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A. Indications for use for BIS EEG Monitor System (VISTA Monitor and BISx4): The BIS EEG VISTA Monitor System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in their proper use. The system, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, one of the VISTA Monitor output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS Index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation. B. Indications for use for BISx device: The BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in their proper use. The BISx, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS Index, one of the BISx output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS Index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation.

A. BIS EEG VISTA Monitor System: The BIS EEG VISTA Monitor System, is comprised of the BISx4, the VISTA Monitor, and associated cables. When the System is connected to a BIS Sensor (which is applied to the patient's forehead, acquires EEG signals from the brain, and is 510(k) cleared) the monitor displays 2 channels of EEG. When the System is connected to a BIS Bilateral Sensor (also 510(k) cleared), the monitor displays 4 channels of EEG. The BISx4 houses the digital signal converter as well as the BIS algorithm (it has no display or user interface), and it performs the computations necessary to produce the Bispectral Index (BIS). It also calculates SQI, EMG, Burst count and Suppression Ratio. The BISx4 may be distributed to business partners that have the ability to display BIS on their patient monitors. The Monitor displays a maximum of 4 channels of EEG, as well as SQI, EMG, Burst Count, Suppression Ratio and a BIS value. The BIS value is acquired using 2 channels of EEG. The Monitor has secondary trend and trend review screens, as well as results of self tests. In addition to the above, when connected to a Bilateral Sensor, the System provides additional capability as follows: BISx4 calculates DSA, Asymmetry, sBIS, and sEMG. The Monitor displays DSA, Asymmetry, sBIS, and sEMG numerically and graphically. B. BISx device: The BISx is a component that processes up to 2 channels of EEG and computes BIS and other EEG parameters (same as the cleared BISx device). The BISx connects to Aspect sensors on one side and the Aspect Monitor or OEM patient monitoring systems on the other, allowing them to display BIS on their integrated patient monitoring systems. The OEMs are responsible for the regulatory pathway to integrate the BISx in their systems. The software is a moderate level of concern. This submission is updating the indications for use statement for the BISx device, to reflect the addition of clinical benefits added at FDA request to the BIS EEG VIEW Monitor, 510(k) (K#062613, recently cleared on 6/18/07). No change is being made to the cleared BISx device (#K040183).

The provided text does not contain detailed information about specific acceptance criteria, device performance metrics, or a study that rigorously proves the device meets those criteria in a quantitative sense suitable for a table. The submission is a 510(k) summary, which focuses on substantial equivalence to predicate devices rather than independent performance validation against predefined clinical acceptance criteria.

The "Summary of Testing" section (in {3}) states: "The following tests/analyses have been completed for the BIS EEG VISTA Monitor System: Software Validation, Hazard Analysis and Risk Assessment. Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use."

This statement confirms that internal tests were conducted to ensure the device performs as intended and is safe, but it does not provide details on:

• Specific performance specifications or acceptance criteria.
• Quantitative results from these tests.
• Methodology of how these criteria were established or evaluated.
• Any clinical study (e.g., MRMC, standalone) involving human readers or a comparison against a clinical ground truth.

Therefore, I cannot provide the requested table or detailed study information based on the given text.

Here's an assessment of the other requested points based on the provided document:

1. A table of acceptance criteria and the reported device performance:

   • Not provided in the document. The document states "Results indicate the device meets its performance specifications and validation test requirements," but does not list these specifications or the corresponding performance outcomes.

2. Sample size used for the test set and the data provenance:

   • Not provided in the document. The document mentions "Software Validation" and "Hazard Analysis and Risk Assessment" as completed tests, but does not specify any test set size or data provenance for these. This typically implies internal engineering and software testing rather than a clinical trial with patient data.

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

   • Not provided in the document. Since no clinical test set is detailed, information about experts and ground truth establishment is absent.

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

   • Not applicable/Not provided. No clinical test set or adjudication process is described.

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 study was not described. The document focuses on substantial equivalence and safety/performance specifications, not on comparative effectiveness with human readers.

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

   • Implied, but details not provided. The BISx4 and BISx calculate the Bispectral Index (BIS) and other parameters algorithmically. The "Software Validation" mentioned implies testing of this algorithm's performance against its specifications, which is a form of standalone testing. However, no specific metrics, methods, or results of this standalone performance are given beyond a general statement of meeting specifications.

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

   • Not provided in the document. Without details on specific performance tests, the type of ground truth used to validate the algorithms (e.g., against reference EEG signals or clinically established states of anesthesia) is not mentioned.

8. The sample size for the training set:

   • Not applicable/Not provided. This device calculates physiological parameters based on established algorithms (e.g., for EEG signal processing, Bispectral Index). It's unlikely to be a machine learning model that requires a distinct "training set" in the modern sense. The algorithms are likely fixed based on biomedical engineering principles and prior research.

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

   • Not applicable/Not provided. (See point 8).

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The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 (BISx Module 91482) is an easy-to-use, slim, single module in the Spacelabs Medical family of Spacelabs Medical Ultraview System (Ultraview) modules. The BISx Module 91482 is a microprocessor based, two-channel EEG unit designed for use on adult and pediatric patients within a hospital or medical facility. Its system configuration includes the BISx Module 91482 with connectors for external serial data connections, a BISx pod, a patient interface cable, disposable sensors, and printer options. The BISx pod, patient interface cable and disposable sensors are manufactured by Aspect Medical Systems, and distributed by Spacelabs Medical for use with the BISx Module 91482, The Spacelabs Medical Ultraview monitor provides the display capabilities for the care provider.

