(157 days)
The Finger Pulse Oximeter is a small portable battery powered device that measures %SpO2, pulse rate, and pulse strength on the finger. It may be used as a spot check device in the home, hospital, or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The pulse oximeter will provide reliable measurements on patients ranging from pediatric to adults. This device is not intended for continous patient monitoring. There are no audible or visible patient alarms.
Fox Oximeter is a portable, lightweight, and battery-operated device that measures %SpO2 pulse rate, and pulse strength on the finger of a patient.
The provided submission, K051736 for the Fox Oximeter, does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and stating that clinical testing was "Not Applicable."
Here's an analysis based on the provided text, highlighting the absence of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
Not available in the provided text. The document refers to compliance with various electrical and electromagnetic compatibility standards (EN 60601-1-2, EN 55011, 47CFR Part 15 Subpart B, EN 61000-4-2, EN 61000-4-3, EN 61000-4-8), but it does not specify performance acceptance criteria for SpO2, pulse rate, or pulse strength measurements, nor does it report the device's performance against such criteria.
2. Sample Size Used for the Test Set and Data Provenance:
Not available in the provided text. The submission states "Discussion on Clinical Tests Performed: Not Applicable," indicating no clinical test set was used for evaluating the device's performance in terms of SpO2, pulse rate, or pulse strength. The non-clinical tests mentioned are related to safety and electromagnetic compatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable, as no clinical test set was used to establish performance.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. The submission does not mention any clinical study, let alone one involving human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The submission does not discuss any algorithm-only performance study for the oximeter's core measurement functions. The evaluation focuses on substantial equivalence and compliance with non-clinical standards.
7. Type of Ground Truth Used:
Not applicable in the context of clinical performance evaluation. For the non-clinical tests, the "ground truth" would be the specifications and requirements of the standards themselves (e.g., passing electromagnetic interference tests).
8. Sample Size for the Training Set:
Not applicable. This device is a hardware medical device (oximeter), and there is no mention of a machine learning algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a machine learning algorithm.
Summary from the provided document:
The K051736 submission for the Fox Oximeter relies on the claim of substantial equivalence to the predicate device (3420 Digit™ Pulse Oximeter, K013171). The manufacturer performed non-clinical tests to ensure compliance with electrical and electromagnetic compatibility standards. No clinical performance testing against specific acceptance criteria for SpO2, pulse rate, or pulse strength was deemed necessary or performed, as indicated by "Discussion on Clinical Tests Performed: Not Applicable." Therefore, the document does not contain the detailed information requested regarding clinical acceptance criteria, study design, sample sizes, or expert involvement for performance evaluation.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).