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Clinical Indications with a Slit Lamp Delivery System: This system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including: Proliferative Diabetic retinopathy, macular degeneration, and retinal detachment. Clinical Indications with a Laser Indirect Ophthalmoscope Delivery System: This system has the same clinical indications as the slit lamp delivery system, but it can only be used for peripheral photocoagulation. Clinical Indications with an Endophotocoagulation (EPCP) Delivery System: The EPCP probe has been designed as a means for intraocular photocoagulation as an adjunct to vitrectomy surgery. Specific indications for use for the EPCP include treatment of complicated rhegmatogenous and tractional retinal detachments, proliferative vitreoretinopathy, proliferative diabetic retinopathy, and various retinal vascular tumors.

The devices that are subject to this Special 510(k) Premarket Notification are the Coherent Laser Indirect Ophthalmoscope, the Acculite Endokit/Endoprobe, the LaserLink HS and LaserLink Z Slip Lamp Laser Delivery Adapter and the Coherent Novus Verdi Frequency-Doubled Nd: Y AG Ophthalmic Photocoagulator.

The provided document is a 510(k) summary statement for a medical device and a subsequent FDA approval letter. It does not include information about specific acceptance criteria, a study proving the device meets those criteria, or the detailed aspects of a clinical study that would lead to such data.

The document primarily focuses on establishing "substantial equivalence" of the new "Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd:YAG Photocoagulator" to existing predicate devices. This means the device is considered safe and effective because it is similar in design, function, and intended use to devices already on the market.

Therefore, most of the requested information cannot be extracted from the provided text. I can only fill in the parts that are explicitly mentioned or can be inferred.

Here's what can be extracted and why other parts cannot be:

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

• Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or other performance metrics) nor does it report specific device performance data from a dedicated study against such criteria. The basis for approval is substantial equivalence to predicate devices, not meeting novel performance criteria.

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

• Cannot be provided. No specific test set, sample size, or data provenance from a performance study is mentioned. The submission relies on demonstrating similarity to already approved devices.

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)

• Cannot be provided. No "test set" requiring ground truth establishment by experts is described as part of this 510(k) submission for the device's performance.

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

• Cannot be provided. No "test set" requiring adjudication 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 document is for a laser delivery system, not an AI-assisted diagnostic or treatment system. Therefore, no MRMC study or AI-related effectiveness data is present.

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

• Cannot be provided. As above, this is not an algorithm-based device.

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

• Cannot be provided. No performance study requiring ground truth is described.

8. The sample size for the training set

• Cannot be provided. This device does not involve machine learning or a "training set" in the context of AI.

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

• Cannot be provided. As above, no training set or ground truth establishment for such a set is relevant to this device's approval process based on the provided text.

Summary of what is available from the document:

The regulatory approval for the Coherent Medical Group Delivery Devices relies on substantial equivalence to previously approved predicate devices, rather than a new clinical study demonstrating specific performance against predefined acceptance criteria. The document states:

• Rationale for Substantial Equivalence: "The Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd: YAG Photocoagulator share the same indications for use, similar design features, functional features and are therefore substantially equivalent to the predicate Viridis Surgical Laser (K960867) and Coherent Medical Group predicate devices (K913127, K885196, K812219)."
• Safety and Effectiveness: "Safety and effectiveness information was provided to demonstrate that the Coherent Medical Group Delivery Devices for use with the Coherent Novus Verdi Frequency-Doubled Nd:YAG Photocoagulator are safe and effective for use in surgical procedures as indicated in K960867." (This implies that the demonstrated safety and effectiveness is tied to its similarity to the predicate devices and their known performance, not new performance data from this submission.)

Therefore, the "acceptance criteria" were effectively the criteria for establishing substantial equivalence, and the "study" proving it met these criteria was the comparison outlined in the 510(k) submission, not a new clinical performance trial with specific metrics.

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