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The Monitor B125/B105 is a portable multi-parameter unit to be used for monitoring, 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 B125/B105 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B125/B105 is not intended for use during MRI.

The Monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network.

The Monitor B125/B105 monitors and displays : ECG (including ST segment, arrhythmia detection, ECG Diagnostic Analysis and Measurement,), 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/Tympani/Rectal/ Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration rate, CO2.

The Monitor B125/B105 is able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Couplet, Bigeminy, Trigeminy, Trigeminy, "R on T", Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Multifocal PVCs, Missing Beat, Premature Ventricular Contraction (PVC) and Ventricular fibrillation.

The Monitor B125/B105 is a multi-parameter patient monitor that is developed based on the predicate Monitor B40 (K151063) platform. The Monitor B125/B105 provides additional support for ECG full arrhythmia (has been claimed in CARESCAPE Monitor B650(K102239)), WLAN (FCC ID: OU5B1X501) and touch screen.

As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 is a multiparameter patient monitor, utilizes 12inches /10inches LCD display with an integrated keypad and a pre-configuration (hemodynamic module) which provide basic parameters: ECG, RESP, NIBP, IBP, TEMP, SPO2.

As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 has optional CO2 parameter provided by the identical E-MiniC module (K052582).

As with the predicate Monitor B40(K151063), the proposed Monitor B125/B105 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 describes a 510(k) premarket notification for the GE Monitor B125/B105. While it details various performance data related to electrical safety, EMC, software verification, environmental, mechanical stress, and packaging tests, it does not include specific acceptance criteria or a study that directly proves the device meets such criteria for parameters like arrhythmia detection accuracy.

The document states:

• "The proposed Monitor B125/B105 provides additional support for ECG full arrhythmia (has been claimed in CARESCAPE Monitor B650 (K102239))"
• "The proposed device uses the same ECG algorithm (EK-Pro V12) as predicate device B40 (K151063)"
• "The proposed device enabled full arrhythmia analysis which disabled in the predicate device B40 (K151063)."
• "Full arrhythmia analyses implemented with EK -ProV12 ECG algorithm was cleared in B650 (K102239)"

This indicates that the arrhythmia detection capabilities rely on a previously cleared algorithm (EK-Pro V12) and that the full arrhythmia analysis feature was enabled on the new device, having been previously cleared in the predicate device B650 (K102239). However, no new study data for arrhythmia detection performance or specific acceptance criteria for these functionalities are presented in this document.

Therefore, based solely on the provided text, I cannot complete the requested information regarding acceptance criteria and a study proving the device meets them for ECG arrhythmia detection. The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and adherence to various safety and performance standards, but not on detailed performance metrics for specific clinical functions like arrhythmia detection.

No information is available for the following points in the provided document:

• A table of acceptance criteria and the reported device performance.
• Sample size used for the test set and the data provenance for arrhythmia detection.
• Number of experts used to establish the ground truth for the test set and their qualifications for arrhythmia detection.
• Adjudication method for the test set for arrhythmia detection.
• Multi-reader multi-case (MRMC) comparative effectiveness study information.
• Standalone (algorithm only) performance information for arrhythmia detection.
• Type of ground truth used for arrhythmia detection.
• Sample size for the training set for arrhythmia detection.
• How the ground truth for the training set was established for arrhythmia detection.

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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 MAC 800 is a portable ECG acquisition, analysis and recording system.

The MAC 800 is intended to be used under the direct supervision of a licensed healthcare practitioner.

The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment as well as used in clinics and physician offices outreach centers to record ECG signals from surface electrodes.

The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years.

The basic system shall provide 2 modes of operation: (1) Resting ECG mode and (2) Arrhythmia mode.

The basic systems shall print 3, 6-leads of ECG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. Transmission and reception of ECG data to and from a central ECG cardiovascular information system shall be optional.

The arrhythmia detection portion of the MAC 800 is provided to the customer for the convenience of automatic documentation.

