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The Harmonie System is indicated for the acquisition, display, review, analysis and archiving of physiological signals including patient video obtained during routine EEG examinations, Long-Term Monitoring in Epilepsy (LTM) and Sleep Studies (polysomnography or PSG) in patients of all ages.

The seizure detection component of the software is intended for post-hoc review for marking sections of the EEG that may correspond to electrographic seizures in adults only. The Burst-Suppression component is intended to be used for the quantification and recognition (mark) of sections of the EEG and PSG that may contain patterns of interest. The seizure detection component and Burst-Suppression Module are for use in adults only.

The Harmonie software is not intended to replace conventional devices or methods used for sleep monitoring in critical care or intra-operative settings.

In no way are any of the system functions represented as being in and of themselves diagnostic. The system requires competent user input, and its output must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

The Harmonie System is a data acquisition device that can record up to 128 channels of EEG and PSG signals at sample rates ranging from 200Hz to 2000Hz per channel according to the specifications of each model. EEG and PSG signals are amplified, filtered and digitized. A Photic Stimulator is optionally provided with the system. The system can also concurrently record synchronized digital patient video, through an optional MPEG4 encoder card and the DV software module. The digital data (EEG and digital video) is stored on the computer workstation's hard disk for review and analysis, either during or after a recording session.

Following is the functional description of various Harmonie models:

• 1. Harmonie System with DUO Recorder
     This is a basic EEG recording system, typically used for routine EEG examination. The DUO recorder is a 20-bit, 44-channel amplifier with user programmable filters, automatic anti-aliasing and sampling rates of up to 2,000 Hz. All components are mounted on a robust enclosed cart, which can accommodate a Photic Stimulator and various models of CCTV cameras, as accessories. The system includes Harmonie EEG software that allows acquisition, display, review, analysis and archiving of EEG data locally or at a remote station.
• 2. Harmonie-S System with DUO Recorder
     The Harmonie-S system uses same DUO recorder described above but uses PSG software to record sleep studies. It includes optionally digital video recording. The amplifier and video camera are placed in the room. The computer and monitor are placed in an observation room where the PSG technologist works. The software includes the Harmonie EEG and the PSG modules. The PSG module is designed specifically for the visualization and scoring of variables commonly used in sleep studies, such as the EEG, EMG, EKG, oxygen saturation, body position , eye movements and respiration signals. The system allows performing the main functions of a sleep study: sleep staging, manual event marking, displaying graphs of sleep stages and events, and various sleep report generation.

• MESA II System with DUO Recorder 3.
  MESA-II is a portable system suitable for EEG examinations, also using the DUO EEG amplifier. It offers the full functionality of the standard Harmonie system, but with a laptop computer and other components mounted on a cart with a smaller foot-print, which enables EEG examinations to be performed in space-limited environments. The cart can accommodate a Photic Stimulator and various models of CCTV cameras, as accessories. The system includes Harmonie EEG software that allows acquisition, display, review, analysis and archiving of EEG data locally or at a remote station.

• Vita ICU System with DUO Recorder 4.
  The Vita ICU system is an EEG recording system designed to facilitate EEG recordings in the ICU, although it can also be used as a routine EEG system. It includes optionally digital video recording. The Vita ICU system is composed of a panel PC (computer and monitor in the same physical entity), including a touch-screen monitor, and is mounted on small footprint cart. It includes the Harmonie EEG software as well as software specific for this application (the Vita ICU software). The Vita ICU software includes a touch-screen interface to facilitate user-interaction with the device.

• 5. Harmonie-E System with eAmp Recorder
     The Harmonie-E system with eAmp recorder is an EEG recording system designed for LTM particularly in the context of the evaluation of patients with epilepsy. The eAmp is an IP-enabled amplifier with the capability to acquire data for up to 128 channels (by combining two 64-channel units). It includes programmable filters from 0.1 to 500Hz and sampling rates up to 2,000Hz that allow measurement of higher frequency EEG. The system includes digital video recording. The amplifier and video camera are placed in the room and the recording computer and monitor and placed in a control room. The system includes Harmonie EEG software that allows acquisition, display, review, analysis and archiving of EEG data locally or at a remote station. The Harmonie-E module for the automatic marking of EEG events of interest, i.e. spike patterns and seizure patterns. This post-hock review marking facilitates the review of the long EEG recordings.

• Harmonie-E System with EEG64 Recorder 6.
  The Harmonie-E system with Schwarzer EEG64 recorder is an EEG recording system designed for LTM particularly in the context of the evaluation of patients with epilepsy. The Schwarzer EEG64 amplifier is equivalent to eAmp with slightly different filtering characteristics than the eAMP amplifier. The system includes Harmonie EEG software that allows acquisition, display, review, analysis and archiving of EEG data locally or at a remote station.

The provided text describes the Harmonie System, an EEG and PSG data acquisition device. However, it does not include the specific information requested about acceptance criteria or a study proving the device meets those criteria for its seizure detection or burst-suppression components.

The "Performance Data" section states: "Bench testing and verification and validation activities were performed to establish the performance, reliability and the functionality of the Harmonie system. Pass/Fail criteria were established based on the published specifications of applicable safety standards, predicate and the current device."

