Search Results

The APO-8284 Fingertip Pulse Oximeter is a non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc). The APO-8284 Fingertip Pulse oximeter is not intended for continuous monitoring.

Our device APO-8284 Fingertip Pulse Oximeter is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user.

It is a noninvasive measurement instrument with a pair of small light-emitting diodes (LEDs) facing a photodiode through a fingertip. One LED is red, with wavelength of 660 nm, and the other is infrared, 880 nm. The MCU calculates the ratio of these two wavelengths and get the results of the SPO2. At the same time, by examining only the varying part of the absorption spectrum, a monitor can ignore other tissues or nail, and discern only the absorption caused by arterial blood to detect the pulse rate.

More over, the APO-8284 also has the function of low battery voltage alarm and automatically power off. The power source is 2 × AAA batteries.

The device is for prescription. It is neither for life-supporting nor for implanting. lt does not contain any drug or biological product and it does not need to be sterile.

Here's a breakdown of the acceptance criteria and the study information for the APO-8284 Fingertip Pulse Oximeter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document explicitly states the APO-8284's SpO2 accuracy as "±2%", which appears to imply it meets or exceeds the predicate's accuracy in both ranges. The SpO2 range is identical, and the pulse rate range and accuracy are either identical or slightly improved (wider range) for the APO-8284. The operation humidity range for the APO-8284 is stated as "<80%", which is broader than the predicate's "15%~80%".

Regarding the study proving the device meets acceptance criteria:

The provided document (510(k) Summary) is a submission for substantial equivalence, not a detailed clinical study report. It asserts that the device meets the performance criteria based on comparison to a predicate device and adherence to international standards. However, it does not provide specific details of a clinical study (like the nitty-gritty of participant recruitment, specific methods of SpO2 and pulse rate measurement against a gold standard, or data analysis) that would typically be described in a dedicated clinical trial report.

Instead, the submission relies on the following to support its claims of safety and effectiveness, and thus meeting acceptance criteria:

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

The document does not specify a sample size for a test set or its data provenance. It implies that "the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness to the new devices," but it doesn't describe the test itself. This suggests that the "test" might refer to internal validation against technical specifications and established standards rather than a formal clinical study with a defined test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No information is provided about experts establishing ground truth for a test set.

4. Adjudication Method:

Not applicable. No information is provided about an adjudication method for a test set.

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

No. The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it mention effect sizes of human readers with or without AI assistance. This device is a standalone oximeter, not an AI-assisted diagnostic tool for interpretation by human readers.

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

Yes, essentially. The device itself is a standalone measurement tool. While the information doesn't detail a specific "algorithm-only" study distinct from typical device performance testing, the validation of its SpO2 and pulse rate accuracy against established standards (ISO 9919:2005) is by definition a standalone performance assessment. The device functions automatically without human input for result generation.

7. Type of Ground Truth Used:

The document implies that the ground truth for performance assessment would be established by reference to a recognized standard for pulse oximeters: ISO 9919:2005: Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use. This standard typically involves comparing oximeter readings against a direct measurement of arterial oxygen saturation (e.g., co-oximetry of arterial blood samples) in carefully controlled studies (often hypoxia studies). However, the document does not explicitly detail how this was done for this specific device in its submitted "test."

8. Sample Size for the Training Set:

Not applicable. The document does not describe a training set because this is a traditional medical device (pulse oximeter) that uses established physical principles (light absorption at different wavelengths) to calculate SpO2 and pulse rate, rather than a machine learning or AI algorithm that requires 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