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The EEG NeuroAmp II.5s is intended to acquire, display, store and archive the electroencephalographic (EEG) signals from a patient's brain obtained by placing two or more electrodes on the head. It must be used in combination with appropriate software and computer. The EEG NeuroAmp II.5s is also intended to be used to provide stimulation and recording of visual and auditory evoked response potentials with appropriate software, computer, and accessories.

The EEG NeuroAmp II.5s can also be used for biofeedback and relaxation purposes of this training task, information for feedback may be derived from the electroencephalographic signals and from as many as eight channels of peripheral physiology measures such as are conventionally used in biofeedback.

The EEG NeuroAmp II.5s is intended to be used only by trained professionals who can ensure sound handling practices. The device is intended for use in clinical environments (not surgical or emergency environments) as well as in medical and therapeutic practices. It can be used with patients of all ages but is not designed for fetal use.

The device does not draw any diagnostic conclusion. Recorded data of electroencephalogram (EEG) signals or event related potentials (ERPs) need to be interpreted by a clinical expert. The results of such interpretation must be considered only in conjunction with other clinical findings.

The EEG NeuroAmp II.5s is a user-friendly high-performance interface between client and clinician computer. It can be used in two different functionalities: In an EEG/ERP measurement and in an EEG biofeedback (neurofeedback) and/or peripheral biofeedback setting. The EEG NeuroAmp 11.5s device itself contains three function blocks:

• 1. EEG amplifier, two channels, interface for 23- or 39-channel EEG recording front-end
• 2. Impedance meter function
• 3. peripheral channels for additional sensors, ERP synchronization and biofeedback

Apart from the EEG-biofeedback functionality, together with the x23/x39 accessories, it is possible to utilize the equipment as an EEG/ERP measurement device. A 23- or 39-channel EEG can be measured with conventional EEG caps, which are not part of the device, according to the standard 10-20 system. The device does not draw any diagnostic conclusions and does not invite the clinician to do so. Recorded data of electroencephalogram (EEG) signals need to be interpreted by a clinical expert. The results of such interpretation must be considered in conjunction with other clinical findings to provide context. There is no therapeutic effect of the EEG NeuroAmp II.5s used in this setting.

The NeuroAmp x23/x39 devices are a full 23-/39-channel digital EEG recording front-end with integrated impedance meter. They are an accessory to the EEG NeuroAmp 11.5s and work only in conjunction with it.

The Corscience EEG NeuroAmp II.5s is an electroencephalograph device that functions for EEG/ERP measurement and biofeedback. The device received 510(k) clearance based on substantial equivalence to predicate devices, demonstrating its safety and effectiveness through performance testing against relevant IEC and ISO standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EEG NeuroAmp II.5s are implicitly defined by its performance against the specified technical requirements, which are shown to be equivalent or superior to predicate devices. The "Discussion on safety and effectiveness" column in the comparative table effectively serves as the acceptance criteria and performance review.

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The COR12 ECG is intended for measuring the surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on a screen or printed on paper. The COR12 ECG can be used for applications in patients age 4 years and older and a weight of 20 kg or higher. The COR12 ECG is intended to be used for routine ECG collection, recording both under resting and stress conditions. The measurement is performed by trained healthcare professionals under the direction of a physician in healthcare facilities (e.g. the doctor's office or hospital).

The COR12 ECG is intended for the recording of 12-lead ECG data of a patient by trained staff, e.g., nurse, doctor's assistant or the doctor. This can be performed as a resting or a stress ECG. It transmits the ECG data in a specified format by Bluetooth transmission to a customer-defined host software running with its own display, which is not part of the COR12. There is no display of ECG waveforms on the COR12.

Here's a breakdown of the acceptance criteria and study information for the COR12 ECG device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The device is claiming substantial equivalence to its predicate (Vyntus ECG – K150810) by stating that they are identical in all aspects. Therefore, the "acceptance criteria" and "reported device performance" are assumed to be the same as the predicate device, as per the submission's claim of identicality.

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The HBldb product is to be used by qualified medical professionals for the post-hoc statistical evaluation of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP).

The Human Brain Index Software (HBldb) product is a software program for the post-hoc statistical analysis and comparison with a reference data (the Human Brain Index Reference Database (HBIRD)) of the human electroencephalogram (EEG) including spontaneous oscillations of the human brain potentials and event-related potentials (ERPs). The EEG is recorded on a separate device under the standardized HBIdb conditions and is transferred to the HBIdb in EDF+ format for

• display .
• . spectral analysis and
• analysis of event-related potentials .
• comparison of the gathered parameters against the Human Brain Index Reference Database . (HBIRD), and
• compilation of a report. .
  Results of comparison of individual EEG/ERP parameters with the database are intended for use as an aid to diagnosis. No medication or treatment is applied based on this comparison alone. The results have to be considered only in conjunction with other clinical findings.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HBIdb software:

Important Note: The provided document is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than proving efficacy or meeting specific performance acceptance criteria through clinical trials. Therefore, the information typically found in a clinical study report regarding detailed acceptance criteria, effect sizes, and deep dives into ground truth establishment is largely absent. The "acceptance criteria" here implicitly refer to demonstrating equivalence in intended use, technology, and performance with predicate devices.

Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary, formal "acceptance criteria" in the sense of specific numerical thresholds for performance metrics are not explicitly stated. The comparison is made against predicate devices, focusing on equivalency of features and intended use. The "device performance" is therefore implicitly that it functions similarly to the predicate devices.

Study Information:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a numerical sample size for a "test set" in terms of subject data. It states, "For verification and validation of the product, all software functions were tested by means of specific EEG test files." This implies a set of pre-defined, synthetic, or existing EEG data files were used to test the software's functionality, not necessarily a clinical dataset for performance evaluation.
   • Data Provenance: Not specified for these "specific EEG test files." Given the manufacturer is German, the test environment and data could be internal or from Germany, but this is not directly stated. The data used for the Human Brain Index Reference Database (HBIRD) is not described here, only that the device compares against it.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable/Not specified. The testing described focuses on software functionality (verification and validation against IEC and FDA guidance), not on diagnostic accuracy of the device's output against a clinical "ground truth" established by experts. The HBIdb product aids diagnosis but doesn't provide a definitive diagnosis on its own.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. Since the testing was for software functionality rather than clinical diagnostic performance adjudicated by experts, no such method is mentioned.

4. 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 was not performed or described in this 510(k) summary. This type of study demonstrates clinical utility with human readers, which is beyond the scope of this type of premarket submission which is focused on substantial equivalence.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, in a sense. The testing performed was "standalone" in that it validated the software's functions (e.g., display, spectral analysis, ERP analysis, comparison against the HBIRD, report compilation) using "specific EEG test files." This focused on the algorithm's correct execution and output formation, not on diagnostic accuracy by itself. The device is an "aid to diagnosis" and meant to be used by "qualified medical professionals," indicating that human interpretation is always in the loop for diagnosis.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the software's functional testing, the "ground truth" would be the expected output or behavior of the software for the "specific EEG test files" based on its design specifications and algorithms. This is a technical ground truth, not a clinical diagnostic ground truth. The HBIdb compares data against a Human Brain Index Reference Database (HBIRD), which is a form of ground truth (normative data), but the method of establishing that database's ground truth is not detailed in this document.

7. The sample size for the training set:

   • Not specified. The document does not mention a "training set" for the HBIdb software itself. This suggests the software is likely rule-based or statistical in nature, comparing inputs against a pre-established "reference database" (HBIRD), rather than a machine learning model that requires a distinct training phase with labeled data. The HBIRD itself would have been built from a large sample, but its size is not in this document.

8. How the ground truth for the training set was established:

   • Not applicable, as a distinct "training set" for a machine learning model is not described. The HBIdb compares data against the Human Brain Index Reference Database (HBIRD). How the "ground truth" for this normative database (HBIRD) was established (e.g., participant selection, EEG acquisition protocols, data processing, statistical methods for defining "normative ranges") is beyond the scope of this 510(k) summary and not provided.

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The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", are battery powered devices capable of acquiring and transmitting a standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and diagnosis performed by medical professionals. The collected data is processed by the B1 device and then transmitted via a standard wireless link to a monitoring device, such as a P or hand-held device for display, review, printing, saving and post event processing by medical professionals. The collected data is not interpreted by the BT device as this is done by the monitoring device operated by medical professionals. Use of the BT devices is not restricted to adult population, but is also intended for infants weighing less than 10 kg (22 lbs.). Measurements taken by the BT devices are only significant if considered in connection with other clinical findings. No therapy or drugs can be administered based solely on ECG data derived from the BT devices. The BT devices are not intended for monitoring critical patients and are not intended for intracardial use.

BT3/6. BT12 is a compact ECG device which is worn on the body and is capable of wireless data transmission. With the BT3/6 type, 2 ECG leads (II - III according to Einthoven) can be measured via a 4-pin cable. The receiving unit can calculate four additional leads (lead I according to Einthoven, aVL, aVR, aVF according to Goldberger).Type BT12 has a 10-pin cable, which, in addition to the leads of the BT3/6 variant, can also measure the 6 leads according to Wilson. With this cable, one can select among 3-, 6- or 12-channel ECG measurements. The cables of the BT are pluggable and therefore can be easily changed. The electrode clips on the patient cables are suitable for connection to button and tab electrodes. It has an integrated electrode contact detector and a heart rate meter, the results of which are displayed on an integrated LCD display. Thanks to the integrated radio data transmission technology, BT3/6, BT12 is able to transmit ECG data online over a range of up to 10 m to a monitor or recording unit for further evaluation. BT3/6, BT12 can be used in all medical applications where the long, stiff trunk cables are a problem due to their weight, their motion artifacts or their electromagnetic susceptibility or because they limit the patient in his freedom of motion. Especially significant are the applications in which it is necessary for the patient to move around freely, for example when the patient is undergoing a stress electrocardiogram. BT3/6, BT12 is compact and simple to operate. A clip allows the device to the patient's clothing. BT3/6, BT12 is powered by two standard AA cells. Patient contacting components are the electrodes. BT3/6, BT12 is intended for use with approved. biocompatible electrodes only.

