(24 days)
The Spot Vital Signs Ultra automatically measures systolic and diastolic pressure, Mean Arterial Pressure (MAP), pulse rate, temperature (oral, adult axillary, pediatric axillary, rectal, and ear), and pulse oximetry (SpO2) of adult and pediatric patients. Furthermore, Spot Vital Signs Ultra allows the manual entry of height, weight, respiration, and pain level. Spot Ultra also calculates Body Mass Index (BMI) following height and weight entry.
The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.
The Welch Allyn Spot Ultra Vital Signs (Spot Vital Signs LXi) is not a monitor, but a one-time vital signs measurement device. This product will not have continuous monitoring capability with timed cycle intervals or any various programmable alarm features. Welch Allyn Spot Vital Signs LXi will include Blood Pressure with Temp, as the base feature, SpO2 is an option. A mobile stand, custom wall mount, an external printer, a barcode reader, weight scales and 802.11 a,b,g wireless communications are accessories that Welch Allyn Spot Ultra Vital Signs Device can be configured.
The Welch Allyn Spot Vital Signs LXi 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 LXi will also calculate 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 Ultra Vital Signs Device convenient for many locations. The Spot Vital Sign LXi will also allow for data entry for weight, height, pain and will calculate Body Mass Index (BMI).
Here's an analysis of the provided text regarding the Welch Allyn Spot Ultra Vital Signs and Welch Allyn Spot Vital Signs LXi, focusing on acceptance criteria and the supporting study:
Important Note: The provided text is a 510(k) summary for a premarket notification. This document primarily focuses on demonstrating "substantial equivalence" to a predicate device (Welch Allyn Spot Ultra Vital Signs K040490) rather than presenting a comprehensive standalone clinical study report. Therefore, some of the requested information, particularly detailed acceptance criteria for a new clinical study and comprehensive study statistics, might not be explicitly stated for the current 510(k) submission but are instead referenced back to the predicate device's clearance.
Acceptance Criteria and Device Performance
The provided 510(k) pertains to a device, the Welch Allyn Spot Ultra Vital Signs (and LXi model), which is stated to have "no hardware or software modifications" from its predicate device (Welch Allyn Spot Ultra Vital Signs K040490). The core argument for this submission is that the new device is substantially equivalent to the predicate. Therefore, the "acceptance criteria" for this specific 510(k) are implicitly met by demonstrating that the device is functionally identical to a previously cleared device.
The essential performance required of the device in this submission is that it performs equivalently to the predicate device, which itself would have met specific performance standards. The key performance aspect highlighted is for Blood Pressure (BP) measurement.
| Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (Reference to Predicate) |
|---|---|
| Blood Pressure (BP) Accuracy: Measured against AAMI SP10 standards. | "STEP Blood Pressure (BP) mode of the SURE BP algorithm is functionally equivalent to the SURE BP Mode and cleared per K040490. A copy of the specification and validation from that study, as presented for the Welch Allyn Spot Ultra Vital Signs submission K040490." |
| Pulse Rate Accuracy: | "The Blood Pressure interface performances have not changed." (Implies same as predicate) |
| Temperature Accuracy: | "The Welch Allyn Spot Vital Signs LXi has equivalent vital signs measurement as the Welch Allyn Spot Ultra Vital Signs (K040490)." |
| SpO2 Accuracy: | "The Welch Allyn Spot Vital Signs LXi has equivalent vital signs measurement as the Welch Allyn Spot Ultra Vital Signs (K040490)." |
| Compliance with Recognized Standards: | "All requirements of the recognized and applicable standards are in compliance: SP10 (AAMI/ANSI), UL 60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4." |
Study Details
Given that the current 510(k) is based on substantial equivalence and states "There are no hardware or software modifications to the Spot Ultra Vital Signs Device," the detailed study information below refers to the validation study conducted for the predicate device (Welch Allyn Spot Ultra Vital Signs K040490), which the current device references for its performance claims.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in this 510(k) summary for the predicate device's validation. The summary refers to an "AAMI SP10 - validation report." AAMI SP10 (now ANSI/AAMI/ISO 81060-2) typically requires a minimum of 85 subjects for clinical validation of non-invasive sphygmomanometers.
- Data Provenance: Not specified in this document. It would have been part of the original K040490 submission.
- Retrospective or Prospective: Not specified in this document for the predicate's study. AAMI SP10 validations are typically prospective clinical studies.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the same way as AI/imaging studies. For blood pressure validation, an independent, "blinded" observer (or two for inter-observer variability checks) typically measures reference blood pressure according to a strict protocol (e.g., using a mercury sphygmomanometer or an oscillometric reference device simultaneously). The qualifications would typically be trained medical personnel, but not "experts" in the context of interpreting complex images or diagnoses.
-
Adjudication method for the test set:
- Not directly applicable to blood pressure validation in the same way it is for imaging. The "ground truth" for blood pressure is established through a standardized, direct measurement protocol (e.g., AAMI SP10 protocol), not through expert consensus or adjudication of ambiguous cases.
-
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:
- No, an MRMC study was not done. This device is a vital signs measurement device, not an AI-assisted diagnostic imaging system. Therefore, the concept of "human readers improving with AI assistance" is not relevant here.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, the performance of the oscillometric blood pressure algorithm and other measurement modules is evaluated in a standalone manner. The "AAMI SP10 – validation report" would demonstrate the inherent accuracy of the device's measurements compared to a reference standard, independent of human interpretation improvements. The vital signs are automatically measured and displayed, meaning the device's accuracy is its standalone performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Reference Standard Measurements: For blood pressure, the ground truth is established through simultaneous, highly accurate, auscultatory blood pressure measurements performed by a trained observer using a calibrated reference device (e.g., mercury sphygmomanometer) as per AAMI SP10 standards. For SpO2 and temperature, similar reference devices and protocols would be used.
-
The sample size for the training set:
- Not specified. For a traditional medical device (not an AI/ML device in the sense of learning from data), there isn't a "training set" in the same way there would be for a machine learning algorithm. The algorithm for oscillometric BP is developed and refined based on engineering principles and physiological models, then validated on a test set.
-
How the ground truth for the training set was established:
- Not applicable as there is no "training set" for the current device in the context of iterative algorithm learning from labeled data. The ground truth for validation (see point 6) is established through reference standard measurements.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).