Search Results

The BIS Quatro sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

This 510(k) is being submitted for the BIS Quatro which is a minor modification to the 510(k) cleared Enhanced Sensor (K#002734). The formulation of the aqueous hydrogel is being changed.

This 510(k) submission (K093183) is for the BIS Quatro Sensor, a cutaneous electrode intended to enable recordings of electrophysiological signals (such as EEG) from the patient's skin. The submission primarily focuses on a minor modification to the predicate device, the Enhanced BIS Sensor (K002734), specifically a change in the formulation of the aqueous hydrogel.

Given the nature of the device (a minor modification to an existing electrode design) and the information provided, the "acceptance criteria" and "device performance" are centered around demonstrating that the modified device remains safe and effective for its intended use, and performs equivalently to the predicate device, particularly regarding its electrical and mechanical properties, shelf life, and biocompatibility.

Absence of a Traditional Clinical Study (MRMC or Standalone AI Performance):
It is crucial to note that this submission does not involve a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study because the device is a simple medical electrode, not an AI-powered diagnostic or therapeutic tool. The "performance" here refers to physical and material properties rather than diagnostic accuracy or algorithmic output. Therefore, sections related to expert ground truth, adjudication, training sets, and AI-specific metrics are not applicable and will be marked as "N/A" (Not Applicable).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating that the modified BIS Quatro Sensor is substantially equivalent to the predicate device and meets its specified performance requirements after the hydrogel formulation change. The device performance is reported as meeting these specifications.

2. Sample Size Used for the Test Set and Data Provenance

The submission does not detail specific sample sizes for tests such as electrical, mechanical, shelf life, or biocompatibility. Given it's a materials-based modification, these tests would typically involve a statistically relevant number of manufactured units or samples of the modified hydrogel and assembled sensors.

• Sample Size for Test Set: Not specified in the provided summary. These would be laboratory tests on a representative sample of devices.
• Data Provenance: Not specified, but likely from internal laboratory testing conducted by Aspect Medical Systems, Inc. (USA-based company). The origin would be prospective manufacturing and testing of the modified device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: N/A (Not Applicable). This is a physical device and material testing, not a diagnostic interpretation task requiring expert consensus for ground truth.
• Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. Ground truth establishment through adjudication by experts is not applicable for this type of device submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This is a medical device, specifically an electrode, not a diagnostic imaging or AI system that would typically undergo an MRMC study.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: N/A, as no AI component is involved.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Standalone Study: No. This is a physical medical device; there is no standalone algorithm to evaluate.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the various tests (electrical, mechanical, shelf life, biocompatibility), the "ground truth" would be the established engineering specifications, industry standards (e.g., for biocompatibility), and performance benchmarks set by the predicate device. These are objective, rather than subjective, data points (e.g., resistance values, tensile strength, sterility, non-cytotoxicity).

8. The Sample Size for the Training Set

• Sample Size for Training Set: N/A. There is no AI model or "training set" in the context of this device.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: N/A.

Ask a specific question about this device

The BIS Click sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

The BIS Click Sensor is a system comprised of the BIS Click disposable sensor and the reusable cable. This 510(k) is being submitted for the BIS Click which is a minor modification to the BIS SRS (K#050313) to enable the reusable cable to be used for indefinite uses with the disposable sensors and to recognize the smart card on the disposable sensor. The disposable sensor has been modified to add a smart card memory device containing information for lot number, expiration date, and number of connections. This information is used by the monitor for end user messaging, like in the Enhanced Sensor (K#002734).

The provided Special 510(k) summary for the K091854 BIS Click Sensor does not contain the detailed information requested to describe the acceptance criteria and the study that proves the device meets those criteria in the format you've requested.

Here's why and what information is available:

• Type of Submission: This is a Special 510(k) submission. Special 510(k)s are used for changes to a manufacturer's own legally marketed device where the modifications do not require a new intended use or fundamental scientific technology. They typically rely heavily on comparison to the predicate device and verification/validation of the changes, rather than extensive clinical studies with specific performance metrics against a "ground truth" as might be found in a De Novo or traditional 510(k) for a novel device.
• Device Type: The BIS Click Sensor is a cutaneous electrode. Its primary function is to enable the recording of electrophysiological signals (like EEG) by providing a connection between the patient's skin and monitoring equipment. It is not an interpretive AI device; therefore, the types of "acceptance criteria" and "ground truth" associated with diagnostic algorithms (e.g., sensitivity, specificity, AUC compared to expert consensus or pathology) are not applicable here.
• Focus of the Submission: The 510(k) states that the BIS Click is a "minor modification" to a previously cleared device (BIS SRS, K#050313). The modifications primarily involve:
  • Enabling a reusable cable for indefinite uses with disposable sensors.
  • Adding a smart card memory device to the disposable sensor for information like lot number, expiration date, and number of connections.
• Testing Summary Provided: The document lists generic categories of tests performed: "Mechanical," "Electrical," "Multiple use," "Shelf Life," and "Hazard Analysis." It states that "Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use." However, it does not provide specific numerical acceptance criteria for these tests, nor the reported device performance against those criteria. It also does not include details on sample sizes, data provenance, ground truth establishment, or expert involvement as would be relevant for an AI/diagnostic device.