Here's an analysis of the provided text to extract the requested information regarding the acceptance criteria and study for the BT3/6, BT12 device.

Important Note: The provided document is a 510(k) Premarket Notification. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a full clinical comparative effectiveness study in the same way a PMA submission might. Therefore, some of the requested information (like effect size for MRMC studies or ground truth for training sets) may not be explicitly present because it's not a required component of a 510(k) for this type of device.

Acceptance Criteria and Device Performance

The device demonstrates compliance with recognized standards and shows performance characteristics that are comparable to or better than a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't define explicit "acceptance criteria" in a pass/fail sense for clinical performance. Instead, it compares the BT3/6, BT12 device's technical specifications and intended use against a legally marketed predicate device (Card Guard CG-7000DX-BT). The "acceptance" is based on demonstrating substantial equivalence, meaning the new device is as safe and effective as the predicate.

Here's a table summarizing the comparison for key parameters:

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 describe a clinical "test set" in the context of diagnostic performance evaluation for a medical device that interprets ECGs. The BT3/6, BT12 device does not interpret ECG data; it merely acquires and transmits it.

The testing mentioned relates primarily to hardware safety and performance standards. The submission states: "The BT3/6, BT12 has been tested according to IEC 60601-1 and IEC 60601-1-2 by accredited laboratories and has shown full compliance to these standards and the standards listed in chapter 9 of this 510(k)." This refers to engineering and electrical safety testing, not clinical studies with patient data to evaluate diagnostic accuracy.

Therefore, there is no information on:

• Sample size for a clinical test set.
• Data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As the device does not interpret ECG data, there was no need for experts to establish ground truth for a diagnostic test set. The device's function is to accurately acquire and transmit the raw ECG signal.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set requiring adjudication in the context of diagnostic performance.

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

Not applicable. This device is a wireless ECG acquisition and transmission device, not an AI-assisted diagnostic tool. No MRMC study was mentioned or performed in the context of reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device's primary function is signal acquisition and transmission, not algorithmic interpretation by itself. Its performance is evaluated on its ability to accurately capture and transmit the raw ECG signal according to technical specifications, not on a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for diagnostic ground truth. The "ground truth" for this device would be its adherence to technical specifications and standards for signal integrity, electrical safety, and wireless transmission, as outlined in IEC 60601-1, IEC 60601-1-2, and the hardware aspects of ANSI/AAMI EC11 and EC38. Compliance with these standards by accredited laboratories serves as the "proof" of its foundational performance.

8. The sample size for the training set

Not applicable. This device is a hardware product for signal acquisition and transmission, not a machine learning model that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this type of device.

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The EEG NeuroAmp is intended for biofeedback and relaxation purposes. To perform its intended function it must be used in combination with a computer and appropriate software.

For purposes of this training task, information for feedback may be derived from one or two channels of EEG and from as many as three channels of peripheral physiology measures such as are conventionally used in biofeedback.

The EEG NeuroAmp is intended to be used in the office by trained professionals who can ensure sound handling practices.

The EEG NeuroAmp is not intended for diagnostic purposes.

The purpose of the EEG NeuroAmp is to act as user-friendly high-performance interface between client and clinician computer for EEG biofeedback) and/or peripheral biofeedback therapy. The EEG NeuroAmp contains four function blocks:

• 1. EEG amplifier, two channels, aligned and high-resolution
• 2. Built-in impedance meter for five electrodes helps achieve good electrode contact and warns if electrodes are worn out
• 3. Peripheral sensor amplifiers, three channels, allow measurement of peripheral biofeedback signals such as GSR (Galvanic Skin Response) and temperature. The latter may be by means of a contact probe (thermistor) or non-contact infrared thermal sensor (infrared thermometer).
• 4. An output for audio/visual/tactile feedback

The Corscience GmbH & Co. KG EEG NeuroAmp is a biofeedback device intended for biofeedback and relaxation purposes.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant standards. It does not explicitly define "acceptance criteria" in terms of specific performance metrics for the overall device's therapeutic effectiveness (e.g., a percentage reduction in a particular symptom). Instead, the acceptance is based on meeting safety and technical standards and demonstrating comparable performance to predicate devices for its intended use.

However, some technical specifications can be viewed as performance characteristics that were likely expected to meet certain thresholds or be comparable to predicate devices.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This device is a hardware biofeedback system, not an AI/ML algorithm that requires a training set of data.

9. How the ground truth for the training set was established:

• Ground Truth for Training Set: Not applicable. As there is no AI/ML algorithm involved, there is no training set or ground truth for such a set.

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