Search Results

The AccuMap® perimetry system uses multifocal recordings of visual evoked potentials as a diagnostic aid in the detection of glaucoma.

The AccuMap comprises the following components:

• Two monitors, one for displaying the stimulus and the other for displaying the input to and output from the OPERA software.
• A computer with specialized hardware and software.
• A four-channel medical amplifier.
• A specially designed headset.
• A hand-held button used by the patient for responding.
  The design of the AccuMap means that all the components fit into one compact, mobile unit.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study proving the device meets these criteria in the way a modern regulatory submission would. The document is a 510(k) summary from 2003, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria.

However, based on the available text, here's what can be extracted and inferred:

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

No explicit acceptance criteria or corresponding performance metrics are provided in the document. The "Testing" section only states: "Product testing was conducted to evaluate conformance to product specification. Testing included electrical safety and electromagnetic compatibility." This implies that the device had internal specifications, but these are not disclosed, nor are any performance results against them, other than stating compliance.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document.

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

The document does not mention any test set, sample size, or data provenance for a performance study evaluating the diagnostic capabilities of the AccuMap. The "Testing" section refers only to product specification conformance, electrical safety, and electromagnetic compatibility.

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)

No information is provided regarding experts or ground truth establishment for a diagnostic performance test set.

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

No information is provided regarding an adjudication method for a diagnostic performance 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. The device, the AccuMap, is described as using "multifocal recordings of visual evoked potentials as a diagnostic aid." It's not an "AI" device as understood today, but rather a system for acquiring and processing physiological signals. The concept of "human readers improve with AI vs. without AI assistance" does not apply to the functionality described for this device.

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

The document does not describe performance studies, standalone or otherwise, of the diagnostic capabilities of the AccuMap system. The "OPERA Firmware" performs "signal extraction (cross correlation) and displays the results," which include "topographical evaluation of latency and amplitude." While this is "algorithm-only" performance in processing raw data, its diagnostic accuracy as a "diagnostic aid in the detection of glaucoma" is not evaluated in a standalone study presented here.

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

No type of ground truth is mentioned for any diagnostic performance study.

8. The sample size for the training set

No information is provided regarding a training set or its sample size. The device is a signal acquisition and processing system, not a machine learning model that would typically have a distinct training set in the modern sense.

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

No information is provided regarding a training set or how its ground truth was established.

Summary of what is provided:

The 510(k) summary for the AccuMap® Automatic Objective Perimeter focuses on demonstrating substantial equivalence to a predicate device (K983983 VERIS multifocal system) rather than providing detailed performance data against specific acceptance criteria for its diagnostic claims. The document states:

• "The AccuMap is equivalent to the predicate VERIS system."
• "The AccuMap employs new technology to help reduce the subjectivity of the response of the patient, the method of operation and outcomes are substantially equivalent."

The "Testing" section is limited to:

• "Product testing was conducted to evaluate conformance to product specification."
• "Testing included electrical safety and electromagnetic compatibility."

This indicates that while the device underwent testing for safety and internal specifications, no clinical performance study data with defined acceptance criteria for its "diagnostic aid in the detection of glaucoma" claim is presented in this 510(k) summary. This type of detailed clinical evidence was often not required for 510(k) clearances in 2003, especially for devices demonstrating substantial equivalence to existing predicate devices.

Ask a specific question about this device