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The Oxygen Concentrator is intended to be used by patients with require supplemental oxygen. The device can be used in home, institution environments. The device is not intended to sustain or support life. The device is intended for use in adults.

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The provided document is a 510(k) clearance letter from the FDA for an Oxygen Concentrator. It describes the device, its intended use, and confirms its substantial equivalence to a predicate device. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method for the test set
5. MRMC comparative effectiveness study results
6. Standalone performance information
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This type of information is typically found in the 510(k) summary or the full 510(k) submission, which is not included in the provided text. The letter only refers to the submission and states that the device has been found substantially equivalent.

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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

Study Details:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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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The Wrist Pulse Oximeter is intended for spot checking in measuring and displaying oxygen saturation of functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospital facilities and home healthcare environments.

This device is a small, lightweight, portable device intended for use in measuring and displaying oxygen saturation of functional arterial haemoglobin (%SpO2) and pulse rate (PR).The device measures SpO2 and PR with a SpO2 senror and displays on the OLED after certain further processing. The device is mainly composed of the motherboard, SpO2 transducer and built-in battery. The power supply is 4.2V Li-battery and also the subject device can be powered by adapter. The subject device has a detachable sensor as an accessory to measure the SpO2 and pulse rate (PR). The subject device is not for life-supporting or life-sustaining and it is not an implantable device. The subject device owns software which has been validated by the manufacturer.

Here's a breakdown of the acceptance criteria and study findings for the Wrist Pulse Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The relevant acceptance criteria and performance data for the Wrist Pulse Oximeter primarily come from the "Substantial Equivalence" section and the "Clinical Test" section.

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

• Sample Size: The clinical evaluation was conducted on a total of 24 healthy adult male and female volunteers.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study participants beyond mentioning "2 white people, and 15 yellow-skin people." It is implied to be a prospective study as it describes a clinical evaluation conducted to generate data for the submission.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. For pulse oximetry, the ground truth is typically established by arterial blood gas (ABG) analysis, which is a laboratory measurement, not directly by "experts" in the sense of human readers. The clinical study compares the device's readings against these reference measurements.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method in the context of human expert review for the test set. For a pulse oximeter, the "ground truth" is typically objective physiological measurements (ABG), not subjective expert interpretation requiring adjudication.

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

No. A MRMC study is typically performed for image-based diagnostic aids where the AI assists human readers. This document describes a medical device (pulse oximeter) that provides a direct physiological measurement, and its accuracy is validated against a gold standard (ABG), not via a comparative effectiveness study with human readers.

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

Yes. The primary study detailed is a standalone performance validation of the Wrist Pulse Oximeter where its measurements (SpO2 and pulse rate) are compared directly against a reference method (likely arterial blood gas measurements, though not explicitly stated for SpO2, it's the standard for oximeter validation). The reported SpO2 accuracy of ±2% is an algorithm-only performance metric.

7. The Type of Ground Truth Used

The ground truth for the SpO2 accuracy validation was established using a physiological reference standard. While not explicitly named for SpO2 in the clinical test section, the widely accepted and regulatory-mandated method for validating pulse oximeter accuracy (specifically the Arms value) involves inducing various levels of hypoxemia and comparing the oximeter readings to co-oximeter measurements of arterial blood samples (Arterial Blood Gas - ABG).

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. The description of validation usually pertains to the final, locked algorithm or device. For devices like pulse oximeters, the core algorithm is often developed based on photometric principles and extensive internal testing, rather than a "training set" in the machine learning sense. The clinical test described is a validation test, not a training activity.

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

As no training set is described in the document, there is no information provided on how ground truth for such a set (if it existed) was established. Device development often involves internal calibration and verification, but these details are not typically part of a 510(k) summary focused on regulatory validation.

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