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The MIRA LASERS is indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications:

• Excision and Incision Biopsies
• Hemostatic assistance
• Treatment of Apthous Ulcers
• Frenectomy
• Frenotomy
• Gingival Incision and Excision
• Gingivectomy
• Gingivoplasty
• Incising and Draining of Abscesses
• Operculectomy
• Oral Papillectomy
• Removal of Fibromas
• Soft Tissue Crown Lengthening
• Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
• Tissue retraction for Impression
• Vestibuloplasty
• Laser assisted whitening/bleaching of teeth
• Light activation for bleaching materials for teeth whitening

The proposed devices, MIRA LASERS ZENO 2 and MIRA LASERS ZENO 4, are new device for 510(k) submission and share the same indication for use and safety compliance, similar design features and functional features with the predicate device.

The proposed device are designed to be compact, portable, reliable and user-friendly. It provides the practitioner with a versatile instrument for applications ranging from excisions and vaporization of tissues to periodontal treatments and tooth whitening. The MIRA LASERS at 810mm are delivered through a flexible optical fiber, or fixed disposable tip. The systems may be utilized for a wide variety of dental surgical and cosmetic procedures.

The proposed devices include two models, the difference of the two models is only laser power, the laser power of ZENO 2 is 0.6W/1.2W/1.8W, and the laser power of ZENO 4 is 1.0w/2.0/3.5W.

The MIRA LASERS are contained within a compact lightweight plastic/metal housing and consists of a laser diode assembly with a self-contained cooling system, a slim battery pack, front panel display all connected to a circuit board, which controls laser output power and other system parameters for laser proper functioning.

The proposed device includes two different working modes, which are continuous wave and 20Hz pulse.

Here's a summary of the acceptance criteria and study information for the MIRA LASERS ZENO 2/ZENO 4, based on the provided text:

Acceptance Criteria and Device Performance

This submission is a Traditional 510(k) for a laser surgical instrument. Traditional 510(k)s rely on demonstrating substantial equivalence to a predicate device, rather than defining novel performance acceptance criteria with specific metrics. The "acceptance criteria" here therefore refer to meeting design specifications and complying with relevant standards to demonstrate equivalence.

Study Information

1. Sample size used for the test set and the data provenance:

   • No specific clinical test set or data provenance (e.g., country of origin, retrospective/prospective) is mentioned.
   • The submission relies on "Bench tests" which are laboratory-based and do not involve human or animal subjects in the way a traditional clinical study would.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This submission is for a laser surgical instrument, and the non-clinical tests involved verifying design specifications and compliance with standards, not establishing ground truth for diagnostic or clinical outcome data.

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

   • Not applicable. There was no clinical test set requiring adjudication.

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:

   • Not applicable. This device is a laser surgical instrument, not an AI-assisted diagnostic or imaging device. No MRMC study was mentioned.

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

   • Not applicable. This is a hardware medical device (laser surgical instrument), not a software algorithm.

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

   • The "ground truth" for this submission would be the established engineering and safety standards (e.g., IEC 60601 series, IEC 60825-1) and the verified design specifications of the device. The device was tested against these known standards and specifications.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set. The "training" for such a device would refer to its design and development process, which is not quantified by a training set sample size.

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

   • Not applicable for the same reason as above. The "ground truth" for the development of such a device is rooted in established engineering principles, material science, and regulatory safety/performance requirements for medical lasers.

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