(168 days)
D-20 continuous non-invasive arterial oxygen saturation and pulse rate monitoring of for patients between 10 and 50 kg
I-20: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of for patients between 3 and 20 kg
The ReNu Medical Reprocessed Nellcor™ D-20 Oxysensor® II and Reprocessed Nellcor™ I-20 Oxysensor II are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.
The provided text is a 510(k) summary for ReNu Medical Reprocessed Nellcor™ D-20 and I-20 Oxysensors. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on bench testing, clinical performance data, and non-clinical performance data. However, this document does not contain the specific acceptance criteria or the detailed study results that prove the device meets those criteria.
Here's an analysis of what information is and isn't present, according to your request:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document states that "ReNu Medical Reprocessed Nellcor™ D-20 Oxysensor II and Reprocessed Nellcor™ I-20 Oxysensor® II function in a manner that is Substantially Equivalent to that of the predicate devices" based on various tests, but it does not specify what performance metrics were measured, what the acceptance criteria for those metrics were, or the actual results obtained in a table format.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document mentions "clinical performance data" but does not specify the sample size used for any test set or the provenance of the data (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. This document describes a reprocessed medical device (oximeter sensor). For such devices, "ground truth" typically refers to engineering specifications met through bench testing or direct comparison to existing validated devices, rather than expert interpretation of medical images or diagnostic outputs. There is no mention of experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Similar to point 3, adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reviewing images). This document does not describe such a study design.
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
- Not applicable. This device is an oximeter sensor, not an AI-powered diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a sensor, not an algorithm. The concept of "standalone algorithm performance" doesn't apply. The performance would be that of the sensor itself, typically measured through engineering and clinical validation studies as described under "bench testing, clinical performance data, and non-clinical performance data." However, the details of these studies are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied ground truth through substantial equivalence. The document implies that the ground truth for the reprocessed sensors' performance is established by demonstrating that they function "Substantially Equivalent" to the original, legally marketed predicate devices (Nellcor™ D-20 Oxysensor® II and Nellcor™ I-20 Oxysensor® II). This would involve comparing the reprocessed devices' measurements (SpO2, pulse rate accuracy) against the known, validated performance of the predicate devices under various conditions. The specific "type" of ground truth would be the validated performance specifications of the predicate devices achieved through their original clinical and bench testing.
8. The sample size for the training set
- Not applicable/Not provided. This document describes a reprocessed hardware device, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" for this type of device.
In summary: The provided document is a regulatory submission focused on demonstrating substantial equivalence of a reprocessed medical sensor to its predicate device. It lacks the detailed study results and specific acceptance criteria that would typically be found in a comprehensive clinical or performance study report. The information required in your prompt primarily pertains to studies involving diagnostic algorithms or human interpretation of medical data, which is not the subject of this 510(k) summary.
§ 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).