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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 ZOLL E Series® Defibrillator is designed for all emergent care situations and provides multi-parameter monitoring of patients in critical care and transport. The ZOLL E Series combines defibrillation, CPR feedback, ECG monitoring, noninvasive transcutaneous pacing, pulse oximetry (SpO2), end tidal CO2 (EtCO2), 12-Lead ECG monitoring, non-invasive blood pressure measurement (NIBP), and data printing and recording in a single instrument.

The proposed enhancement, the ZOLL E Series® with SpCO/SpMet Option, is intended to provide personnel trained in its use with the ability to monitor carbon monoxide concentration in arterial blood and oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.

Defibrillator Function: The E Series products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team.

Intended Use - Manual Operation: Use of the E Series products in the manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In manual mode, the E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate. The advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).

Intended Use - Semiautomatic Operation (AED): The E Series AED unit is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation.

Intended Use - CPR Monitoring: The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.

External Pacemaker (Pacer Version Only) Intended Use - Pacemaker: This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia.

Pediatric Pacing: Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.

Monitor Intended-Use Multi-parameter Monitoring: This product may be used for monitoring various patient vital signs, including, electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP).

ECG monitoring is performed by connecting the patient to the unit via the 3 or 5 lead patient cable, MFE Pads, or through the paddles.

SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.

SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.

SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.

EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients.

12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias.

NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

The ZOLL E Series® Defibrillator, which was originally reviewed and cleared by the FDA under premarket notification K042007, is designed for all emergent care situations and provides multi-parameter monitoring of patients in critical care and transport. The ZOLL E Series combines defibrillation, CPR feedback, ECG monitoring, noninvasive transcutaneous pacing, pulse oximetry (SpO2), end tidal CO2 (EtCO2), 12-Lead ECG monitoring, non-invasive blood pressure measurement (NIBP), and data printing and recording in a single instrument. The proposed enhancement, the ZOLL E Series® with SpCO/SpMet Option, is intended to provide personnel trained in its use with the ability to monitor carbon monoxide concentration in arterial blood and oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.

This 510(k) summary (K092598) describes the ZOLL E Series® Defibrillator with an added SpCO/SpMet Option. The device is a multi-parameter monitor and defibrillator, and the new option allows for monitoring of carbon monoxide (SpCO) and oxidized hemoglobin (SpMet) in arterial blood.

The submission claims substantial equivalence to existing devices and technologies. A critical point is that the SpCO/SpMet option is achieved by integrating the "Masimo Rainbow™ SET® technology," which was previously reviewed and cleared by the FDA under 510(k) K061204. This implies that the performance testing for SpCO/SpMet was conducted as part of the Masimo Rainbow™ SET® technology's clearance, and the current submission leverages that prior clearance.

Therefore, for aspects related to SpCO and SpMet monitoring, the detailed study information regarding acceptance criteria, sample sizes, ground truth establishment, etc., would primarily be found in the K061204 submission for the Masimo Rainbow™ SET® Radical 7 Pulse CO-Oximeter, rather than in this K092598 summary.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Extensive performance testing ensures that the ZOLL E Series Defibrillator meets all of its functional requirements and performance specifications." However, it does not provide specific numerical acceptance criteria or performance metrics for the new SpCO/SpMet option within this summary. It relies on the prior clearance of the Masimo Rainbow™ SET® technology (K061204).

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

The provided document (K092598) does not specify the sample size for a test set for the SpCO/SpMet option, nor does it provide data provenance (country of origin, retrospective/prospective). This information would likely be detailed in the supporting documentation for K061204.

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

This information is not provided in K092598. This would have been established during the clearance of the Masimo Rainbow™ SET® technology (K061204).

4. Adjudication Method for the Test Set:

This information is not provided in K092598. This would have been established during the clearance of the Masimo Rainbow™ SET® technology (K061204).

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

No MRMC comparative effectiveness study is mentioned in this submission (K092598) regarding the SpCO/SpMet option. The focus is on integrating an already cleared technology.

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

The SpCO/SpMet option is a monitoring device intended to display values to a human user. While the underlying algorithm operates in a standalone manner to generate the SpCO and SpMet values, the device itself is not typically evaluated in the context of "algorithm only without human-in-the-loop performance" in the way an AI diagnostic tool might be. Its performance would be assessed against a gold standard in terms of accuracy of its readings, which implies a standalone performance of the technology. This would have been established during the clearance of the Masimo Rainbow™ SET® technology (K061204).

7. The Type of Ground Truth Used:

For pulse co-oximetry devices like those measuring SpCO and SpMet, the ground truth is typically established through measured arterial blood gas (ABG) values analyzed by a laboratory co-oximeter. This is generally considered the "gold standard" for blood gas analysis. This information would have been part of the K061204 submission.

8. The Sample Size for the Training Set:

The provided document (K092598) does not mention a training set or its sample size. The algorithm (Masimo Rainbow™ SET® technology) was already developed and cleared.

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

This information is not provided in K092598. The ground truth for the development of the Masimo Rainbow™ SET® technology (K061204) would have been established using clinically acquired arterial blood samples analyzed by a laboratory co-oximeter.

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