(184 days)
The Stat-Shell Disposable SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring for patients weighing more than 30 kg. It is intended for single patient reuse.
The Stat-Shell SpO2 Disposable Sensor is an electro-optical sensor which functions without skin penetration, electrical contact, or heat transfer. It is an accessory to compatible SpO2 oximeters. 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 photodiode is housed in a textured, rigid shell that is contoured for patient digit placement. The LED's are housed in a foam tape that is positioned over the nail bed and wrapped around the patient's digit.
The sensor cable is 2 feet in length and is terminated in a DB-9 style connector. An adapter cable extends the length and converts the connector to a Hypertronics style.
The provided text describes a 510(k) summary for the Stat-Shell Disposable SpO2 Sensor. Based on the document, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for the Stat-Shell Disposable SpO2 Sensor in terms of specific performance metrics (e.g., accuracy ranges for SpO2 or pulse rate). Instead, it focuses on demonstrating substantial equivalence to a predicate device and meeting certain standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Oximeter Compatibility with Smaller Photodiode | "Simulated use bench testing was performed to verify oximeter compatibility with the smaller photodiode." (Passed) |
| Biocompatibility | "bench testing was performed to verify that the device meets the same standards as the predicate device, with regard to biocompatibility..." (Passed) |
| EMC (Electromagnetic Compatibility) | "...EMC..." (Passed) |
| Safety | "...safety..." (Passed) |
| Pulse Oximeter Standards | "...and pulse oximeter standards." (Passed) |
| Same Theory and Principle of Operation as Predicate Device | "The Stat-Shell SpO2 Disposable Sensor uses the same theory and principle of operation as the predicate device." (Met) |
| No effect on accuracy due to changes (compared to predicate) | "Changes to the predicate device do not affect those aspects of the device related to accuracy." (Met) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a quantitative sample size for the "simulated use bench testing" or the other bench testing. It refers to "bench testing" in general terms.
- Data Provenance: The document does not provide details about the country of origin of the data or whether it was retrospective or prospective, as the testing described appears to be laboratory/bench testing rather than clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The testing described is bench testing, not a clinical study involving expert assessment or ground truth derived from human interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. The testing described is bench testing, not a clinical study involving human judgment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes bench testing to ensure substantial equivalence and adherence to standards, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an SpO2 sensor accessory to a pulse oximeter, which is inherently a sensor that generates a measurement. The "algorithm" or measurement capability resides within the pulse oximeter it connects to. The testing described is for the sensor itself to ensure it functions correctly as an input to the oximeter. Therefore, a standalone algorithm performance study in the sense of AI evaluation is not applicable or described. The performance of the sensor (mechanical, electrical, optical) was assessed.
7. The Type of Ground Truth Used
The ground truth for the bench testing would have been established by engineering specifications, calibration standards, and validated test equipment. For example, for "oximeter compatibility," the ground truth would be successful communication and accurate readings provided by the oximeter when connected to the Stat-Shell sensor, verified against known references or the predicate device's expected performance. For biocompatibility, EMC, and safety, the "ground truth" is adherence to established industry and regulatory standards.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The Stat-Shell Disposable SpO2 Sensor is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. The Stat-Shell Disposable SpO2 Sensor is not an AI/ML device that requires a training set.
§ 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).