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The Opto Hyalus Green Laser is indicated for retinal photocoagulation. Used for the following ophthalmic medical condition and treatment:

• Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroids, including:
  • Proliferative and nonproliferative diabetic retinopathy
  • Choroidal neovascularization
  • Branch retinal vein occlusion
  • The treatment of choroidal neovascularization associated with wet age related macular degeneration Retinal tears and detachments
• Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and open angle glaucoma

The Opto Hyalus Green Laser solid state, frequency-doubled, green Nd;YAG surgical laser system is an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm.
The equipment consists of three encoders which enable the physician to adjust the pulse duration, the laser power and the interval between successive pulses. All information is displayed on a color display 240x324 pixels TFT technology. On this display there is a touch-screen film responsible for the navigation software and by setting preferences, such as loudness, intensity laser sighting and display brightness.
Physicians have the option of applying single pulses or pulse trains previously adjusted. Power levels ranging from 50mW up to 2000mW, with resolution of 10mW. The duration can be set between 10ms and 1000 ms with a resolution of 10ms. The interval between pulses can be set between 50ms and 3000ms with 10ms resolution or can be set to single pulse (in this case, the range is set to zero).
The Opto Hyalus Green Laser beam has a wavelength of 532nm, which is in the visible spectrum and is a green light. A red aiming beam is used to position the treatment green beam prior to delivery.
The Opto Hyalus Green Laser is a solid state, Optical Pumped Semiconductor surgical laser.
It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm.
Compatible delivery devices include: slit lamp adapters/, laser indirect ophthalmoscopes (LIO) and Probe. All these accessories are specific for Opto Hyalus Green Laser.

The provided 510(k) summary for the Opto Hyalus Green Laser focuses heavily on demonstrating substantial equivalence to a predicate device through technical specifications and intended use comparison, rather than presenting a detailed study with acceptance criteria and clinical performance metrics. Therefore, much of the requested information regarding detailed study design (sample size, ground truth, adjudication, etc.) is not explicitly available in this document.

Here's the information that can be extracted or inferred, along with what is not provided based on this document:

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

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

• Not provided. The document states, "No Clinical information is required." and that "Laboratory testing was conducted to validate and verify that the proposed device, Opto Hyalus Green Laser met all design specifications and was substantially equivalent to the predicate device." This indicates that no clinical "test set" in the sense of patient data was used to evaluate performance against acceptance criteria. The evaluation was based on non-clinical, laboratory, and engineering testing, and comparison to a predicate device.

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. As no clinical test set was required or conducted, there were no experts establishing ground truth for such a set.

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

• Not applicable. No clinical test set.

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 device is a surgical laser, not an AI-assisted diagnostic or therapeutic tool that would involve human readers.

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

• Not applicable. This is a physical medical device (surgical laser), not a software algorithm. Its "standalone" performance would be its functional operation in isolation from a human operator, which would be covered by its technical specifications and safety testing (e.g., emission wavelength, power output, pulse duration accuracy). The document indicates such non-clinical testing was performed to verify design specifications and substantial equivalence.

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

• For the non-clinical laboratory testing, the "ground truth" would be established engineering specifications, performance standards (e.g., IEC standards), and the known performance of the predicate device. These are objective measurements and comparisons rather than clinical ground truth types.

8. The sample size for the training set

• Not applicable. This is a hardware medical device; there is no "training set" in the context of machine learning algorithms.

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

• Not applicable. No training set.

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