(85 days)
The OxiBlue Fingertip Puls) Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arterial overan saturation (SpO2) and pulse rate of patients in home care. It is intended for adu't and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiBlue can transmit in the either a USB cable or wireless Bluetooth technology.
The OxiPro Fingertip Pulse Oximeter is indicated for continuous or spot-checking in measuring and displaying functional arter. V oxygen saturation (SpO2) and pulse rate of patients in home care. It is intended for adu' and pediatric patients on finger between 0.3-1.0 inch (0.8 - 2.5 cm) thick. The OxiPro can transmit Pro vio : USB cable, and does not include Bluetooth technology.
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This document is a 510(k) premarket notification decision letter from the FDA for the OxiBlue and OxiPro Fingertip Pulse Oximeters. It states that the devices are substantially equivalent to legally marketed predicate devices.
Based on the provided text, the following information can be extracted:
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A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria or device performance data in a table format. It focuses on the substantial equivalence determination rather than specific performance metrics. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the given document. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided in the given document. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the given document. -
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:
This information is not provided in the given document. The device is a pulse oximeter, which typically measures physiological parameters directly rather than relying on human interpretation, so an MRMC study related to AI assistance is not applicable here. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided in the given document. The device itself is a standalone measurement tool. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided in the given document. For pulse oximeters, ground truth is typically established against co-oximetry blood gas analysis. -
The sample size for the training set:
This information is not provided in the given document. -
How the ground truth for the training set was established:
This information is not provided in the given document.
Summary of missing information:
The provided document is an FDA 510(k) clearance letter, which primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device. It does not contain the detailed technical study results, performance metrics, or validation methodology that would typically be found in a clinical study report or a more comprehensive technical submission. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and sample sizes is not available in this specific document.
§ 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).