Therefore, I cannot populate the table or provide specific answers to most of your numbered questions because that level of detail is not present in the provided FDA submission document.

Here is a summary of what can be extracted from the provided text, acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for any of the tests.
• Data Provenance: Not specified. As an electrode, the testing would likely involve bench testing and possibly some limited in-vivo testing to confirm signal integrity, but no details are provided.

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

• This is not applicable for this device and submission type. The device is a cutaneous electrode, not a diagnostic interpretive device requiring expert-established ground truth. Performance is assessed against engineering specifications, safety standards, and functional requirements.

4. Adjudication method for the test set:

• Not applicable as no expert adjudication is described or required for the type of testing performed (mechanical, electrical, etc.).

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 not an AI-enabled diagnostic tool that would participate in an MRMC study.

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

• Not applicable. This device is a sensor, not an algorithm.

7. The type of ground truth used:

• For this type of device (cutaneous electrode), the "ground truth" for performance would be engineering specifications, industry standards (e.g., for electrical safety, biocompatibility), and functional requirements (e.g., signal quality, adhesive strength, material compatibility).

8. The sample size for the training set:

• Not applicable. This device is a hardware component (electrode), not an AI algorithm requiring a training set.

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

• Not applicable for a hardware device.

In conclusion: The provided documentation focuses on showing substantial equivalence through verification and validation of engineering changes for a Class II cutaneous electrode, rather than providing the detailed clinical study data and performance metrics typically associated with AI/diagnostic devices that require extensive "ground truth" and expert consensus.

Ask a specific question about this device

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).

Ask a specific question about this device

Intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS Monitor 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; 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 BIS 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.

The BIS EEG Monitor, VIEW, is an EEG Monitor that displays EEG, as well as reports and graphs the BIS valuc by acquiring two channels maximum of EFG from sensors attached to the patient's head, and performing the computations necessary to produce the Bispectral Index (BIS). The BIS is then numerically displayed for the clinician's use.

It also displays other parameters such as SQI (signal quality) and EMG.

The provided documentation describes a Special 510(k) Summary for the Aspect Medical Systems BIS EEG Monitor, VIEW. This type of submission is typically used for devices that are substantially equivalent to a previously cleared predicate device, but may have minor changes in technology or indications for use.

Based on the document, the device is considered substantially equivalent to its predicate, the Aspect Medical Systems A-3000 EEG Monitor with BIS (K052362). The focus of the submission is to demonstrate that the new device performs similarly and is as safe and effective as the predicate, despite having fewer features (e.g., no secondary data trending, soft keys in place of touch screen, smaller screen, different housing color).

Therefore, the "acceptance criteria" for this submission are primarily focused on equivalence to the predicate device, rather than specific performance metrics against a defined ground truth for a novel AI algorithm. The study for this type of submission is typically limited to demonstrating that the core functions (EEG signal acquisition, BIS value computation, display of parameters) are equivalent and that the changes do not introduce new safety or effectiveness concerns.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for a device with fewer features that is substantially equivalent to a predicate, the acceptance criteria are not explicitly stated as quantitative performance metrics (e.g., sensitivity, specificity) against a clinical ground truth. Instead, the "performance" is demonstrated through equivalence to the predicate device in its core function and safety.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" sample size or data provenance for a clinical performance study. This is because the submission is a Special 510(k) focusing on equivalence to a predicate with fewer features, not a de novo submission for a novel algorithm requiring extensive clinical validation against a new dataset. The "testing" mentioned is primarily focused on engineering verification and validation (software, risk assessment) to ensure the changed product still functions as intended and is safe.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable or provided in the document. For a Special 510(k) focused on technological equivalence of a monitor, there isn't typically a ground truth established by medical experts in the way it would be for an AI diagnostic device. The "ground truth" for previous BIS monitor validations (likely the predicate) would have involved correlations between BIS values and clinical states (e.g., level of consciousness, anesthetic depth), but these studies are not detailed here.

