(238 days)
The indications for use for the Atlas Monitor, model numbers 200, 210, and 220, include the monitoring of the following human physiological vital signs:
- O Blood Oxygenation (SpO2) measurement
- O ECG waveform derived from 3 or 5 Lead measurement
- Q Respiration rate/waveform derived from ECG or CO2
- □ Temperature measurement via YSI 400 series probes
- വ Non Invasive Blood Pressure (NIBP) measurement
- CO₂, End-tidal sidestream/waveform
- O Heart Rate derived from selected source (ECG, SpO2)
The target populations are adult and pediatric populations. The monitor is intended for use within the healthcare facility setting.
The Atlas Monitor (including model numbers 200, 210, and 220) is a multiparameter device used to monitor human physiological vital signs. It combines a CRT to display ECG and CO2 waveforms and LED's for other numeric values. An optional printer is available on models 200 and 210 and it comes standard for 220 model.
Here's a breakdown of the acceptance criteria and study information for the Welch Allyn Atlas Monitor based on the provided text, using the specified format:
Acceptance Criteria and Device Performance
The provided document describes the Welch Allyn Atlas Monitor as substantially equivalent to predicate devices for monitoring various physiological vital signs. As such, the acceptance criteria are mainly tied to safety standards and functional performance comparable to legally marketed predicate devices. The document does not provide a table with specific numerical acceptance criteria (e.g., accuracy ranges for SpO2, NIBP) and corresponding reported performance metrics for this particular device. Instead, it states that the device "performs within its design parameters as well as the legally marketed predicate devices" and conforms to several safety standards.
Therefore, a table of specific numerical acceptance criteria and reported device performance cannot be generated directly from the provided text. The effectiveness is summarized qualitatively, stating the device utilizes "currently available technology found in many legally marketed devices" and "performs within its design parameters."
Study Information
Based on the provided "510(k) SUMMARY," the primary "study" proving the device meets acceptance criteria is a demonstration of substantial equivalence to predicate devices and adherence to relevant safety standards. This is typical for a 510(k) submission. No detailed clinical trial or performance study with specific metrics, sample sizes, or expert involvement is described in the provided document.
Here's a breakdown of the requested information, acknowledging the limitations based on the provided text:
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A table of acceptance criteria and the reported device performance
As explained above, the provided document does not contain a discrete table with numerical acceptance criteria and reported performance metrics for the Atlas Monitor. The effectiveness summary is qualitative, indicating conformity to design intent and legal predicate devices.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a test set sample size or data provenance for performance evaluation. The "completed design reviews and scheduled testing" are mentioned, but no specifics about the nature or scope of this testing are provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
No information is provided regarding the use of experts to establish ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
No information is provided regarding adjudication methods for a test set.
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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 vital signs monitor, not typically an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned in the document.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document does not describe a standalone algorithm performance study. The device is a "multiparameter device used to monitor human physiological vital signs," implying direct measurement and display, rather than a separate algorithm's performance being evaluated.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in the context of diagnostic accuracy (like pathology for imaging) is not directly applicable or discussed for this vital signs monitor in the provided text. The primary "truth" being evaluated is the device's ability to accurately measure physiological parameters compared to established, legally marketed predicate devices and safety standards.
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The sample size for the training set
The document does not describe a "training set" as would be used in machine learning or AI development. The device's design is based on "currently available technology."
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How the ground truth for the training set was established
Since a "training set" is not described, the method for establishing its ground truth is not provided.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).