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The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intrahospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI.

The proposed Monitor B40V3 is still a multi-parameter patient monitor. It retains the features of the predicate Monitor B40V2.1 (K133576) and now complies with IEC60601-1 3rd edition and RoHS (Restriction of Hazardous Substances) requirements, enabled time synchronization in HL7(Health Level 7) network environment, verified compatibility with CARESCAPE Central Station (K133882) and supported OAC (Optional Activation Codes) tool used in manufacturing and service for product license control. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to interface with following optional extension modules: E-MiniC module (K052582), Airway Gas Option Module (N-CAiO) (K133576), CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) and Entropy module. Comparing with E-Entropy module version (E-ENTROPY-00) (K061907) supported in predicate device, the proposed Monitor B40V3 supports improved E-Entropy module version (E-ENTROPY-01) (K150298). As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 continues to be compatible with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) with spirometry function disabled. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 still includes features and subsystems that are optional or configurable. The proposed Monitor B40V3 will continue interfacing to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40V2.1 (K133576), the proposed Monitor B40V3 keeps a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided text describes the GE Medical Systems China Co., Ltd. Monitor B40 (K151063), a multi-parameter patient monitor. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in terms of analytical or clinical performance.

Instead, the document focuses on:

• Substantial Equivalence: Demonstrating that the Monitor B40 (V3) is substantially equivalent to its predicate device (Monitor B40V2.1, K133576).
• Design Changes and Rationale: Explaining minor design modifications (e.g., compliance with IEC60601-1 3rd edition, RoHS compliance, time synchronization, compatibility updates, component upgrades due to end-of-life parts) and asserting that these changes do not impact the device's ability to obtain patient measurements or its safety/effectiveness.
• Compliance with Standards: Listing numerous voluntary and international standards the device and its applications comply with (e.g., IEC 60601-1, IEC 62304, ISO 80601-2-56).
• Quality Assurance Measures: Detailing the development process, including risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, safety).

Therefore, many of the requested points cannot be extracted from the provided text. The document explicitly states: "The subject of this premarket submission. The proposed Monitor B40V3 did not require clinical studies to support substantial equivalence." This indicates that detailed performance metrics from a dedicated clinical study for this specific device (B40V3) are not present in this submission.

Here is what can be inferred or explicitly stated based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly listed as quantitative performance metrics for a specific function (e.g., arrhythmia detection sensitivity/specificity, NIBP accuracy). Instead, acceptance criteria implicitly refer to compliance with the listed international standards and demonstrating substantial equivalence to the predicate device, implying that its performance is at least as good as the predicate.
• Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision) are provided for any of the monitored parameters (ECG, SpO2, NIBP, etc.) for the Monitor B40V3 itself. The document claims "no changes to the parameter measuring principle" and that "all related risks were re-evaluated and found to be unchanged," implying performance is comparable 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)

• Not provided. The document does not describe specific test sets for analytical or clinical performance of the device's monitoring functions. It mentions "Testing on unit level," "Integration testing," "Final acceptance testing," "Performance testing," and "Safety testing" as part of quality assurance, but no details on size, provenance, or type of data are given.

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/Not provided. Since no specific clinical or analytical performance study with a 'test set' requiring expert ground truth is described, this information is absent. The submission focuses on technical compliance and substantial equivalence rather than de novo performance validation.

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

• Not applicable/Not provided. As no performance study with a test set requiring adjudication 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

• Not applicable/Not provided. This device is a physiological monitor, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or described.

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

• Not explicitly described as a standalone performance study. The device itself functions in a "standalone" mode as a monitor, and its algorithms (e.g., ECG EKPRO V12, NIBP) operate without human intervention in their core function. However, no specific "standalone study" with performance metrics for these algorithms is described in this document for the B40V3. The document states that the Monitor B40 can be a stand-alone monitor or interfaced to other devices.

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

• Not applicable/Not provided. For a physiological monitor, ground truth would typically be established against highly accurate reference devices or established clinical standards. However, since no specific clinical performance study is detailed, the method for establishing ground truth for performance metrics is not mentioned. Compliance testing for standards (e.g., IEC, ISO) would rely on defined test methodologies and reference values.

8. The sample size for the training set

• Not applicable/Not provided. There is no mention of a "training set" for AI or machine learning algorithms within this submission. The device uses established algorithms for physiological parameter monitoring.

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

• Not applicable/Not provided. As there is no mention of a training set.

