Search Results

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). Capnography (ETCO2, inCO2, RR), a two-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 neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status.

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 BCI 9200 vital signs monitor has been updated to include a new capnography option. This new feature uses the same technology as existing legally marketed devices. This device is designed to provide full featured monitoring capabilities in a table top design. The full system features an ECG cable interface, two invasive pressure interfaces, two YSI 400/700 compatible temperature interfaces, an NIBP cuff hose connection, an SpO2 sensor interface, a capnography tubing interface and filters, an internal printer, display of patient and waveform data via a color liquid crystal display (LCD), system power status LEDs, a rotary control knob and the function keypad area consisting of five keys ( on/off, IP zero, NIBP start/stop, print start/stop and alarm silence). The monitor has analog and serial output ports that are used for data communications to personal computers, printers, chart recorders, or the Life Sensing Instrument Company, Inc. HTS 820 Central Station.

The provided text describes the BCI 9200 vital signs monitor with a new capnography option. The document is a 510(k) summary of safety and effectiveness, indicating the device's substantial equivalence to predicate devices. While it states that performance testing was conducted, it does not explicitly provide a table of acceptance criteria and reported device performance for specific metrics or a detailed study section with the requested information.

However, based on the type of device (a vital signs monitor with capnography) and the nature of the document (a 510(k) submission primarily focused on substantial equivalence), we can infer certain aspects of the testing and the kind of information that would typically be gathered for such a device, even if the specific numerical data isn't present in this summary.

Here's a breakdown of what can be gleaned and what is explicitly missing from the provided text:

1. A table of acceptance criteria and the reported device performance:

The document does not include a specific table of acceptance criteria and reported device performance values (e.g., accuracy, precision, bias for ETCO2 or respiration rate). It generically states:

• "The results demonstrated that the BC10 9200 vital signs monitor is in compliance with the guidelines and standards referenced in the reviewer's guides and that it performs within its specifications and functional requirements."
• "The results demonstrated that the BCI® 9200 vital signs monitor performed within its specifications."

For capnography devices, typical performance metrics would include accuracy of ETCO2 measurement (e.g., ± 2 mmHg or 10% of reading, whichever is greater, within a specified range), accuracy of respiration rate (e.g., ± 1 breath per minute), rise time, and drift. While these are implied to have been met, the specific values are not presented.

2. Sample sized used for the test set and the data provenance:

• Test Set Sample Size: The document mentions "clinical testing of the ETCO2 and respiration rate measurements" and "bench and clinical tests" for the capnography feature. However, it does not specify the sample size (number of patients, number of measurements) used for these clinical tests.
• Data Provenance: The document does not explicitly state the country of origin. Given the submission is to the FDA (United States), it is highly probable the clinical tests, if performed, included data from the United States, but this is not confirmed. It is a prospective study implied for the clinical testing of the new capnography option, as it's part of the premarket submission for a new feature.

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):

This information is not provided in the document. For a vital signs monitor, ground truth for parameters like ETCO2 and respiration rate in clinical tests would typically be established using a reference standard device (e.g., another highly accurate and calibrated capnograph or a spirometer for respiration rate), not necessarily human experts in the same way, for direct physiological measurements. If "experts" were involved, it would likely be in setting up and validating the reference standard, or in clinical assessment, but this is not detailed.

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

This information is not provided. Adjudication methods are more common in subjective assessment (e.g., image interpretation) or when there's ambiguity in ground truth. For physiological measurements like capnography, performance is usually assessed against a "gold standard" or reference device, rather than through expert adjudication of the results themselves.

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:

• MRMC Study: An MRMC comparative effectiveness study is not applicable to this device. This type of study is relevant for diagnostic imaging interpretation where human readers (e.g., radiologists) use AI assistance to interpret images. The BCI 9200 is a vital signs monitor, and the capnography feature provides direct physiological measurements, not interpretations requiring human reader input with or without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Yes, standalone performance for the device's capnography measurements (ETCO2 and respiration rate) was implicitly and explicitly done. The document states:

  • "Testing of device performance included clinical testing of the ETCO2 and respiration rate measurements made by the BC10 9200 vital signs monitor."
  • "Further performance testing of the capnography parameter was also conducted in accordance with EN 864 (international standard for capnography)."
  • "The results demonstrated that the BCI® 9200 vital signs monitor performed within its specifications."

