(63 days)
The sensor is indicated for use as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
The Hygia Health Services reprocessed pulse Oximeter sensors are non-invasive sensors used to provide continuous SpO2 monitoring and pulse rate. The sensors contain a dual wavelength light emitting diode (LED), and an optical photodiode sensor which are housed in a pad which attaches to the patient using adhesive material. The LED emits red and infrared light in alternate pulses, governed by the Oximeter instrument. The photodiode sensor responds to the light and generates a current that is interpreted by the Oximeter instrument. The Oximeter instrument interprets the different amounts of each light type (red and infrared) from the output of the photodiode and interprets the information and displays a reading. The sensor operates without any type of tissue penetration, electrical contact, or heat transfer to the patient. The sensors use optical means to determine the light absorption of functional arterial hemoglobin.
This document is a 510(k) summary for the Hygia Health Services Reprocessed Sensors, which are reprocessed pulse oximeter sensors. It asserts substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria or quantitative performance metrics for the reprocessed sensors in a format that would typically be seen for AI/software-as-a-medical-device (SaMD) performance.
Instead, the summary focuses on demonstrating that the reprocessed sensors are substantially equivalent to predicate devices through various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety & Effectiveness comparable to predicate devices | Biocompatibility, functional testing, and cleaning validation demonstrate equivalence and safety/effectiveness for intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on sample size, data origin (country), or whether the study was retrospective or prospective for the performance testing. It generally refers to "functional testing, cleaning validation, and biocompatibility testing."
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or provided in the context of this device. The device is a reprocessed physical sensor, not an AI or diagnostic imaging system that relies on expert interpretation for ground truth.
4. Adjudication Method
This information is not applicable or provided for this type of device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable or provided. This is not an AI/SaMD product, so a MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable or provided. The device is a physical sensor, not an algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/diagnostic performance is not directly relevant here. For a a reprocessed physical medical device like this, performance is usually assessed against:
- Predicate device performance specifications: Ensuring the reprocessed device performs within the same range as the original.
- Biocompatibility standards: Ensuring no adverse tissue reactions.
- Cleaning validation: Ensuring proper sterilization and absence of contaminants.
- Functional tests: Verifying physical and electrical properties.
The summary states that "Biocompatibility and performance/functional testing demonstrate that the devices are equivalent and are safe and effective for their intended use."
8. Sample Size for the Training Set
This information is not applicable or provided. This device is not an AI/machine learning product and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. As mentioned, there is no training set for this type of 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).