This statement confirms that performance testing was done and acceptance criteria were established, but it does not provide details on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts for ground truth, or adjudication methods for any test set related to the seizure detection or burst-suppression components.
3. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of AI assistance.
4. Whether a standalone (algorithm only) performance study was done.
5. The specific type of ground truth used.
6. The sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill the request for a detailed description of the acceptance criteria and the study that proves the device meets them, as the necessary information is not present in the provided document. The document primarily focuses on the device's description, intended use, and its substantial equivalence determination by the FDA based on general performance, reliability, and functionality, rather than a specific clinical performance study for an AI/algorithm component.

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The Notta Ambulatory Recorder is indicated for the recording and study of EEG and other physiological signals obtained during routine EEG exams, long-term monitoring in epilepsy (LTM) and sleep studies (PSG or polysomnography) either at home, at a clinical setting, or other suitable environment under physician's order.

The Notta Ambulatory Recorder is indicated for use with children and adults under the supervision of a physician or other trained health care professional. The device is intended to be worn by the patient during a recording session.

The Notta Ambulatory Recorder is not intended to be used for the monitoring of vital sigus, in critical care or intra-operative settings.

In no way are any of the device functions represented as being in and of themselves diagnostic. The system requires competent user input, and its output must be reviewed and interpreted by a physician or other trained health care professional who will exercise professional judgment in using this information.

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This document is a 510(k) clearance letter from the FDA for a device called "Notta Ambulatory Recorder." It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The letter primarily:

• Confirms the device's substantial equivalence to a predicate device.
• Outlines general regulatory requirements for marketed medical devices.
• States the "Indications for Use" for the Notta Ambulatory Recorder (for recording EEG and other physiological signals in various settings for children and adults under physician supervision, but not for vital signs monitoring or critical care).

Therefore, I cannot provide the requested information from the provided text as it is not present in this document.

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The indications for use of the Luna™ software for Windows® 95 are the same as those of Stellate Systems' ECLIPSE Version 3.0 software for MS-DOS®.

J.una™ can be used only in conjunction with Stellate Systems' HARMONIE™ software package.

Luna™ may be used for sleep recordings (polysomnography) in research or clinical cuvironments for:

• · Digital rooording of high-level output signals (such as EBO, respiratory and oximety signals) from the Digital recording of might-level cations (society costs of amplifiers, by means of a personal computer (PC) and PC-based data acquisition board.
• · Selection of recorded signal sections for on-sereen review, annotation and marking of sleep stages.
• · Manual event-marking and annotation of polygraphic signal sections.
• · Computer-assisted event marking and quantitative analysis of EEG, respiratory and oximelry signals.
• · Computer-assisted reporting of simple measures obtained from the recorded signals (such as magnitude, time and frequency, and simple statistical measures of marked events.)

The software is not intended to replace conventional devices or methods used for sloup monitoring in critical care or intra-operative scilings.

The software requires competent user input, and its output must be reviewed and interpreted by trained The sollware requires or neurologists who will excruise professional judgment in using this information.

The software does not make any judgment of normality of the displayed signals or of the results of an analysis. In no way are any of the software functions represented as being in and of themselves diagnostic.

Prescription Use
(Per 21 CFR 801.109)

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I'm sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Luna." This document primarily focuses on the regulatory clearance process and does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving those criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details on how ground truth was established for test sets.
• Information on the number or qualifications of experts, or adjudication methods for test sets.
• Details about multi-reader multi-case (MRMC) studies or standalone performance studies.
• Sample sizes for training sets or how ground truth was established for training sets.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its 510(k) clearance. However, it does not provide the underlying study data that would demonstrate specific performance metrics against defined acceptance criteria.

The "Indications For Use" section describes what the software can be used for (e.g., digital recording, selection of signal sections, manual and computer-assisted event marking and analysis), but not specific performance metrics or studies.

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Not Found

I am sorry, but the provided text does not contain any information regarding the acceptance criteria, study details, or device performance for "Eclipse Version 3.0" (Trade/Device Name: Eclipse Version 3.0, K955577). The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device.

Therefore, I cannot provide the requested table and information.

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HARMONIE™ and Sensa™ is a set of software programs which represent an improved implementation of Stellate Systems' RHYTHM and MONITOR software. The software remains consistent with its original design objectives:

• to assist in the scientific analysis of the electroencephalogram (EEG) in the field of human and animal neurophysiology.
• to offer digital EEG recording by means of a personal computer and PC-based data acquisition boards.
• to assist in the selection of EEG sections of potential interest and offer a variety of display, playback and review capabilities.
• to complement the conventional continuous EEG recording, not replace it.
  The software does not make any judgment of normality of the displayed EEG or the results of an analysis. It is not intended EEG monitoring used in critical care or intra-operative cettings. In no way is the software or its function represented as being in and of itself divenestic

HARMONIE and Sensa EEG Software

The provided text is an FDA 510(k) clearance letter for the "Harmonie and Sensa EEG Software." It details the device's classification, regulation, and general controls, but it does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states: "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." This implies that the device's performance was not evaluated against specific acceptance criteria in a standalone study, but rather its equivalence to existing predicate devices was established.

Therefore, I cannot provide the requested information based solely on the text provided. The document focuses on regulatory clearance based on substantial equivalence, not on the results of a detailed performance study with acceptance criteria.

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