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The CSF-3 is intended to record, store, transfer, and display single-channel electrocardiogram (ECG) rhythms. The ECG signal is for quality checks of the data and for manual interpretation of heart rate. The CSF-3 is also indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2). The CSF-3 is for adult patients and health-conscious individuals in hospitals, clinics, long-term care facilities, and homes. The CSF-3 is a prescription device and should be used under the care of a physician. CSF-3 does not provide any alarms. It is not intended for pediativ use or use in critical care settings.

The CSF-3 is a non-invasive system consisting of software, hardware and mechanical components that enables the user to measure electrocardiography (ECG) and oxygen saturation of arterial hemoglobin (SpO2). The CSF-3 consists of 3 main components: 1) CS Watch 3 with CSF-3 Watch firmware ("Watch"): The Watch is a wrist worn device embedded with non-invasive sensors. The Watch includes firmware that activates the sensors, synchronizes the data sampled by the sensors, processes the data, stores the processed data in non-volatile memory, and provides the data to the user. The processed data is transferred to the Mobile App via a secured BLE communication channel. In addition, the watch sends realtime raw data signals to the Mobile App. 2) CSF-3 Mobile Application ("Mobile App"): The Mobile App works on both Android OS and iOS. The Mobile App communicates with the Watch via BLE and to the Cloud App via HTTPS, thus acting as the Watch gateway to the Cloud App. The Mobile App caches the processed data from the Watch and transfers it to the Cloud App. It allows the user to conveniently view the measurement results and real time raw data. The Mobile App provides the user with the capability of creating an on-demand report and sharing it using 3rd party sharing applications. 3) CSF-3 Cloud Application ("Cloud App"): The Cloud App securely stores the user and processed data over designated databases. It provides the mechanism of creating and sending periodical reports which are sent to the user's email both automatically and on-demand.

The provided text pertains to a 510(k) premarket notification for a medical device called CSF-3, for which CardiacSense is the manufacturer. The document details the device's intended use, technological characteristics, and various testing performed to demonstrate its substantial equivalence to a predicate device (Withings Scan Monitor).

Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes performance criteria primarily for ECG (QRS detection and Heart Rate accuracy) and SpO2 measurement accuracy.

Note on "Acceptance Criteria (Implicit)": The document states that the performance "is above XY%" or "varies between AB%," implying that these are the levels deemed acceptable for demonstrating substantial equivalence. The exact numeric acceptance criteria are not explicitly defined as "must be at least X" but are presented as the achieved performance which is satisfactory.

Study Details

The document describes both non-clinical (bench) and clinical testing.

1. Sample Size and Data Provenance:

   • Bench Testing (QRS and HR accuracy): The performance of the QRS algorithm was evaluated against three databases:
     • MIT-BIH Arrhythmia database
     • AHA database
     • MIT-BIH Noise Stress database
       The number of recordings/samples within these databases is not specified. The provenance of these databases (e.g., country of origin, retrospective/prospective) is also not explicitly mentioned, but these are standard, publicly available, and widely accepted benchmark databases for ECG algorithm testing.
   • Clinical Study (ECG HR performance): "The study included 52 subjects and a total of 23,579 samples resulted with sensitivity of 99.6% and false detection rate of 0.54% and ARMS of 1.54 BPM."
     • Sample Size: 52 subjects, 23,579 samples.
     • Data Provenance: Not explicitly stated (e.g., country, retrospective/prospective), but implied to be prospective clinical data collected for this study, as it involved "comparing the CSF-3 to a Holter."
   • Clinical Study (SpO2 Accuracy): "The clinical study with n=234 samples, the SpO2 range was validated to be from 70% to 100% with accuracy of 2.96%."
     • Sample Size: 234 samples.
     • Data Provenance: Conducted in the Hypoxia Research Laboratory, Department of Anesthesia Perioperative Care, University of California at San Francisco (UCSF) in compliance with the ISO 80601-2-61:2017 standard. This implies a prospective, controlled clinical study.

2. Number of Experts and Qualifications:

   • For Bench Testing (QRS and HR): Not applicable for the algorithmic evaluation against standard databases. The ground truth in these databases is established through expert annotation by the creators of these databases, but not by experts specifically for this submission.
   • For Clinical Studies (ECG HR and SpO2): The document does not specify the number or qualifications of experts (e.g., cardiologists, anesthesiologists) involved in reviewing or establishing ground truth for the clinical studies. It mentions comparison to a "Holter" for ECG and "A-line as a reference" for SpO2, which are established clinical measurement standards. The implication is that the reference measurements serve as the ground truth, not human expert interpretation of the CSF-3 output.

