(171 days)
preserving the full fidelity of the original EEG waveform data in the EEG patient population while providing tools for displaying and printing EEG waveforms for review and interpretation by trained health care professionals.
The Equinox™ Digital EEG System incorporates products produced by Physiometrix and Neuro Concepts to provide a superior system for EEG recording that provides cost benefits to the user. The Equinox™ System features several Physiometrix products including the Biosensor electrodes, e-Net headpiece. Patient Module, fiber optic cable and DSP Interface Card and computer hardware. The last component of the system is the Neuro Concepts software described in K905435B UNIQUANT'M System. The Equinox™ is an EEG system that offers a choice of paper or paperless approaches to reading of EEG records and automatic archival of EEG data onto optical disks. The highest priority of the system is to ensure the quality of the EEG data acquisition and storage thus preserving the full fidelity of the raw analog EEG waveform for reproduction onto paper or for display on a computer monitor. EEG data that is acquired on the Equinox™ System is always archived directly onto optical disk with no means available to the system operator to modify or process the raw digitized data.
The provided text describes the Physiometrix Equinox™ Digital EEG System, but it does not contain information related to specific acceptance criteria, a study proving device performance against those criteria, or the detailed aspects of a clinical study (like sample sizes, ground truth establishment, or expert involvement).
The document is a 510(k) Premarket Notification summary, which focuses on establishing substantial equivalence to predicate devices. It emphasizes maintaining the fidelity of EEG data acquisition, storage, and display compared to existing systems.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- No Acceptance Criteria: The document does not list quantitative or qualitative acceptance criteria that the device had to meet (e.g., accuracy percentages, sensitivity, specificity, or specific performance metrics for EEG signal quality).
- No Performance Study Details: While the document states the system ensures "quality of the EEG data acquisition and storage" and "preserves the full fidelity of the original EEG waveform data," it doesn't describe an actual study conducted to demonstrate this. There are no reported device performance numbers.
- Focus on Substantial Equivalence: The text primarily argues that the Equinox™ System has the "same intended use" and "basic functionality" as its predicate devices (K930080 HydroDot NeuroMonitoring System and K905435B UNIQUANT™ System). This is a regulatory argument for market clearance, not a summary of a clinical performance study with defined acceptance criteria.
- "Minor Concern" Classification: The document refers to the FDA Draft Reviewer Guidance for Computer Controlled Products and classifies the software as having "minor concern" because there is "no risk or danger to the patient" even with inadvertent misuse. This speaks to safety, not diagnostic or interpretive performance.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, experts, adjudication, MRMC studies, or standalone performance because this information is not present in the provided 510(k) summary.
The document is a regulatory submission aimed at demonstrating equivalent technology and safety, not a detailed report of a performance study against specific, measurable criteria.
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Kg62447
Physio netrix, Inc. 510(k), Premarket Notification
Equinox™ Digital E-3G System
DEC 1 2 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
| Date: | June 21, 1996 |
|---|---|
| Company: | Physiometrix, Inc.Five Billerica Park101 Billerica AvenueN. Billerica, MA 01862 |
| Contact: | Dawn E. FrazerDirector, Regulatory Affairs & Quality Assurance(508) 670-2422(800) 474-9746 |
| Subject Device: | Equinox ™ Digital EEG System |
| Predicate Device: | K930080, HydroDot NeuroMonitoring SystemK905435B UNIQUANT ™ System |
| This submission describes an EEG recording system that is comprisedof a combination of components described in two separate 510(k)submissions. The system components are Biosensor electrodes, e-NetHeadpiece, Patient Module, Fiber Optic Cable, DSP Interface Cable,Computer Hardware and Software Application. | |
| The first three items were originally discussed in PhysiometrixPremarket Submission K930080, HydroDot NeuroMonitoring System.Subsequently several modifications have been submitted to the FDAfor review. This file, Physiometrix Premarket Submission K962157,NeuroLink NeuroMonitoring System, is pending substantial equivalencedecision. Therefore, all applicable items contained in K962157 havebeen duplicated in this submission. | |
| The last two items, the computer hardware and software applicationare described in Neuro Concepts K905435B, UNIQUANT ™ System.The software application described in this submission is called theAdministrator. A business agreement has been arranged betweenPhysiometrix and Neuro Concepts, Inc. whereby the Administratorsoftware application will be incorporated into the Physiometrix Systemby Neuro Concepts, Inc. | |
| Classification: | Class II, CFR 21 Part 882.1320, Cutaneous ElectrodesClass II, 21 CFR Part 882.1400, ElectroencephalographClass II, 21 CFR Part 882.1835, Physiological Signal Amplifier |
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Physiometrix, Inc. 510(k), Premarket Notification Equinox™ Digital EEG System
The Equinox™ Digital EEG System incorporates products produced by Description: Physiometrix and Neuro Concepts to provide a superior system for EEG recording that provides cost benefits to the user. The Equinox™ System features several Physiometrix products including the Biosensor electrodes, e-Net headpiece. Patient Module, fiber optic cable and DSP Interface Card and computer hardware. The last component of the system is the Neuro Concepts software described in K905435B UNIQUANT'M System. The Equinox™ is an EEG system that offers a choice of paper or paperless approaches to reading of EEG records and automatic archival of EEG data onto optical disks. The highest priority of the system is to ensure the quality of the EEG data acquisition and storage thus preserving the full fidelity of the raw analog EEG waveform for reproduction onto paper or for display on a computer monitor. EEG data that is acquired on the Equinox™ System is always archived directly onto optical disk with no means available to the system operator to modify or process the raw digitized data. The Equinox™ System has the same intended use as the Neuro Intended Use: Concepts UNIQUANT™ System, that is preserving the full fidelity of the original EEG waveform data in the EEG patient population while providing tools for displaying and printing EEG waveforms for review and interpretation by trained health care professionals. The Physiometrix Equinox™ System has the same intended use as the Technology: predicate devices described in K905435B, UNIQUANT™ System, which is preserving the full fidelity of the original EEG waveform data in the EEG patient population while providing tools for displaying and printing the waveforms for analysis and interpretation by trained health care professionals. The Equinox™ System is similar to the UNIQUANT™ System in that they use identical computer hardware and software applications. The Equinox™ System differs mainly from the UNIQUANT™ in that the Equinox™ is comprised of all the components necessary to acquire and display waveforms. The UNIQUANT™ system does not include electrodes or electrode placement tools that are a part of the Equinox™ System. These components are described in the Physiometrix K930080. The requirements of the Equinox™ System are consistent with the Conclusion: basic functionality of the predicate devices as well as conventional EEG machines that acquire and display EEG records on paper. Since there is no change in intended use from either of the predicate devices, there are no failure modes or latent design flaws in the software that would be expected to result in physical injury to the patient Thus, the software that controls this device poses no
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Physiometrix, Inc. 510(k), Premarket Notification Equinox™ Digital EEG System
substantial risk or danger to the patient. It therefore meets the criteria for minor concern as outlined in the FDA Draft Reviewer Guidance for Computer Controlled Products. The concern is minor because even if there is an inadvertent misuse of the software, there is no risk or danger to the patient.
§ 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).