(22 days)
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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.