(486 days)
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.
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NOV 1 4 2003
K022304 1/2
510(k) Summary
General Information
Classification Class I
Trade Name
AccuMap® Automatic Objective Perimeter
Submitter
ObjectiVision Pty Ltd Level 12 139 Macquarie St Sydney 2000 Australia
61-2-9252-9833
Contact
John Newton CEO
Intended Use
The AccuMap® perimetry system uses multifocal recordings of visual evoked potentials as a diagnostic aid in the detection of glaucoma.
Predicate Device
K983983 VERIS multifocal system Electro-Diagnostic Imaging, Inc.
Device Description
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.
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The design of the AccuMap means that all the components fit into one compact, mobile unit.
Monitors
The system includes two monitors, a 21-inch high-resolution monitor which displays the stimulus for the patient, and a touch screen which the technician uses to run the OPERA Firmware.
The stimulus is a dartboard pattern projected by the monitor for visualization by the patient.
AccuMap computer
The computer which is part of the AccuMap and which runs the OPERA Firmware is a Pentium III or better system.
Medical amplifier
The amplifier is a four-channel model and is driven by Windows-based software.
Electrode lead sockets
The electrode sockets, located behind the patient's chair, are labeled with the same bright colors as the electrode leads to make it easier to plug the leads in correctly.
Electrode cross
The ObjectiVision electrode cross holds the four bipolar electrodes used to record patient responses to the stimulus. The cross is based on a simple patented design and is easy to use. Two electrodes are positioned along the midline above and below the inion, and two additional electrodes are placed four centimeters on either side of the inion.
The holder standardizes the electrode positioning and speeds up the preparation and placement of the electrodes. The holder is easy to clean and is suitable for use on children as young as six years.
The electrode cross is lightweight and comfortable for the patient with the result that their neck muscles remain relaxed during the recording. A chin rest is not required and may, in fact, increase muscle tension. "An ear clip electrode provides the earth.
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Virtual keyboard
Because the AccuMap uses a touch screen there is no physical keyboard. Instead there is a virtual keyboard which displays automatically when you need to type something in. To use the keyboard, touch the appropriate key.
Hand-held button and fixation control
To help the patient concentrate on the center of the stimulus, they are asked to press a hand held button whenever they see a particular randomly generated number displayed
OPERA Firmware
The OPERA Firmware is used for recording and analysis. It generates the stimulus on the patient's monitor, performs signal extraction (cross correlation) and displays the results. The results include topographical evaluation of latency and amplitude, and are presented in a familiar format for easy interpretation. An asymmetry coefficient, unique to the AccuMap, compares right and left eyes allowing for the detection of very subtle changes.
Materials
All materials used in the manufacture of the AccuMap are suitable for this use and have been used in numerous previously cleared products.
Testing
Product testing was conducted to evaluate conformance to product specification. Testing included electrical safety and electromagnetic compatibility.
Summary of Substantial Equivalence
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2003
ObjectiVision Pty Ltd c/o Mr. Fred Henry, MS Vice President, U.S. Regulatory Affairs Omnicare Clinical Research, Inc. 630 Allendale Road King of Prussia, Pennsylvania 19406
Re: K022304
Trade/Device Name: AccuMap® Automatic Objective Perimeter Regulation Number: 21 CFR 882.1890 Regulation Name: Evoked response photic stimulator Regulatory Class: II Product Code: GWE Dated: October 29, 2003 Received: November 3, 2003
Dear Mr. Henry:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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Page 2 - Mr. Fred Henry, MS
This letter will allow you to begin marketing your device as described in vour Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
AccuMap® Automatic Objective Perimeter
Indications for Use:
The AccuMap® perimetry system uses multifocal recordings of visual evoked potentials as a diagnostic aid in the detection of glaucoma.
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022304
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
§ 882.1890 Evoked response photic stimulator.
(a)
Identification. An evoked response photic stimulator is a device used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye for use in evoked response measurements or for electroencephalogram (EEG) activation.(b)
Classification. Class II (performance standards).