3. Adjudication Method for Test Set:

   • Not specified. Given that the ground truth for clinical studies relies on established reference devices (Holter, A-line), a separate human adjudication method for the device's output against a human-reviewed ground truth is not explicitly described. For the bench tests, the ground truth is pre-established within the databases.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is described for how human readers improve with AI vs. without AI assistance. The device is for recording and displaying ECG and SpO2 data for manual interpretation or quality checks, not for AI-assisted image interpretation or diagnosis. The ECG signal is stated to be "for quality checks of the data and for manual interpretation of heart rate," implying human readers will interpret the output from the device.

5. Standalone (Algorithm Only) Performance:

   • Yes, for QRS detection and HR accuracy on the bench. The document states: "The performance of the QRS algorithm was evaluated against three databases following the requirements stated in the IEC-60601-2-47 standard." This describes the algorithm's standalone performance.
   • Not explicitly for SpO2 beyond the stated accuracy. The SpO2 accuracy (2.96%) is a measure of the device's (including its algorithm's) performance against a reference standard.

6. Type of Ground Truth Used:

   • Bench Testing (ECG): Established, publicly available, and expertly annotated databases (MIT-BIH Arrhythmia, AHA, MIT-BIH Noise Stress). These database annotations serve as the ground truth.
   • Clinical Study (ECG HR): Comparison to a "Holter" device. The Holter recording and its interpretation serve as the ground truth.
   • Clinical Study (SpO2): Comparison to "the A-line as a reference" and performance "in compliance with the ISO 80601-2-61:2017 standard." This implies an arterial blood gas analysis or a similar precise clinical measurement as the ground truth reference.

7. Sample Size for Training Set:

   • The document does not provide a sample size for a training set. This suggests that the QRS detection and HR algorithms were either developed using proprietary datasets (not explicitly detailed in the document) or were designed using general signal processing principles rather than being deep learning models requiring large, labelled training datasets as typically described for AI/ML devices. For a 510(k), particularly for devices like ECG monitors, comprehensive training data details aren't always required if the algorithms are well-established.

8. How Ground Truth for Training Set Was Established:

   • As no training set details are provided, the method for establishing its ground truth is also not mentioned.

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The IDM100 for use by clinicians and patients to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional. The IDM100 is intended for use on neonate (up to 28 days), pediatric (29 days to 12 years), adolescent (>12 years &

The IDM100 is an integrated medical tablet with diagnostic equipment and secure HIPAA-compliant video conferencing capability facilitating Virtual Exam Rooms (VER) between patients and care providers anywhere. It captures patient vital signs and cardiopulmonary information with clinical accuracy. The IDM100 syncs the data seamlessly with electronic medical records (EMR) providing real-time access for all stakeholders in the continuum of care. The IDM100 transmist the the patient data over a secure internet connection.

The provided document is a 510(k) Summary for the IDM100 device. While it describes various tests performed for safety and effectiveness, it does not clearly present specific acceptance criteria in a table format for performance metrics or a detailed study proving the device meets these criteria in the way typically expected for a detailed clinical performance study report.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Tempus IC2, K152124) by comparing indications for use, technological characteristics, and by performing various verification and validation tests against recognized standards.

Here's an attempt to extract and synthesize the requested information based on the provided text, highlighting where information is not explicitly available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by conformity to specific standards and satisfactory results from various tests, rather than explicit numerical thresholds given in a table. The document focuses on demonstrating that the IDM100's components meet established standards for similar devices or that its overall performance is comparable to a predicate device.

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

• ECG Clinical Testing:
  • Sample Size: "18 normal and abnormal ECG patients" were compared for the 12-lead ECG function.
  • Data Provenance: Not specified (e.g., country of origin). It's described as a "clinical evaluation," suggesting prospective data collection for this specific comparison, but this is not explicitly stated.
• Other Tests (e.g., Low Perfusion, Tympanic Thermometer, NIBP): Sample sizes are not mentioned. These appear to be bench or lab-based tests rather than patient studies.

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

• ECG Clinical Testing: The document states that the IDM100 and the Welch Allyn CP150 (predicate) "provide comparable testing result, with no impact to the interpretation of the patients ECG." This implies that the interpretation was assessed, likely by experts, but the number and specific qualifications of these experts are not provided.
• Other Tests: Ground truth for these tests would typically be established by calibrated instruments or reference standards, not human experts in the conventional sense.

4. Adjudication Method for the Test Set

• ECG Clinical Testing: An explicit adjudication method (e.g., 2+1, 3+1) is not described. The statement "no impact to the interpretation of the patients ECG" suggests an expert review or comparison, but the process is not detailed.
• Other Tests: Adjudication methods are not applicable for these types of technical compliance tests.

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

• A formal MRMC comparative effectiveness study, comparing human readers with AI assistance versus human readers without AI assistance, was not mentioned or described in this document. The device itself is a vital signs monitor and data collection system, not an AI interpretation device that assists human readers in diagnostic tasks.