  These statements confirm that the device's ability to measure these parameters was evaluated as an algorithm/device-only function. The "human-in-the-loop" aspect for this type of device primarily involves clinicians using the measurements, not interpreting raw data generated by the device to produce a measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth for the clinical and bench testing of the capnography feature would have been established using reference standard devices or methods known to be highly accurate for measuring ETCO2 and respiration rate. The document mentions "Comparison of the new capnography feature was made to BCI® 9000 monitor's capnography function using both bench and clinical tests." This suggests the predicate device (BCI 9000's capnography function) might have served as a reference standard, or another validated reference system as per EN 864 standard.

8. The sample size for the training set:

• This information is not applicable and not provided. The BCI 9200 monitor with its capnography option is not described as an AI/machine learning device that requires a training set in the conventional sense. Its function is based on established physiological measurement principles and signal processing, not on learning from a large dataset to make predictions or classifications.

9. How the ground truth for the training set was established:

• This information is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The 6004 NIBP monitor is a low cost portable NIBP monitor for spot checking or monitoring of a patient's systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional SpO3, optional oral/rectal temperature, and/or inter. The device will provide NIBP measurements on patients ranging from neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. An LED indicator illuminates when the monitor is configured for NIBP neonate mode. The BCI oximetry options work with all BCI oximetry sensors when providing SpO2 and pulse rate on all patients from neonate to adult in both NIBP adult and neonate mode. The Nellcor oximetry option provides SpO3 and pulse rate data on adult patients using the Nellcor DS 100A sensor. The electronic thermometry option is intended for intermittent "spot checks" of oral or rectal temperature for patients neonate through adult and requires WelchAllyn thermometry probes and probe covers. The temperature option works for all patients in NIBP adult or neonate mode. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use.

The currently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional pulse oximeter, electronic thermometer and printer has been updated to include an additional Nellcor pulse oximeter option which uses the same technology as existing legally marketed devices. The BCI 6004 NIBP monitor with Nellcor pulse oximetry uses the Nellcor MP506 pulse oximetry module. This same module is used in the Nellcor Oximax N-550 Pulse Oximeter (K021090). The Nellcor MP506 board uses the same technology in a very similar design to that found in the Nellcor N-595 Pulse Oximeter.

This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top NIBP monitor with a desk top charger. Features include an NIBP cuff hose connection, an optional SpO2 sensor interface, an optional temperature probe interface and holder, an optional internal printer, display of patient data via an LED display (systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature), system status LEDs (battery, sensor, alarm silence, alarm, and alert), and the function keypad area consisting of eleven keys (power, start, cancel, stat, up and down arrows, interval, recall, manual/auto, alarm set, and alarm silence). The monitor has a serial port that is used for data communication.

Here's a breakdown of the acceptance criteria and study information for the BCI MiniTorr Plus NIBP monitor (model 6004) with the new Nellcor pulse oximetry option, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific thresholds for accuracy or precision. Instead, it relies on demonstrating equivalence to legally marketed predicate devices. The performance data focuses on establishing that the new device performs "the same" as or "as well as" the predicate devices for each measured parameter.

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

The document does not explicitly state the sample sizes used for the comparison testing (e.g., number of patients/measurements). It mentions "Comparison testing" was done for both the NIBP/thermometry and SpO2 components.

• Sample Size: Not specified for any of the comparison tests.
• Data Provenance: Not explicitly stated, but the nature of comparison testing suggests controlled, possibly internal, studies rather than broad multi-country clinical trials. The bench-top testing was done by Nellcor using their proprietary simulators. Whether the comparison tests involved human subjects or entirely bench testing is not clear from the text. The term "patient's" is used in the intended use, implying human subject testing would be relevant for performance claims.

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

This information is not provided in the document. The studies described are comparison tests against predicate devices or bench-top tests against proprietary simulators and specifications, not studies establishing a new ground truth based on expert review of data from the device itself.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the comparison and bench testing, an adjudication method in the context of expert review (like 2+1 or 3+1) is unlikely to have been applied as the ground truth was either a predicate device's output or a simulator's defined output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

No, an MRMC comparative effectiveness study was not conducted. This device is a monitoring device, not an AI diagnostic tool requiring human interpretation. The study focuses on the device's measurement accuracy and equivalence to predicate devices, not on improving human reader performance.

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

Yes, standalone performance evaluation was done through:

• Comparison testing: The new device was directly compared against predicate devices (BCI 6004 NIBP monitor for NIBP/temperature; Nellcor N-595 for SpO2) to show equivalent performance. This implies the new device's readings were compared directly to the predicate's readings without human intervention influencing the measurement itself.
• Bench-top performance testing by Nellcor: This involved using "proprietary simulators" to ensure the Nellcor MP506 pulse oximetry board performed to its specifications, which is a standalone assessment.
• Software validation test: This confirmed the modifications operated as intended, an intrinsic evaluation of the device's internal workings.

