(69 days)
The Hygia Health Services Reprocessed Pediatric and Adult Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive oxygen saturation is required for pediatric patients weighing 40 kg, respectively. The Hygia reprocessed sensor has been validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only.
The noninvasive 5100C Cerebral/Somatic Oximeter is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The prospective clinical value of data from the 5100C Cerebral/Somatic Oximeter has not been demonstrated in disease states. The OEM suggests the 5100C Cerebral/Somatic Oximeter should not be used as the sole basis for diagnosis or therapy.
The Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensors (CSS) are optical devices which use dual-wavelength light to determine a patient's current regional oxygen saturation level. Once a sensor has been applied to the patient, a light source in the sensor sends red and near-infrared light through the skin surface and photodiodes measure the reflected light. This signal is sent back to a monitor which calculates the patient's trending oxygenation levels.
The Hygia Health Services Reprocessed Cerebral-Somatic Oximetry Sensors are intended to be used in the same manner as the predicate devices. They are designed to be applied to the forehead and other appropriate portions of the body to measure regional oxygenation saturation during surgery or other applications related to the use of anesthesia.
1. Table of Acceptance Criteria and Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional performance equivalent to OEM sensors | "Functional testing… demonstrates that the reprocessed oximetry sensors perform as intended" |
| Cleaning validation successful | "cleaning validation… demonstrates that the reprocessed oximetry sensors perform as intended" |
| Biocompatibility demonstrated | "biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended, and are safe and effective." |
| Intended use with Somanetics INVOS 5100C Oximeter | "validated with the OEM's Cerebral/Somatic Oximeter, Model 5100C and is intended to be used with the Cerebral/Somatic Oximeter, Model 5100C only." |
| Maximum of 2 reprocessing cycles | Specified in the 'PRODUCT SUBMISSION CHART' for both adult and pediatric sensors. |
| For pediatric patients weighing 40 kg | Specified in "Indications For Use" |
2. Sample size used for the test set and the data provenance:
The document summarizes that "functional testing, cleaning validation, and biocompatibility data demonstrates that the reprocessed oximetry sensors perform as intended." However, it does not provide details on the specific sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not mention the involvement of experts for establishing ground truth for any tests conducted. The performance assessment appears to be based on engineering functional tests, cleaning validations, and biocompatibility assessments, rather than interpretation by clinical experts.
4. Adjudication method for the test set:
Since the document does not mention the involvement of experts for ground truth establishment, there is no information provided regarding any adjudication method for a test set.
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:
This device is an oximetry sensor, not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study. Therefore, no MRMC comparative effectiveness study was done, and this information is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is a reprocessed physical sensor, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device's performance relies on its physical and electrical characteristics when used with a compatible oximeter.
7. The type of ground truth used:
The "ground truth" for the device's performance seems to be based on:
- Functional performance standards: Comparisons to the performance of the original OEM sensors.
- Cleaning validation standards: Criteria for ensuring the device can be effectively reprocessed and cleaned.
- Biocompatibility standards: Criteria for ensuring the reprocessed device is safe for patient contact.
The document states, "The Hygia Health Services CSS are identical to the original OEM devices in reference to the technological characteristics." This implies that the ground truth for functional performance is essentially the performance of the new OEM devices.
8. The sample size for the training set:
As this is a reprocessed physical medical device and not a machine learning model, the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established:
Since there is no training set in the context of this device, this question is not applicable.
§ 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).