The MAC 800 ECG acquisition, analysis and recording system can print and display multiple leads of ECG data. The MAC 800 will provide, in resting ECG mode, ECG quality information using the hookup advisor. The hookup advisor advises users of poor lead quality based on noise measurement It can be upgraded to provide options such as ECG measurement and interpretation with 12SL. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is also optional. Multiple QT correction formulas including Bazett, Framingham and Fridericia will be available as a user selectable option. Clinical Trials Data Guard and audit trail options are also available to support electronic record requirements.

The MAC 800 delivers multiple leads of ECG on full-size reports and includes an SMS/text message telephone keypad for patient demographics and other data entry with T9 input method, an integrated 7" color display, and an integrated thermal writer. The thermal writer will print real time continuous waveform, alphanumeric data and non-real time reports. The device can print the resting ECG report via the external laser printer including USB laser printer and network laser printer. The device will have optional internal memory and removable storage to store resting ECG records. The device also can export the resting ECG record to SD card/shared directory/FTP server as an optional function. An optional barcode reader and magnetic card scanner to enter patient information is available. The MAC 800 can be used as a portable unit.

This document is a 510(k) premarket notification for the GE MAC 800 Resting ECG Analysis System (MAC 800V2). It largely focuses on demonstrating substantial equivalence to a predicate device (MAC 800V1) and other GE algorithms (MUSE and 12SL ECG Analysis Program), rather than presenting a standalone study with detailed acceptance criteria and performance data.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, and ground truth establishment are not directly available in the provided text.

Based on the available information, here's what can be extracted:

Acceptance Criteria and Device Performance (Not fully detailed as it's a substantial equivalence submission)

The document asserts "The design changes made have no effect on the device's ability to acquire and analyze ECG data" and that the MAC 800V2 is "as safe, as effective, and performance is substantially equivalent to the predicate devices." This implies that the acceptance criteria are met if the new device's performance is deemed equivalent to the previously cleared predicate.

Explicit Acceptance Criteria: Not stated for specific performance metrics in this document. The primary "acceptance criterion" for this submission is demonstrating substantial equivalence to the predicate device.

Reported Device Performance: Not quantified in this document. The document states that the proposed MAC 800V2 uses the "identical 12SL ECG algorithm (K060833)" and has "identical Resting ECG mode and Arrhythmia mode as the predicate MAC 800V1 (K090212)". This implies that the performance is expected to be the same as the predicate and the 12SL algorithm.

Study Details (Based on available information)

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

   • Test Set Sample Size: Not specified in this document, as a new clinical study to evaluate the device's performance against specific acceptance criteria was not required for this submission. The submission relies on substantial equivalence to previously cleared devices and algorithms.
   • Data Provenance: Not specified. The document indicates that the 12SL ECG algorithm (K060833) is used, and the predicate device is MAC 800V1 (K090212). The performance of these previously cleared components would have been established in their respective submissions.

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

   • Not specified or applicable in this 510(k) submission, as it did not require new clinical studies. The ground truth for the 12SL ECG algorithm (K060833) would have been established during its original clearance process.

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

   • Not specified or applicable, as no new clinical study was conducted for this submission.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was done for this specific submission. The document explicitly states: "The subject of this premarket submission, the proposed MAC 800V2 did not require clinical studies to support substantial equivalence." The device is an ECG analysis system, which may or may not involve AI in the way a modern "AI assistance" study would assess. The 12SL algorithm performs "interpretive analysis," which could be considered an automated interpretation, but the document does not focus on human reader improvement with or without this analysis in this submission.

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

   • Not explicitly described as a new standalone performance study for the MAC 800V2.
   • However, the document states the device "uses identical 12SL ECG algorithm (K060833)." The 12SL algorithm itself is a standalone interpretive algorithm. Performance data for that algorithm would have been part of its original 510(k) submission (K060833). This current submission implicitly leverages the established standalone performance of the 12SL algorithm.

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

   • Not specified for this submission. For ECG interpretation algorithms like 12SL, ground truth is typically established by expert consensus of cardiologists on ECG recordings, sometimes correlated with clinical outcomes or other diagnostic tests, as would have been done in the K060833 submission.

