(88 days)
The SC 7000 and SC 9000XL INFINITY Modular Bedside monitors are capable of monitoring:
- Heart rate
- Respiration rate
- Invasive pressure
- Non-invasive pressure
- Arrhythmia
- Temperature
- Cardiac output
- Arterial oxygen saturation
- Pulse rate
- End-tidal carbon dioxide
- (central) apnea
- ST segment analysis
With the MultiGas™ and MultiGas+™ modules the SC 7000 and SC 9000XL are capable of measuring:
- Respiration rate
- Inspired and expired Carbon Dioxide (CO2)
- Inspired and expired Oxygen (MultiGas+TM only)
- Average inspired Oxygen (MultiGas™ only)
- Inspired and expired gas concentrations of Enflurane, Isoflurane, Desflurane, Desflurane, Sevollurane, and Nitrous Oxide.
The SC 7000 and SC 9000XL can interface with third party devices.
The devices are intended to be used in the environment where patient care is provided by Healtheare. 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 devices are 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; and Arrhythmia which is intended for use in the adult population only.
The SC 7000 and SC 9000XL modular bedside monitors are enhanced versions of the SC 9000 (predicate device - original submission K946306) and use the same front panel display and user interface as the SC 9000. In addition, the SC 9000 docking station is compatible with the SC 7000 and SC 9000XL for power and communication capabilities.
The SC 7000 (mid-level monitor) and the SC 9000XL (high-end monitor) are additions to the Siemens INFINITY Modular Portable Bedside Monitoring Series. Both the SC7000 and SC 9000 XL utilize the same electronics and software, but with different base configurations and available options.
I am sorry, but the provided text does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving device performance for the Siemens SC7000 and SC9000XL INFINITY Modular Bedside Monitors.
The document is a 510(k) notification and summary, which primarily establishes substantial equivalence to a predicate device (Siemens SC9000). It focuses on:
- Device Description: Explains that the SC7000 and SC9000XL are enhanced versions of the SC9000 and share electronics/software.
- Intended Use: Lists the physiological parameters the devices are intended to measure and alarm functions.
- Predicate Device Identification: Specifies the Siemens SC9000 as the predicate.
- Table of Device Similarities and Differences: Compares the new devices to the predicate in terms of manufacturer, intended use, population, environment, display, waveforms, and various measurement capabilities, noting mostly "Same."
- Assessment of non-clinical and clinical performance data for equivalence: The document refers to Sections U and V for this assessment but does not include the content of these sections.
- FDA Letter: Confirms substantial equivalence but does not detail performance studies.
- Indications for Use: Reiterates the parameters monitored and populations.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This level of detail regarding specific performance metrics and their acceptance thresholds, along with the device's actual measured performance, is not present.
- Sample sizes used for the test set and the data provenance: No information on test set sample sizes or data origin is provided.
- Number of experts used to establish the ground truth for the test set and their qualifications: No mention of experts or ground truth establishment for a test set.
- Adjudication method for the test set: Not discussed.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No mention of such a study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not discussed, as this device does not appear to be an AI/algorithm-only device in the context usually implied by this question. It's a physiological monitor.
- The type of ground truth used: Not specified.
- The sample size for the training set: Not applicable for a traditional physiological monitor without AI/machine learning training sets in the modern sense.
- How the ground truth for the training set was established: Not applicable.
The document focuses on establishing substantial equivalence to a legally marketed predicate device, which is a different regulatory pathway than providing detailed performance studies for novel AI/algorithm-driven devices with specific acceptance criteria. For physiological monitors like these, compliance is typically demonstrated through engineering testing, adherence to recognized standards, and comparison of specifications to the predicate device, rather than the types of clinical studies you've outlined for AI.
§ 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.