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The Burdick 200 Pulse Oximeter provides SpO2, Pulse Rate, and Pulse Strength measurements. It may be used in the hospital or clinical environment, during emergency land or air transport, or for in home use.

The intended patient population is neonates to adults. The oximeter permits patient monitoring with adjustable alarm limits as well as visual and audible alarm signals.

The Oximeter has three modes of operation: Clinician Mode, Home-use Mode, and Sleep Study Mode.

The Clinician Mode aids the health care professional in monitoring patient activity.

The Home Use Mode permits the home-use caregiver to monitor a patient within the home environment.

The Sleep Study Mode allows the health care professional to record sleep study data which may be later transferred to a PC and analyzed.

The Burdick 200 is a hand held stand alone Pulse Oximeter designed to detect (SpO2) Oxygen saturation, pulse rate, and pulse strength on any patient from neonates to adults and output the measurements.

The Burdick 200 consists of two units, a hand held pulse oximeter and a table top charger base. Nine probes of various sizes and configurations are available to accommodate the spectrum of body sizes and sites.

This 510(k) summary does not contain sufficient information to answer all the requested questions about acceptance criteria and device performance studies. The document primarily focuses on establishing substantial equivalence to a predicate device and briefly mentions some functional and environmental tests performed due to minor dimensional and material changes.

Here's an attempt to extract and infer information based on the provided text:

Acceptance Criteria and Device Performance Study Summary

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Precise numerical acceptance criteria for SpO2 accuracy, pulse rate accuracy, or specific environmental limits are not provided in this summary.

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

The document describes tests performed on "a modified unit" (singular).

• Sample Size: 1 unit (a modified Burdick 200 Oximeter).
• Data Provenance: Not explicitly stated, but the functional and environmental testing appears to be conducted on the Burdick 200 Oximeter itself, likely in a controlled laboratory environment. It is not patient or clinical data, but rather device performance data.

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

This information is not provided in the document. The tests described are functional and environmental, likely based on engineering specifications and laboratory measurements rather than expert clinical assessment of patient data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (functional and environmental), an adjudication method in the context of expert review of clinical cases would not be applicable.

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

No MRMC comparative effectiveness study was done. This document describes a 510(k) for a standalone medical device (pulse oximeter), not an AI-assisted diagnostic tool. Therefore, a study to measure the effect size of human readers with vs. without AI assistance is not relevant or included.

6. Standalone (Algorithm Only) Performance Study

The document does describe functional tests of the device itself, which operates as a standalone algorithm/device.

• Standalone Performance Study Done: Yes, functional tests were performed as described under "TESTS."
• Details:
  • A "functional test was performed on the unit prior to environmental testing to establish that the unit to be tested was operating properly."
  • "Following the environmental test an expanded functional test was performed."
  • The "software accomplishing these measurements and calculations was developed by BCI International for their model 3302 and is used by Burdick Inc. in their model 200 in an unaltered form." This implies reliance on the already established performance of the BCI 3302's algorithm.

However, detailed performance metrics (e.g., accuracy, precision, bias) of the SpO2 and pulse rate measurements against a gold standard are not reported in this summary. The summary focuses on showing that the modified unit functions properly and withstands environmental stress, preserving the performance characteristics of the predicate device.

7. Type of Ground Truth Used

For the functional tests, the ground truth would typically be established by comparison to:

• Known input signals: For SpO2 and pulse rate measurements, this would involve using calibrated simulators or reference devices that provide known oxygen saturation and pulse rate values.
• Engineering specifications/reference standards: For environmental tests, the "ground truth" is adherence to specified environmental conditions and the device's ability to maintain functionality within those conditions.

The document does not explicitly state the specific ground truth methods or devices used but implies comparison to "normal established limits" and "established limits." Given it's a 510(k) seeking equivalence, the ground truth for overall device performance is implicitly based on the predicate device's established performance.

8. Sample Size for the Training Set

This information is not applicable as the document describes a hardware device (pulse oximeter) with embedded software, not a machine learning model that requires a "training set" in the conventional AI sense. The software's calculations are based on established physiological principles and algorithms, not machine learning trained on large datasets.

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

This information is not applicable for the same reasons as #8. The "ground truth" for the software's functionality would have been established during the development and validation of the BCI 3302 software, likely using physiological models and clinical studies, but these details are not provided here.

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