7. The sample size for the training set:

   • Not specified in this document. This submission focuses on a new version of hardware/software based on existing algorithms. The training set for the underlying 12SL ECG algorithm (K060833) would have been described in its original submission.

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

   • Not specified in this document. Similar to the test set, the ground truth for the training of the 12SL algorithm (K060833) would have been established through a rigorous process, likely involving expert cardiologists' interpretations and adjudication, as is standard for ECG algorithms.

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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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The PROCARE Monitor B20 is a portable multiparameter 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 PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner.

The PROCARE Monitor B20 is not intended for use during MRI.

The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring.

Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.

The PROCARE Monitor B20 is a multi-parameter patient monitor. The PROCARE Monitor B20 has a10.4 inch LCD display with integrated keypad and a pre-configuration patient parameter measurement module (Hemo module), the PROCARE Monitor B20 also supports a thermal recorder and Airway gas module (E-MiniC, K052582) with an extension rack.

The PROCARE Monitor B20 includes features and subsystems that are optional or configurable. The PROCARE Monitor B20 interfaces to a variety of existing central station systems via a cabled network interface.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the PROCARE™ Monitor B20:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there are no specific, quantitative acceptance criteria or performance metrics explicitly stated for the PROCARE™ Monitor B20, as it is claiming substantial equivalence to a predicate device. The claim of performance is based on the assertion that its technical specifications remain the same as the predicate, with the exception of the screen size and backlight.

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

• Test Set Sample Size: Not applicable. The document states, "The subject of this premarket submission, The PROCARE Monitor B20 did not require clinical studies to support substantial equivalence." This means no dedicated test set from clinical trials was used to prove the performance of this specific device.
• Data Provenance: Not applicable. As no clinical studies were performed for this device, there is no clinical data provenance to report. The justification for equivalence is based on technical and design comparisons to the predicate device.

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

• Number of Experts: Not applicable. Since no clinical studies were performed, no experts were needed to establish ground truth for a test set for this device.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical test set.

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:

• MRMC Study: No. This device is a multi-parameter patient monitor, not an AI-assisted diagnostic or interpretive system that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance.
• Effect Size: Not applicable.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance: Yes, implicitly. The device itself performs monitoring and analysis of physiological parameters (e.g., arrhythmia and ST segment analysis, SpO2, NIBP, heart rate). The claim of substantial equivalence implies that these internal algorithms perform adequately, as they are stated to be unchanged from the predicate device. However, no specific performance metrics for these algorithms are provided in this summary, nor are they evaluated in a standalone clinical study for this specific submission. The "standalone" here refers to the device's inherent functional performance as a monitor.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: Not applicable for this submission directly. The "ground truth" for the performance of the PROCARE Monitor B20 is established by its direct functional and technical equivalence to the predicate device, the PROCARE Monitor B40, which presumably had performance established through its own clearances. The submission relies on the assertion that "there are no changes to the parameter measuring hardware" and "all technical specification remains the same."

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is a patient monitor, and the submission does not describe it as using machine learning or AI models that would require a "training set" in the conventional sense for its physiological parameter measurements. Its functionality is based on established signal processing and measurement algorithms.

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

• Ground Truth for Training Set: Not applicable. As no training set is described for this device, no method for establishing its ground truth is mentioned.

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Achilles OsteoReportN is software used with the Achilles family of ultrasonometers to provide a patient database, customized reporting, and communication with Health Information Systems. Achilles OsteoReportN together with the Achilles ultrasonometers measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index.

The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.

Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorptiometry. Either the stiffness index t-score or x-ray absorptiometry t-score can be utilized by a physician. in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes.

Achilles OsteoReportN is a software program running on PC to enter patient information, remote control and retrieve measurement results of GE ultrasonometer to help physicians to analysis the osteoporotic fracture risk and communicate with hospital information system.

Achilles ultrasonometers measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index.

The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.

Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorpiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorpiometry, which makes it suitable for monitoring bone changes.

