(88 days)
Reusable sensor for continuous non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. with the Datex Satlite and AS/3 monitors.
The Epic Medical Equipment Services. Inc. E403-09 SpO2Finger Sensor is a reusable clip-on finger sensor with the optical components, protected in a hard plastic case. It functions without skin penetration, electrical contact, or heat transfer. This electrooptical sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The E403-09 Finger Sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector.
The E403-09 is three feet in length and is terminated in a DB9 style connector as is the predicate sensor. The E403-09 is used with E710-09 10 foot cable which both extends the length of the E403-09 as well as adapts the DB9 connector to a Nicolay style connector which connects to the oximeter.
The E412-09 is equivalent to the E403-09 (3 foot) plus E710-09 (10 foot). The E412-09 is 12 feet long and terminates with a Nicolay style connector.
This document describes the 510(k) submission for the Epic Medical Equipment Services E403-09 SpO2 Finger Sensor. The information provided outlines the device's technical characteristics, non-clinical tests, and limited details on clinical tests.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for the E403-09 SpO2 Finger Sensor. However, it indicates that the device's accuracy was established through comparison with blood samples analyzed on a multiwavelength hemoximeter. The conclusion states that "Clinical validation studies demonstrates the successful use of the sensor and its ability to provide accurate information."
Therefore, based on the provided text, the acceptance criterion implicitly relates to demonstrating accurate SpO2 measurements. No specific numerical performance metrics (e.g., accuracy range, bias, precision) are given in the summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device provides accurate functional arterial oxygen saturation. | Clinical validation studies demonstrate "successful use of the sensor and its ability to provide accurate information." |
Study Information
The document provides very limited details about the clinical study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified, but the study was described as "Controlled hypoxia studies."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not specified. The ground truth method was "blood samples analyzed on a multiwavelength hemoximeter," implying laboratory analysis rather than expert consensus on images or interpretations.
4. Adjudication Method for the Test Set
- Not applicable. The ground truth was established by instrumental analysis ("multiwavelength hemoximeter") of blood samples, not by human expert review requiring adjudication.
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
- Not applicable. This device is an SpO2 finger sensor, not an AI-assisted diagnostic imaging device. No MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, this was a standalone performance study. The device's SpO2 measurements were compared directly against blood gas analysis, without human interpretation as part of the primary measurement pathway.
7. The Type of Ground Truth Used
- Clinical Ground Truth: Blood samples analyzed on a multiwavelength hemoximeter. This is a common and accepted method for establishing the ground truth for arterial oxygen saturation.
8. The Sample Size for the Training Set
- Not applicable. This device is a sensor and does not utilize machine learning or AI algorithms requiring a training set in the conventional sense. Its "training" or calibration would be inherent to its physical design and factory calibration processes rather than a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set mentioned for this device.
§ 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).