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510(k) Data Aggregation
(103 days)
HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
The Hygia Health Services Reprocessed Masimo LNCS Pulse Oximeter sensors are used as a non-invasive method to provide continuous SpO2 monitoring and pulse rate monitoring. This device is intended for prescription use.
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.
Here's an analysis of the provided 510(k) summary regarding the Hygia Health Services Reprocessed Sensors, focusing on acceptance criteria and supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a table format. However, it indicates the overall performance goal is substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (Safety) | Testing demonstrates safety and effectiveness. |
| Performance/Functional Equivalence | Functional testing demonstrates that the reprocessed devices perform as intended. |
| Clinical Performance (SpO2 monitoring and pulse rate) | Clinical Testing demonstrated that the reprocessed devices used with the Masimo Radical SET pulse oximeter perform as intended and are safe and effective. |
| Cleaning Validation | Cleaning validation demonstrates safety and effectiveness. |
| Substantial Equivalence to Predicate | Hygia Health Services concludes that the Hygia Health Services reprocessed pulse Oximeter sensors are substantially equivalent to the Masimo LNCS predicate sensors based on all testing. |
2. Sample Size for Test Set and Data Provenance
The 510(k) summary does not specify the sample size used for the clinical or functional testing. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth Establishment
The 510(k) summary does not provide information on the number of experts used to establish ground truth or their qualifications. Given the nature of a reprocessed medical device, the "ground truth" would likely be the performance of new, original equipment manufacturer (OEM) sensors, but no details are given on how this comparison was rigorously established.
4. Adjudication Method for the Test Set
The 510(k) summary does not mention any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported in this 510(k) summary. The device is a pulse oximeter sensor, which provides objective measurements (SpO2 and pulse rate) rather than relying on interpretation by human readers. Therefore, such a study would not be applicable.
6. Standalone Performance Study (Algorithm Only)
The device itself is a reprocessed sensor, meaning it's a hardware component rather than a standalone algorithm. While the sensor outputs data that an oximeter algorithm interprets, the document focuses on the sensor's performance. The "clinical testing" mentioned likely evaluates the sensor's ability to provide accurate readings when used with an oximeter, implying a form of standalone performance evaluation for the sensor's output. However, it's not an "algorithm-only" study in the typical AI/software sense.
7. Type of Ground Truth Used
The ground truth implicitly used for this device's performance evaluation would be the performance of legally marketed, new (non-reprocessed) OEM pulse oximeter sensors, specifically the Masimo LNCS Pulse Oximeter Sensors. The goal is to demonstrate that the reprocessed sensors perform equivalently. The document states that "Clinical Testing demonstrated that the reprocessed devices used with the Masimo Radical SET pulse oximeter perform as intended and are safe and effective," which implies comparison against expected, accurate readings.
8. Sample Size for the Training Set
The product is a reprocessed physical medical device (sensor), not an AI/ML algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size does not apply here. The reprocessed sensors are evaluated for their equivalence to new sensors after processing, not "trained" on data.
9. How Ground Truth for the Training Set Was Established
As established above, the concept of a "training set" is not applicable to this device.
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