(89 days)
This sensor is indicated for use in continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
The devices are reprocessed Low Noise Cabled Sensors (LNCS)® Series - Adult, Pediatric, and Infant SpO2 adhesive sensors. The sensors are disposable devices used for continuous noninvasive arterial oxygen saturation and pulse rate monitoring.
The provided document states that the Reprocessed Pulse Oximeter Sensors have identical indications for use, technological characteristics, design, materials, and intended use as the predicate devices. Therefore, the acceptance criteria are implicitly that the reprocessed devices perform as "originally intended" by the manufacturer of the predicate devices. The study conducted to prove this involved bench and laboratory testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Maintain original intended performance (safety and effectiveness) | Bench and laboratory testing demonstrated that Reprocessed Pulse Oximeter Sensors perform as originally intended. Key tests included: Biocompatibility, Validation of reprocessing, Function test(s), Packaging Validation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "bench and laboratory testing" and "each individual Pulse Oximeter Sensor is tested," suggesting that a robust testing protocol was followed but does not provide specific numbers for the test set.
- Data Provenance: Not explicitly stated. The document does not mention the country of origin of data or whether it was retrospective or prospective. It describes general testing conducted by the applicant, Ascent Healthcare Solutions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The "ground truth" here is the performance specifications of the original, new device. The testing conducted by Ascent Healthcare Solutions was to verify that the reprocessed devices meet these pre-defined specifications through direct measurement and physical/chemical analysis, not through expert interpretation of clinical data on the reprocessed devices themselves.
- Qualifications of Experts: Not applicable, for the reasons above.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The testing described is objective, physical, and chemical in nature, designed to confirm that the reprocessed devices meet established performance parameters. There is no subjective interpretation requiring an adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a reprocessed medical device, and the evaluation focused on its functional equivalence to the original device through bench and laboratory testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical medical sensor, not an algorithm. The performance evaluation is of the sensor itself.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the reprocessed sensors is the performance specifications and characteristics of the original, new predicate devices (Masimo LNCS and SPO2.COM Sensors). The objective was to demonstrate that the reprocessed devices continue to meet these original manufacturer specifications after reprocessing.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML algorithm that requires a "training set." The device is a reprocessed physical medical device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as 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).