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The Fingertip Pulse Oximeter (Wireless) are intended for measuring function of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and professional caring environment. It is designed for fingers between 0.8cm and 2.3cm (0.3 inches) and for patients during nomotion condition.

The main function of the Fingertip Pulse Oximeter (Wireless) is to measure the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking monitoring. The subject determines the functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine SpO2 reading and pulse rate. The characteristic of the device is a stand-alone device with 1 AAA Alkaline battery. It includes an OLED display screen and a warning or indicator function for abnormal readings. The Fingertip Pulse Oximeter (Wireless) is also built in with a Bluetooth low energy (BLE) function to perform data transmission.

The provided documentation is for a 510(k) premarket notification for the Leadtek Fingertip Pulse Oximeter (Wireless). It establishes substantial equivalence to a predicate device (K193350) and does not present detailed new clinical study data for the subject device beyond referencing the predicate. Therefore, some of the requested information cannot be fully provided from the given document as it refers to the predicate device's clinical testing.

Here's a breakdown of the requested information based on the provided text, focusing on the subject device's demonstrated performance and criteria where available, and referencing the predicate device's clinical study for SpO2 accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance (e.g., country of origin of the data, retrospective or prospective)

For the SpO2 accuracy, the document explicitly states that no new clinical testing was performed for the subject device because its pulse oximetry algorithm and measuring technology are the same as the predicate device (K193350). Therefore, the clinical data refers to the predicate device's clearance.

The document does not provide the specific sample size, country of origin, or whether the study was retrospective or prospective for the predicate device's clinical test. It only states that "A clinical study was conducted on the predicate device for K193350 clearance to demonstrate the safety and performance."

For non-clinical performance and wireless coexistence, these were laboratory-based tests and not human clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. As the clinical study was for the predicate device and the details are not elaborated here, the specifics of ground truth establishment and expert qualifications are absent. Typically, for pulse oximeter accuracy studies, arterial blood gas measurements (co-oximetry) performed by trained medical personnel serve as the reference standard (ground truth).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the document.

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

This is not applicable. The device is a Fingertip Pulse Oximeter, which directly measures physiological parameters (SpO2 and pulse rate). It does not involve "human readers" interpreting images or data that would be enhanced by AI assistance in the way an MRMC study would assess. The "Wireless" aspect refers to data transmission, not AI-driven interpretation.

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

Yes, the core SpO2 and pulse rate measurement algorithm performs in a standalone manner. The device outputs direct measurements based on light absorption. The "Wireless" functionality is for data transmission, not for an AI algorithm interpreting the results for a human. The non-clinical performance testing validated the algorithm's accuracy (Arms value

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The Leadtek Fingertip Pulse Oximeter are intended for measuring functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as non-invasive spot checking in home and 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 main function of the Leadtek Fingertip Pulse Oximeter is to measure the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate as non-invasive spot checking. The Fingertip Pulse Oximeter determines the functional oxygen saturation of arterial hemoglobin (SpO2) by measuring the absorption of red and infrared light passing through perfused tissue. Changes in absorption caused by the pulsation of blood in the vascular bed are used to determine SpO2 reading and pulse rate. The characteristic of the device is a stand-alone device with 1 AAA Alkaline battery. It includes an OLED display screen and a warning or indicator function for abnormal readings.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text for the Leadtek Fingertip Pulse Oximeter (K193350).

Key Takeaways from the Document:

• This device is a Fingertip Pulse Oximeter intended for non-invasive spot checking of SpO2 and pulse rate in adults and adolescents.
• It's seeking Substantial Equivalence (SE) to a predicate device (Onyx Vantage 9590, K112843).
• The primary performance evaluation is for SpO2 accuracy and Heart Rate (HR) accuracy.
• The device's performance is gauged against recognized a standard: ISO 80601-2-61:2011 (Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: A total of 10 subjects were enrolled for the clinical evaluation.
• Data Provenance:
  • Country of Origin: Not explicitly stated in the provided text.
  • Retrospective or Prospective: The clinical evaluation was "conducted," implying a prospective study where data was collected for this submission. The text doesn't mention the use of pre-existing data.

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

• The document describes a clinical evaluation where SpO2 accuracy was measured against a reference method (likely arterial blood gas analysis, though not explicitly stated, this is standard for pulse oximeter accuracy studies).
• It does not mention the use of "experts" in the sense of human readers interpreting data, as would be common for an AI/imaging device. The ground truth for pulse oximetry is derived from instrumental measurements, not human interpretation. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth is not applicable in this context.

4. Adjudication Method for the Test Set

• Not applicable. As noted above, the ground truth for SpO2 accuracy is typically established by invasively measured arterial oxygen saturation (SaO2) via co-oximetry, not by human adjudication of readings from the device itself.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance. For a pulse oximeter, the core performance is algorithmic (device output) and doesn't involve human interpretation to the same degree. The study here focuses on the device's accuracy against a clinical reference standard.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance evaluation was indeed done. The clinical evaluation specifically assessed the "Leadtek Fingertip Pulse Oximeter" and its "SpO2 accuracy" and "performance results" against a reference standard. This is the direct, unassisted performance of the device's algorithm.

7. The Type of Ground Truth Used

• The ground truth for SpO2 accuracy was established through clinical evaluation conducted in accordance with ISO 80601-2-61. This standard typically requires comparing the device's SpO2 readings with values obtained from a reference co-oximeter measuring arterial oxygen saturation (SaO2) in desaturation studies. The document states "The functional oxygen saturation (SpO2) measurements were validated in accordance with ISO 80601-2-61." and that the accuracy was "calculated using the root-mean-square (Arms)." This strongly implies direct physiological measurements from subjects desaturated to various SpO2 levels.

8. The Sample Size for the Training Set

• The document does not mention a "training set" or "training data." This device is a traditional medical device (hardware with embedded software for signal processing and calculation), not an AI/Machine Learning model in the modern sense that typically requires a large training dataset distinct from a test set. The performance validation relies on the device itself as a complete system, built according to specified engineering principles, and then tested for accuracy and safety.

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

• Not applicable, as no separate "training set" is described or implied for this type of device and its validation.

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