(95 days)
The MICRO2+ is intended for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused, using a range of compatible sensors. The device will produce visual and aural alarms if these parameters vary beyond preset limits.
The MICRO2+ is indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, and for patients who are well or poorly perfused.
The release of software version VA1 includes a re-labeling of the MicrO2+ and the recognition of Nellcor OxiMax sensors. The modifications implemented with the release of software version VA1 have not altered the basic fundamental technology of the MicrO2+.
The provided text is a 510(k) summary for the Siemens MicrO2+ with VA1 Software. This document focuses on a Special 510(k) Notification for modifications to an already legally marketed device (MICRO2+, 510(k) K012770). Special 510(k)s typically involve modifications to a manufacturer's own legally marketed device where the modification does not alter the fundamental technology or intended use.
Therefore, the submission primarily demonstrates that the modifications (re-labeling and recognition of Nellcor OxiMax sensors, and updated software) do not raise new questions of safety and efficacy compared to the predicate device. It does not present a detailed study proving the device meets acceptance criteria as would be found in an original 510(k) submission for a new device, or a comprehensive de novo submission.
Information regarding detailed performance studies, specific acceptance criteria values, sample sizes for test and training sets, expert qualifications, and ground truth establishment, as requested in the prompt, are not present in this Special 510(k) summary. These types of detailed performance data would have been part of the original 510(k) for the predicate device (K012770) or would be available in the full submission, not just the summary.
Based on the provided text, I cannot complete most of the requested information because the document is a Special 510(k) focused on modifications to an existing device rather than a comprehensive performance study for a new device.
However, I can extract what limited information is available and explain why other details are missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in this document. For oximeters, acceptance criteria typically involve accuracy (bias and precision) against a reference standard over a range of SaO2 values and under various conditions (motion, low perfusion). This information would have been part of the predicate device's cleared 510(k).
- Reported Device Performance: The document states:
- "Testing with VA1 software indicates no new issues relative to safety and efficacy."
- This implies that the modified device's performance is considered equivalent to the predicate device, which presumably met certain acceptance criteria. However, specific performance metrics for the VA1 software itself are not detailed here.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in this document.
- Data Provenance: Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. The document does not describe the establishment of a ground truth for a test set in the context of human interpretation or expert review, as this is a pulse oximeter.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/not specified. This type of adjudication is typically for image-based diagnostic devices where expert consensus is needed.
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 a pulse oximeter, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device (Siemens MicrO2+) is an oximeter, which inherently functions as a "standalone" algorithm device in that it directly measures and displays physiological parameters. The "algorithm" here refers to the processing of sensor data to derive SpO2 and pulse rate. The document doesn't detail performance studies specific to the VA1 software beyond stating "no new issues relative to safety and efficacy." The original 510(k) for the predicate device would have included the standalone performance of its oximetry algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For pulse oximeters, the ground truth is typically established using arterial blood gas analysis (co-oximetry), which is considered the gold standard for measuring arterial oxygen saturation (SaO2). The original performance studies for the predicate device would have compared the device's SpO2 readings to SaO2 values obtained from co-oximetry. This information is not present in the provided document.
8. The sample size for the training set:
- Not applicable/not specified. The document describes modifications to an existing device, not the development of a new algorithm where training set sizes are typically reported.
9. How the ground truth for the training set was established:
- Not applicable/not specified.
Summary of what can be gleaned from the text:
- Device: Siemens MicrO2+ with VA1 Software (Modified Pulse Oximeter).
- Key Modification: Re-labeling and recognition of Nellcor OxiMax sensors, and updated software.
- Regulatory Path: Special 510(k) Notification, meaning the submission focused on demonstrating that the modifications did not alter the basic fundamental technology or raise new issues of safety and efficacy compared to the predicate device (K012770).
- Performance Statement: "Testing with VA1 software indicates no new issues relative to safety and efficacy." This implies the modified device performed equivalently to the predicate device, which previously met its performance requirements.
- Intended Use: Continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate during both no motion and motion conditions, for well or poorly perfused patients.
The provided text is a high-level summary for a specific type of regulatory submission (Special 510(k)) and is not designed to contain the detailed technical validation data requested.
§ 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).