Search Results

This device is capable of monitoring:

• heart rate
• respiration rate
• invasive pressure
• non-invasive pressure
• arrhythmia
• temperature
• cardiac output
• arterial oxygen saturation
• pulse rate
• cardiac output
• end-tidal carbon dioxide and (central) apnea.

This device can be connected to third party devices. Siemens SV300™ ventilator and the Baxter Vigilance™ blood gas/continuous cardiac ourput monitor. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will devermine when use of the device is indicated, based upon their professional assessment of the patient's medical condition. The device is intended to be used on Adult, Pediatric and Noonatal populations, with the exception of the parameter Cardiac Output which is intended for use in the adult and pediaric populations only; and Arrhythmia which is intended for use in the adult population only.

The Siemens SC9000/ SC9015 Bedside Monitoring System with modified Arrhythmia Monitoring is an updated software version of the Siemens SC900/ SC9015 Bedside Monitoring System. The modification improves the detection and monitoring of arrhythmia. The hardware of the SC9000/SC9015 is unchanged.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the arrhythmia monitoring functionality:

Acceptance Criteria and Reported Device Performance

The device's performance is compared against the predicate device through software modifications designed to improve arrhythmia detection. The key performance metrics are related to the accuracy and range of the ECG and QRS detection.

Note: The primary "acceptance criteria" here are implied by the claim that the "Clinical performance is equal to, or surpasses that of the predicate device" and compliance with specific AAMI and FDA guidelines. The table highlights where the modified device directly matches or improves upon the predicate.

Study Details

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

   • The document states that the "assessment of clinical performance is attached in appendix V," but Appendix V is not provided. Therefore, the specific sample size, country of origin, and whether the data was retrospective or prospective for the clinical performance assessment cannot be determined from the provided text.
   • However, the device's design and testing comply with AAMI (ECAR - D-94) "Draft: Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms' March 1994," and FDA "Guidelines for Submitting Data in Support of Pre-market Notification (510(K)) Applications for Arrhythmia Detectors (1990)." These guidelines typically specify protocols for test data and datasets.

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

   • This information is not explicitly stated in the provided text. The document refers to "assessment of clinical performance" but does not detail how ground truth was established or the number/qualifications of experts involved.

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

   • This information is not explicitly stated in the provided text.

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 comparative effectiveness study involving human readers and AI assistance is mentioned. The device described appears to be a standalone monitoring system, not primarily an AI-assisted diagnostic tool for human readers in the context of image interpretation or similar. The "AI" would be the arrhythmia detection algorithm itself, which is integrated into the monitoring system.

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

   • Yes, a standalone assessment of the algorithm's performance was done. The entire submission focuses on the "modified arrhythmia algorithm" in the Siemens SC9000/SC9015 Bedside Monitoring System. The device directly processes physiological signals (ECG) to detect and monitor arrhythmia. The compliance with AAMI (ECAR - D-94) guidelines specifically for "Ventricular Arrhythmia Detection Algorithms" indicates a standalone algorithmic evaluation.

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

   • While not explicitly stated for the clinical assessment, for arrhythmia detection algorithms complying with standards like AAMI, ground truth is typically established through expert annotation of ECG waveforms. This involves cardiologists or trained technicians meticulously marking arrhythmia events on reference ECG databases.

7. The sample size for the training set:

   • This information is not explicitly stated in the provided text. The document describes an "updated software version" and "modified arrhythmia algorithm," implying a development and potentially a training phase, but details of the training set are absent.

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

   • This information is not explicitly stated in the provided text. Similar to the test set, it would typically involve expert annotation of ECG waveforms, but the specifics are not provided.

Ask a specific question about this device

This device is capable of monitoring heart rate, respiration rate, invasive pressure, non-invasive pressure, arthythmia (adult only), temperature, cardiac output (adult only), arterial oxygen saturation, pulse rate, end-tidal carbon dioxide and (central) apnea and ST Segment Analysis (adult only). This device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The Siemens SC9000/ SC9015 Bedside Monitoring System enhanced with ST Segment Analysis is an updated software version of the Siemens SC9000/ SC9015 Bedside Monitoring System. The modification adds software to determine the ST Segment of the ECG signal and to compute the deviation of this ST Segment from the iso-electric point (baseline). This is the same algorithm that is used in the Siemens 1481(T) Digital Telemetry System with S-T Segment Analysis Option (K951371). The hardware of the SC9000/SC9015 is unchanged.

The ST Segment Analysis is not active when the Siemens SC9000/SC9015 Monitor is in the neonatal functionality

The modified software (version VB2) is compatible with previously sold versions of the monitor. A retrofit will be offered to the owners of units with previous software versions. There are no hardware changes required for the upgrade.

Here's an analysis of the provided 510(k) summary regarding the Siemens SC9000/SC9015 Bedside Monitoring System enhanced with ST Segment Analysis:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the stated accuracy improvements.

Study Proving Acceptance Criteria:

The submission states: "Performance was qualified by testing versus a standard clinical patient database per AAMI recommendations."

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

• Sample Size: Not explicitly stated. The document only mentions "a standard clinical patient database."
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is referred to as a "standard clinical patient database."

