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The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

The Fiber Optic Endoillumination Probe is provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.

The provided text is a 510(k) summary for the MicroVision, Inc. Fiber Optic Endoillumination Probe. It does not describe an "acceptance criteria and the study that proves the device meets the acceptance criteria" in the typical sense of a clinical or performance study with defined metrics. Instead, this document focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested elements for a study that "proves the device meets acceptance criteria" are not applicable or cannot be extracted from this document, as it's not a report of such a study.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document doesn't define quantitative acceptance criteria for performance; instead, it establishes equivalence based on descriptive characteristics.

Study Details (Not Applicable/Cannot be Extracted from a 510(k) Summary for Substantial Equivalence):

The 510(k) summary is a premarket notification to demonstrate substantial equivalence, not a detailed report of a performance study with specific acceptance criteria in the sense of clinical trial outcomes or detailed engineering specifications. It relies on comparing descriptive and technological characteristics to a legally marketed predicate device.

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

• Not applicable. This document describes the device itself and its comparison to a predicate, not a performance study on a test set. There is no mention of a "test set" of patients or data.

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. Ground truth establishment for a test set is not relevant to a 510(k) substantial equivalence submission for this type of device. The "ground truth" here is essentially the characteristics of the predicate device.

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

• Not applicable. 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

• Not applicable. This device is a fiber optic endoillumination probe, a physical medical device for illumination during surgery, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

• Not applicable. This device is a physical surgical tool, not an algorithm.

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

• For the purpose of substantial equivalence: The "ground truth" is the established characteristics and performance of the predicate device (Infinitech, Inc. Fiber Optic Probe, K870942). The claim is that the new device is functionally identical or very similar.

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.

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

• Not applicable. No training set is involved.

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The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.

The Fiber Optic Endoillumination Probe provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.

This 510(k) summary (K980636) for the Fiber Optic Endoillumination Probe does not describe a study with acceptance criteria and reported device performance. Instead, it demonstrates substantial equivalence to a predicate device (Infinitech, Inc. Fiber Optic Probe, K870942) based on operational and technological characteristics.

Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.

Here's a breakdown of what can be extracted and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided.

The submission relies on a comparison table to establish substantial equivalence, not to report performance against specific acceptance criteria. The "Comparison Criteria" act as attributes that are matched for equivalence rather than performance metrics with thresholds.

Note: The predicate device details for "Sterilization Method" and "Packaging" are "Not Known," indicating that Dutch Ophthalmic's methods were assessed for safety and effectiveness on their own merits and found acceptable, rather than directly comparing to a known predicate value.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This submission does not detail an experimental test set with sample sizes. It's a regulatory submission for substantial equivalence based on descriptive and technological characteristics.

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

Not applicable/Not provided. No test set or ground truth established by experts is described.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or adjudication method 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

No. This is not an AI-enabled device. It's a fiber optic endoillumination probe. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

No. This is not an algorithm-only device.

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

Not applicable/Not provided. No ground truth is described as the device is for illumination, not diagnosis or measurement requiring ground truthful comparison.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/machine learning device, so there is no training set mentioned.

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

Not applicable/Not provided. As there's no training set, there's no ground truth established for one.

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