Achilles OsteoReportN is a windows based application running on PC and will provide the following capabilities for Achilles series device:

• 1. A patient database
• 2. Customizable reporting
• 3. Operation of the Achilles unit from the PC to provide ergonomic relief to the operator
• 4. Communication to the hospital/clinic information system

The objectives of this program including:

• Support Windows 7 (64 bit)/Windows XP(32bit) . operating system
• . Support merging the database with older version of Achilles product with the database used with the newer Achilles ultrasonometers, which is stored on the device.
• . Support remote control of EXPII's measurement and retrieve measurement results
• Support customized report printing .
• . Support DICOM

The provided text describes a 510(k) premarket notification submission for the "Achilles OsteoReportN" software. This software is intended to be used with Achilles ultrasonometers to provide a patient database, customized reporting, and communication with Health Information Systems, ultimately assisting in the diagnosis of osteoporosis.

Here's an analysis of the provided information regarding acceptance criteria and studies:

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

The submission documentation does not explicitly state specific quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the device's performance in diagnosing osteoporosis. Instead, it focuses on the device's functional equivalence and technical characteristics relative to its predicate device.

The reported device performance emphasizes that:

• "The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip."
• "Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry."
• "The stiffness index has a precision error in older women comparable to that of x-ray absorptiometry, which makes it suitable for monitoring bone changes."
• "Achilles OsteoReportN employs the same fundamental scientific technology as its predicate devices."

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

The document explicitly states: "The subject of this premarket submission, Achilles OsteoReportN, did not require clinical studies to support substantial equivalence."

This indicates that there was no specific test set or clinical study conducted for this particular 510(k) submission. The device's substantial equivalence was based on its functional and technological similarity to a predicate device, Achilles EXP II.

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)

Since no clinical studies were conducted for this submission, there were no experts specifically utilized to establish ground truth for a test set related to Achilles OsteoReportN.

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

Not applicable, as no clinical studies were conducted.

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. The device is a software program designed to assist in analysis and reporting, not explicitly an "AI" for image interpretation, and no MRMC studies are mentioned.

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

Not applicable, as no clinical studies were conducted. The software itself is an analytical and reporting tool that operates "with the Achilles family of ultrasonometers."

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

For this specific submission, the "ground truth" for proving substantial equivalence was primarily the established performance and indications for use of the predicate device (Achilles EXP II), rather than a new clinical ground truth established for the Achilles OsteoReportN. The underlying scientific principle (Stiffness Index from os calcis ultrasound) had previously been shown to be comparable to BMD from X-ray absorptiometry.

8. The sample size for the training set

The document does not mention any training sets or machine learning model development for the Achilles OsteoReportN software itself. Its development focused on functionalities like database management, customizable reporting, remote control, and DICOM support, rather than learning from a dataset.

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

Not applicable, as no training set is mentioned in the provided text for the Achilles OsteoReportN software.

Summary of Device Acceptance and Study Detail:

The acceptance of Achilles OsteoReportN was based on a demonstration of substantial equivalence to a predicate device (Achilles EXP II), rather than new clinical performance trials for the software itself. The submission highlighted the software's functional capabilities (patient database, reporting, communication) and its reliance on the same fundamental scientific technology as the predicate device for generating the Stiffness Index measurements.

The submission specifically states: "The subject of this premarket submission, Achilles OsteoReportN, did not require clinical studies to support substantial equivalence."

Instead, the following quality assurance measures were applied to the development of the system:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation)

The provided information focuses on the software's functionality, compatibility, and its intended use in conjunction with existing Achilles ultrasonometers, assuming the clinical efficacy of the Stiffness Index measurements themselves, which were presumably established and accepted for the predicate devices.

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

The PROCARE Monitor B40 is not intended for use during MRI.

The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring.

Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.

The PROCARE Monitor B40 is a multi-parameter patient monitor including both new and existing subsystems. The PROCARE Monitor B40 has a12 inch display with integrated keypad and a fixed pre-configuration patient parameter measurement module (Hemo module). The PROCARE Monitor B40 also supports a thermal recorder and Airway gas module (E-MiniC, K052582) with an extension rack.