7. The Type of Ground Truth Used

The ground truth for the comparison studies was:

• Predicate Device Performance: For NIBP, heart rate, and temperature, the predicate BCI 6004 NIBP monitor was used as the reference. For SpO2, the predicate Nellcor N-595 Pulse Oximeter was used as the reference.
• Manufacturer Specifications/Simulator Output: For the Nellcor MP506 pulse oximetry board, Nellcor's "proprietary simulators" and their associated "specifications" served as the ground truth.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is an updated version of an existing monitor with an added module. There is no mention of machine learning or AI components that would require a "training set" in the conventional sense. The device's functionality relies on established physiological measurement principles and validated software, not on trained algorithms.

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

This information is not applicable as there is no training set involved in the development or validation of this device.

Ask a specific question about this device

The BCI® 3178 Pediatric Pulse Oximetry Sensor is a reusable finger sensor that can be used to non-invasively measure oxygen saturation (SpO2), pulse rate and wethysmographic pulse waves. It's performance was validated with the BCI® 3304 pulse oximeter. The BCT® 3178 Pediatric Pulse Oximetry Sensor will provide reliable spot check measurements on patients weighing from 10 to 100 lbs (5 -45 kg). The sensor is not intended for prolonged use.

The BCI® 3178 pediatric pulse oximetry sensor is similar to other existing finger sensors, legally marketed by BCI, Inc. and others. This new finger sensor is designed to work with all BCI pulse oximeters on pediatric patients from 10 to 100 lbs. The sensor is made up of three major parts, the cable with the molded connector, the top part of the shell containing the LEDs and the bottom part of the shell containing the photo detector.

This document describes the regulatory submission for the BCI® 3178 Pediatric Pulse Oximetry Sensor. It focuses on demonstrating its substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics as might be found in a more comprehensive clinical study report.

However, based on the provided text, we can extract information regarding overall performance and the studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for SpO2 accuracy for this specific device. Instead, it relies on demonstrating that the new device performs "within its specifications" and "as well as the legally marketed predicate device(s)."

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

• Adults: The sample size for adults tested under desaturation conditions is not specified ("Tests on adults showed...").
• Pediatric Subjects: The sample size for pediatric subjects (not desaturated) is not specified ("Additional tests on pediatric subjects...").
• Data Provenance: The document does not specify the country of origin. It implicitly describes prospective testing as part of the device's validation.

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

This information is not provided in the document. For pulse oximetry, the "ground truth" for SpO2 accuracy is typically established using arterial blood gas (ABG) analysis with a co-oximeter, not usually expert consensus in the same way it would be for interpreting images or clinical findings. The text only states that testing was done under "desaturation conditions," implying a controlled study where reference measurements (like ABG) would be taken.

4. Adjudication Method for the Test Set

This information is not applicable to pulse oximetry accuracy testing, as the "ground truth" (e.g., co-oximetry via ABG) is an objective measurement, not subject to interpretation that would require expert adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging or interpretation tasks where multiple readers evaluate cases. Pulse oximetry involves direct measurement, not interpretation of cases by multiple readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone performance study was done. The described testing of the BCI® 3178 Pediatric Pulse Oximetry Sensor for SpO2 accuracy and functionality is by its nature a standalone performance evaluation of the device itself. The sensor produces an output (SpO2, pulse rate) based on its algorithm and hardware, independent of human interpretation or assistance beyond initial placement and monitor reading.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth. However, for pulse oximetry accuracy testing, especially during desaturation studies, the gold standard for ground truth is typically arterial blood gas (ABG) analysis using a co-oximeter. The statement "Tests on adults showed the sensor to be accurate during desaturation conditions" strongly implies the use of such a reference method.

8. Sample Size for the Training Set

• This information is not applicable or not provided in the context of this traditional medical device submission. Pulse oximeters, like the BCI® 3178, typically rely on established optical and physiological principles, not on machine learning algorithms trained on large datasets in the way an AI diagnostic algorithm would be. Therefore, there wouldn't be a "training set" in the sense of AI/ML development. The design is based on known physics and engineering, refined through testing.

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

• As a training set is not applicable (see point 8), this question is also not applicable.

Ask a specific question about this device

The BCI 3180 pulse oximeter is indicated for continuous patient monitoring of patient SpO2, pulse rate, and pulse strength measurements. It is intended for the hospital or clinical environment and during emergency land transport. It is intended for use in critical environments, including ventilatory applications, patient transport, and anesthesia. It is not intended for use in the home. The pulse oximeter is intended for use with all BCI pulse oximetry sensors, providing SpO2 and pulse rate measurements on all patients from neonate to adult.