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The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The B40i is intended for use under the direct supervision of a licensed health care practitioner. The B40i is not intended for use during MRI. The B40i can be a stand-alone monitor or interfaced to other devices via a network. The B40i monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

The proposed monitor B40i is a multi-parameter patient monitor that is developed based on the predicate Monitor B40 (K133576) platform. The proposed monitor B40i provides support for optional modules (E-Entropy module (K061907) and CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195). The proposed monitor B40i is also compatible with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) but with disabled spirometry function. The proposed monitor B40i supports Airway Gas Option (N-CAiO). The proposed monitor B40i expands the impedance respiration parameter feature to cover the neonatal patient population compared to the predicate Monitor B40 (K133576). This parameter feature patient population extension to cover neonatal patient population uses Patient Data Module as predicate (K071073), which impedance respiration implementation especially concerning the algorithm used is based on the predicate Aware Transport (K042642). The proposed monitor B40i utilizes 12 inch LCD display panel and LED backlight with an integrated keypad and a pre-configuration patient parameter measurement module. The proposed monitor B40i interfaces with the optional E-MiniC (K052582) and Thermal Recorder with an extension rack. As with the predicate Monitor B40, the proposed monitor B40i includes features and subsystems that are optional or configurable. The proposed monitor B40i interfaces to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40, the proposed monitor B40i has a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided text is a 510(k) Summary for the GE Healthcare B40i Patient Monitor. This document describes the device and its claimed substantial equivalence to predicate devices, but it does not contain a study demonstrating that the B40i device meets specific acceptance criteria based on performance data.

The document primarily focuses on:

• Device Description and Intended Use: Outlining what the B40i monitors (ECG, SpO2, NIBP, temperature, airway gases, Entropy) and for which patient populations (adult, pediatric, neonatal) and environments (hospital, intra-hospital transport).
• Comparison to Predicate Devices: A detailed table comparing the B40i to similar legally marketed devices (Monitor B40 and Patient Data Module), highlighting that most features/functions are identical or enhanced (e.g., neonatal impedance respiration expanded).
• Summary of Non-Clinical Tests: Listing the quality assurance measures and voluntary standards (IEC, AAMI, ISO) with which the device complies. This indicates that safety and performance were tested according to recognized standards.
• Statement on Clinical Tests: Explicitly stating that "No additional clinical tests were performed for proposed monitor B40i."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from this document. The document relies on comparison to predicate devices and compliance with standards to establish substantial equivalence, rather than presenting a novel performance study with specific acceptance criteria.

However, I can extract the acceptance criteria implied by the comparison to predicate devices and the listed standards, and present the device's reported performance as stated for the predicate devices, since the submission claims substantial equivalence and often refers to the same performance specifications.

Based on the provided K143676 510(k) Summary, here's what can be inferred and extracted, recognizing that this document does not present a new performance study with specific acceptance criteria for the B40i itself, but rather establishes equivalence to predicate devices which presumably met these criteria:

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

The device claims to be substantially equivalent to its predicates, which means its performance should meet or exceed the performance of the predicate if they are identical. The acceptance criteria are typically defined by recognized international standards (e.g., AAMI, IEC, ISO) and the specifications of the predicate devices. The reported device performance for the B40i is stated as identical to the predicate device's performance for most parameters.

Regarding the study that proves the device meets the acceptance criteria:

The document explicitly states: "No additional clinical tests were performed for proposed monitor B40i."
Instead of a new performance study for the B40i, the submission relies on bench testing against voluntary standards and comparison to legally marketed predicate devices (K133576 Monitor B40 and K071073 Patient Data Module) to demonstrate substantial equivalence. The argument is that the B40i's fundamental technology, performance specifications, and intended use are sufficiently similar to (or improved upon but within the same performance envelope as) the predicate devices, which were previously cleared by the FDA.

Therefore, for questions 2-9 requiring details about a study, the direct answer based on this document is that no new clinical performance study with specific acceptance criteria for the B40i was conducted or presented. The device's performance is asserted through comparison and compliance with standards.

