(232 days)
The MD300M122/MD300M222/MD300M322 handheld pulse oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult and pediatric patients in hospitals and home care.
The applicant device MD300M122 Handheld Pulse Oximeter is integrated with Bluetooth® technology allowing the user to transfer measurement data any time and anywhere. The oximeter is designed with the measurement, storage, review, visible and audible alarms and data transmission function. The MD300M122 Handheld Pulse Oximeter works by applying a external sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 940nm, which is infrared light. The applicant device of MD300M122 Handheld Pulse Oximeter is the handheld equipment, which mainly function are measurement, display, alarm, data storage & replay etc.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The provided document, K111494, focuses on the substantial equivalence of the Handheld Pulse Oximeter Model: MD300M122, MD300M222, MD300M322 to a predicate device, rather than explicitly stating acceptance criteria in a table format with specific performance metrics. However, it does imply acceptance criteria through its adherence to standards and the results of its clinical testing.
The primary acceptance criteria are derived from the applicable standard, ISO 9919:2005 Annex EE, which specifically addresses pulse oximeter accuracy. The study aimed to demonstrate compliance with the "specification claimed by the manufacturer compared with 'Golden Standard' Co-Oximeter."
Here's a table based on the implicit criteria and the reported outcome:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of SpO2 and Pulse Rate measurement | The clinical study following ISO 9919:2005, Annex EE.2 determined that the "accuracy of the proposed device is compliance to the specification claimed by the manufacturer compared with 'Golden Standard' Co-Oximeter." |
| Safety | The device passed bench tests according to IEC 60601-1:1988+A1:1991+A2:1995 (General requirements for safety) and IEC 60601-1-2:2007 (Electromagnetic compatibility). |
| Functional Equivalence | The device was found to have the "same classification, same intended use, same design principle, similar specifications and same safety performance as the predicate device," with "no obvious differences to influence the effectiveness and safety." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document indicates that "The Clinical Tests following ISO 9919:2005, Annex EE.2 are conducted," and that "Procedures of testing required in EE.2 are adopted." ISO 9919:2005 Annex EE.2 typically outlines methodologies for clinical evaluation of pulse oximeter accuracy, which involves human subject testing over a range of oxygen saturation levels. The specific number of subjects and measurements within that framework is not detailed in this submission.
- Data Provenance: The study was conducted in a clinical lab in Beijing, China, specifically at the "Beijing Military General Hospital." The study is prospective in nature, as it is clinical testing for the purpose of demonstrating device performance and gaining regulatory clearance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document refers to a "Golden Standard" Co-Oximeter for ground truth. This implies a gold standard instrument rather than expert consensus on subjective data. Therefore, the concept of "experts establishing ground truth" in the traditional sense of image interpretation or diagnosis is not directly applicable here. The accuracy of the Co-Oximeter itself is assumed to be established and validated. The individuals operating the Co-Oximeter and conducting the study would be trained clinical professionals, but their specific number and qualifications as "experts establishing ground truth" are not detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- As the ground truth is established by an objective "Golden Standard" Co-Oximeter measurement, an adjudication method for reconciling differing human expert interpretations is not relevant or described. The comparison is between the device's SpO2 and PR readings and the Co-Oximeter's readings.
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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, an MRMC comparative effectiveness study was not conducted. This device is a standalone pulse oximeter for measuring SpO2 and pulse rate. It does not involve human "readers" interpreting data or an AI component designed to assist human interpretation.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance evaluation described, which compares the device's measurements directly against a "Golden Standard" Co-Oximeter, represents a standalone performance assessment of the oximeter's algorithm and sensing capabilities. There is no human-in-the-loop component in the accuracy validation described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth used was continuous physiological measurement from a "Golden Standard" Co-Oximeter. This is an objective, instrumental measurement considered highly accurate for blood oxygen saturation.
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The sample size for the training set:
- The document does not provide information on a training set. Pulse oximeters typically rely on established physiological principles and sensor technology rather than machine learning algorithms that require extensive training data. If any internal algorithm optimization occurred during development, details about its data would not typically be included in a 510(k) summary focused on validation.
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How the ground truth for the training set was established:
- As no training set is described for an algorithm in the machine learning sense, this question is not applicable based on the provided text. The device's design is based on established scientific principles of light absorption by oxygenated and deoxygenated hemoglobin.
§ 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).