(76 days)
The Welch Allyn Spot Vital Signs is intended for measurement of blood pressure, pulse rate, temperature and oxygen saturation (SpO2) of adult and pediatric patients. The device is not designed, sold or intended for use except as indicated.
- The Welch Allyn Spot Check Device is not designed for use with neonates. To ensure pediatric blood pressure accuracy and safety, note that the Welch Allyn small cuff (5200-03) and the small One Piece cuff (5200-13) are the smallest cuffs approved for use with young children and infants. The circumference of the child's arm must fit within the range markings on the cuff.
- The Welch Allyn Spot Check Device should not be used on patients who are linked to heart/lung machines.
- The Welch Allyn Spot Check Device is not designed for use of axillary temperature option above three years of age in children.
- The Welch Allyn Spot Check Device is not intended to monitor patient's vital signs.
- The Welch Allyn Spot Check Device is not defibrillator proof.
The Welch Allyn Spot Vital Signs is not a monitor, but a one-time vital signs measurement device. This product will not have continuous monitoring capability with timed cycle intervals, memory, or any various programmable alarm features. The device is intended to provide the physician, physician's assistant, or nurse, facing high patient traffic or multiple tasks, a cost effective method to determine a one-time vital signs reading on the spot. The base unit will have non-invasive blood pressure (BP) measurement. Options will also be offered such as SureTemp® thermometry, Nellcor® pulse oximetry (SpO2), mounting bracket, and rolling stand. The device may be interfaced with an external printer via an infrared port.
The Welch Allyn Spot Vital Signs is designed to non-invasively measure systolic and diastolic blood pressure, pulse rate, temperature and oxygen saturation (SpO2) for adult and pediatric patients. The Welch Allyn Spot Vital Signs also calculates Mean Arterial Pressure (MAP). All blood pressure, pulse, temperature and SpO2 values are displayed on a large, easy-to-read LCD display, and may be printed via an external thermal printer, as desired. The rechargeable battery and wide variety of mounting accessories make the Welch Allyn Spot Vital Signs convenient for many locations.
This 510(k) summary for the Welch Allyn Spot Vital Sign Monitor with MP506 primarily focuses on regulatory compliance and substantial equivalence to predicate devices, rather than presenting a detailed clinical study demonstrating device performance against specific acceptance criteria.
However, based on the provided text, we can infer some information about acceptance criteria and the methods used to show compliance with relevant standards.
Here's an attempt to structure the information as requested, drawing conclusions where explicit details are missing:
Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied from Standards) | Reported Device Performance (Implied from Standards Compliance) |
|---|---|---|
| Non-invasive Blood Pressure (NIBP) Accuracy | Meets requirements of AAMI SP10 and EN60601-1 | Device meets these requirements, indicating acceptable accuracy for NIBP measurements. |
| Pulse Oximetry (SpO2) Accuracy | Meets requirements of EN 865 and EN60601-1 | Device meets these requirements, indicating acceptable accuracy for SpO2 measurements. |
| Temperature Accuracy | Meets requirements of ASTM 1112-86 and EN60601-1 | Device meets these requirements, indicating acceptable accuracy for temperature measurements. |
| Electrical Safety | Meets requirements of EN60601-1, EN60601-1-1, EN60601-1-2 | Device meets these requirements, indicating acceptable electrical safety. |
| Electromagnetic Compatibility (EMC) | Meets requirements of EN60601-1-2 | Device meets these requirements, indicating acceptable EMC. |
| Software Life Cycle Processes | Meets requirements of EN60601-1-4 | Device meets these requirements, indicating acceptable software development and maintenance processes. |
Explanation: The document states that the "Welch Allyn Spot Vital Sign with MP506 Pulse Oximeter OEM module meets the requirements called out in these standards." This implies that the acceptance criteria for the device's performance are defined by the referenced national and international standards (AAMI SP10 for NIBP, ASTM 1112-86 for temperature, EN 865 for pulse oximetry, and the EN60601 series for general medical electrical equipment safety, EMC, and software). The reported device performance is that it meets these standards.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document refers to compliance with standards, which would typically involve testing on a certain number of subjects or samples, but the specific details are not present.
- Data Provenance: Not explicitly stated. Given the nature of a 510(k) summary focused on standards compliance, the testing data would likely be generated in a controlled environment to demonstrate adherence to the specified standard protocols. It is not indicated whether the data is retrospective or prospective, or the country of origin, beyond being generated by Welch Allyn to demonstrate compliance.
3. Number of Experts and Qualifications for Ground Truth
- This document does not describe a study involving human experts to establish ground truth in the context of diagnostic accuracy. The compliance is against defined engineering and performance standards, which often have their own established methods for "ground truth" (e.g., reference measurements from calibrated equipment for blood pressure or temperature).
4. Adjudication Method for Test Set
- Not applicable as the document does not describe a study using expert adjudication for a test set. Compliance is based on meeting the technical specifications and accuracy requirements outlined in the cited standards through direct measurement and testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this document. This device is a vital signs measurement device, not an imaging or diagnostic device that typically involves human interpretation that AI could assist.
6. Standalone (Algorithm Only) Performance Study
- The device itself is a standalone measurement device, intended to provide objective vital signs readings (BP, SpO2, Temp). The performance reported is its standalone performance against technical standards. It does not contain an AI algorithm in the contemporary sense that would have separate "algorithm only" performance. The document focuses on the device's ability to accurately measure physiological parameters.
7. Type of Ground Truth Used
- The ground truth for demonstrating device performance would be established by reference methods and calibrated instrumentation as prescribed by the respective standards:
- NIBP: Likely comparison against an invasive arterial line or a highly accurate auscultatory method by trained observers following AAMI SP10 protocols.
- SpO2: In vivo studies using controlled hypoxia or in vitro testing against a co-oximeter, as described in EN 865.
- Temperature: Comparison against a highly accurate reference thermometer in a controlled environment as per ASTM 1112-86.
8. Sample Size for Training Set
- Not applicable. This device is a hardware vital signs monitor, not a machine learning model that requires a "training set" in the context of AI/ML. Its design and calibration are based on engineering principles and established physiological models, not data-driven learning from a specific training dataset in the AI sense.
9. How Ground Truth for Training Set was Established
- Not applicable, as there is no "training set" for this type of device. The accuracy and performance of the device's measurement algorithms are validated against established physical and physiological principles and reference standards during the engineering and design phases.
§ 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).