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The indications for use for the Atlas Monitor, model numbers 200, 210 and 220 include the monitoring o the following human physiological vital signs:

• Blood Oxygenation (SpO2) measurement .
• ECG waveform derived from 3 or 5 lead measurement .
• Respiration rate/waveform derived from ECG or CO2 e
• Temperature measurement via YSI 400 series probes .
• Non-Invasive Blood Pressure (NIBP) measurement .
• CO2 End-Tidal side stream/waveform .
• Heart Rate derived from selected source (ECG, SpO2) .
  The target populations are adult and pediatic populations. The monitor is intended for use within the healthcare facility setting.

The Atlas Monitor is a multi-parameter 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. There are (3) different models available.

The ECG front end will meet all applicable AAMI and harmonized EU standards (see safety reference section for particular standards). The Atlas Monitor will provide a 5 wire front end and will be compatible with both a 3 wire and 5 wire cable. Diagnostic (0.05Hz to 100Hz) and monitor (0.5Hz to 40Hz) bandwidth will be provided. The corresponding ECG waveform is displayed on the CRT. User can select which lead the monitor is displaying. If optional printer is installed that waveform can be printed.
The SpO2 value is obtained by the measurement of the red and infrared light absorbed by the patient's tissue. A probe, consisting of a detector and emitter, is placed on a patient at a point where profusion of a body part is close to the skin surface, like a hand digit. The changes in absorption are used to determine oxygen saturation and heart rate. The pulse signal graph LED bar indicates the relative strength of the pulses detected by the SpO2 module. The control board requires a single voltage input and generates all the necessary internal voltages. Communication to the Atlas Main board is via an internal serial communication interface. The SpO2 capability in Atlas is obtained by the utilization of OEM modules.
The NIBP portion of the Atlas monitor utilizes the oscillometric method of blood pressure determination. In this method, the patient's arm is compressed and blood flow occluded through the use of a cuff and bladder combination. Each time the patient's heartbeats, a slight variation of pressure occurs in the cuff. The cuff pressure is decreased in a step fashion. The device measures and catalogs the pressure pulses at each step in cuff pressure. The patient's systolic and diastolic pressures are determined through the examination of these pulses.
The temperature portion of the Atlas monitor uses well established precision YSI 400 probes to monitor surface temperature of a patient. The YSI probes work on the principle of interchangeable thermistors (NTC Type) that exhibits a steep drop in resistance as temperature changes, providing high sensitivity to temperature changes.
The impedance respiration feature utilizes the ECG lead set and patient surface ECG electrodes, together with additional electronics processing. The respiration rate in breaths/minute is displayed in numerical format on the CRT.
The end tidal CO2 (ETCO>) measurement is performed by utilizing an OEM PCB from Prvon Corporation. The Pryon side stream CO2 control board (LC101) is designed to acquire CO2 data utilizing an on board pump to aspirate a patient gas sample. Employing a proprietary side stream sensor, the C-cap bench. Patient waveform is obtained. The sensor is based on single beam single frequency and dual thermopile detector. The control board requires a single voltage input and generates all the necessary internal voltages. The control board outputs the CO2 waveform and performs all calculations for CO2 data and respiration rate, Communication to the Atlas main board is via an internal serial communication interface.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Welch Allyn Atlas Monitor. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain the detailed performance testing results, acceptance criteria, or study design information typically found in a clinical study report or a more comprehensive validation document.

Therefore, I cannot populate most of the requested fields because the information is not present in the provided text.

Here's what can be extracted:

Acceptance Criteria and Device Performance (Limited Information)

Missing Information (Not found in the provided text):

2. Sample size used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This type of device does not typically rely on expert human interpretation for its outputs like an AI diagnostic tool would. Its performance is validated against established measurement standards for vital signs.
4. Adjudication method: Not applicable/specified.
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: Not applicable. This is a vital signs monitor, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The monitor operates standalone in terms of its vital signs acquisition and display. The summary indicates it was "tested and found to comply with recognized national and international performance, safety and electromagnetic compatibility standards," which implies standalone performance evaluation against these standards. However, specific details of these tests are not provided.
7. The type of ground truth used: For vital signs monitors, ground truth is typically established using calibrated reference devices or validated physiological models according to recognized standards (e.g., AAMI, ISO standards). The document states compliance with "recognized national and international performance, safety and electromagnetic compatibility standards," which would implicitly define the ground truth methods used, but doesn't explicitly state them.
8. The sample size for the training set: Not applicable. This product is a vital signs monitor, not an AI/machine learning device that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

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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:

1. 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.

2. 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.

3. 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.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   No information is provided regarding adjudication methods for a test set.

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 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.

6. 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.

7. 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.

8. 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."

9. 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.

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