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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 Device utilizes an Oscillometric BP Algorithm and temperature technology, similar to Spot Vital Signs and utilizes the same SpO2 OEM as the Welch Allyn Spot Vital Signs. The new Spot Ultra Vital Signs will incorporate a new temperature module (Braun 4000) and a new SpO2 OEM module the Masimo SET as options.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Welch Allyn Spot Ultra Vital Signs device:

Welch Allyn Spot Ultra Vital Signs Device: Acceptance Criteria and Study Information

This 510(k) summary describes the Welch Allyn Spot Ultra Vital Signs device, which measures blood pressure, pulse rate, temperature, and pulse oximetry. The summary establishes substantial equivalence to existing predicate devices (Welch Allyn Spot Vital Signs) by comparing technological characteristics and adherence to relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on the provided 510(k) Summary):

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device (Welch Allyn Spot Vital Signs) by outlining technological similarities and adherence to recognized standards. It does not describe a separate, de novo clinical study with detailed methodology for establishing acceptance criteria and device performance. Instead, it relies on the predicate device's existing approvals and the updated standards.

Here's a breakdown of the study-related information, acknowledging the limitations of a 510(k) summary in providing detailed study protocols:

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not explicitly state a specific sample size for a test set for the Spot Ultra Vital Signs device. The performance claims for blood pressure and temperature accuracy are linked to industry standards (AAMI SP10-2002, ASTM E1112-00, EN12470). For SpO2, the performance is attributed to the OEM modules (Nellcor and Masimo SET).

Therefore, the "data provenance" for the Spot Ultra's performance is derived from conformance to these standards and the established performance of the OEM components. It is implicitly assumed that the OEM components and the new device features meet their respective, independently validated performance specifications according to these standards.

• Country of Origin: Not specified for any specific testing related to the Spot Ultra. The company is Welch Allyn Inc., based in New York, USA.
• Retrospective or Prospective: Not applicable as a separate clinical study for the Spot Ultra is not detailed in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the 510(k) summary. The summary relies on the standards themselves (AAMI, ASTM, EN) as the basis for performance validation, which would have their own established methods for ground truth and expert involvement, but these are not internal to the Welch Allyn submission for the Spot Ultra.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the 510(k) summary. Given the reliance on industry standards and OEM specifications, formal adjudication methods for a specific test set are not mentioned.

5. 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 MRMC study was performed or is referenced in this 510(k) summary. This device is a vital signs monitor, not an AI-assisted diagnostic tool that would involve human "readers" interpreting output.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This 510(k) summary does not describe a standalone algorithm-only performance study. The device itself is a standalone vital signs monitoring device. Its "algorithms" (e.g., for oscillometric BP determination) are part of the integrated system, and its performance is assessed against recognized standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the device's performance is based on its adherence to recognized industry standards:

• Blood Pressure: AAMI SP10-2002, which specifies requirements for accuracy against reference methods (often invasive arterial pressure measurements).
• Temperature: ASTM E1112-00 and EN12470, which define methods for evaluating the accuracy of electronic thermometers against calibrated reference thermometers.
• SpO2: The performance of the Nellcor and Masimo SET OEM modules, which are themselves validated against reference oximeters and blood gas analysis (co-oximetry) to determine arterial oxygen saturation.

8. The Sample Size for the Training Set

This information is not applicable or provided in the context of this 510(k) summary. The device does not appear to employ machine learning algorithms that require explicit "training sets" in the typical sense. Its functions are based on established physiological measurement principles and validated OEM components.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or provided, as there is no mention of a "training set" for machine learning in this 510(k) summary.

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