(90 days)
This device is capable of monitoring:
- Heart Rate .
- Respiration Rate ●
- Invasive Pressure .
- Non-Invasive Pressure ●
- Arrhythmia ●
- Temperature .
- Arterial oxygen saturation .
- Pulse rate .
- (central) apnea .
- end-tidal 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, trained on the use of the device, 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 Arrhythmia which is not intended for the neonatal population.
The INFINITY SC 6002XL is an addition to Siemens INFINITY patient monitoring series that has combined the technologies of two predicate devices: the INFINITY SC 600X and the INFINITY SC 7000. Like the SC 600X the INFINITY SC 6002XL is a compact, configured monitor whose small size allows for ease of portability. Modifications have been made to the SC 600X software to make it more analogous to the SC 7000 platform. The front panel display is similar in design to the SC 7000 for a more uniform look to the INFINITY product line. In addition to A/B clinical performance tests that compared the new INFINITY SC 6002XL to the SC 7000, in-house verification and validation tests were performed. All tests confirmed that the new INFINITY SC 6002XL is as safe and effective as the predicate devices.
The provided text is a 510(k) Notification for the Siemens INFINITY SC 6002XL Portable Patient Monitor. This type of submission is for medical devices to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and efficacy. Therefore, the document primarily focuses on comparing the new device against existing ones.
As such, detailed acceptance criteria and a study proving the device meets them in the way modern clinical trials would are not present in this type of submission. This document highlights that "in-house verification and validation tests were performed" and "All tests confirmed that the new INFINITY SC 6002XL is as safe and effective as the predicate devices." However, it does not provide the specific metrics, methodologies, or results of these tests in detail.
Thus, most of the requested information cannot be extracted from the provided text.
Here is what can be inferred or stated based on the document:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the 510(k) summary. The document states that "in-house verification and validation tests were performed" and "All tests confirmed that the new INFINITY SC 6002XL is as safe and effective as the predicate devices." This implies that the acceptance criteria were likely based on matching the performance of the predicate devices for each monitored parameter (Heart Rate, Respiration Rate, Invasive Pressure, Non-Invasive Pressure, Arrhythmia, Temperature, Arterial oxygen saturation, Pulse Rate, (central) Apnea, and end-tidal CO2). However, specific numerical acceptance thresholds or detailed performance metrics are not given.
2. Sample size used for the test set and the data provenance:
This information is not provided. The document mentions "A/B clinical performance tests" and "in-house verification and validation tests" but gives no details on sample size, data source (country), or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided.
4. Adjudication method for the test set:
This information is not provided.
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 irrelevant for a patient monitor and certainly not mentioned. Patient monitors like this do not involve "human readers" or "AI assistance" in the way an imaging diagnostic device might.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a patient monitor, which inherently operates in a standalone manner by continuously measuring and displaying physiological parameters. The "algorithm only" aspect would refer to the internal signal processing of the monitor. The document confirms that "in-house verification and validation tests were performed," which would include testing the accuracy and reliability of these internal algorithms. However, a separate "standalone" study in the context of an AI algorithm is not applicable here given the device's function as a physiological monitor.
7. The type of ground truth used:
This information is not provided. For a patient monitor, ground truth would typically be established using validated reference measurement devices or established clinical standards for each physiological parameter.
8. The sample size for the training set:
This information is not provided. For a device like this, there isn't a "training set" in the machine learning sense. The device's algorithms are developed through engineering and validated against known physiological signals and simulated conditions.
9. How the ground truth for the training set was established:
This information is not provided. As noted above, the concept of a "training set" with established ground truth as in machine learning is not directly applicable to this type of device development as described in the 510(k) notice.
§ 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.