The PROCARE Monitor B40 includes features and subsystems that are optional or configurable. The PROCARE Monitor B40 interfaces to a variety of existing central station systems via a cabled network interface.

The provided text does not contain specific acceptance criteria or details about a study designed to prove the device's performance against such criteria. Instead, it refers to summaries of non-clinical tests and states that clinical studies were not required to support substantial equivalence.

Here's a breakdown of the information that is available and what is missing:

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

   • Missing. No specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are listed for the PROCARE Monitor B40's performance. The document focuses on regulatory compliance and substantial equivalence to predicate devices rather than direct performance metrics against pre-defined criteria.

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

   • Missing. Since no clinical studies were performed, there is no test set or associated sample size discussed.

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

   • Missing. No expert-established ground truth is mentioned, as no clinical tests were conducted for this submission.

4. Adjudication method for the test set

   • Missing. Not applicable, as no test set requiring adjudication was used.

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

   • Missing. No MRMC study was done, as clinical studies were explicitly stated as "not required." The device is a patient monitor, not an AI-assisted diagnostic tool for human readers.

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

   • Missing. While the device contains algorithms (e.g., "identical arrhythmia algorithm, EK-Pro V12," and "identical NIBP hardware and SuperStat algorithm" to predicate devices), the document does not describe standalone performance studies for these algorithms. Performance is implied through substantial equivalence to predicate devices.

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

   • Missing. Not applicable, as no clinical studies requiring a ground truth were performed.

8. The sample size for the training set

   • Missing. The document mentions the device has "identical arrhythmia algorithm, EK-Pro V12" and "identical NIBP...SuperStat algorithm" as predicate devices, implying these algorithms were developed previously. However, details about the training sets for these algorithms are not provided in this submission for the PROCARE Monitor B40.

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

   • Missing. Similar to item 8, details on how the ground truth for the training sets of the existing algorithms (EK-Pro V12 and SuperStat) were established are not provided in this document.

Summary of Device Performance (based on provided text):

The PROCARE Monitor B40's performance is not evaluated directly against novel acceptance criteria in this submission. Instead, the submission argues for substantial equivalence based on the following:

• Technology: "The PROCARE Monitor B40 is a new monitor that essentially is a combination of the features and parameters of three existing predicate monitor platforms."
• Algorithms: It uses "identical arrhythmia algorithm, EK-Pro V12, as the CARESCAPE Monitor B650 (K102239)" and "identical NIBP hardware and SuperStat algorithm with CARESCAPE V100 Vital Signs Monitor (K073203)."
• Non-Clinical Tests: The device claims compliance with voluntary standards and underwent internal quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, module verification, system verification, validation, performance testing, safety testing).
• Conclusion: "GE Healthcare considers the PROCARE Monitor B40 to be as safe, as effective, and performance is substantially equivalent to the predicate devices."

In essence, the "study" proving the device meets its acceptance criteria (which is substantial equivalence) is the comparison to predicate devices and adherence to design control and quality assurance processes, rather than a clinical trial with specific performance metrics.

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The Achilles ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptiometry at the spine or hip.

Stiffness index results expressed as t-scores are used to assist the physicians in the diagnosis of osteoporosis in the same way as are t-scores or obtained by x-ray absorpiometry. Either the stiffness index t-score or x-ray absorpiometry t-score can be utilized by a physician, in conjunction with other clinical risk factors, to provide a comprehensive skeletal assessment.

The stiffness index has a precision error in older women comparable to that of x-ray absorpiometry, which makes it suitable for monitoring bone changes.

Achilles EXPII measures ultrasound variables of the os calcis to provide a clinical measure called Stiffness Index. The Stiffness Index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (BMD) as measured by X-ray absorptometry at the spine or hip.

GE Healthcare's Achilles EXPII Bone Sonometer measures ultrasound variables of the os calcis to provide a Stiffness Index. This index indicates the risk of osteoporotic fracture in postmenopausal women, comparable to bone mineral density (BMD) measured by X-ray absorptiometry at the spine or hip. The device's performance was compared to its predicate device, the Achilles Express.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

The document mentions "A clinical study GE3120 was performed". However, the sample size for this clinical study and the data provenance (e.g., country of origin, retrospective or prospective nature) are not provided in the provided text.