6. Standalone (Algorithm Only) Performance Study

• This device is not an algorithm that provides standalone diagnostic interpretations; it's a medical tablet integrating various diagnostic tools. Therefore, a standalone algorithm performance study, as typically understood for AI/ML devices, was not performed or described. The components (e.g., ECG, NIBP, SpO2) within the IDM100 undergo their own performance evaluations against standards, which implicitly represent their "standalone" capability. The statement "Passing IEC 60601-02-25 confirms the safety and accuracy for IDM100 12-lead and 3-lead IDM ECG testing" relates to the standalone performance of the ECG module.

7. Type of Ground Truth Used

• ECG Clinical Testing: The ground truth for the "normal and abnormal ECG patients" is implicitly their clinical presentation/diagnosis as determined by standard clinical practice and the predicate device's output, which the IDM100 was compared against. It's a comparison to a predicate device's output and clinical interpretation, rather than de novo gold standard like pathology or long-term outcomes.
• Other Tests (e.g., Tympanic Thermometer, NIBP): The ground truth for these tests comes from calibrated reference standards as defined by the respective international standards (e.g., EN1060-3 for NIBP).

8. Sample Size for the Training Set

• This document describes a medical device integrating existing, FDA-cleared diagnostic components and a tablet interface for data collection and transmission. It does not mention the use of a machine learning or AI algorithm that would require a distinct "training set" for an AI model.

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

• As the document does not describe the use of a machine learning or AI algorithm requiring a training set, this question is not applicable.

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The Nellcor Portable SpO2 Patient Monitoring System is indicated for prescription use only for spot check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, mobile, and home environments.

The Nellcor Portable SpO2 Patient Monitoring System is a modification of the OxiMax NPB-40 and N-600X Pulse Oximetry Systems. It is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using Nellcor pulse oximetry sensors with OxiMAX technology, and the oximetry sensor cable. The monitor displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The Nellcor Portable Sp02 Patient Monitoring System is powered by four AA batteries.

This document is a 510(k) summary for the Nellcor Portable SpO2 Patient Monitoring System (K141542). It claims substantial equivalence to two predicate devices: OxiMAX NPB-40 Pulse Oximeter (K051352) and N-600X Pulse Oximeter (K123581).

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of acceptance criteria with corresponding performance metrics for the Nellcor Portable SpO2 Patient Monitoring System itself. Instead, it relies on the established performance of its predicate devices and states that its performance is equivalent.

However, it does mention adherence to standards, which imply certain performance expectations:

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

The document leverages clinical data from the predicate devices (K060576 and K123581). Since these studies are not detailed within this document, the specific sample sizes for their test sets and data provenance (e.g., country of origin, retrospective/prospective) are not directly provided in this K141542 summary.

The current device (K141542) underwent non-clinical/bench testing. For the pulse rate accuracy test during motion, it refers to using a "functional tester" and "simulated motion," which implies a test set of situations/scenarios rather than human subjects. The details of this test set are not specified (e.g., number of different motion patterns, duration).

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

This information is not provided in the K141542 summary. As the device relies on clinical data from predicate devices, details about how ground truth was established in those earlier studies (K060576 and K123581) would be necessary for a full answer. For the non-clinical testing of K141542, ground truth would likely be based on calibrated equipment for measurements like pulse rate.

4. Adjudication Method for the Test Set:

This information is not provided in the K141542 summary.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done, nor is it applicable in this context. This device is a pulse oximeter, which directly measures physiological parameters (SpO2 and pulse rate) and presents them to a user. It is not an AI-assisted diagnostic imaging or interpretation tool where human readers would improve with AI assistance.

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

The performance discussed is inherently "standalone" in the sense that it refers to the device's ability to accurately measure SpO2 and pulse rate. The "oximetry performance verification" and "pulse rate accuracy during motion" tests evaluate the device's technical capabilities directly, without requiring human interpretation as part of the core measurement process.

7. The Type of Ground Truth Used:

For the clinical data referenced from K060576 and K123581, the ground truth for SpO2 measurements in pulse oximetry studies typically involves arterial blood gas analysis (co-oximetry) as the gold standard for measuring actual arterial oxygen saturation. For pulse rate, an ECG often serves as the reference.

For the non-clinical testing of K141542, particularly for pulse rate accuracy during motion, the "functional tester" would likely have a precisely controlled and known output for pulse rate, serving as the instrument-based ground truth.

8. The Sample Size for the Training Set:

This document is for a medical device (pulse oximeter) that performs direct physiological measurements, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would refer to its design, engineering, and calibration processes. Therefore, the concept of a "training set sample size" as typically understood for AI is not applicable.

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

As mentioned above, the concept of a "training set" as it applies to AI/ML is not relevant for this specific device. The device's performance is based on its underlying technology and algorithms, which are developed and validated against established physiological principles and measurement standards.

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