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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.

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