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Hyperion is a long pulsed Nd:YAG laser intended for treatment of wrinkles, Removal of unwanted hair for stable long term or *permanent hair reduction, treatment of pseudofolliculitis barbae (PFB), surgical incision, excision, vaporization, ablation and coagulation of soft tissue, and photocoagulation and hemostasis of pigmented and vascular lesions in dermatology. *Permanent hair reduction is defined as the long-term stable reduction in the number of hairs re-grown when measured at 6, 9, and 12 months after the completion of a treatment regimen

Hyperion is a long pulse Nd:YAG laser system that produces laser emission at the wavelength of 1064nm. The system consists of three interconnected sections: a) the main cabinet, which houses the power supply, cooling system, microprocessor, and the laser generator, b) the optical fiber with hand pieces which can be used selectively depending on the size of the laser beam exposure, c) the footswitch.

This document describes the 510(k) summary for the Hyperion Long Pulsed Nd:YAG Laser. It indicates that the device's substantial equivalence is based on its similarity to predicate devices, rather than on new performance data from a specific study directly proving its acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The Study Proving the Device Meets Acceptance Criteria

The provided document does not describe a performance study with acceptance criteria in the traditional sense of a clinical trial demonstrating efficacy against specific endpoints. Instead, the "study" for proving acceptance relies on demonstrating Substantial Equivalence to legally marketed predicate devices.

The justification for the Hyperion Long Pulsed Nd:YAG Laser meeting acceptance criteria is based on the following:

• Non-clinical testing: This included visual and mechanical inspection, electrical and mechanical safety testing, and software testing in a bench environment.
• Compliance with standards: Electrical testing was performed in accordance with IEC 60601-1 and 60601-1-2 standards.
• Comparison to predicate devices: The core argument is that the Hyperion device has the same intended use, utilizes the same underlying technology (Nd:YAG laser at 1064nm), operates on the same principle, and has essentially the same power range and indications for use as the legally marketed predicate devices:
  • Candela, Inc. - Gentle YAG Laser System (K022951)
  • Fotona d.d. - XP Nd:YAG Laser System (K090126)
  • Cynosure, Inc. Apogee Elite Laser (K034030)

The submission concludes that, based on this analysis, no significant differences exist between Hyperion and its predicate devices, and therefore, it should not raise new safety or effectiveness issues.

Specific Information Requested (Based on the document):

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

   • N/A. The document does not describe a clinical "test set" for a performance study. The evaluation is based on non-clinical bench testing and comparison to existing predicate devices.

2. 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):

   • N/A. As no clinical test set with a ground truth determination is described.

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

   • N/A. As no clinical test set requiring adjudication is described.

4. 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:

   • N/A. This device is a laser system, not an AI-assisted diagnostic or therapeutic device requiring a MRMC study.

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

   • N/A. This device is a medical laser, not an algorithm. Bench testing for safety and operational parameters was performed.

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

   • N/A. The "ground truth" for demonstrating substantial equivalence rests on the established safety and effectiveness of the predicate devices for their indicated uses, which would have been based on their own clinical evidence at the time of their clearance. For the Hyperion itself, the "ground truth" for its acceptance criteria is compliance with engineering standards and direct comparison of its technical specifications and intended uses to the predicate devices.

7. The sample size for the training set:

   • N/A. The device is a laser, not a machine learning model, so there is no training set in this context.

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

   • N/A. Not applicable, as there is no training set.

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