(83 days)
The VSM series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature. noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.
The most likely locations for patients to be monitored are general med/surg, floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.
The model 53000 Series of monitors are intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpOz), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients.
The most likely locations for patients to be monitored are general med/surg. floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.
The provided text is a 510(k) summary for a medical device cleared through substantial equivalence, not a detailed study report with specific acceptance criteria and performance metrics. Therefore, much of the requested information (such as specific performance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods) is not explicitly stated in this document.
However, based on the available text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the 510(k) summary. The document states that the device "will be tested in accordance with the Test Plan / Report, #831-0719-00, and Clinical Validation Report #831-0752-00 included with the submission," but the content of these reports, including specific acceptance criteria and performance data, is not summarized here. Instead, it relies on substantial equivalence to predicate devices, implying that its performance should be comparable.
| Feature | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|---|
| Noninvasive Blood Pressure | Assumed to meet industry standards and performance of predicate devices | Equivalent to Welch Allyn Tycos CVSM monitor and Protocol Systems Propaq Model 200 Series |
| Pulse Rate (NIBP or SpO2) | Assumed to meet industry standards and performance of predicate devices | Equivalent to Welch Allyn Tycos CVSM monitor, Protocol Systems Propaq Model 200 Series, and Nellcor Puritan Bennett Pulse Oximeter Model N-550 |
| SpO2 | Assumed to meet industry standards and performance of predicate devices | Equivalent to Nellcor Puritan Bennett Model N-550 Pulse Oximeter |
| Body Temperature (SureTemp™ Plus module) | Assumed to meet industry standards and performance of the specified module | Same temperature module used in Welch Allyn model 53000 Series monitors and Welch Allyn Clinical temperature meter SureTemp™ Plus |
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly provided. The document mentions a "Clinical Validation Report #831-0752-00," which would contain this data, but the summary does not detail it.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not explicitly provided.
4. Adjudication Method for the Test Set
This information is not explicitly provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size
This information is not explicitly provided. The document focuses on substantial equivalence based on technical specifications and performance compared to predicate devices, not on a comparative study with human readers for improved effectiveness.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not explicitly provided. Given the device is a vital signs monitor, its core function is to produce readings directly, which implies a standalone performance would be inherent. However, specific details about such testing are not in this summary.
7. The Type of Ground Truth Used
This information is not explicitly provided. For vital signs monitors, ground truth would typically come from reference standards for each measurement (e.g., arterial line measurements for NIBP, co-oximetry for SpO2, calibrated thermometers for temperature), but this is not detailed in the summary.
8. The Sample Size for the Training Set
This information is not applicable/provided. This device is a vital signs monitor that likely uses established algorithms and hardware for measurement, not a machine learning or AI-based device requiring a "training set" in the typical sense.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the same reasons as point 8.
§ 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).