The BCI 3180 pulse oximeter is a new monitor with the same parameters as existing devices legally marketed by BCI, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an SpO2 sensor interface, display of patient and waveform data via an LCD display, power status LED, and the function keypad area consisting of six keys (on/off, waveform / trend, alarm audio pause/off, menu / enter, up arrow & down arrow). The monitor has an infrared serial port that is used for data communications to a printer and can download trend data to a printer of personal computer through connection to the SpQ2 sensor interface (sensor must be removed from the device).

Here's a breakdown of the acceptance criteria and study information for the BCI 3180 Pulse Oximeter, based on the provided documents:

Acceptance Criteria and Device Performance Study for BCI 3180 Pulse Oximeter

The BCI 3180 Pulse Oximeter is presented as a redesign of the BCI 3100 Pulse Oximeter, aiming to meet current product standards with an updated design while maintaining similar functionality. The primary claim for proving met acceptance criteria is that there is "no functional difference" between the BCI 3180 and its predicate device (BCI 3100 Pulse Oximeter), and that it performs within its specifications.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a dedicated table format. Instead, it refers to compliance with guidelines and standards, and performance "within specifications." Based on the provided text, the inferred acceptance criteria relate to safety, accuracy, and compliance with general medical device standards.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not specify a numerical sample size for "clinical testing of the SpO2 parameter." It simply states that testing was done.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It mentions "clinical testing," which implies prospective data collection, but no further details are provided.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide any information regarding experts used to establish ground truth, their number, or qualifications. This suggests the validation relied on instrumental measurements and comparison to a predicate device rather than human expert interpretation of results.

4. Adjudication Method for Test Set

The document does not specify any adjudication method. Given the type of device (pulse oximeter) and the nature of "clinical testing of the SpO2 parameter," it's highly likely that ground truth was established through validated reference instrumentation rather than expert adjudication.

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

There is no indication that a Multi Reader Multi Case (MRMC) comparative effectiveness study was done. The device measures physiological parameters (SpO2, pulse rate, pulse strength) and doesn't involve human interpretation of images or complex data where AI assistance for human readers would be applicable.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was performed in the sense that the device's output (SpO2, pulse rate) was directly tested against its specifications. The document states: "Testing of device performance included clinical testing of the SpO2 parameter and overall software validation. The results demonstrated that the BCI 3180 pulse oximeter performed within its specifications." This refers to the algorithm's (or device's) direct measurement capability.

7. Type of Ground Truth Used

The type of ground truth used was likely instrumental reference measurements for SpO2 and pulse rate. The document mentions "clinical testing of the SpO2 parameter," which typically involves comparing the device's readings against a gold-standard measurement method (e.g., arterial blood gas analysis for SpO2, or a reference ECG for pulse rate) in a clinical setting.

8. Sample Size for Training Set

The document does not mention a training set or its sample size. This is expected as the BCI 3180 is a physical medical device (pulse oximeter) that performs direct physiological measurements, not a machine learning or AI-driven diagnostic tool that would require a distinct training set in the conventional sense. Its "training" is in its engineering design and calibration.

9. How Ground Truth for Training Set Was Established

Since there is no mention of a "training set" in the context of machine learning, there is no information on how ground truth for a training set was established. The device's fundamental parameters and algorithms would have been developed based on established physiological principles and engineering best practices for pulse oximetry, validated through the performance testing described.

Ask a specific question about this device

The BCI 1621 Oximetry Data Management Program analyzes data recorded using the BCI 3403 pulse oximeter and provides a printed oximetry data analysis report and graphical SpO2 trend. This information can aid in the analysis of pulse oximetry data from sleep screening, oxygen therapy validation, and/or related studies. Data from the BCI 3403 pulse oximeter are downloaded for analysis using a unique cable.

The BCI® 1621 Oximetry Data Management Program is a software program used as a pulse oximetry accessory.

The provided document is a 510(k) summary for the BCI® 1621 Oximetry Data Management Program. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone clinical study for performance.

Here's a breakdown of the information requested, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating that the new device performs "within its specifications" and "as well as the legally marketed predicate device(s)."

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

• Sample Size: Not specified. The document mentions "clinical testing of the desaturation identification algorithm and overall software validation using simulators." It does not provide the number of patients, cases, or simulator runs.
• Data Provenance: Not specified regarding country of origin. The testing is described generally as "clinical testing" and "overall software validation using simulators." It does not clarify if the data was retrospective or prospective.