4. Adjudication Method for the Test Set

This information is not applicable or provided for the same reasons as above. There is no mention of a human expert adjudication process for this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done or reported. The device is an EEG monitor that calculates and displays a Bispectral Index (BIS) value; it's not an AI diagnostic tool that human readers would use in conjunction with to improve their performance. The improvement for clinicians comes from the information the device provides, not from an AI assistance paradigm relative to human interpretation of raw EEG.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is implicitly the type of performance being claimed for the core BIS algorithm, though not detailed as a separate study in this document. The BIS algorithm's output is the "standalone" performance. The document states the device "performs the computations necessary to produce the Bispectral Index (BIS)." The effectiveness of the BIS algorithm itself would have been established in prior studies for the predicate device, demonstrating its correlation with anesthetic depth and awareness. This current submission assumes the core algorithm remains unchanged and effective. No new standalone study specifically for the "VIEW" monitor's algorithm is described.

7. Type of Ground Truth Used

For the original validation of the BIS algorithm (part of the predicate device, K052362), the ground truth for measuring the "state of the brain" and "effects of anesthetic agents" would typically involve:

• Clinical Endpoints/Outcomes Data: e.g., patient movement in response to surgical stimulus, recall of intraoperative events (for awareness studies), emergence and recovery times.
• Expert Consensus/Clinical Judgment: Anesthesiologists' assessment of anesthetic depth.
• Other Physiological Markers: Though not mentioned, other physiological parameters (heart rate, blood pressure) might be correlated.

However, for this specific submission (K062613), the document does not describe establishing a new ground truth as it relies on the predicate's established performance.

8. Sample Size for the Training Set

This information is not applicable or provided. The BIS algorithm, while complex, operates on principles of EEG signal processing and largely uses fixed mathematical models rather than being a deep learning AI model that requires a training set in the modern sense. There is no mention of retraining or a "training set" for the "VIEW" monitor itself.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or provided for the reasons stated above (not a modern AI deep learning algorithm requiring a "training set").

Ask a specific question about this device

The Zipprep Electrode is applied directly to the patient's skin to enable recording of physiological signals.

The Zipprep Electrode is a single patient use, disposable pre-gelled electrode that is applied directly to the patient's forehead to record electro-physiological signals.

The provided text describes a 510(k) premarket notification for the Zipprep Electrode, a cutaneous electrode used for recording physiological signals. This submission seeks to demonstrate substantial equivalence to a predicate device, focusing on minor design changes rather than clinical performance.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or therapeutic efficacy, is not applicable to this 510(k) submission.

Here's why and what information is relevant:

The device is an electrode, a Class II device. The 510(k) filing primarily addresses design changes (shape, material of snap stud, tape, and shelf life) from a previously cleared device. The focus is on demonstrating that these changes do not raise new questions of safety or effectiveness, not on proving clinical accuracy or diagnostic performance.

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria:
  • Biocompatibility in accordance with ISO10993.
  • Electrical testing as per ANSI-AAMI EC12:2000.
  • Maintain same indications for use as predicate.
  • Maintain same intended use as predicate.
  • Maintain same fundamental scientific technology as predicate.
  • Maintain same basic design (with minor modifications noted).
  • Maintain biocompatibility.
  • Achieve an 18-month shelf life.
• Reported Device Performance (as stated in the submission materials):
  • Biocompatibility testing performed in accordance with ISO10993 was referenced to support the device.
  • Electrical testing performed as per ANSI-AAMI EC12:2000 was referenced to support the device.
  • The device has the "Same indications for use," "Same intended use," "Same fundamental scientific technology," "Incorporates the same basic design" (with noted minor differences), and is "Biocompatible."
  • The device has an "18 month shelf life."
  • The submission asserts that these modifications "do not raise new questions of safety or effectiveness."
  • The FDA's decision of "substantial equivalence" indicates the device met their criteria for market clearance.

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

• Not applicable for clinical performance. The document refers to "Biocompatibility testing" and "electrical testing." These are likely bench tests on a sample of the electrodes, not a clinical test set with human subjects for performance evaluation in the context of diagnostic accuracy. The specific sample sizes and provenance for these engineering tests are not provided in the summary.

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 applicable. No ground truth in a clinical diagnostic sense was established for a "test set" in this submission. The tests referenced (biocompatibility, electrical) are standard engineering and safety tests, not clinical evaluations.

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

• Not applicable. No clinical test set requiring adjudication was conducted or referred to.

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 an electrode, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

• Not applicable. This is not an algorithmic device.

