(130 days)
General Patient Monitors is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (BP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.
The proposed device, M Series Patient Monitor (M66, M69, M8000 and M9000) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters. It has the physical and technical alarming function with audio and visual alarming, The device can driven by AC or DC power supply.
The provided text is a 510(k) summary for a general patient monitor. It describes the intended use and states that performance testing was conducted. However, the document does not contain the specific details required to answer your questions about acceptance criteria and the study proving the device meets them.
The summary only states: "Performance testing including clinical and bench testing was conducted to validate and verify that the proposed device, General Patient Monitors met all design specifications." It then concludes with a statement of substantial equivalence to a predicate device.
Therefore, for each of your requested points, the answer is: Not provided in the given text.
Here's a breakdown of why each piece of information is missing:
- A table of acceptance criteria and the reported device performance: This level of detail about specific performance metrics and their acceptance thresholds is not included in the 510(k) summary.
- Sample size used for the test set and the data provenance: The summary mentions "clinical and bench testing" but does not provide any sample sizes, nor does it specify the origin or nature (retrospective/prospective) of any clinical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts, ground truth establishment, or their qualifications.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information on adjudication is provided.
- 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 device is a general patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study in that context would not be applicable, and no such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a monitor, meaning its primary function involves displaying physiological parameters. While it has algorithms for processing data (e.g., heart rate calculation from ECG), the concept of "standalone performance" in the context of an AI diagnostic algorithm is not directly applicable here, and no specific algorithmic performance metrics are detailed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No information about the type of ground truth is provided.
- The sample size for the training set: The document does not discuss any "training set." This type of detail typically applies to machine learning or AI-driven devices, which this patient monitor is not described as.
- How the ground truth for the training set was established: As there is no mention of a training set, there is no information on how its ground truth might have been established.
In summary, the provided 510(k) summary is a high-level document stating that performance testing occurred and the device met design specifications, but it lacks the granular details about the studies and acceptance criteria you are requesting.
§ 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.