Here's an attempt to answer the remaining points based on the understanding that no new performance study specific to the B40i is detailed here:

2. Sample size used for the test set and the data provenance: Not applicable, as no new clinical or performance test set for the B40i is described in this document. Performance claims are based on substantial equivalence to predicate devices and compliance testing to standards, but details of those predicate studies' sample sizes or data provenance are not provided here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance testing would typically be established during the development and clearance of the predicate devices or through standard reference methods. This document does not detail such for the B40i.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is a patient monitor, not an AI-powered diagnostic imaging device involving human reader interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device as a "multi-parameter patient monitor" which inherently has a standalone monitoring function. Performance measurements like SpO2 accuracy, NIBP accuracy, ECG arrhythmia detection (algorithms like EKPRO V12 and SuperStat DINAMAP) are implicitly standalone algorithm performances tested against specified accuracy ranges as part of standard compliance. However, details of such tests (e.g., specific test protocols, datasets) for the B40i are not provided beyond the statement of compliance to standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For parameters like SpO2 and NIBP, ground truth would typically be established using invasive reference methods (e.g., co-oximetry, arterial line) for physiological signals. For ECG/arrhythmia, it would involve expert review of annotated ECG waveforms, often from standard databases. The B40i relies on algorithms (EKPRO V12, SuperStat) that were validated against such ground truths during their initial development and predicate device clearances.
8. The sample size for the training set: Not applicable to this FDA submission for the B40i. Training sets relate to algorithm development. The document refers to existing algorithms (e.g., EKPRO V12 for ECG, SuperStat DINAMAP for NIBP, Nellcor/Masimo for SpO2) from predicate devices or modules. Details of their training sets are not included here.
9. How the ground truth for the training set was established: Not applicable, for the reasons mentioned in point 8.

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The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport.

The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner.

The Monitor B40 is not intended for use during MRI.

The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network.

The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring.

Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

The proposed Monitor B40V2.1 still is a multi-parameter patient monitor. It retains the features of the predicate Monitor B40V2 (K130584) and now includes supporting for an additional optional extension module Airway Gas Option (N-CAiO), and few software improvements by adding alarm breakthrough, extending the upper limit of ECG PVC (Premature Ventricular Contraction) alarm and providing four waveform scale options for Masimo SpO2 and Nellcor SpO2. Same as the predicate Monitor B40V2 (K130584), the proposed Monitor B40V2.1 continues interfacing with following optional extension modules: E-MiniC module (K052582), CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) and E-Entropy module (K061907). The compatibility with CARESCAPE Respiratory modules (E-sCOV and E-sCAiOV) (K123195) is also provided but with spirometry function disabled.

The proposed Monitor B40V2.1 still has a 12.1 inch LCD display but is from different LCD manufacturer and LCD backlight is changed from CCFL to LED due to RoHS compliance.

As with the predicate Patient Monitor B40V2 (K130584), the proposed Patient Monitor B40V2.1 still includes features and subsystems that are optional or configurable. The proposed Patient Monitor B40V2.1 will continue interfacing to a variety of existing central station systems via a cabled network interface.

As with the predicate Patient Monitor B40V2 (K130584), the proposed Patient Monitor B40V2.1 keeps a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

The provided text describes a 510(k) premarket notification for a multi-parameter patient monitor (Monitor B40V2.1) and its substantial equivalence to a predicate device, the Monitor B40V2 (K130584).

Here's an analysis of the requested information:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria or reported device performance in the typical sense of quantitative metrics for an AI/algorithm. Instead, the "acceptance criteria" are implied by the determination of "substantial equivalence" to a predicate device. The performance is assessed based on whether the changes made to the device have a significant impact on its ability to obtain patient measurements.

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

The document explicitly states: "The proposed Monitor B40V2.1 did not require clinical studies to support substantial equivalence." Therefore, there is no test set sample size and no data provenance mentioned for a clinical study related to this specific device (B40V2.1). The evaluation was based on non-clinical tests and a comparison to the predicate device.

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

Since no clinical studies were performed for the B40V2.1, there were no experts used to establish ground truth for a test set. The evaluation relies on the established safety and efficacy of the predicate device and the non-clinical assessment of the changes.

4. Adjudication method for the test set:

As no clinical test set was used, there was no adjudication method employed.

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 was done as this device is a multi-parameter patient monitor, not an AI or imaging diagnostic tool that would typically involve human "readers" in the context of AI assistance. The focus is on the device's ability to continuously monitor physiological parameters.

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

The device is a standalone multi-parameter patient monitor, meaning it operates to collect and display physiological data. However, the evaluation described is not a "standalone algorithm performance" study in the typical sense of AI, but rather a demonstration of the device's inherent functionality as a medical instrument. No specific algorithm-only performance study details are provided beyond the statement that "there are no changes to the parameter measuring hardware."