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

• Engineering Standards and Benchmarking: The "ground truth" here is defined by compliance with established international and national standards for medical devices (ISO10993 for biocompatibility and ANSI-AAMI EC12:2000 for electrical performance). The comparison to the predicate device also serves as a "ground truth" of sorts, as the predicate's performance is already accepted.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or a "training set."

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

• Not applicable.

Ask a specific question about this device

The BIS Bilateral Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patient's forehead to record electrophysiological signals. It has an electronic smart card memory device in the tab area that contains configuration and identification information.

This 510(k) submission (K062692) is for a medical device called the "BIS Bilateral Sensor," a cutaneous electrode. The submission primarily focuses on establishing substantial equivalence to a predicate device (K002734, Aspect Enhanced XP BIS Sensor) rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance results directly related to an AI/algorithm.

The document indicates that the device is a simple cutaneous electrode for recording electrophysiological (EEG) signals. The "study" referenced in the 510(k) summary is a comparison of similarities and differences between the new device and the predicate device. It does not describe a clinical study in the format typically used to prove performance against acceptance criteria for an AI or algorithm-based device.

Therefore, many of the requested points for describing an AI/algorithm study are not applicable to this submission, as it's for a sensor, not an AI or algorithm.

Here's an attempt to answer the questions based on the provided text, while acknowledging the inherent limitations due to the nature of the device and submission:

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

Based on the provided text, no specific "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC are mentioned, as this is a sensor and not an AI/algorithm with such output. The "performance" described is in terms of substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as this submission relates to a physical device (sensor) and its substantial equivalence to a predicate, not a dataset-driven AI/algorithm performance study. No test set for an algorithm is mentioned.

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)

This information is not applicable. There is no "test set" in the context of an AI/algorithm study described in this submission, and thus no ground truth established by experts.

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

This information is not applicable. No adjudication method is described as there is no test set for an AI/algorithm.

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

This information is not applicable. This is a submission for a sensor, not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or reported.

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

This information is not applicable. This is a submission for a sensor, not an algorithm.

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

This information is not applicable. There is no ground truth data described in the context of an AI/algorithm performance study.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/algorithm.

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

This information is not applicable. There is no "training set" and no ground truth establishment for it mentioned.

Ask a specific question about this device

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.

Ask a specific question about this device

The Aspect Medical Systems BIS EEG Monitor, A-3000, is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BIS Monitor 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 Aspect Medical Systems, Inc. BIS EEG Monitor, A-3000 is an easy to use, microprocessor- based, 2 channel maximum, EEG monitoring system.

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the A-3000 EEG Monitor. Instead, it focuses on demonstrating substantial equivalence to predicate devices, primarily by highlighting similarities in indications for use, technological characteristics, and stating that "Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use." This suggests the "study" was more of a validation against internal specifications rather than a comparative effectiveness or standalone performance study as might be conducted for novel AI devices.

However, based on the information provided, here's an attempt to answer the questions, assuming performance refers to meeting internal specifications rather than clinical efficacy:

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

No explicit quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, precision) for the device's core function (EEG monitoring, BIS algorithm output) are provided in the document. The document states:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified.
• 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 applicable. The document does not describe a clinical study involving human assessment for ground truth determination. The testing mentioned (Software Validation, Hazard Analysis and Risk Assessment) appears to be internal engineering and safety validation.

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

Not applicable. No expert-based ground truth adjudication or a test set where such methods would be relevant 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 MRMC comparative effectiveness study is mentioned. The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, not on improving human reader performance with AI assistance.

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

The document implies the device (A-3000 EEG Monitor with BIS algorithm) was tested as a standalone system to ensure it meets its "performance specifications and validation test requirements" and is "safe for its intended use." However, specific details about the nature and results of this standalone testing (e.g., algorithm accuracy against a reference standard) are not provided. The BIS algorithm itself is stated to be identical to the predicate device, implying its performance characteristics are assumed to be consistent.

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

Not explicitly stated. For "Software Validation" and "Hazard Analysis and Risk Assessment," the 'ground truth' would likely refer to internal design specifications, international standards, and safety requirements. For the BIS algorithm itself (which is stated as unchanged from the predicate), its original validation would have established its efficacy, likely against clinical outcomes or expert assessment of anesthetic depth, but these details are not provided for the A-3000 device itself in this submission.

8. The sample size for the training set

Not applicable. This device is an updated version of an existing EEG monitor with an identical BIS algorithm. The document does not refer to a "training set" in the context of machine learning model development. The BIS algorithm's training (if any) would have occurred during its initial development, prior to the predicate device's clearance.

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

Not applicable. See point 8.

Ask a specific question about this device

The BIS SRS is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.

