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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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The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead / 5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). A 2-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from children (pediatric) to adults when using the appropriate BCI accessories.

The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor. The monitor is not intended for neonatal use.

The BCI 9200 Vital Signs Monitor is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a table top design. The system features an ECG cable interface, two invasive pressure interfaces, two YSI compatible temparature interfaces, an NBP cuff hose connection, an SpO2 probe interface, the optional internal printer, display of patient and waveform data via a color LCD, system power status LEDs, a rotary control knob and the function keypad area consisting of five keys ( on/off, zero (IP zero), NIBP start/stop, print start/stop & alarm silence). The monitor has a serial port that is used for data communications.

Here's a breakdown of the acceptance criteria and the studies performed for the BCI 9200 Vital Signs Monitor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Oximetry: Not explicitly stated, though a "deep desaturation test" was run on the OEM board. It was done at the VA Medical Center in Milwaukee. The data provenance is prospective (clinical study with volunteers).
• Respiration: 31 volunteers. The test was conducted at BCI. Data provenance is prospective (clinical study with volunteers).
• NIBP (Mini-Study): 31 volunteers. The test was conducted at BCI. Data provenance is prospective (clinical study with volunteers).
• NIBP (SP-10 Testing): Not explicitly stated, but conducted under an approved IRB. Conducted at the VA Medical Center in Milwaukee and at BCI International. Data provenance is prospective (clinical study with volunteers).
• Bench Tests (all parameters): 3 devices were tested on simulators. Data provenance is internal lab testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• Oximetry: Values compared to an OSM-3 co-oximeter. The co-oximeter serves as the reference standard, not human experts for ground truth.
• Respiration: Values compared to a BCI 9004 Capnograph (CO2 gas monitor). The capnograph serves as the reference standard, not human experts.
• NIBP (Mini-Study): A "single human observer taking a manual NIBP reading" on the same arm. The qualifications of this observer are not specified.
• NIBP (SP-10 Testing): Compared to "the average of the manual readings." It is implied that multiple manual readings were taken, but the number of observers and their qualifications are not specified.
• Bench Tests: Ground truth established by commercially available simulators with known settings. No human experts involved in establishing ground truth.

4. Adjudication Method for the Test Set

• Oximetry, Respiration, Bench Tests: Comparison to a reference device/simulator. No human adjudication method described.
• NIBP (Mini-Study): Direct comparison to a single human observer's manual reading. No adjudication described.
• NIBP (SP-10 Testing): Compared to "the average of the manual readings." This averaging serves as a form of consensus/adjudication for the manual readings but no explicit adjudication process between multiple observers is detailed beyond that.

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

• No, an MRMC comparative effectiveness study was not done. This document describes a traditional medical device performance study, not an AI-based diagnostic tool study. Therefore, there is no mention of AI assistance or human reader improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, in essence, portions of the testing represent standalone algorithm performance. The bench tests with simulators and the comparisons to reference devices (co-oximeter, capnograph) evaluate the device's measurement capabilities independently of human interpretation. For example, the oximetry and respiration studies assess how accurately the device itself measures these parameters.

7. The Type of Ground Truth Used

• Reference Devices/Simulators: For most parameters (ECG, SpO2, Respiration, IBP, NIBP in bench tests).
• Manual Observations: For NIBP (mini-study and SP10 testing), involving a single or averaged manual cuff readings.
• Performance Standards: For ECG (ANSI/AAMI EC13-1992) which involves adherence to specified technical and functional requirements.

8. The Sample Size for the Training Set

• Not Applicable. This device is a vital signs monitor, not a machine learning or AI algorithm in the context of this document. Therefore, there is no "training set" as understood in AI/ML development. The device design utilizes "currently available technology," implying established engineering principles and algorithms, rather than data-driven machine learning models.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the information provided.

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The BCI 3404 Monitor is a portable ECG and oximetry monitor with optional impedance respiration. It continuously and non-invasively monitors and displays functional oxygen saturation of arterial hemoglobin(SpO2), pulse rate, respiration rate, plethysmogram and ECG waveforms. Alarms are available for ECG and oximetry. There are no respiration rate alarms. The 3404 may be used in the hospital or clinical environment, and during emergency land transport.

The device will provide fast, reliable measurements on patients ranging from pediatric to adult when using the appropriate BCI accessories.

The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor. The monitor is not intended for neonatal use.

The BCI 3404 Oximeter / ECG Monitor is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a table top design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys ( on/off, waveform / trend, alarm silence, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs.

Here's a breakdown of the acceptance criteria and study details for the BCI 3404 Oximeter / ECG Monitor, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Bench Tests: The specific number of devices tested on simulators was "Three devices." The data provenance for the simulators is that they are "commercially available." There is no explicit mention of data origin (e.g., country) or whether these were retrospective or prospective tests, but simulator tests are inherently prospective.
• Clinical Tests (Oximetry): Not explicitly stated, but implies a cohort of subjects undergoing deep desaturation at the VA Medical Center in Milwaukee. This would be prospective data.
• Clinical Tests (Respiration): "Thirty volunteers were tested." The test was conducted at BCI. This would be prospective data.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts or their qualifications for establishing ground truth in the clinical tests.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It appears that comparisons were made directly to established reference devices or simulator settings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The studies focused on the performance of the device against reference standards/devices, not on human readers' improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

• Bench Tests: These tests can be considered standalone performance in that the device's readings are compared directly to simulator settings, without human interpretation for the measurement output itself.
• Clinical Tests: While human volunteers were involved, the performance evaluation compares the device's measurements directly to reference devices (co-oximeter, capnograph), indicating a standalone performance assessment of the device's measurement capabilities.

7. Type of Ground Truth Used

• Bench Tests: Ground truth was established by simulator settings.
• Clinical Tests (Oximetry): Ground truth was established by a reference co-oximeter (OSM-3).
• Clinical Tests (Respiration): Ground truth was established by a reference capnograph (BCI 9004 Capnograph).
• ECG Performance Standards: Ground truth was established by compliance with the ANSI/AAMI EC13-1992 standard.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. The device described is a monitor utilizing existing technology, and the testing focuses on its performance verification rather than the development of a trained algorithm. Therefore, the concept of a training set as typically understood in AI/ML contexts does not apply here.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable. The device's underlying technology uses established principles of ECG and oximetry, not a learnable model requiring a specific training dataset from the manufacturer for its core function.

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