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

For the specific device (Monitor B40V2.1), no explicit ground truth based on expert consensus, pathology, or outcomes data was used because clinical studies were not required. The "ground truth" for demonstrating substantial equivalence was effectively the established performance and safety of the predicate device (Monitor B40V2) and the assessment that the changes introduced did not alter these fundamental aspects. The non-clinical tests (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, Performance testing, Safety testing) are intended to ensure the device performs as intended and meets relevant standards.

8. The sample size for the training set:

Not applicable. This document describes a traditional medical device (patient monitor) and its modifications, not an AI/machine learning algorithm requiring a "training set."

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

Not applicable for the same reason as above.

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The Monitor B40 is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring (including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

The proposed Monitor B40V2 is a multi-parameter patient monitor that is developed based on the predicate Monitor B40V1 (K120598) platform. The proposed Monitor B40V2 provides additional support for optional modules (E-Entropy module (K061907) and CARESCAPE Respiratory modules (E-sCO and E-sCAiO) (K123195) compared with predicate Monitor B40V1 (K120598). The proposed Monitor B40V2 is also compatible with CARESCAPE Respiratory modules (E-sCOV and EsCAiOV)(K123195) but with disabled spirometry function. The proposed Monitor B40V2 utilizes the existing 12 inch LCD display with an integrated keypad and a pre-configuration patient parameter measurement module. The proposed Monitor B40V2 will continue to interface with the optional E-MiniC (K052582) and Thermal Recorder with an extension rack. As with the predicate Monitor B40V1, the proposed Monitor B40V2 includes features and subsystems that are optional or configurable. The proposed Monitor B40V2 interfaces to a variety of existing central station systems via a cabled network interface. As with the predicate Monitor B40V1, the proposed Monitor B40V2 has a mounting plate on the bottom of the monitor. The monitor can be mounted in a variety of ways (e.g. shelf, countertop, table, wall, pole, or head/foot board) using existing mounting accessories.

This document describes the GE Monitor B40V2, a multi-parameter patient monitor. The primary focus of the provided text regarding acceptance criteria and studies is on the SpO2 accuracy performance for the neonatal patient population.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document specifically mentions an SpO2 accuracy performance study for the neonatal population. However, it does not explicitly state numerical acceptance criteria (e.g., specific accuracy ranges or statistical thresholds) within the provided text. It only reports that the study "demonstrated SpO2 accuracy performance."

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

• Sample Size for Test Set: Not explicitly stated in the provided text. The document only mentions "Neonatal patient population" for the clinical study.
• Data Provenance: Not explicitly stated in the provided text regarding country of origin. The study was a "Clinical study of the GE SpO2 TruSignalV2 on Neonatal patient population." It is described as a prospective study since it was a "clinical study" performed "in accordance to ISO 14155-1, ISO14155-2, ISO9919 and FDA Guidance."

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

Not explicitly stated in the provided text.

4. Adjudication Method for the Test Set

Not explicitly stated in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study described is a clinical study for SpO2 accuracy in neonates, not a comparison of human reader performance with and without AI assistance.

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

Yes, a standalone performance study was done. The clinical study was performed to demonstrate the "SpO2 accuracy performance of the TruSignal V2 technology on the neonate population," which implies an evaluation of the algorithm's performance independent of human interpretation.

7. The Type of Ground Truth Used

The ground truth for the SpO2 accuracy study would typically be established by a co-oximeter or a reference device known to precisely measure arterial oxygen saturation (SaO2) from blood samples. While not explicitly stated as "co-oximetry," clinical studies for SpO2 accuracy universally rely on such reference measurements.

8. The Sample Size for the Training Set

Not applicable/Not stated. The document refers to a clinical study for performance demonstration, not the training of an AI algorithm. The device primarily consists of a "TruSignal V2 algorithm" which is likely a fixed, developed algorithm, not one that undergoes continuous training in the context described.

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

Not applicable/Not stated. As above, this document describes performance testing of a developed algorithm, not the training phase.

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This GL Entropy Sensor is intended to be used for adults and pediatric patients older than 2 years with GE Entropy measurement devices to enable recording of physiological signals (such as EEG). To connect this sensor to the measurement device, use the GE Entropy Cable.