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

Not explicitly stated. The document refers to "standard clinical patient database per AAMI recommendations," implying a pre-existing, validated dataset where ground truth would have been established, but the details of its establishment are not part of this submission.

4. Adjudication Method for the Test Set

Not explicitly stated.

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

No, an MRMC comparative effectiveness study was not done. The submission focuses on the standalone performance of the device and its comparison to a predicate device based on technical specifications and database testing.

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

Yes, a standalone performance evaluation was done. The document states, "Performance was qualified by testing versus a standard clinical patient database." This implies evaluating the algorithm's output against the ground truth derived from the database, without a human in the loop interpretating the device's results.

7. The Type of Ground Truth Used

The ground truth was established by a "standard clinical patient database per AAMI recommendations." This suggests that the database contains reference ST segment measurements and related ECG annotations established through expert consensus or other validated methods that align with AAMI (Association for the Advancement of Medical Instrumentation) guidelines for ECG analysis.

8. The Sample Size for the Training Set

Not explicitly stated. The 510(k) summary focuses on the performance of the algorithm (which was previously cleared in K951371) in a new monitoring system, rather than the development of the algorithm itself. Therefore, training set details are not provided here.

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

Not explicitly stated. As mentioned above, the submission pertains to the application of an existing algorithm to a new device, not the development of the algorithm.

Ask a specific question about this device

The intended use of this device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, cardiac output, arterial orygen saturation, pulse rate, cardiac output, end-tidal carbon dioxice and (central) apnea. This device will produce visual and alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to the Siemens SIRENET or Infinity (Olympus) network.

The Siemens SC900V SC9015 Bedside Monitoring System, with enhanced Neonatal Functionality is an enhanced software version of the Siemens SC9000/ SC9015 Bedside Monitoring System. The enhancement adds neonatal monitoring.

This 510(k) notification describes an enhanced software version of an existing bedside monitoring system, adding neonatal functionality. The submission does not contain a study that establishes acceptance criteria and proves the device meets them in the traditional sense of an AI/algorithm-driven device performance study. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Siemens Sirecust 1260/1261/960961 series Neonatal Monitoring system, K952054) by comparing features and default settings.

Here's an analysis based on the provided text, addressing your points where possible, and noting where information is not present:

Description of Acceptance Criteria and Device Performance Study

The document outlines changes to default settings for various monitoring parameters in the enhanced Siemens SC9000/SC9015 Bedside Monitoring System with Neonatal Functionality. The "acceptance criteria" here are implicitly tied to the performance and safety of the predicate device, as the new device is an enhanced software version. The study to "prove" the device meets acceptance criteria is not a separate performance study, but rather a comparison of specifications and features to the predicate device, with an explanation for any differences.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a comparison to a predicate device and not a standalone performance study with defined acceptance criteria, a direct table of "acceptance criteria" for the new device's performance metrics isn't provided. Instead, the document compares default settings with the predicate device. The "reported device performance" refers to these new default settings.

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

Not applicable. This submission is for enhanced software functionality, and there is no mention of a "test set" in the context of clinical performance data in this document. The assessment explicitly states "Assesment of non-clinical performance data for equivalence: Not applicable" and "Assesment of clinical performance data for equivalence: Not applicable." This indicates that a separate performance study with a test set was not conducted or reported in this 510(k) summary for the purpose of demonstrating equivalence.

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

Not applicable. No ground truth establishment by experts is mentioned as part of this submission, as no new performance study was reported.

4. Adjudication Method for the Test Set

Not applicable. No test set mentioned.

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

No. This submission is for a bedside monitoring system with enhanced software. MRMC studies are typically for imaging or diagnostic algorithms where human readers interpret results, and an "AI" component would assist. This is not the type of device for which an MRMC study would typically be conducted.

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

No. The device is a monitoring system that provides measurements to clinicians. The "enhancements" are in software that impacts default settings for these measurements, not a standalone diagnostic algorithm.

7. The type of ground truth used

Not applicable. As no new clinical performance study was conducted to establish new performance metrics, the concept of "ground truth" for a test set is not discussed. The "ground truth" in this context is implicitly the established reliability and safety of the predicate device, and the modifications are presented as merely changes to default settings based on user preference without altering fundamental measurement accuracy or safety (which would typically require new performance data).

8. The sample size for the training set

Not applicable. This document is not describing an AI/machine learning algorithm that requires a training set. It's an enhancement to existing monitoring software.

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

Not applicable. No training set is mentioned.

Summary of the Document's Approach:

This 510(k) notification relies on demonstrating substantial equivalence to an existing cleared device. The "study" here is essentially a comparison of the new device's specifications and default settings to those of the predicate device. Where differences exist (e.g., apnea delay time, heart rate limits, SpO2 pulse limit), the explanation is typically "customer preference" or a similar justification, implying these changes do not alter the fundamental safety or effectiveness of the device compared to the predicate. The document explicitly states that both non-clinical and clinical performance data for equivalence are "Not applicable," meaning no new studies were submitted to confirm the performance of these changed parameters.

Ask a specific question about this device