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The intended use statement for the device is to measure heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia(only for adults), temperature, SpO2 and central apnea. The device will produce visual and aural alarms if any of the above parameters vary beyond preset limits and produce timed or alarm recordings.

The SC 6000 and SC 6000P Portable patient monitors with neonatal monitoring enhancement are software enhanced versions of the SC 6000 and SC 6000P Portable patient monitors. The software modifications have been undertaken to expand the Intended Patient Population from pediatric and adults to also include neonatal patients.

The provided text describes the Siemens SC 6000 & SC 6000 P Neonatal Monitoring Enhancement, which is a software upgrade to expand the intended patient population of existing monitors to include neonatal patients. The filing is a 510(k) submission, comparing the enhanced device to a predicate device (Siemens SIRECUST 1261).

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly the specifications of the predicate device, as the submission aims to demonstrate substantial equivalence. The reported device performance is the specifications of the SC 6000 & SC 6000 P.

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

The provided text mentions "validation results and other information in this submission" but does not specify the sample size, data provenance (country of origin), or whether the data was retrospective or prospective for any test sets used.

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)

The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for a test set. This type of information is typically related to clinical trials or performance testing involving human interpretation, which is not detailed here.

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

The document does not provide any information about an adjudication method. This is relevant for studies where multiple experts assess data, and discrepancies need to be resolved.

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 applicable. The device is a patient monitoring system, not an AI-assisted diagnostic tool that human readers would use to interpret cases. The submission is for a software enhancement to expand the patient population, focusing on technical specifications for vital sign monitoring.

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

The provided text describes a "software enhanced version" of existing patient monitors. The performance metrics presented (e.g., accuracy of heart rate, SpO2, blood pressure) are inherently "standalone" in the sense that the device outputs these measurements automatically. The "validation results" mentioned implicitly refer to testing the device's ability to accurately measure these parameters without human intervention in the measurement process itself. However, the document does not explicitly describe a study designed to evaluate standalone algorithm performance in isolation from the hardware.

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

Given that this is a patient monitoring device, the ground truth for parameters like heart rate, respiration rate, SpO2, and blood pressure would typically be established using reference medical devices or gold standard measurement techniques. For example:

• Heart Rate/Respiration: Manually counted by trained personnel, or derived from reference ECG/respiration waveforms.
• SpO2: Measured by a highly accurate reference oximeter or blood gas analysis.
• Blood Pressure: Measured directly via arterial line (for invasive) or by a validated reference oscillometric or auscultatory method (for non-invasive).
  However, the document does not explicitly state the type of ground truth used for its validation. It refers to "validation results," but doesn't detail the methodology.

8. The sample size for the training set

The document does not mention any training set or its sample size. This is common for 510(k) submissions for non-AI devices, where performance is often evaluated against engineering specifications and predicate device equivalence rather than machine learning model training.

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

As no training set is mentioned (see point 8), there is no information on how its ground truth was established.

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The intended use of this device is to measure heart rate, respiration rate, invasive pressure, noninvasive pressure, temperature, arterial oxygen saturation and provide ECG ectopic beat and arrhythmic rhythm detection. This device will produce visual and aural alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to the Siemens SIRENET network.

The Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring Systems with Cardiac Arrhythmia Detection Option is an enhanced version of the Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring Systems granted premarket approval under 510 K file number K944350. The enhanced system has modified software to suppor added features. The enhanced software is equivalent to the software used in the Siemens SC 9000 patient monitor. The Siemens SC 6000 & SC 6000 F with Optional Cardiac Arrhythmia Detection System is an enhanced software version of the Siemens SC 6000 & SC 6000 P portable patient monitor. The enhanced version adds cardiac arrhythmia monitoring and a number of user convenience features.