The provided text describes the Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The document is a 510(k) Premarket Notification summary focusing on the general safety and effectiveness, device description, and indications for use as part of the FDA approval process. It confirms substantial equivalence to existing devices but does not detail device performance studies or their results.

Therefore, I cannot populate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based solely on the provided text. The requested information, such as sample sizes, ground truth establishment, expert qualifications, and specific performance metrics, is not present in this document.

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The BISx4 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISx4 is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The BISx4 is a device that houses both the EEG digital signal converter, as well as the host interface software and BIS algorithm. The device will acquire up to four channels of referential EEG and compute BIS and other EEG parameters.

The BISx4 will have no display or user interface. Aspect Medical Systems is submitting this 510(k) in response to anesthesiologists/users who are interested in obtaining more than 2 channels of EEG.

The provided text describes a 510(k) submission for the BISx4 device, comparing it to a predicate device (BISx). However, it does not contain any information about specific acceptance criteria or a study that proves the device meets those criteria.

The submission focuses on establishing substantial equivalence based on similarities in design, technology, indication for use, and core functionality, with the key difference being the addition of two more EEG channels. The "Testing" section only broadly mentions "Software, electrical, hazard analysis, EMI statement," without providing details of acceptance criteria or performance results.

Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or describe a study proving the device meets acceptance criteria, as this information is not present in the provided text.

Specifically, the following information is missing from the provided text:

• A table of acceptance criteria and the reported device performance: No such criteria or performance data are listed.
• Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned beyond the general statement of "testing."
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not discussed.
• Adjudication method for the test set: Not applicable as no test set data is provided.
• 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 MRMC study is mentioned. This device also doesn't involve "readers" or "AI assistance" in the typical sense; it measures physiological signals.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device's primary function is algorithmic processing of EEG, but no performance metrics for this are given.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not discussed.
• The sample size for the training set: No training set mentioned.
• How the ground truth for the training set was established: No training set mentioned.

The document concludes with a determination of "Substantial Equivalence" based on the comparison to the predicate device, not on specific performance data against pre-defined acceptance criteria for the new features.

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The BISx is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatic patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.

The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The BISx is a component that processes up to two channels of EEG and computes the Bispectral (BIS) Index and other EEG parameters (same as predicate device), uniting the functionality of the Digital Signal Converter (DSC-XP) and the BIS algorithm into a single enclosure. The BISx mates on one side with Aspect's BIS sensors (up to 2 channel, all currently marketed). On the other side, the BISx attaches to OEM (other equipment manufacturers) patient monitoring systems, allowing them to display Aspect's proprietary BIS Index on their integrated patient monitoring display.

Combining the functions of the DSC-XP and the BIS algorithm into a single enclosure provides our OEM Business Partners with a more durable, more compact, and less expensive way to include the BIS Index parameter into their patient monitoring systems.

The provided text describes a 510(k) summary for the BISx EEG Monitor, focusing on its substantial equivalence to a predicate device, the Aspect Medical Systems A-2000 (XP) EEG Monitor with BIS System. The summary primarily details the device's technical specifications, intended use, and a comparison with the predicate device, along with verification and validation testing.

Based on the provided document, the following information regarding acceptance criteria and device performance can be extracted:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Risk analysis	PASS
   Software validation	PASS
   Electronic verification	PASS
   Mechanical/environmental validation	PASS
   Device is substantially equivalent to predicate device	Yes, all tests/analyses PASS, device determined substantially equivalent.
   Safe for its intended use	Yes, all tests/analyses PASS, device determined safe and effective for intended use.

   Note: The document states "Results show all tests/analyses PASS. Therefore, the device is substantially equivalent to the predicate device, and safe for its intended use." This serves as the overarching performance statement for the listed criteria.

2. Sample size used for the test set and the data provenance: Not specified in the provided text. The document refers to "analysis/verifications/validations" but does not detail the specific test sets, their sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified in the provided text.

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 specified in the provided text. The device is a monitor intended for data acquisition and display, not an AI-assisted diagnostic tool that aids human readers in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the BISx as a component that processes EEG and computes the Bispectral (BIS) Index, uniting the functionality of a Digital Signal Converter and the BIS algorithm. The testing described ("Software validation," "Electronic verification") would inherently assess the standalone performance of these components and the algorithm. However, no specific "standalone performance study" with clear metrics like sensitivity/specificity for a clinical endpoint is detailed. The focus is on the device's equivalence to a predicate, which implies its computational output is comparable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified in the provided text. The "ground truth" for the verification and validation tests would be the established engineering and functional specifications for the device's performance, but the clinical "ground truth" (e.g., actual anesthetic depth for BIS index accuracy) is not discussed in the context of specific studies for this submission. The device is intended to monitor the state of the brain; its clinical efficacy is primarily established through its predicate.

8. The sample size for the training set: Not applicable for this submission. The BISx is described as building upon existing and validated BIS technology from the predicate device. There is no mention of a particular "training set" in the context of machine learning model development for this specific submission. The BIS algorithm itself would have been developed and validated previously.

9. How the ground truth for the training set was established: Not applicable for this submission (see point 8).

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