(82 days)
This product is intended for use by a trained EEG reader.
This software is intended for use by a trained EEG technician or neurologist.
The Persyst Prism is a software only product. It runs on a personal computer and requires no specialized hardware. It displays digitized EEG signals, power spectra, topographic maps, etc. These functions are all controlled and interpreted by the digitized EEG input is read from a file on the personal computer (or available across the network).
Neither the computer nor the software control the delivery of energy, the administration of parenteral drugs, or another form of life sustaining function to the patient.
The provided text is a 510(k) summary for the PERSYST PRISM device, submitted in 1997. Unfortunately, it does not contain the detailed information required to answer many of the questions. The document primarily focuses on demonstrating substantial equivalence to a predicate device (STELLATE RHYTHM) based on descriptive characteristics and intended use, rather than presenting a performance study with acceptance criteria and results.
Here's a breakdown of what can be extracted and what information is missing:
Description of the Device
The Persyst Prism is a software-only product that runs on a personal computer. It displays digitized EEG signals, power spectra, topographic maps, etc. It requires the EEG signal to be digitized by a separate EEG acquisition system. It is intended for use by a trained EEG reader.
Missing Information Based on Source Document:
The provided 510(k) summary does not include any information regarding:
- Acceptance criteria for device performance.
- A performance study or clinical trial demonstrating the device meets specific criteria.
- Sample sizes for test or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Effect size of AI assistance for human readers.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- How ground truth for any set was established.
Based on the provided document, the only aspect that remotely touches upon "performance" is the comparison of technological characteristics to a predicate device. This is not a performance study in the manner typically expected for acceptance criteria.
Therefore, a table of "acceptance criteria" and "reported device performance" as requested cannot be constructed from this document. The document states:
"Both Prism and Rhythm support the following digital EEG plots: average power spectrum, compressed spectral arrays, topographic spectrum, topographic voltage plots, and correlation and lag. Neither product utilizes a normative database. Rhythm is capable of digitizing an analog signal while Prism requires that the signal be digitized by a separate EEG acquisition system. Both are software only products."
This describes features, not performance metrics against acceptance criteria.
Summary of available and missing information:
- Table of acceptance criteria and reported device performance: Not provided in the document. The document describes functional characteristics but not performance metrics or acceptance criteria.
- Sample size used for the test set and the data provenance: Not provided in the document. No performance study details are included.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document. No ground truth establishment is described.
- Adjudication method for the test set: Not provided in the document.
- 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 provided in the document. The device is a "software only product" for displaying EEG signals, not an AI-assisted diagnostic tool in the modern sense.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided in the document. The device is intended "for use by a trained EEG reader."
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the document.
- The sample size for the training set: Not provided in the document.
- How the ground truth for the training set was established: Not provided in the document.
Conclusion:
The provided 510(k) summary from 1997 is a demonstration of substantial equivalence based primarily on a comparison of intended use, technological characteristics, and predicate device classification. It does not include the detailed performance study information, acceptance criteria, or ground truth establishment methodologies that are typically found in more recent regulatory submissions for devices that involve AI or machine learning algorithms with specific performance claims. At the time of this submission, the regulatory requirements and the nature of the device (a display and analysis tool, not an automated diagnostic system) likely did not necessitate such extensive performance data in the summary.
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Section 2 - Summary of Safety and Effectiveness
MAR - 9 1998
Submitter
Persyst Development Corporation 316 Skyline Drive Prescott, AZ 86303 520/708-0705 Contact: Scott Wilson Submitted: December 12, 1997
Device
PERSYST PRISM Classification: 21 CFR 882.1420
Predicate Device
STELLATE RHYTHM Classification: 21 CFR 882.1420
Description
The Persyst Prism is a software only product. It runs on a personal computer and requires no specialized hardware. It displays digitized EEG signals, power spectra, topographic maps, etc. These functions are all controlled and interpreted by the digitized EEG input is read from a file on the personal computer (or available across the network).
Neither the computer nor the software control the delivery of energy, the administration of parenteral drugs, or another form of life sustaining function to the patient.
Intended Use
This product is intended for use by a trained EEG reader.
Comparison Summary of Technological Characteristics
Both Prism and Rhythm support the following digital EEG plots: average power spectrum, compressed spectral arrays, topographic spectrum, topographic voltage plots, and correlation and lag. Neither product utilizes a normative database. Rhythm is capable of digitizing an analog signal while Prism requires that the signal be digitized by a separate EEG acquisition system. Both are software only products.
5974718
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three flowing ribbons extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 1998
Mr. Scott B. Wilson · President Persyst Development Corporation 316 Skyline Drive 86303 Prescott, Arizona
Re: K974718 PERSYST PRISM Trade Name: Regulatory Class: I Product Code: GMS December 12, 1997 Dated: Received: December 17, 1997
Dear Mr. Wilson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set ... . forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Wilson
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K974718
Device Name: PERSYST PRISM
Indications For Use:
: 1
This software is intended for use by a trained EEG technician or neurologist.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K974718 |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| (Optional Format 1-2-96) |
§ 882.1420 Electroencephalogram (EEG) signal spectrum analyzer.
(a)
Identification. An electroencephalogram (EEG) signal spectrum analyzer is a device used to display the frequency content or power spectral density of the electroencephalogram (EEG) signal.(b)
Classification. Class I (general controls).