Here's an analysis of the Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring Systems with Cardiac Arrhythmia Detection Option, based on the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance (Cardiac Arrhythmia Detection Option Only)

The document primarily focuses on the Cardiac Arrhythmia Detection Option due to its regulatory classification as Class III and the specific testing mentioned. For other features, the document largely states equivalence to a predicate device or mentions software upgrades without specific, quantified acceptance criteria or performance metrics in this section.

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

• Cardiac Arrhythmia Detection Option: The document references "the AAMI (ECAR-1987) 'Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms' and the FDA 'Guidelines For Submitting Data In Support of Premarket Notification (510(k)) Applications for Arrhythmia Detectors' (1990)." These guidelines typically recommend testing against standardized arrhythmia databases (e.g., MIT-BIH Arrhythmia Database). However, the specific sample size (number of ECG recordings, duration, patients) and precise data provenance (country of origin, retrospective/prospective) are not provided in this summary. It only states that the testing was conducted per the recommended practices.
• Other Features: No specific sample sizes for test sets are mentioned for any other enhanced features. The document generally refers to "validation testing" in Exhibit R.

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

• Cardiac Arrhythmia Detection Option: The document explicitly states that the testing followed AAMI and FDA guidelines for arrhythmia detection algorithms. These guidelines typically rely on expert-annotated databases where ground truth (e.g., arrhythmia labels, QRS complex identification) has been established by cardiologists or other qualified experts. However, the precise number of experts or their qualifications for the specific test set used are not detailed in this summary. It is implied that standard, independently annotated databases were used.
• Other Features: Not applicable, as detailed ground truth establishment for these features is not discussed in the provided text.

4. Adjudication Method for the Test Set

• Cardiac Arrhythmia Detection Option: For algorithm validation against standardized databases (as implied by AAMI/FDA guidelines), the ground truth in these databases is often established through expert consensus, typically involving multiple cardiologists to resolve discrepancies. However, the specific adjudication method for the test set used (e.g., N+1, N-way consensus) is not explicitly stated in this summary.
• Other Features: Not applicable.

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

• No, the document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the performance of the device's arrhythmia detection algorithm itself, comparing it to established guidelines and a predicate device. There is no mention of human readers or the effect size of AI assistance on human performance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, a standalone performance study of the Cardiac Arrhythmia Detection Option was performed. The document states: "the SC 6000 & SC 6000 P Cardiac Arrhythmia Detection system has been tested using the test and results reporting called out in the AAMI (ECAR-1987) "Recommended Practice for Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms" and the FDA "Guidelines For Submitting Data In Support of Premarket Notification (510(k)) Applications for Arrhythmia Detectors" (1990)." This implies testing the algorithm's performance against a ground truth database without human intervention during the detection process.
• The results for "IRIS Arrhyhtmia Test QRS Classifiaciton Performance Consecutive VEB Performance Ventricular Fibrillation Performance Ventricular Tachicardia Performance" are referenced in Exhibit R.

7. Type of Ground Truth Used

• Cardiac Arrhythmia Detection Option: The ground truth used for testing would be based on expert consensus annotations of ECG waveforms from standardized arrhythmia databases, as mandated by the AAMI and FDA guidelines referenced. This ground truth includes accurate identification and labeling of QRS complexes, ventricular ectopic beats (VEBs), ventricular tachycardia, and ventricular fibrillation episodes.
• Other Features: For other features like temperature alarms or respiration rate improvements, the ground truth would likely involve physical measurements against calibrated standards or human observation/annotation of physiological parameters. However, specific details are not provided in this text.

8. Sample Size for the Training Set

• The document does not provide any information regarding the sample size used for the training set for the software algorithms. This information is typically proprietary and not often disclosed in 510(k) summaries, which focus on testing and validation.

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

• The document does not provide any information regarding how the ground truth for the training set was established. Similar to the training set size, details on model development and training methodologies are generally not included in this type of regulatory summary. It can be inferred that if the algorithm was trained on similar data to what it was tested on, the training ground truth would also be established by expert annotations or standardized measurements.

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