Search Results

For general ophthalmic imaging, visualization, and fluorescein angiography including anterior and posterior segments of the eye.

Not Found

This appears to be a 510(k) clearance letter from the FDA for a device named "Anterior Segment Analysis Device" (or later, "Pathfinder"). This type of document (a 510(k) clearance letter) does not typically contain the detailed technical study information like acceptance criteria, performance metrics, sample sizes, or ground truth establishment methods.

The 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, not on proving clinical efficacy or detailing specific performance studies in the same way a PMA (Premarket Approval) would. The letter confirms that the FDA has reviewed the submission and found the device substantially equivalent.

Therefore,Based on the provided text, I cannot answer most of your detailed questions regarding acceptance criteria and the study that proves the device meets those criteria. The document is a regulatory clearance letter, not a technical study report.

Here's what I can infer from the document, and what I cannot:

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

• Cannot provide. This information is not present in the 510(k) clearance letter. The letter states the device is substantially equivalent to a predicate, but doesn't detail performance metrics or acceptance criteria for that equivalence.

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

• Cannot provide. This information is not present in the 510(k) clearance letter.

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 provide. This information is not present in the 510(k) clearance letter. The letter mentions "ophthalmic imaging," implying ophthalmologists would be involved, but no specifics are given.

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

• Cannot provide. This information is not present in the 510(k) clearance letter.

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:

• Highly unlikely to be relevant or present. The device name "Anterior Segment Analysis Device" and "Pathfinder" suggests an imaging or analysis tool, but the provided text does not describe an AI component or a study on human reader improvement with AI assistance. It's a 2004 clearance, predating widespread clinical AI in many fields.
• Cannot provide specifics. This information is not present in the 510(k) clearance letter.

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

• Cannot provide. This information is not present in the 510(k) clearance letter.

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

• Cannot provide. This information is not present in the 510(k) clearance letter.

8. The sample size for the training set:

• Cannot provide. This information is not present in the 510(k) clearance letter.

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

• Cannot provide. This information is not present in the 510(k) clearance letter.

In summary, the provided document is a formal FDA clearance letter, confirming regulatory approval based on substantial equivalence. It does not contain the detailed technical data or study methodology you are requesting. To find such information, you would typically need access to the full 510(k) submission document or a peer-reviewed publication about the device's development and testing.

Ask a specific question about this device

Ask a specific question about this device