(118 days)
Model 2000 Pulse Oximeter is indicated for the continuous nonitoring of arterial oxygen saturation (SpO2) and pulse rates for adult, pediatric and neonatal patients in a hospital and mobile environment (within the hospital).
In addition the Model 2000 is indicated for the continuous non-invasive monitoring of arterial oxygen saturation (SpO2) and pulse rates for adults during patient motion conditions.
The Model 2000 pulse oximeter is a device consisting of the Masimo SET® technology (license to Ivy Biomedical), Masimo connecting cable, and Masimo oximetry sensors to nonivasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It features an easy-to-read LCD display that presents patient data and status information.
Here's an analysis of the provided text regarding the Model 2000 Pulse Oximeter, structured to address your specific questions.
Important Note: The provided document is a 510(k) Summary from 1998 for a pulse oximeter. These summaries generally outline the testing performed to demonstrate substantial equivalence to a predicate device, rather than detailed clinical trial reports. Therefore, some of your requested information, especially related to modern AI/ML device study standards (e.g., MRMC studies, detailed data provenance, specific expert qualifications, adjudication methods for training sets), may not be explicitly present or not applicable to this type of device and regulatory submission from that era. I will extract what is available and note where information is not provided.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for pulse oximeters, especially in 1998, are typically expressed in terms of accuracy (e.g., RMS difference, bias, precision) compared to a co-oximeter, often across different SpO2 ranges and conditions (motion/non-motion).
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Validation |
|---|---|---|
| SpO2 Accuracy (Non-Motion) | Validated for human blood studies against a laboratory CO-oximeter for healthy adult volunteers in induced hypoxia, within the range of 70-100% SpO2. | "The Masimo SET® module with LNOP-Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70-100% SpO2, against a laboratory co-oximeter and ECG monitor. This variation equals plus or minus one standard deviation." (Implies a statistical measure of accuracy, likely an RMS difference, but the specific numerical value is not given for non-motion as it's grouped with motion studies.) Though it says "motion accuracy", the initial validation would cover non-motion as a baseline. |
| SpO2 Accuracy (Motion) | Validated for human blood studies against a laboratory CO-oximeter during various motion conditions, within the range of 70-100% SpO2. | "The Masimo SET® module with LNOP-Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz at an amplitude of 1 to 2 cm and non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2, against a laboratory co-oximeter and ECG monitor. The variation equals plus or minus one standard deviation." (Again, implies a statistical measure of accuracy, but specific numerical value for this standard deviation is not provided.) |
| Environmental Performance | Meet requirements of Reviewers Guidance for Premarket Submission - November 1993. | "The results of the environmental testing demonstrates that the Model 2000 pulse oximeter met the requirements of Reviewers Guidance for Premarket Submission - November 1993." |
| Biocompatibility | Meet requirements of ISO-10993-1: 1992 for Surface Devices with skin contact for prolonged contact duration (>24 hr to 30 days). | "The results of the biocompatibility testing demonstrates the patient contacting material met the requirements of ISO-10993-1: 1992 Biological Evaluation of Medical Devices Part 1: Guidance on Selection of Test Surface Devices with skin contact for prolonged contact duration (>24 hr to 30 days)." |
| Bench Testing Performance | Meet performance requirements against a simulator for specified saturation and pulse rates. | "The results of the bench testing demonstrates that the Model 2000 pulse oximeter meets its performance requirements." |
| Substantial Equivalence | Perform as well as the predicate device (Masimo SET® MS-1P pulse oximeter). | "The testing performed demonstrates that the Model 2000 pulse oximeter is safe, effective, and performs as well as the predicate device, the Masimo SET® MS-1P pulse oximeter, and therefore, it is substantially equivalent to the Masimo SET® pulse oximeter." |
Note on numerical values: The document mentions "plus or minus one standard deviation" for SpO2 accuracy but does not provide the specific numerical value (e.g., ±2% SpO2). This was common for 510(k) submissions of this era, implying that the device met the generally understood accuracy standards for pulse oximeters at the time.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "healthy adult volunteers" for the human blood studies in induced hypoxia. However, it does not specify the number of volunteers or the number of data points collected.
- Data Provenance: The data was collected from "human blood studies on healthy adult volunteers" in "induced hypoxia states." The origin country is not explicitly stated but is implicitly the US, given the submission to the FDA. The studies are prospective as they involved inducing hypoxia and motion in volunteers for the purpose of testing the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Ground Truth Establishment: The ground truth for SpO2 was established using a "laboratory CO-oximeter and ECG monitor."
- Number/Qualifications of Experts: This type of study primarily relies on the accuracy of the reference instrument (CO-oximeter) rather than expert human interpretation of images or signals. Therefore, there's no mention of human experts establishing ground truth in the way one might for diagnostic imaging. Expertise would lie with the personnel operating the CO-oximeter and conducting the induced hypoxia studies, but their specific numbers or qualifications are not provided.
4. Adjudication Method for the Test Set
- Given that the ground truth is established by a co-oximeter and ECG monitor, there is no human adjudication method described or necessary in the typical sense (e.g., concensus among radiologists). The comparison is directly between the device's reading and the co-oximeter's reading.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is a key metric, often involving image interpretation. For a pulse oximeter, the primary evaluation is the device's accuracy in measuring physiological parameters, not its impact on human readers' diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance evaluation was done. The entire validation reported for the Model 2000 Pulse Oximeter, particularly the human blood studies, is a standalone performance evaluation of the device as it measures SpO2 and pulse rate. There is no indication of a human-in-the-loop component for these accuracy tests. The device is intended for continuous monitoring, with the practitioner using the displayed information, but the core accuracy validation is intrinsic to the device itself.
7. The Type of Ground Truth Used
- The primary ground truth used for SpO2 accuracy was laboratory CO-oximeter measurements (considered a gold standard for SpO2 in blood samples) and ECG monitoring (for pulse rate verification, though not explicitly detailed).
8. The Sample Size for the Training Set
- The document does not explicitly mention a "training set" in the context of machine learning. In 1998, this device used the Masimo SET® technology, which employed algorithms based on spectrophotometry and plethysmography. The "look-up table" used by the Masimo SET® software was "built into the Masimo SET® software" based upon "human blood studies against a laboratory CO-oximeter on healthy adult volunteer in induced hypoxia states." This implies that data from human studies was used to develop and calibrate these algorithms/look-up tables.
- Therefore, the sample size for this developmental data (analogous to a training set) is not specified, only that "human blood studies" were used.
9. How the Ground Truth for the Training Set Was Established
- The ground truth for the data used to build the internal "look-up table" (which is essentially the core of the algorithm's understanding of SpO2) was established "against a laboratory CO-oximeter" in "healthy adult volunteer in induced hypoxia states." This is the same method described for the validation (test set), indicating a consistent approach to ground truth determination.
§ 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).