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510(k) Data Aggregation
(388 days)
The Fingertip Pulse Oximeter is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatic patients in hospitals, hospital facilities and home healthcare environments.
This device is a small, lightweight, portable device intended for use in measuring and displaying functional oxygen saturation of arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senor and displays on the OLED after certain futher processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery.
The provided text describes a 510(k) premarket notification for a Fingertip Pulse Oximeter and includes information about its acceptance criteria and the study conducted to prove it meets these criteria.
Here's the breakdown of the information requested based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Target) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | 70% to 100% saturation range, Root-Mean-Square (Arms) value of ±2% | Root-Mean-Square (Arms) value of ±2% (for 70% to 100% saturation) |
| Pulse Rate Accuracy | 25bpm~250bpm, ±3bpm (for predicate device) | ±3bpm (for 25bpm~250bpm) |
| Biocompatibility | No toxicity to cells, no delayed contact sensitization, no irritation to skin, compliance with ISO10993-1 | No toxicity to cells, no delayed contact sensitization, no irritation to skin, compliant with ISO10993-1 |
| Electrical Safety | Compliance with IEC60601-1 | Compliant with IEC60601-1 |
| EMC | Compliance with IEC60601-1-2 | Compliant with IEC60601-1-2 |
| Home Healthcare Env. Safety | Compliance with IEC 60601-1-11 | Compliant with IEC 60601-1-11 |
| General Pulse Oximeter Requirements | Compliance with ISO 80601-2-61 | Compliant with ISO 80601-2-61 |
| Software Validation | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices | Compliant with FDA Guidance |
Study Details:
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 24 healthy adult male and female volunteers.
- Data Provenance: The document does not explicitly state the country of origin for the volunteers or whether the data was retrospective or prospective. However, given that it's a clinical evaluation for a regulatory submission, it is almost certainly a prospective study. The racial distribution of the volunteers is mentioned: 2 white people, 7 black people, and 15 yellow-skin people.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- The document implies that the ground truth for SpO2 measurements was established using a reference method as per ISO 80601-2-61:2011 and FDA guidance - "Pulse Oximeter Premarket Notification Submissions." It does not explicitly state that human experts were involved in establishing the ground truth for the test set, but rather that functional oxygen saturation measurement itself (presumably measured by co-oximetry, the reference standard for pulse oximeters) was the ground truth. Therefore, no specific number of experts or their qualifications for establishing ground truth are provided.
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Adjudication Method for the Test Set:
- Not applicable/Not mentioned. The ground truth method for SpO2 measurements in pulse oximetry studies typically involves a reference co-oximeter (a laboratory instrument that directly measures arterial oxygen saturation from blood samples), not human adjudication of images or signals.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study (MRMC) is typically performed for AI/CAD systems where human readers interpret medical images. For a pulse oximeter, the study focuses on the device's accuracy against a physiological gold standard.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance data presented (SpO2 accuracy Arms value) is the direct performance of the device itself, without human intervention in its measurement process. The study validates the device's ability to measure SpO2 alone.
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The Type of Ground Truth Used:
- The document states that the clinical evaluation "is in compliance with the criteria of ISO 80601-2-61:2011 standard and FDA guidance - 'Pulse Oximeter Premarket Notification Submissions'." These standards and guidance documents for pulse oximeter testing mandate the use of reference co-oximetry measurements from simultaneously drawn arterial blood samples (often during induced hypoxia in healthy volunteers) as the ground truth for SpO2. This is a form of physiological/biometric ground truth.
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The Sample Size for the Training Set:
- Not applicable/Not mentioned. The device described appears to be a hardware-based medical device with integrated software, not an AI/Machine Learning algorithm that requires a separate "training set" in the conventional sense. The "software validation" mentioned refers to traditional software engineering validation, not AI model training.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a traditional "training set" for an AI/ML algorithm.
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