(181 days)
The software is intended for use by a qualified/trained EEG technologist or physician on both adult and pediatric subjects for the visualization of human brain function and structure by fusing a variety of EEG information with MRI images.
The software is intended for use by a qualified/trained EEG technologist or physician on the visualization of human brain electrical activity by fusing a variety of Lilit information with MKI images.
The software imports digital EEG data (in a variety of formats) and MKI data and permits the fusing and viewing of both types of data. No direct intervention, treatment, or on-line monitoring of the patient is performed.
The provided text is a 510(k) summary for the IMAGE VUE EEG Software, stating that the device is substantially equivalent to predicate devices. It does not contain a detailed study with acceptance criteria and reported device performance metrics in the way a modern, statistically rigorous clinical validation study would.
Instead, the document relies on "bench and user testing" to claim substantial equivalence. This type of submission, especially from 1998, typically means the manufacturer demonstrated that the new device functions similarly to existing, legally marketed devices and does not raise new questions of safety or effectiveness. There isn't an explicit "acceptance criteria" table or a detailed "study that proves the device meets the acceptance criteria" in the contemporary sense of evaluating AI/software performance.
Therefore, for aspects of your request that pertain to detailed performance metrics (like sensitivity, specificity, or improvement with AI over human readers), sample sizes for test sets, expert qualifications, adjudication methods, or separate training/test sets with ground truth, the information is not available in the provided text.
Here's an analysis based on the information that is present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity). The overarching acceptance criterion for a 510(k) submission is "substantial equivalence" to predicate devices for safety and effectiveness.
- Reported Device Performance:
- "The results of bench and user testing indicate that the new device is as safe and effective as the predicate devices."
- "it is the conclusion of SAM Technology, Inc. that the IMAGE. VUF. F.F.G. software is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only mentions "bench and user testing."
- Data Provenance: Not specified.
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 specified. The methodology for "bench and user testing" is not detailed to this extent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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, an MRMC comparative effectiveness study is not mentioned. The device described (IMAGE VUE EEG Software) is for "visualization of human brain function and structure by fusing a variety of EEG information with MRI images" and "No direct intervention, treatment, or on-line monitoring of the patient is performed." It's not described as an AI-assisted diagnostic tool that would typically undergo an MRMC study to compare human performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The text describes the software's function ("imports digital EEG data... and MRI data and permits the fusing and viewing of both types of data"). It does not mention a standalone performance evaluation in terms of diagnostic accuracy by the algorithm itself. The comparison is based on overall safety and effectiveness similar to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. Given the nature of a 1998 510(k) for an EEG visualization software, "ground truth" would likely have been established through expert interpretation of standard EEG and MRI data, but this is not explicitly detailed.
8. The sample size for the training set
- Not applicable/Not specified. This document pertains to a 510(k) submission from 1998 for software that primarily fuses and visualizes data. It is not described as a machine learning or AI-driven diagnostic algorithm that would typically have a distinct "training set" in the modern sense. The "bench and user testing" refers to validation of the software's functionality and comparison to existing devices.
9. How the ground truth for the training set was established
- Not applicable/Not specified (as above).
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e 1938 AUG
EXHIBIT 2 SAM Technology, Inc. One Rincon Center 101 Spear Street Suite 203 San Francisco CA 94105 Tel 415-227-4900 Fax 415-546-7122 sam(@eeg.com
980477
Contact: Alan S. Gevins, President July 28, 1998 510(k) Summary of Safety and Effectiveness
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- Identification of the Device: Proprietary-Trade Name: IMAGE VUL LEG Software Clessification Name: Electroencephalograph, OL, X, Regulation # 882.1400 Common/Usual Name: Electroencephalograph Software
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- Indications for Use (intended use) The software is intended for use by a qualified/trained EEG technologist or physician on both adult and pediatric subjects for the visualization of human brain function and structure by fusing a variety of EEG information with MRI images.
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- Description of the Device: The software imports digital EEG data (in a variety of formats) and MKI data and permits the fusing and viewing of both types of data. No direct intervention, treatment, or on-line monitoring of the patient is performed.
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- Safety and Fifectiveness, comparison to predicate device. The results of hench and user testing indicate that the new device is as safe and effective as the predicate devices.
6. Conclusion
After analyzing both bench and user testing data, it is the conclusion of SAM Technology, Inc. that the IMAGE. VUF. F.F.G. software is as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.
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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 image of an eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sam Technology, Inc. c/o Daniel Kamm. P.E. Regulatory Engineer Kamm and Associates P.O. Box 7007 Deerfield, Illinois 60015
APR - 9 2012
Re: K980477
Trade/Device Name: Image Vue EEG Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLX Dated (Date on orig SE ltr): May 15, 1998 Received (Date on orig SE Itr): June 5, 1998
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of August 6, 1998.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Mr. Daniel Kamm
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Kesia A
Malvina B. Eyd
Director
Sincerely yours.
Malvina B. Eydelman, M.D. Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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j) Indications for Use
510(k) Number _ K980477
Device Name: IMAGE VUE EEG Software
Indications for Use:
The software is intended for use by a qualified/trained EEG technologist or physician on I no solvide is intended to the visualization of human brain electrical activity by fusing a variety of Lilit information with MKI images.
| Concurrence of CDRH, Office of Device Evaluation (ODF.) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K980477 |
Prescription Use OR Over the Counter Use
(Per 21 CFR 801.109)
NI
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).