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The PC-60NW Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries. This device is applicable for spotchecking of SpO2 and pulse rate in home and clinic for adult and pediatric patients. This device is recommended for use on the index finger, for patients with fingers of 1.0 - 2.2 cm thick.

The PC-60NW Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, and indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries, it is small in size, convenient to use, and easy to carry. This device is applicable for spot-checking of SpO2 and pulse rate in home and clinic. The index finger is the recommended site. It is intended for spotchecking adult and pediatric patients on fingers between 1.0 -2.2 . cm thick. This oximeter has the function of wireless data transmission. The user can effectively transmit the data to computer through the wireless communication module.

The provided 510(k) summary for the PC-60NW Fingertip Oximeter does not contain the detailed study information typically requested for acceptance criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device (PC-60 Fingertip Oximeter K063641) based on meeting relevant standards and general performance rather than presenting a specific clinical or technical study with detailed performance metrics against predefined acceptance criteria.

The document states: "The Model PC-60 Fingertip Oximeter substantially has been tested in accordance with the system V & V plan and summary included with the submission using production equivalent units prior to release to market." It also mentions "Testing performed to Electrical Safety IEC 60601-1-1:1988, EMC Requirements IEC 60601-1-2, Biocompatibility IEC 10993-1, SPO2 Basic Safety and performance ISO 9919:2005, Basic Electrical safety and performance for Pulse Oximeters, ISO 80610-2-61 and pertinent FDA quidance documents, complied with the specific requirements for safety and performance."

Therefore, much of the requested information regarding detailed study design, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert involvement, and comparative effectiveness is not explicitly available in this 510(k) summary. The summary focuses on compliance with established standards rather than a specific performance study with a standalone acceptance criteria table.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table of acceptance criteria with corresponding performance results. Instead, it states that the device "complied with the specific requirements for safety and performance" according to various standards (IEC 60601-1-1, IEC 60601-1-2, IEC 10993-1, ISO 9919:2005, ISO 80610-2-61) and FDA guidance documents. These standards typically define the acceptance criteria for pulse oximeters, such as accuracy limits for SpO2 and pulse rate under various conditions. Without access to the full submission or the specific standards, the exact numerical acceptance criteria and detailed performance against them cannot be precisely tabulated from this summary.

Inferred Performance (based on compliance with standards):

• Pulse Oximetry Accuracy (SpO2): Expected to meet the accuracy requirements specified in ISO 9919:2005 and ISO 80610-2-61 for pulse oximeters, which typically outline a range of accuracy (e.g., ±2% or ±3% for SpO2 values between 70-100%).
• Pulse Rate Accuracy: Expected to meet the accuracy requirements specified in the relevant standards.
• Electrical Safety, EMC, Biocompatibility: Complies with the specified IEC standards.

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

The 510(k) summary does not specify a sample size for a test set (e.g., a specific number of patients or recordings used for performance evaluation). It mentions "system V & V plan" and "production equivalent units" but does not elaborate on the details of human subject testing or data provenance for performance validation.

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

This information is not provided in the 510(k) summary. The summary refers to compliance with standards, which might imply the use of reference devices or ground truth established by methodologies recognized within those standards, but it doesn't detail expert involvement.

4. Adjudication Method for the Test Set:

This information is not provided in the 510(k) summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. This type of study is more common for diagnostic imaging AI systems where human interpretation is a key component. For a pulse oximeter, the focus is on the device's direct measurement accuracy, not on human interpretation or improvement with AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance assessment (algorithm only without human-in-the-loop performance) was implicitly done. The statement "The Model PC-60 Fingertip Oximeter substantially has been tested in accordance with the system V & V plan and summary included with the submission using production equivalent units prior to release to market" indicates that the device's performance characteristics (SpO2 and pulse rate measurement) were evaluated independently against specified requirements. However, the details of this evaluation (e.g., number of subjects, conditions tested, specific accuracy results) are not elaborated in the summary.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. For pulse oximeters, the typical ground truth for SpO2 accuracy studies involves co-oximetry measurements from arterial blood samples (gold standard for oxygen saturation) compared to the oximeter readings under induced hypoxia conditions in healthy volunteers. While not stated, it is highly probable that expert consensus, pathology, or outcomes data were not directly used for establishing SpO2 ground truth; rather, a reference co-oximeter would be the expected ground truth method to which the device's measurements are compared.

8. Sample Size for the Training Set:

This information is not provided in the 510(k) summary. For a device like a pulse oximeter, "training set" is generally not applicable in the sense of machine learning algorithms that learn from data. The device's algorithms are typically based on well-established physiological models and empirical calibration, not a "training set" in the modern AI sense.

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

As "training set" is not applicable in the typical AI sense, this information is not provided. The calibration and empirical basis for the oximetry algorithm would have been established during the device's development using reference methods, likely involving human subject testing with co-oximetry as described in point 7.

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