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The device is intended as a laser delivery system for use by an opthalmologist in the treatment of ocular tissue.

1. RETINAL PHOTOCOAGULATION
2. TRABECULOPLASTY

When connected by fiber optic to a laser and properly attached to a 900 BQ or 900 BM slit lamp, the device directs and focuses laser energy on target tissue parfocally with the slit lamp image. An operator protective filter is incorporated into te device. The spot diameter is user adjustable, and the filter is removable to permit unimpaired viewing through the slit lamp microscope.

The provided text describes a 510(k) premarket notification for the "BQ/BM Integrated Laser Delivery System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided document.

The document states: "The BQ/BM Laser Delivery System does not raise new questions of safety and effectiveness and is substantially equivalent to the Rodenstock Ro 5000 AR/FDY and the Zeiss 130 SL." This indicates that A.R.C. Laser Corporation's submission relies on showing that their device has the same technological characteristics, intended use, materials, design, method of manufacture, and labeling as these previously cleared predicate devices.

Here's a breakdown of what can be extracted, and why the other information is missing:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria or detailed performance metrics from a dedicated study. The "performance" claimed is substantial equivalence to predicate devices, meaning it performs similarly in its intended function.

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

• Cannot be provided. No test set or clinical study data is mentioned in the document.

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

• Cannot be provided. As there's no described test set or ground truth establishment, this information is not present.

4. Adjudication method for the test set:

• Cannot be provided. 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:

• Cannot be provided. This device is a laser delivery system, not an AI-powered diagnostic tool. MRMC studies are not relevant to this type of device and are not mentioned.

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

• Cannot be provided. This is a hardware device for laser delivery, not an algorithm. Standalone performance as typically understood for AI algorithms is not applicable.

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

• Cannot be provided. No clinical study or ground truth establishment is detailed. The "ground truth" for a 510(k) in this context is the safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Cannot be provided. No machine learning or algorithm training is mentioned for this device.

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

• Cannot be provided. No training set or ground truth establishment relevant to AI/ML is detailed.

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