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The PC-60 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 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 Shenzhen Creative Industry Co., LTD, Model PC-60 Fingertip oximeter is to monitor pulse rate and SPO2, for adult and pediatric patients in home use and clinical applications. This monitor is available for sale by the order of a physician or licensed health care professional.

The provided text describes a 510(k) submission for the Shenzhen Creative Industry Co., LTD. PC-60 Fingertip Oximeter. However, it does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria.

Instead, the submission focuses on establishing substantial equivalence to a predicate device (Nonin Onyx® II Fingertip Oximeter, Model 9550). This means the device is considered safe and effective if its performance is comparable to the legally marketed predicate.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing specific numerical acceptance criteria (e.g., SpO2 accuracy within +/- X%, heart rate accuracy within +/- Y bpm) and detailed performance data against those criteria.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated. The submission mentions "performance testing" but no details on patient cohorts or data points.
• Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided. The common method for pulse oximeter accuracy is comparison against arterial blood gas analysis in a controlled desaturation study, often involving clinical experts to monitor subjects and collect data, but no such study details are present.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Since there's no detailed clinical performance study described, an adjudication method is not applicable and not mentioned.

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

• No MRMC study was performed or described. This device is a standalone measurement device, not an AI-assisted diagnostic tool for human readers.

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

• Yes, implicitly. The device itself performs the measurement (algorithm only) and displays the results. The "Summary of Performance Testing" refers to testing the "system V & V plan and summary included with the submission using production equivalent units." However, the results of this testing, beyond the claim of equivalence, are not detailed in this public summary. For pulse oximeters, standalone performance is the primary focus, measuring its accuracy against established reference methods.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not explicitly stated. For pulse oximeters, the ground truth for SpO2 accuracy is typically co-oximetry readings from arterial blood samples (a gold standard for measuring fractional hemoglobin oxygen saturation). While implied for demonstrating equivalence to the predicate, this specific methodology is not described as being used by the applicant in this document.

8. The sample size for the training set

• Not applicable/Not mentioned. This device is a hardware sensor and signal processing unit, not a machine learning model that requires a "training set" in the typical sense.

9. How the ground truth for the training set was established

• Not applicable/Not mentioned (see point 8).

Conclusion:

The provided 510(k) summary for the PC-60 Fingertip Oximeter establishes substantial equivalence to the Nonin Onyx® II Fingertip Oximeter. It states that the "measurement specifications and performance are equivalent." However, it does not provide detailed clinical study results, specific acceptance criteria with numerical performance data, or detailed methodologies for establishing ground truth or sample sizes for specific tests beyond the general statement of "Summary of Performance Testing" in accordance with a V&V plan. Such specific data would typically be found in the full 510(k) submission, but is not included in this publicly available summary.

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