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

The provided text does not mention the use of experts or the establishment of ground truth in the context of radiologists or similar qualified professionals guiding the clinical study. The study focuses on comparing the device's output (Stiffness Index) with its predicate.

4. Adjudication method for the test set

The provided text does not describe any adjudication method like 2+1 or 3+1. The study appears to be a direct comparison of measurements between two devices.

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 is not an MRMC comparative effectiveness study in the context of human readers and AI assistance. The Achilles EXPII is a diagnostic device for measuring bone health, not an AI-assisted interpretation tool for human readers. Therefore, an effect size of human reader improvement with/without AI is not applicable and not mentioned.

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

This device functions as a standalone device (an ultrasonometer) that measures physical properties to calculate a Stiffness Index. Its performance, as described, is independent of human interpretation or input for the primary measurement itself, though physicians use its output in conjunction with other clinical factors. The comparison made in the study (device vs. predicate device) is a standalone performance comparison.

7. The type of ground truth used

The "ground truth" in this context is the Stiffness Index values obtained from the predicate device, the Achilles Express Ultrasonometer. The study aimed to demonstrate that the Achilles EXPII’s measurements are equivalent to those of the legally marketed predicate. The predicate device itself (Achilles Express) would have been validated against a clinical truth, likely Bone Mineral Density (BMD) as measured by X-ray absorptiometry, which is mentioned as the comparative standard for the Stiffness Index in general.

8. The sample size for the training set

The provided text does not mention a training set in the context of machine learning or AI models. The Achilles EXPII is a measurement device, not explicitly based on a machine learning model that requires a training set.

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

As there's no mention of a training set in the provided documentation, this question is not applicable.

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The subject modified device is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intraoperative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transesophageal, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.

The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ e and Vivid e, each with options and features suited for its It has an integrated keyboard, LCD display and several interchangeable electronic-array market niche. transducers with an approximate size of 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.

The provided text is a 510(k) Summary and related Indications for Use forms for the GE LOGIQ i, LOGIQ e, and Vivid e Diagnostic Ultrasound systems. It describes the device, its intended uses, and claims substantial equivalence to a predicate device.

Key takeaway: This documentation explicitly states, "Clinical Tests: None required." Therefore, there are no specific acceptance criteria or a study provided to prove the device meets performance criteria beyond safety and effectiveness compared to a predicate device. The information requested regarding performance metrics, sample sizes, expert qualifications, ground truth, and MRMC studies is not available in these documents because clinical studies were not performed for this 510(k) submission.

However, I can extract the information that is present concerning the device and its regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

As per the "Non-clinical Tests" section (Section b.1), the device was evaluated for its conformity with applicable medical device safety standards.
The core acceptance criterion for this 510(k) submission is Substantial Equivalence to a legally marketed predicate device (GE LOGIQ-ile & Vivid-e Compact Ultrasound, 510(k) No: K091374).

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

• No clinical test set was used. The submission explicitly states: "Clinical Tests: None required." This is a regulatory filing asserting substantial equivalence based on technical characteristics and safety standards, not a performance study using patient data.

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

• Not applicable. As no clinical test set was used, no experts were required to establish ground truth for a test set.

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

• Not applicable. No clinical test set and thus no adjudication method were used.

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 study was done. This device is an ultrasound imaging system, and the submission does not mention any AI components or features that would warrant an MRMC study comparing human reader performance with and without AI assistance.

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

• Not applicable. This device is an ultrasound imaging system, not an algorithm being tested in a standalone fashion.

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

• Not applicable. No clinical studies requiring ground truth were performed for this submission. The basis for clearance is substantial equivalence to a predicate device and compliance with safety standards.

8. The sample size for the training set

• Not applicable. No clinical training set was used as no new algorithm requiring such a set was part of this 510(k) submission.

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

• Not applicable. As there was no clinical training set, no ground truth needed to be established for it.

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