The GF. Entropy Sensor (M1038681) is a sensor ussembly with three (3) pre-gelled EEG electrodes. The GE Entropy Sensor is applied to the skin of the patient to record electrophysiological (such as EEG and FEMO) signals. It is a low impedance, single patient use, non-sterile disposable clectrode sensor that is designed for application to the frontal/temporal area. The GE Entropy Sensor is designed to provide ease of use and electrode placement accuracy. It is used in conjunction with the M-ENTROPY and E-ENTROPY module. The Entropy sensor collects EEG and facial EMG signals from these arcas, and the differential signal from the temple to the center of the forehead is used to calculate the Entropy variables. To obtain the Jowest possible skin impedance, a preparation pad is used to lightly abrade the skin to remove the insulating outer layer. One preparation pad is included with each sensor. The GE Entropy Sensor is individually packaged inside a moisture tight foil pouch. One preparation pad is included inside the same foil pouch. A selling box for the GE Entropy Sensor contains 25 sensor pouches and an instruction insert. The GE Entropy Sensor is connected directly to the sensor-end of the GL Entropy Cable and the device-end of the cable is connected directly to the M-L'NTROPY or E-ENTROPY module.

The provided document is a 510(k) Premarket Notification summary for the GE Entropy Sensor (REF M1038681). This document does not contain a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or performance study report typically would.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (GE Entropy Sensor REF M1123614, cleared Dec. 21, 2007 (K062580)). The primary changes described for the new device are:

1. Labeling modification to incorporate pediatric use in patients older than 2 years. This claim is based on the predicate device's associated GE Entropy measurement device (K061907) being cleared for pediatric use.
2. Internal wire rerouting and removal of a shrink wrap/flag sticker to change electrode order from 2-1-3 to 1-2-3, solely for improved usability, with no impact on form, fit, function, safety, or effectiveness.

Therefore, the document does not present a study with specific acceptance criteria, sample sizes, expert ground truth, or MRMC studies that would typically be associated with proving a device's performance against new clinical metrics. The "acceptance criteria" are instead compliance with recognized standards and a demonstration that the minor changes made to the sensor do not introduce new questions of safety or effectiveness compared to the predicate.

Here's the information based on the provided text, categorized to match your request, while highlighting the absence of typical performance study details:

Acceptance Criteria and Device Performance (as inferred from the 510(k) document)

• FDA 21 CFR Part 898, § 898.12 (Performance standard for electrode lead wires and cables)
• EN 60601-1:2005 (Part 1: General requirements for safety)
• IEC 601-2-26:1994 (Particular requirements for electroencephalographs)
• ANSI/AAMI EC12-2000
• ANSI/AAMI ES1:1993
• UL 2601-1
• CAN/CSA C22.2NO601.1
• IEC 664-1 (Insulation coordination for equipment within low-voltage systems)
• ANSI/AAMI EC53-1995 (ECG cables and leadwires)
• FDA /ODE Guidance for Content of Premarket Submission for Software Contained in Medical Devices, May 11, 2005
• ISO 15223:2000 (Medical Devices - Symbols to be used with medical device labeling and information to be supplied)
• EN 980+AI+A2 (Graphical symbols for use in the labeling of medical devices)
• ISO 10993-1, -5, -10 (Biological evaluation of medical devices)
• ISO 14971:2000 (Medical devices -- Application of risk management to medical devices) |
  | Functionality: Ability to record physiological signals (EEG, FEMG) via 3 pre-gelled electrodes. | The device is a "sensor assembly with three (3) pre-gelled EEG electrodes" designed to "record electrophysiological (such as EEG and FEMG) signals." The changes made (electrode order) do not affect this core function and "improves usability." |
  | Biocompatibility: Safe for skin contact. | Assessed against ISO 10993-1, -5, -10 "Biological evaluation of medical devices." |

Since this is a 510(k) for substantial equivalence based on minor non-clinical changes and leveraging prior clearances of associated devices, the following requested information is not applicable or not provided in this type of submission:

2. Sample size used for the test set and the data provenance: Not applicable; no specific clinical test set for performance evaluation is described. The assessment is based on design changes and standard compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth establishment for a test set is described.
4. Adjudication method for the test set: Not applicable.
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 EEG sensor, not an AI diagnostic algorithm, and no MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this is a sensor, not an algorithm.
7. The type of ground truth used: Not applicable; no new ground truth was established for performance evaluation of the sensor itself, beyond compliance with standards and the predicate device's existing performance.
8. The sample size for the training set: Not applicable; this is a physical sensor, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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