(360 days)
Medke Oximetry Finger Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate(PR) for adult patients weighing greater than 40kg,
The Medke Oximetry Finger Sensors are compatible sensor for use with major types of patient monitors and oximeter devices of Original Equipment Manufacturer (OEM). The sensors are made up of connector, cable, two specific wavelength LEDs & a photo detector assembled into the sensor housing. The sensors use optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The Medke Oximetry Finger Sensors contain finger clip type and soft tip type. The finger clip sensor is comprised of a plastic shell with silicone pads which position the optical components, and a cable with OEM compatible connector. The soft finger sensor consists of an integrated silicone rubber tip which is installed the optical components, and a cable with OEM compatible connector. The Medke Oximetry Finger Sensors have unique labeling and specifications designed for compatibility with Nellcor patient monitor(NPB40) cleared in K963707.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Parameter/Measurement | Acceptance Criteria (from Comparator) | Reported Device Performance (Medke Oximetry Finger Sensor) | Meets Criteria? |
|---|---|---|---|
| SpO2 Accuracy | ±2% (70-100%) | 1.37% (70-100%) for Model P9119 | |
| 1.39% (70-100%) for Model P8119 | Y (per manufacturer's conclusion, as 1.37% and 1.39% are less than 2%) | ||
| Pulse Rate Accuracy | ±2 (30-250 bpm) | 1.63 (30-250 bpm) for Model P9119 | |
| 1.67 (30-250 bpm) for Model P8119 | Y (per manufacturer's conclusion, as 1.63 and 1.67 are less than 2) |
Note on Acceptance Criteria: The document states the predicate device has a SpO2 Accuracy of "±2%(70-100%)" and Pulse Rate Accuracy of "±2(30-250bpm)". While the Medke device reports RMS values (Arms), the conclusion states they "meets the requirements of ISO80601-2-61," implying these results fall within acceptable limits based on that standard, and are presented as meeting the predicate's performance or being substantially equivalent.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (SpO2 Accuracy): 12 healthy adults were selected as subjects. Each subject provided 25 data samples, resulting in a total of 300 data pairs (SpO2 vs. SaO2).
- Data Provenance: The study involved an "invasive 'breathe-down' test" on "healthy adult volunteers." The location or country of origin for these volunteers is not explicitly stated, but the company is based in Shenzhen, China. The study appears to be prospective as it involves active testing on human subjects.
- Sample Size for Test Set (PR Accuracy): Not explicitly stated, but tested using a "simulator."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for SpO2 accuracy was established through direct measurement of arterial blood SaO2 using a CO-Oximeter, which is a clinical reference method, not through expert interpretation of images or other subjective data.
- Qualifications of Experts: Not applicable for establishing ground truth as it was based on objective measurements.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The SpO2 accuracy was determined by comparing the device's SpO2 readings directly with SaO2 measured by a CO-Oximeter from arterial blood samples. There was no mention of multiple reviewers or adjudication of subjective data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This study focuses on device accuracy against a reference standard in controlled conditions, not on how human readers perform with or without AI assistance. The device is an oximetry sensor, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in essence, the accuracy studies for both SpO2 and Pulse Rate represent the standalone performance of the device. The device's output (SpO2 and PR) was directly compared against established ground truth (CO-Oximeter for SpO2, simulator for PR). There is no "human-in-the-loop" interaction described that would affect the device's measurement performance for these parameters.
7. The Type of Ground Truth Used
- SpO2 Accuracy: The ground truth was outcomes data/physiological measurement (SaO2 measured directly from arterial blood samples using a CO-Oximeter). This is an objective, gold-standard method for determining true oxygen saturation.
- PR Accuracy: The ground truth was established by using a simulator with known pulse rates (30-250 BPM). This is also an objective, controlled method.
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not provide information about a "training set" or "training data." This type of device (oximetry sensor) is based on fundamental biophysical principles and calibrated during manufacturing. It does not typically involve machine learning or AI models that require a separate training dataset for algorithm development in the way a diagnostic AI would. The studies described are for verification/validation of the finished product's performance.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for an AI/ML model for this device. The device's underlying measurement principles are well-established for pulse oximetry.
§ 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).