The BIS SRS (Semi-reusable sensor) is a single patient use, disposable, pre-gelled 4 electrode array with a patented Zipprep design that is applied directly to the patient's forehead to record electro-physiological signals. The electrodes have a standard snap construction. There is an electronic smart card memory device in the multiple use cable. The SRS will be packaged as a set, composed of 100 disposable electrode arrays along with 1 multiple use cable.

This document is a 510(k) summary for the Aspect Medical Systems BIS SRS (Semi-reusable sensor), which is a cutaneous electrode for recording electrophysiological signals.

Here's an analysis of the provided text in relation to the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not specify explicit acceptance criteria or quantifiable device performance metrics in terms of diagnostic accuracy, sensitivity, specificity, or other clinical outcomes for the BIS SRS. The submission focuses on substantial equivalence based on technical and functional similarities to predicate devices.

The document states:
"Electrical and mechanical testing was conducted. Results indicate the device is safe for its intended use."

This is a general statement about safety and does not provide specific performance data or acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention any human subject test set or clinical study for performance evaluation that would involve a sample size. The testing appears to be limited to "electrical and mechanical testing."

• Sample Size for Test Set: Not applicable/Not mentioned.
• Data Provenance: Not applicable/Not mentioned, as no human subject data for performance claims is presented.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Since no human subject testing or clinical performance study is described, there is no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no human subject test set requiring ground truth establishment is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. The submission focuses on substantial equivalence to predicate devices rather than comparative effectiveness with human readers or an AI-assisted workflow.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This device is an electrode, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's function is to enable the recording of electrophysiological signals, not to interpret them or make diagnoses autonomously.

7. Type of Ground Truth Used

Not applicable, as no clinical performance study requiring ground truth is described for this device. The regulatory submission primarily relies on technical and material equivalence to predicate devices.

8. Sample Size for the Training Set

The device itself is a piece of hardware (an electrode). It does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this hardware device.

In summary, the provided 510(k) document is concerned with demonstrating substantial equivalence of a new medical device (an electrode) to already cleared predicate devices, based on its design, materials, manufacturing, and intended use. It does not contain information typically found in submissions for AI/ML-based devices regarding clinical performance studies, acceptance criteria, sample sizes for test/training sets, or expert ground truth establishment.

Ask a specific question about this device

The BIS Pediatric Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals in pediatric patients.

The Sensor is a single patient use, disposable, pre-gelled 4 electrode array that is applied directly to the pediatric patient's forehead to record electro-physiological signals. It has an electronic smart card memory device in the tab area that contains configuration and identification information.

This 510(k) premarket notification for the BIS Pediatric Sensor by Aspect Medical Systems, Inc. does not contain a study to prove that the device meets specific acceptance criteria based on performance metrics. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K001980 and K002734).

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:
   The document does not specify quantitative acceptance criteria or report performance data for the BIS Pediatric Sensor. The submission asserts that the device is "substantially equivalent" to predicate devices, implying similar performance.

2. Sample size used for the test set and the data provenance:
   No test set, performance study, or associated sample size is mentioned in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   There is no mention of experts or ground truth establishment for a test set, as no performance study is detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no test set or performance study 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:
   This device is a physical sensor, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. The device is a sensor for recording biological signals, not an algorithm. The assessment is for its physical design and functionality related to signal acquisition, not algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   No ground truth is discussed, as no performance study requiring such data is presented. The "ground truth" for this type of device typically revolves around its ability to accurately and reliably capture the intended physiological signal (EEG), which would be assessed through standard engineering and clinical validation tests, but these are not detailed in this summary.

8. The sample size for the training set:
   Not applicable. This device is a hardware sensor, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for a machine learning model.

Summary of the document based on your questions:

The 510(k) summary focuses on demonstrating that the BIS Pediatric Sensor is "substantially equivalent" to two predicate devices (K001980 and K002734). The key points for this determination are:

• Intended Use/Indications for Use: Same as predicate devices (recording electrophysiological signals in pediatric patients).
• Fundamental Scientific Technology: Same operating principle (flexible tines disk, hydrogel) and basic design as predicate devices.
• Materials and Shelf Life: Same as predicate devices.
• Differences: Smaller size and different basepad shape compared to the Enhanced Sensor to better accommodate smaller heads, and the addition of a 4th electrode and corresponding shape change for the Pediatric Sensor. These modifications are explicitly stated to "not raise new questions of safety or effectiveness."

No specific performance studies with acceptance criteria or reported performance metrics are included in this 510(k) summary. The FDA's clearance (JUL - 6 2004) is based on the finding of substantial equivalence.

Ask a specific question about this device