ground truth is described as no performance study was detailed.

8. The sample size for the training set:

   • Absent. No training set is described.

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

   • Absent. No training set or ground truth establishment is described.

In essence, this 510(k) submission relies on device comparison and shared indications for use for regulatory clearance, not on a new, independent clinical performance study.

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