(117 days)
The N600x Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
The N-600x Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients who are well or poorly perfused in hospitals, hospital-type facilities, intra-hospital transport, and home environments.
The N-600x with SPD feature is intended for use on adults to detect patterns of desaturation that are indicative of repetitive reductions in airflow through the upper airway and in to the lungs.
This section describes the N-600x Pulse Oximeter with SPD. The N-600x with SPD is comprised of the N-600x Pulse Oximeter with SPD software and a variety of OxiMax Adult Sensors and cables that have been previously cleared.
The Saturation Pattern Detection (SPD) is a software option which is compatible with the N-600x. The software option is intended to add an advanced SpO2 trend analysis feature. SPD will detect patterns in the saturation trend that are associated with a reduction in airflow and provide annunciation. The SPD feature mines information that is present in the SpO2 trend history stored in the monitor and alerts the caregiver to patterns in that trend. The SPD feature is a means of evaluating the SpO2 information being collected by the oximeter, analogous to the threshold or SatSeconds™ alarm features currently available on the predicate device. The addition of the SPD feature to the predicate device does not affect the device hardware.
The provided text is a 510(k) summary for the Covidien OxiMax N-600x Pulse Oximeter with Saturation Pattern Detection (SPD). While it details the device description, intended use, technological characteristics, and regulatory approval, it does not include specific acceptance criteria or a detailed study description with performance metrics, sample sizes, ground truth establishment, or multi-reader multi-case study results.
The document states that "Clinical and non-clinical tests were performed to support the determination of substantial equivalence" and that "The technological characteristics... and the results of non-clinical and clinical tests do not raise new questions of safety or effectiveness." However, it does not provide the specifics of these tests.
Therefore,Based on the provided text, I cannot provide the complete information requested in the prompt. The document is a 510(k) summary focused on regulatory clearance based on substantial equivalence, rather than a detailed study report with performance metrics and acceptance criteria.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | Not specified in the provided text. |
The document mentions that "Clinical and non-clinical tests were performed to support the determination of substantial equivalence" but does not detail what specific performance metrics were measured or the thresholds for acceptance for the SPD feature.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states that "Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- MRMC Study: Not mentioned or implied for the SPD feature. The SPD feature is described as a "software option which is compatible with the N-600x" and "a means of evaluating the SpO2 information being collected by the oximeter," suggesting it's an automated alert system rather than a tool for human readers to interpret directly in a comparative effectiveness study.
- Effect Size of AI vs. Without AI Assistance: Not applicable or not provided.
6. If a Standalone Study (Algorithm Only) was Done:
- The description of SPD as "a software option... intended to add an advanced SpO2 trend analysis feature" that "detects patterns in the saturation trend... and provides annunciation" strongly suggests a standalone algorithmic performance study would have been conducted to validate its ability to detect these patterns. However, the details of such a study are not provided in this summary.
7. Type of Ground Truth Used:
- The SPD feature is intended "to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs." Therefore, the ground truth would likely involve polysomnography (PSG) or other definitive methods for identifying actual repetitive airflow reductions or desaturation events, but this is not explicitly stated in the document.
8. Sample Size for the Training Set:
- Sample Size (Training Set): Not specified.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment (Training Set): Not specified.
§ 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).