(125 days)
The Nonin Model 3100 WristOx TM Pulse Oximeter is a small, wrist-worn device indicated for use is measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate. It may be used for spot-checking and/or data collection and recording of adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused. The intended use environments are hospitals, medical facilities, ambulatory, subacute, sleep study environments, and mobile units.
Model 3150 is a wrist-worn device with memory for patient data collection and Bluetooth wireless communication capability. The device is a simple-touse pulse oximeter for both long and short term measurements. The device can be integrated into a telemedicine system, interfaced to other health data collection systems through the wireless connection, or used with Nonin's nVISION® Data Management Software K033307. The basic functions of the Model 3150 with an external sensor will be: ■ Measurement of SpO2 and pulse rate, . Motion artifact detection, . Collection and storage of data, and Communication via a wired connection and / or Bluetooth wireless connection.
The provided 510(k) summary focuses primarily on establishing substantial equivalence for the Nonin Model 3150 WristOx2 Pulse Oximeter to its predicate device, the Nonin Model 3100 WristOx. It highlights functional and safety testing but does not provide detailed acceptance criteria and performance data in the structured format requested for device accuracy.
Therefore, many of the requested points about detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not present in this document. Pulse oximeter submissions typically rely on human desaturation studies to assess accuracy, but the specifics of such a study are not detailed here.
Here's a breakdown of what can be extracted and what is missing:
Acceptance Criteria and Device Performance
The document states that the device successfully underwent testing to demonstrate it meets the requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data. While it states the device meets these requirements, the specific numerical acceptance criteria and the precise reported device performance (e.g., RMS error for SpO2) are not provided in this summary.
| Acceptance Criteria (Stated as "Meets ISO 9919:2005 Clause 50") | Reported Device Performance (Missing, but implied to meet criteria) |
|---|---|
| ISO 9919:2005 Clause 50 requirements for accuracy | Not explicitly stated (e.g., SpO2 accuracy ± X%) |
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified regarding country of origin or whether the data was retrospective or prospective. Pulse oximeter accuracy studies are typically prospective human desaturation studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. For pulse oximetry, the ground truth is typically established by co-oximetry readings from arterial blood samples, which are laboratory measurements rather than expert interpretations.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the ground truth for pulse oximetry accuracy studies is typically objective laboratory measurement (co-oximetry) rather than expert consensus requiring adjudication.
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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 requiring MRMC studies for human reader performance. Its primary function is direct physiological measurement.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, for pulse oximeters, the primary accuracy testing is a standalone assessment of the device's ability to measure SpO2 and pulse rate against a reference standard (co-oximetry). The mention of "clinical testing" and meeting "ISO 9919:2005 Clause 50 Accuracy of Operating Data" refers to this standalone performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The typical ground truth for pulse oximeter accuracy is co-oximetry readings from arterial blood samples. This is strongly implied by the reference to ISO 9919:2005 Clause 50, which details accuracy testing methods using induced hypoxemia and arterial blood gas analysis.
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The sample size for the training set:
- Not applicable and not specified. Pulse oximeters are typically developed and calibrated rather than "trained" in the machine learning sense. The device's algorithms are based on physiological principles and empirical spectral data, not a machine learning training set in the way AI algorithms are.
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How the ground truth for the training set was established:
- Not applicable as there isn't a "training set" in the machine learning context for this type of device. Calibration and algorithm development would rely on controlled experimental data with known oxygen saturation levels and corresponding optical measurements.
§ 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).