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

• This information is not provided in the document. The document describes "clinical testing of the desaturation identification algorithm" but does not detail how ground truth for this testing was established or who established it.

4. Adjudication Method for the Test Set

• This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done as described. This device is a "Pulse Oximeter Display Software" designed to provide analysis reports and graphical trends for healthcare professionals. It is not an AI-assisted diagnostic tool for human readers in the sense of improving their interpretation accuracy. Its function is to process and present oximetry data, which would then be interpreted by a healthcare professional. Therefore, the concept of improving human reader performance with AI assistance in this context is not applicable based on the device's stated function.

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

• Yes, a standalone evaluation of the algorithm's performance was implied. The document states: "Testing of device performance included clinical testing of the desaturation identification algorithm and overall software validation using simulators." This indicates that the algorithm's ability to identify desaturations and the overall software's functionality were tested independently of human interpretation of the raw data. The phrase "performed within its specifications" suggests a standalone evaluation against predefined criteria for the software's output.

7. The Type of Ground Truth Used

• The document states "clinical testing of the desaturation identification algorithm." While not explicitly detailed, the "ground truth" for identifying desaturations in this context would typically be established by established physiological definitions of desaturation events based on SpO2 measurements, potentially validated by expert review of raw oximetry waveforms or comparison to a gold standard measurement, though this is not specified. The "overall software validation using simulators" would use known, controlled inputs to verify the software's processing and output.

8. The Sample Size for the Training Set

• This information is not provided in the document. The document primarily discusses testing and validation, not the development or training of the "desaturation identification algorithm." Given the age of the document (2002) and the nature of the device (software for displaying and analyzing oximetry data), it is unlikely to involve machine learning in the contemporary sense requiring a "training set" in the way an AI diagnostic algorithm would. The "algorithm" likely refers to a predefined set of rules or calculations for identifying desaturation events.

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

• This information is not provided as a "training set" in the context of machine learning is not discussed. If the "algorithm" refers to rule-based logic, its "training" would be inherent in its design based on established medical definitions and physiological principles for desaturation.

Ask a specific question about this device

The BCI® 3420 Digit™ Pulse Oximeter is a handheld, finger-mounted pulse oximeter that combines the monitor and sensor into one assembly that measures SpO2, pulse rate, and pulse strength. It may be used as a spot check device in the home, hospital or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The BCI 3420 Digit™ Pulse Oximeter will provide reliable measurements on patients ranging from pediatric to adults.

The BCI® 3420 Digit™ Pulse Oximeter consists of an pulse oximeter monitor and sensor contained on a single assembly. The device includes an LED display and power on key, and is powered by two "AAA" batteries.

The provided documentation for the BCI® 3420 Digit™ Pulse Oximeter describes safety and performance testing to demonstrate substantial equivalence to predicate devices, but it does not detail specific acceptance criteria as numerical thresholds or perform a statistical study against such criteria. The document focuses on compliance with general medical device standards and functional equivalence rather than a precise quantitative evaluation against predefined acceptance metrics.

Therefore, many of the requested elements for a detailed acceptance criteria and study description cannot be extracted directly from this document.

Here's an attempt to answer based on the available information, with clear indications where information is not provided:

Acceptance Criteria and Device Performance Study for BCI® 3420 Digit™ Pulse Oximeter

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Clinical Testing for SpO2): Not specified. The document mentions "clinical testing of the SpO2 parameter" but does not provide details on the number of subjects or data points.
• Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified. The document does not describe the establishment of a "ground truth" using experts in the context of a performance study with a test set. The focus is on compliance with standards and functional equivalence to predicate devices.

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

• Not specified. This level of detail about adjudication methods is not present in the document.

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. This document describes a pulse oximeter, which is a medical device for direct measurement, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study or AI-related effectiveness is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This device is a standalone pulse oximeter that directly measures physiological parameters. Its performance is inherently "standalone" in this context, meaning it operates without a human-in-the-loop for interpreting the core measurement output beyond standard clinical use. The "clinical testing of the SpO2 parameter" would evaluate this standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For SpO2 measurement, the "ground truth" (or reference standard) in clinical testing typically involves simultaneous measurements against a well-calibrated co-oximeter or arterial blood gas analysis. The document states "clinical testing of the SpO2 parameter" was performed, implying such a reference standard would have been used, but the specific method is not detailed.
• For safety and environmental testing, the "ground truth" is compliance with the specified international and national standards (e.g., EN 60601-1).

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

• Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device