(379 days)
The P10 pulse oximeter is intended to be used to monitor functional arterial oxygen saturation (SpO2) and pulse rate in all areas of a hospital, hospital, hospital-type facilities, intra-hospital transport and home environments. Users should be skilled at the level of a technician, doctor, nurse or medical specialist.
Note: The continuous monitoring and Spot check mode are user-selectable. The mode of operation is the continuous monitoring except when the Spot Check Mode (03) is enabled.
The P10 Pulse Oximter is to monitor non-invasive functional oxygen saturation of arterial hemoglobin (SpOz) and pulse rate for adult, pediatric and neonate patients in general hospital and alternate care facilities by medically trained personnel. This monitor is available for sale only upon the order of a physician or licensed health care professional.
The Mediana P10 Pulse Oximeter is a lightweight and compact device (58×105×21mm and 90g) powered by 3 Alkaline AAA batteries. The monitor provides patient data and monitoring status on LCD displays. MD1 module is used for SpO2 module, and YM-1 reusable sensor is used for SpO2 sensor.
Here's a breakdown of the acceptance criteria and the study details for the Mediana P10 Pulse Oximeter, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting explicit numerical acceptance criteria for a new device. However, the core performance metric for a pulse oximeter is its accuracy in measuring functional arterial oxygen saturation (SpO2). The clinical testing was conducted to support the device's accuracy claims.
| Acceptance Criteria Category | Specific Criteria (Inferred from Predicate Equivalence & Clinical Study) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy | Equivalent to predicate devices (Mediaid 3X Series, Masimo RAD-5) | Data obtained from clinical tests support device accuracy claims for the specified saturation range. (Specific numerical accuracy, e.g., ±2%, is not detailed in the provided summary, but implied by equivalence to predicates and "ARMs accuracy in accordance with recognized methods"). |
| Pulse Rate Accuracy | Equivalent to predicate devices (Mediaid 3X Series, Masimo RAD-5) | Performance derived from Non-Invasive Pulse Oximetry (SpO2) are equivalent to predicate devices. |
| Biocompatibility | Conformance to ISO 10993 | Testing performed to demonstrate conformance. |
| Electrical Safety | Conformance to ISO 60601-1 | Testing performed to demonstrate conformance. |
| EMC (Electromagnetic Compatibility) | Conformance to ISO 60601-1-2 | Testing performed to demonstrate conformance. |
| Pulse Oximetry Standards | Conformance to ISO 9919 | Testing performed to demonstrate conformance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 10 human adult volunteers.
- Data Provenance: Clinical hypoxia testing was performed in the context of an institutionally approved protocol, indicating a prospective study. The subjects were described as a mix of White, Hispanic, and African American individuals. The location of the study is not explicitly stated, but Mediana Co.,Ltd. is based in Korea and the 510(k) submission was processed in the US, suggesting the study could have been conducted in either region or internationally.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The ground truth for arterial oxygen saturation (SaO2) was established by a co-oximetry reference method on radial arterial blood samples. This method itself (co-oximetry) is the gold standard for measuring SaO2. While not explicitly stated as "experts," the performance of this co-oximetry method and the collection of arterial blood samples would necessitate highly skilled medical professionals (e.g., physicians, nurses, lab technicians) with expertise in arterial blood sampling and operating co-oximeters. The number of such professionals involved is not specified.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by direct measurement using a co-oximetry reference method, not by expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the standalone accuracy of the pulse oximeter against a reference standard, not on how human readers' performance would improve with AI assistance. Pulse oximeters are typically standalone measurement devices.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance study was done. The clinical hypoxia testing evaluated the accuracy of the P10 pulse oximeter against the co-oximetry reference method. This assesses the device's inherent measurement capabilities.
7. The Type of Ground Truth Used
The ground truth used was outcomes data / reference standard measurement in the form of arterial oxygen saturation (SaO2) obtained by the co-oximetry reference method from radial arterial blood samples. This is considered a highly accurate and direct measure for assessing pulse oximeter performance.
8. The Sample Size for the Training Set
The provided 510(k) summary does not explicitly mention a "training set" or "training data" in the context of a machine learning or AI algorithm. Pulse oximeters operate on well-established physiological principles and signal processing, rather than requiring extensive machine learning training sets in the same way an AI diagnostic imaging device would. The "clinical validation report" for the SpO2 module (MD1) mentioned in section 17-O might contain more details about any internal data used for calibration or algorithm refinement, but it's not detailed in this summary.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is mentioned in the context of machine learning, this question is not directly applicable. If the device uses algorithms that were developed using internal data, the ground truth for that development would typically be established through similar methods (e.g., comparison to co-oximetry) during the R&D phase of the SpO2 module.
§ 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).