(42 days)
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The 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 optical components are housed in a foam and Velcro wrap. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datex-compatible models.
This submission describes the Flexi-Stat SpO2 Sensor, an accessory to a pulse oximeter for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The summary provided primarily focuses on the substantial equivalence of the Flexi-Stat SpO2 Sensor to existing predicate devices, rather than detailed acceptance criteria and supporting studies for a novel or significantly modified device. Therefore, some information requested, particularly regarding specific numerical acceptance criteria and a detailed study design as might be seen for a new algorithmic device, is not explicitly present in the provided text.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Specific numerical acceptance criteria (e.g., accuracy ranges for SpO2 measurements) are not explicitly stated in the provided text for the Flexi-Stat SpO2 Sensor itself. Instead, the document states: "The Flexi-Stat was compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be equivalent to predicate device accuracy claims." This implies that the acceptance criteria for the Flexi-Stat SpO2 Sensor were to meet or be equivalent to the accuracy claims of its predicate devices.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Accuracy (SpO2) | Equivalent to predicate device accuracy claims | "found to be equivalent to predicate device accuracy claims" based on comparison to arterial blood samples analyzed on a laboratory co-oximeter. |
| Biocompatibility | Conformance with established industry standards | "Biocompatibility... was also performed to demonstrate conformance with established industry standards." |
| Electrical Safety | Conformance with established industry standards | "electrical safety... was also performed to demonstrate conformance with established industry standards." |
| EMC (Electromagnetic Compatibility) | Conformance with established industry standards | "EMC testing was also performed to demonstrate conformance with established industry standards." |
| Principle of Operation | Same as predicate device | "The Flexi-Stat SpO2 Sensor uses the same theory and principle of operation as the predicate device." |
| Design Characteristics | Equivalent to predicate device in terms of safety and effectiveness | "Design characteristics are equivalent in terms of safety and effectiveness, as demonstrated by product testing and accuracy claims." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: This information is not explicitly stated in the provided text. The document mentions "clinical hypoxia studies" but does not give the number of subjects.
- Data Provenance: The studies were described as "clinical hypoxia studies conducted in an independent research lab." No specific country of origin is mentioned, but the company is US-based. It is a prospective study as clinical hypoxia studies involve actively inducing hypoxia in subjects under controlled conditions.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of device and study. The ground truth was established using an objective measurement from a laboratory co-oximeter and arterial blood samples, not through expert consensus on interpretations.
4. Adjudication Method for the Test Set
This information is not applicable. The ground truth was based on objective laboratory measurements (co-oximetry of arterial blood samples), not on expert interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., radiology AI), not for objective physiological measurement devices like an SpO2 sensor where the output is a direct numerical reading.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
Yes, the accuracy assessment described ("The Flexi-Stat was compared to arterial blood samples analyzed on a laboratory co-oximeter") represents a standalone performance evaluation of the device's measurement capabilities. There is no human intervention mentioned in the process of generating the SpO2 values from the Flexi-Stat sensor and comparing them to the ground truth.
7. The Type of Ground Truth Used
The ground truth used was objective physiological measurement:
- "arterial blood samples analyzed on a laboratory co-oximeter"
8. The Sample Size for the Training Set
This information is not applicable as the Flexi-Stat SpO2 Sensor is not a machine learning or AI-based device that typically requires a "training set" in the conventional sense. Its function is based on electro-optical principles, not learned patterns from data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons mentioned above.
§ 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).