(30 days)
The MEDLEY SpO2 Module and accessories are intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals and hospital-type facilities.
The MEDLEY SpO2 Module and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions, and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.
The MEDLEY SpO2 Module, Model 8210, is essentially the same as the previously cleared device (MEDLEY SpO2 Module, Model 8220). The MEDLEY SpO2 Module (Models 8220 and 8210) and accessories is a device capable of non-invasively monitoring functional oxygen saturation of arterial hemoglobin and pulse rate. The system consists of an SpO2 Module, a Programming Module, connecting cable, and oximetry sensors.
The MEDLEY Programming Module (PM) and SpO2 Module snap together. The Nellcor board contains all of the pulse oximetry algorithms used to measure saturation and pulse rate. The patient cable and oximetry sensors, manufactured by Nellcor, work in combination with the MEDLEY SpO2 Module to utilize Nellcor's technology to measure functional oxygen saturation and pulse rate.
The provided text does not contain detailed information about specific acceptance criteria and the comprehensive study results to demonstrate that the MEDLEY SpO2 Module, Model 8210, meets these criteria. It primarily focuses on demonstrating substantial equivalence to predicate devices and states that verification testing was completed.
However, based on the general nature of the submission for a pulse oximeter, we can infer some aspects and present the available information within the requested structure.
Here's an attempt to answer the questions based on the provided text, with explicit notes where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "The performance information provided demonstrates that the MEDLEY SpO2 Module, Model 8210 and accessories perform as intended and within the required specifications to demonstrate the safety and effectiveness of the device." However, it does not provide a specific table of acceptance criteria (e.g., accuracy ranges for SpO2 or pulse rate) or detailed reported device performance values. These would typically be found in Section 8, which is only referenced.
| Acceptance Criteria (Inferred for Pulse Oximeters) | Reported Device Performance (Not explicitly stated in the provided text) |
|---|---|
| Accuracy of functional oxygen saturation (SpO2) | "perform as intended and within the required specifications" |
| Accuracy of pulse rate | "perform as intended and within the required specifications" |
| Performance during no motion conditions | Covered by the general statement |
| Performance during motion conditions | Covered by the general statement |
| Performance for well-perfused patients | Covered by the general statement |
| Performance for poorly perfused patients | Covered by the general statement |
| Software V&V (Verification and Validation) | "complete, acceptable and design output matches design input" |
| Design verification testing | "complete, acceptable" |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated in the provided text.
- Data provenance: Not explicitly stated in the provided text. Clinical data for pulse oximeter accuracy typically involves human subject studies, but the details (e.g., country of origin, retrospective/prospective) are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated in the provided text. For pulse oximeters, ground truth for SpO2 is usually established via co-oximetry of arterial blood samples. This does not typically involve "experts" in the sense of clinicians reviewing data, but rather laboratory analysis.
4. Adjudication method for the test set:
- Not applicable as the nature of the test set (if involved human review) is not described. For objective physiological measurements like SpO2, adjudication in the sense of multiple expert reviews is not typically used for ground truth establishment.
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:
- No, an MRMC comparative effectiveness study was not done. The device is a pulse oximeter, which directly measures physiological parameters. It does not involve "human readers" or "AI assistance" in the interpretation of complex images or data in a diagnostic context that would warrant an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. A pulse oximeter is a standalone device that provides direct measurements (SpO2 and pulse rate) via its internal algorithms without continuous human-in-the-loop performance influencing its primary output. The "design verification testing including software V&V" would encompass standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Inferred: For SpO2 measurements, the gold standard (ground truth) is typically co-oximetry of arterial blood samples. The document does not explicitly state this, but it's the standard for pulse oximeter validation.
8. The sample size for the training set:
- Not explicitly stated. The document refers to the device utilizing "Nellcor's technology" and its "pulse oximetry algorithms." The training of these algorithms would have occurred during the development of the Nellcor technology itself, rather than being a specific training set for this particular 510(k) submission, which is primarily focused on substantial equivalence.
9. How the ground truth for the training set was established:
- Not explicitly stated. For Nellcor's existing algorithms, the ground truth would have been established through extensive physiological studies using co-oximetry of arterial blood samples across a range of subjects and conditions, typically involving induced hypoxia.
§ 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).