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The OxiprobE is indicated for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. Individual models are labeled for the intended use. It is for prescription use only.

The OxiprobE Pulse Oximetry Sensors are used for non-invasive measurement of blood oxygen saturation and pulse rate measurement. The disposable sensors are designed to enable the sensor's light source and photo detector to be securely and properly positioned on the patient. The adhesive stabilizes these important optical components and provides a comfortable fit. The adhesive sensors are patient-dedicated and can travel with the patients. The single-use, disposable sensors do not present the risk of cross-contamination caused by products that are reused from patient to patient. This 510(k) seeks premarket clearance for a line extension model BM-500, compatible with the BM-2070 extension cable and the Nellcor N-395 Pulse Oximeter (a legacy oximeter.). The BM-2070 extension cable was cleared for use with the predicate BMT sensors under K092549.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided document describes a 510(k) submission for the OxiprobE Pulse Oximetry Sensors (model BM-500). The submission focuses on demonstrating substantial equivalence to a predicate device (BMT Sensors, K092549) rather than a comprehensive, de novo clinical study proving novel performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The reported device performance for the subject device (BM-500) is presented as being "Same" or "SE" (Substantially Equivalent) to the predicate device's specifications, implying it meets or is comparable to the predicate's acceptance criteria. For SpO2 and Pulse Rate accuracy, the BM-500 aligns with the specifications of one of the predicate models (BM-400 for SpO2 and both for Pulse Rate).

2. Sample Size for the Test Set and Data Provenance

The document states, "Nonclinical Bench Testing (No new clinical data was required to support this 510(k)) was included to support substantial equivalence." This indicates that no human clinical test set was used for this particular submission. The "test set" consisted of the device itself undergoing various bench tests.

Sample Size: Not applicable in the context of a human test set. For bench testing, the sample sizes would refer to the number of devices or components tested, which is not specified in this summary.
Data Provenance: Not applicable for clinical study provenance as no clinical data was generated for this submission. The performance assessment relied on bench testing.

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

Not applicable as no human clinical test set was used to establish ground truth from patient data. The "ground truth" for the non-clinical tests would be the established international standards and internal specifications the device was tested against.

4. Adjudication Method for the Test Set

Not applicable as no human clinical test set or subjective expert evaluation was involved for this submission requiring an adjudication method.

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

No. A MRMC comparative effectiveness study was not performed. The submission explicitly states "No new clinical data was required" and focuses on bench testing to establish substantial equivalence with a predicate device. This type of study is more relevant for diagnostic aids involving human interpretation of images or data.

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

Yes, in essence, standalone non-clinical performance was evaluated. The "Pulse and SpO2 accuracy" testing, along with other bench tests (EMC/EMI, electrical safety, durability), evaluated the device's inherent performance without a human in the loop interpreting its output. The device itself (the sensor) is a measurement tool, and its accuracy is inherent to its design and function. The output of the device (SpO2 and pulse rate readings) is the standalone performance.

7. Type of Ground Truth Used

For the accuracy parameters (SpO2 and Pulse Rate accuracy), the ground truth would have been established by a reference standard or validated measurement method during the original development and testing of the predicate device and likely followed established physiological measurement standards for oximetry. The current submission relies on the established accuracy of the predicate and demonstrates that the new device meets similar specifications via bench testing.

For the other performance tests (e.g., EN ISO 60601-1, EN ISO 80601-2-61, EMC/EMI), the ground truth is defined by the specific requirements and limits set forth in these international technical standards. The device's performance is compared against these normative requirements.

8. Sample Size for the Training Set

Not applicable. This device, an oximetry sensor, does not involve machine learning or an "algorithm" that requires a training set in the conventional sense for diagnostic image analysis or similar AI applications. Its function is based on established optical and physiological principles, and its parameters are set by design, not by learning from labeled data.

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

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

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