(67 days)
The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® uSpO2™ Pulse Oximetry Cable is indicated for use with adult, pediatric and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The Masimo SET® uSpO2™ Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate when installed in a compatible OEM host system.
In this submission, the uSpO2 Pulse Oximetry Cable incorporates a distal integrated LNCScompatible 9-pin sensor connector with a length of cable used to interface to the host device, the GE ApexPro Telemetry System (K080251). The proximal end of the cable incorporates a connector that is compatible with the host device.
The provided 510(k) summary for the Masimo SET® uSpO2™ Pulse Oximetry Cable does not include specific acceptance criteria or a detailed study proving the device meets those criteria. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific numerical thresholds in a clinical or analytical study.
Here's an analysis of the available information against your requested points:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. The document states that "The following testing of the uSpO2 Pulse Oximetry Cable was performed... to demonstrate substantial equivalence of the modified device to the cleared device," but it does not specify what performance criteria (e.g., accuracy, bias, precision for SpO2 or PR) were used or what the specific test results were.
2. 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. The summary lists types of testing conducted (e.g., Design Review, Risk Analysis, Software Verification, EMC, Electrical Safety, Environmental, Component/System, System Compatibility), but none of these descriptions include details about sample sizes for a test set or data provenance.
3. 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. Given that the listed tests are primarily engineering and system compatibility tests, it is unlikely that "experts" in the sense of clinical specialists establishing ground truth were involved in these specific tests as described. Clinical performance testing (if performed) for SpO2 devices typically involves arterial blood gas analysis, which is an objective measurement rather than an expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed in the listed tests.
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
This information is not provided. MRMC studies are not relevant for a pulse oximetry cable, which is a sensor and cable connecting to a host system, not an AI-powered diagnostic tool requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself (the uSpO2 Pulse Oximetry Cable) operates as a standalone component connecting to a host system. The summary implies that "System Compatibility Testing (GE ApexPro Telemetry System)" would assess the cable's performance in conjunction with the host, which is a form of integrated system performance. However, there's no "algorithm only" performance study in the sense of an independent software assessment described. The Masimo SET® technology is inherent to the oximetry process, and its performance characteristics would have been established during the original clearance of Masimo SET® products (e.g., K040259, the predicate device). This submission focuses on the cable's compatibility and functional equivalence when integrated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided for the studies listed. For pulse oximeters, the typical ground truth for SpO2 accuracy is arterial blood gas analysis, which is an objective physiological measurement. However, this specific 510(k) emphasizes testing related to the cable's functionality and compatibility, not a de novo clinical accuracy study of the oximetry technology itself.
8. The sample size for the training set
This information is not provided. Training sets are generally associated with machine learning or AI algorithms. This submission is for a medical device (a cable for a pulse oximeter) and does not involve AI/ML technology that would have a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of a training set or AI/ML algorithm in this 510(k) submission.
Summary of Device Performance as Reported:
The 510(k) summary for the Masimo SET® uSpO2™ Pulse Oximetry Cable does not provide specific performance data or numerical acceptance criteria. Instead, it concludes:
"The information in this 510(k) submission demonstrates that the subject Masimo SET uSpO2 Pulse Oximetry Cable is substantially equivalent to the existing device with respect to safety, effectiveness, and performance."
This statement implies that the device meets performance requirements by being equivalent to a previously cleared device (K040259 - Masimo SET® IntelliVue Pulse Oximeter Module), which itself would have had its performance validated. The tests conducted (Design Review, Risk Analysis, Software Verification, EMC, Electrical Safety, Environmental, Component/System Testing, System Compatibility Testing with GE ApexPro Telemetry System) are primarily aimed at demonstrating that the new cable does not introduce new risks or alter the established performance characteristics of the Masimo SET technology when integrated with the specified host system.
§ 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).