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In the YAG mode (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy.

In the SLT mode (Tango Neo, Tango Reflex Neo) : -Selective Laser Trabeculoplasty (SLT)

These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma.

All these devices consist of the below main parts: Delivery Head, Microscope and Slit lamp Illumination, Console and Table Top, Joystick fire button, Total solution table, Display unit.

This FDA 510(k) summary does not contain the information required to populate a table of acceptance criteria and reported device performance related to clinical effectiveness. This submission is for an ophthalmic laser system (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo) and the FDA has determined that clinical data is not required because the new devices use the same technology and principles as a previously cleared predicate device (Ellex YAG/SLT, K212630).

Therefore, many of the requested fields cannot be filled. However, based on the non-clinical testing performed, we can infer some "acceptance criteria" related to safety and performance specifications, though not in the typical format of clinical outcomes.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As clinical data was not required, there are no specific clinical acceptance criteria or reported clinical device performance metrics in this summary. The "acceptance criteria" are implied by compliance with various safety and performance standards for medical devices and lasers.

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

This information is not provided. As per Section IX, "clinical data is not required" for the substantial equivalence determination. The "tests" mentioned are non-clinical safety and performance tests against standards, not clinical studies with patients.

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

Not applicable, as no clinical ground truth was established for a test set in this submission.

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

Not applicable, as no clinical test set requiring adjudication was used.

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. This is a laser device, not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This is a physical laser device, not a standalone algorithm.

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

Not applicable, as no clinical ground truth was established for a clinical study in this submission. For the non-clinical tests, the "ground truth" is adherence to international and federal safety and performance standards.

8. The sample size for the training set

Not applicable. No AI/ML component requiring a training set is mentioned.

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

Not applicable. No AI/ML component requiring a training set is mentioned.

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