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The Fingertip Pulse Oximeter are intended for measuring function of atterial hemoglobin (SpO2) and pulse rate for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches to 0.9 inches) and for patients during no-motion condition. The device is prescription only.

The subject device AVITA Pulse Oximeter with Bluetooth is non-invasive spot checking, not provided sterile, multi-use device, which can measure and display user's oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through finger during no-motion condition. The subject device is not for lifesustaining, not for implant and does not contain drug or biological products. The device is for prescription use. The subject device consists of sensor, electronic circuits, display and plastic enclosures. It is a battery powered device and is adopted with two color OLED screen to display SpO2 and PR. It is software-driven and does not include alarms.

The provided text is a 510(k) Summary for the AViTA Pulse Oximeter (SP62B). It addresses medical device regulation, but it does not describe acceptance criteria and a study that proves the device meets specific acceptance criteria in the manner requested (e.g., in the context of an AI/ML algorithm's performance).

Instead, the document details the equivalence of the new device to a predicate device based on various non-clinical performance and safety tests, and a clinical validation of SpO2 performance.

Therefore, I cannot fully answer your request based on the provided text because the information specifically about "acceptance criteria and a study that proves the device meets the acceptance criteria" for an AI/ML device's performance, including details like sample size for test sets, data provenance, expert ground truth establishment, adjudication, MRMC studies, or standalone algorithm performance, is not present.

The document mentions "acceptance criteria" generally for biocompatibility tests, electrical safety, and EMC testing, but not for an AI/ML performance study as implied by your detailed questions.

Here's what can be extracted and inferred from the text regarding the device's overall performance validation, with limitations noted:

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

The document states performance specifications rather than explicit acceptance criteria in a table format for each test, but the overall statement is that the device "met the acceptance criteria" for various tests. For SpO2 accuracy, the performance is explicitly stated.

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

• Test set sample size: For the clinical performance testing, it mentions "healthy, adult volunteers." The exact number (sample size) is not specified in the provided text.
• Data provenance: "healthy, adult volunteers." The country of origin is not specified. The study was prospective as it involved clinical validation testing.

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

• This information is not applicable in the context of a pulse oximeter's SpO2 accuracy against a reference measurement. Pulse oximeters are typically validated against arterial blood gas (ABG) measurements (co-oximetry) in a controlled desaturation study, where the ABG is the direct, objective ground truth. Expert readers are not usually involved in establishing ground truth for SpO2 values.
• The document implies the adherence to ISO 80601-2-61 for clinical performance, which outlines the methodology for such studies.

4. Adjudication method for the test set:

• Not applicable/Not specified. For SpO2 accuracy, the "ground truth" is typically the co-oximeter measurement from arterial blood, not a subjective interpretation requiring adjudication.

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 is not an AI/ML device for diagnostic image interpretation. It is a pulse oximeter measuring physiological parameters.

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

• Not applicable in the AI/ML sense. The device itself is "standalone" in that it directly measures SpO2 and PR; it's not an AI algorithm assisting a human interpreter.

7. The type of ground truth used:

• For SpO2 accuracy, the ground truth is implied to be co-oximetry measurement from arterial blood gas (ABG), as is standard for pulse oximeter validation according to ISO 80601-2-61. The document states "Clinical performance was conducted per ISO 80601-2-61. The clinical validation testing of the SpO2 performance under no motion on healthy, adult volunteers in the range of 70% to 100%."

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense.

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

• Not applicable. (See point 8)

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The AVITA Pulse Oximeter is intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults as non-invasive spot checking in professional caring environment. It is designed for fingers between 0.8cm and 2.5cm (0.3 inches to 1 inches) and for patients during no-motion condition. The device is prescription only.

The AViTA Pulse Oximeter SPO2 is non-invasive spot checking, not provided sterile, multi-use device, which can measure and display user's oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through finger during no-motion condition. The subject device is not for life-sustaining, not for implant and does not contain drug or biological products. The device is for prescription use only. The subject device consists of sensor, electronic circuits, display and plastic enclosures. It is a battery powered device and is adopted with two color OLED screen to display SpO2 and PR. It is software-driven and does not include alarms.

Here's a breakdown of the acceptance criteria and the study that proves the AViTA Pulse Oximeter meets them, based on the provided text:

Acceptance Criteria and Device Performance

Note: The SpO2 accuracy of ±2% for the 70-100% range and the Pulse Rate accuracy are specifications, while the ARMS of 1.89% is the result of the clinical performance study. The 1.89% ARMS falls within the generally accepted range for pulse oximeters, which is often considered to be within ±2-3% for this range of SpO2.

Study Details

The primary study proving the device meets its acceptance criteria is a clinical performance study and various performance tests conducted in accordance with international standards.

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

• Clinical Performance Study: The study was conducted on healthy, adult volunteers. The specific number of volunteers (sample size) is not explicitly stated in the provided text.
• Data Provenance: The origin of the data is not specified beyond "healthy, adult volunteers." It is a prospective study as indicated by "clinical validation testing... under no motion."

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

The ground truth for pulse oximeters in clinical validation studies does not typically involve human expert consensus on the SpO2 values. Instead, it relies on a co-oximeter (or similar arterial blood gas analysis device), which provides a highly accurate, invasive measurement of arterial oxygen saturation (SaO2). The text states "oxygenated hemoglobin characterization testing" and "clinical validation testing of the SpO2 performance," which implies comparison against a reference method, likely a co-oximeter. Therefore, there is no mention of experts establishing ground truth in this context, nor their specific qualifications.

4. Adjudication method for the test set:

Not applicable for this type of medical device performance testing. Pulse oximeter accuracy is evaluated by comparing the device's readings against a precise, objective reference standard (like a co-oximeter), not by expert adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices (e.g., imaging AI) where human readers interact with the output. The AViTA Pulse Oximeter is a direct measurement device; it does not involve human interpretation of complex data that would be enhanced by AI assistance.

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

Yes, a standalone performance evaluation was done. The results presented ("ARMS for SpO2 under no motion was found to be 1.89%") directly reflect the performance of the device's algorithms and hardware in measuring SpO2, without any human interpretation component for the measured value itself.

7. The type of ground truth used:

The type of ground truth used for the clinical performance study, though not explicitly named, would be a highly accurate, invasive arterial oxygen saturation measurement (SaO2) obtained via a co-oximeter. This is the standard reference method for validating non-invasive pulse oximeters. The text refers to "oxygenated hemoglobin characterization testing" which supports this assumption.

8. The sample size for the training set:

Not applicable. The AViTA Pulse Oximeter is a hardware-based device that employs principles of spectrophotometry to mechanically and optically measure SpO2 and PR. While it is "software-driven," it is not described as using machine learning or AI algorithms that would require a distinct "training set" in the conventional sense (e.g., for image classification or prediction). Its algorithms are based on established physiological models of light absorption by blood.

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

Not applicable. As noted above, there is no indication of a "training set" for AI/ML models in this context. The core operating principles rely on physics and established physiological relationships.

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