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The SC 8000 Bedside monitor with Advanced Communication Option is capable of monitoring:

• Heart rate .
• . Respiration rate
• Invasive pressure .
• Non-invasive pressure ●
• Arrhythmia .
• Temperature
• Cardiac output
• Arterial oxygen saturation ●
• Pulse rate .
• (central) apnea
• . ST Segment Analysis
• . 12-Lead ST Segment Analysis

With the MultiGas™ and MultiGas+™ modules the SC8000 is capable of measuring:

• Respiration rate
• . Inspired and expired Carbon Dioxide (CO2)
• Inspired and expired Oxygen (MultiGas+TM only) .
• . Average inspired Oxygen (MultiGasTM only)
• Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Sevoflurane, . and Nitrous Oxide.

The SC 8000 Bedside Monitor can interface with third party devices.

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 determine 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 Neonatal populations, with the exception of the parameter Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediatric populations only; Arrhythmia which is intended for use in the adult population only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

Siemens SC 8000 Bedside Monitor with Advanced Communication Option

This document is a 510(k) premarket notification letter from the FDA to Siemens Medical Systems for their SC 8000 Bedside Monitor with Advanced Communication Option. It informs Siemens that their device has been found substantially equivalent to legally marketed predicate devices.

The document does not contain information about specific acceptance criteria, a study proving the device meets these criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about training sets. These types of details are typically found in the clinical study reports or technical documentation submitted as part of the 510(k) application, not in the FDA's clearance letter itself.

The provided text only includes:

• Device Name: Siemens SC 8000 Bedside Monitor with Advanced Communication Option
• Intended Use/Indications for Use: A list of parameters the device is capable of monitoring (Heart rate, Respiration rate, Invasive pressure, Non-invasive pressure, Arrhythmia, Temperature, Cardiac output, Arterial oxygen saturation, Pulse rate, (central) apnea, ST Segment Analysis, 12-Lead ST Segment Analysis, Inspired and expired Carbon Dioxide (CO2), Inspired and expired Oxygen, Average inspired Oxygen, Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Sevoflurane, and Nitrous Oxide). It also specifies the intended user (Healthcare Professionals) and patient populations (Adult, Pediatric, Neonatal with specific exceptions).
• MRI Compatibility: Not compatible for use in an MRI magnetic field.
• Regulatory Class: III
• Product Code: MXH
• Date of Clearance: March 25, 1999 (correcting an earlier letter from March 19, 1999)

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, and other performance-related information based on the provided text.

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The SC 8000 Bedside monitor is capable of monitoring:

• . Heart rate
• Respiration rate .
• Invasive pressure .
• Non-invasive pressure .
• Arrhythmia ●
• Temperature .
• Cardiac output .
• Arterial oxygen saturation .
• . Pulse rate
• (central) apnea ●
• ST segment analysis .
• 12-Lead ST Segment Analysis ●
• tcpO2/CO2 .

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 determine 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 Neonatal populations, with the exception of the parameter Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediatric populations only; Arrhythmia which is intended for use in the adult population only; and tcpO2/CO2 which is to be used in the neonatal population only.

The SC 8000 bedside monitor is a modified version of the SC 7000/SC 9000XL INFINITY Modular Bedside Monitors (K982730). The SC 8000 supports all SC 7000 software based options and offers all of the standard I/O connections of the SC 7000 plus interface plate. The hardware has been reengineered as a unit without a display that allows customers the option of providing their own medical-grade display.

The Siemens SC 8000 Bedside Monitor is a modified version of the SC 7000/SC 9000XL INFINITY Modular Bedside Monitors. This device is intended to monitor various physiological parameters and produce alarms if these parameters vary beyond preset limits.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria or provide a table of performance data for the SC 8000 Bedside Monitor. The document focuses on establishing substantial equivalence to a predicate device (Siemens SC 7000/SC9000 XL INFINITY Modular Bedside Monitors, K982730) rather than presenting a detailed performance study with defined acceptance criteria for the new device.

The "Intended Use" section lists the parameters the device is capable of monitoring, but it does not specify performance metrics (e.g., accuracy, sensitivity, specificity, or error margins) for these parameters.

Therefore, I cannot generate the requested table of acceptance criteria and reported device performance from the provided text.

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

The document states, "Assessment of non-clinical performance data for equivalence: See Section L" and "Assessment of clinical performance data for equivalence: Not applicable." This indicates that clinical performance data was not considered applicable for demonstrating equivalence.

Since no clinical performance study for the SC 8000 is described, there is no information on sample size, test set, or data provenance (country of origin, retrospective/prospective).

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

As no clinical performance study is described as applicable for the SC 8000, there is no information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method

Given that no clinical performance study or ground truth establishment for the SC 8000 is described, there is no information on an adjudication method.

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

The document states, "Assessment of clinical performance data for equivalence: Not applicable." This clearly indicates that a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or considered necessary for this submission. Therefore, there is no information on the effect size of human readers with vs. without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document does not describe any standalone algorithm performance studies for the SC 8000. The focus is on the device's functional capabilities and its equivalence to a predicate device, not on the performance of a specific embedded algorithm in isolation. Therefore, no standalone performance study is explicitly mentioned.

7. Type of Ground Truth Used

As clinical performance data was deemed "Not applicable" for this submission, the document does not specify the type of ground truth used for evaluating the SC 8000's performance. The equivalence relies on the predicate device's established performance and the changes being non-substantive from a clinical perspective.

8. Sample Size for the Training Set

The document does not describe the development or training of any algorithms for the SC 8000. It refers to the device as a "modified version" of existing monitors. Therefore, there is no information regarding the sample size for a training set.

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

Since no training set is described (as per point 8), there is no information on how the ground truth for a training set was established.

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