(50 days)
The Welch Allyn Device Connectivity Software Developer's Kit (SDK) is an Original Equipment Manufacturer (OEM) software product that will be integrated into software applications, such as Computerized Patient Record (CPR) systems. The Device Connectivity SDK is designed to as communicate with and collect data from electronic diagnostic devices to enable an application to request, retrieve and review device data.
The Device Connectivity SDK is an enabling data communication tool and is not intended to be an end, finished product.
The Welch Allyn Device Connectivity Software Developers Kit (SDK) is strictly a software product.
It is designed to work with the following operating systems (Microsoft Windows 2000, XP Professional and Server 2003) and software development environments (Microsoft Visual C++ 6.0, Visual Basic 6.0, Visual Basic .NET 2003, C# .NET 2003 and Borland Delphi 8.0).
It communicates with select Welch Allyn medical devices via USB, TCP/IP and RS232 (see figure 1).
Once integrated with a third-party Computerized Patient Record (CPR), the Device Connectivity SDK will provide the CPR the ability to request and receive physiological data, device information, patient information, healthcare provider information, configuration information and error information from select Welch Allyn medical devices.
The Device Connectivity SDK will also provide an Application Programming Interface (API), communication, device errors in a human readable form, electronic help and user support information (overall description, explanation of input and outputs, online support locations and phone number).
Welch Allyn will provide a Device Connectivity Software Developer's Kit (SDK) as an OEM product licensed to 3td party software developers, such as CPRS vendors that will enable the software developer to automate communication with and data collection from Welch Allyn's electronic medical diagnostic devices and save and store the data within the CPR's database. This Device Connectivity SDK will provide the software developers the ability to connect and capture the data through an Application Programming Interface (API).
The provided documentation for the Welch Allyn Device Connectivity Software Developers Kit (SDK) does not contain information about specific acceptance criteria or a study demonstrating device performance against such criteria.
The document primarily focuses on describing the device, its intended use, technological characteristics, and its substantial equivalence to a predicate device for 510(k) clearance. As a "software only product and not an end product," the FDA deemed typical safety and effectiveness studies, as would be expected for a diagnostic device, unnecessary.
Here's a breakdown of what is and is not present, in relation to your requested information:
1. A table of acceptance criteria and the reported device performance
- Not found. This information is absent from the provided document. The device is described as an "enabling data communication tool" that "reads data from Welch Allyn (WA) electronic diagnostic devices and does not set any ranges, tolerances, or accuracy of measurements." Therefore, quantitative performance metrics and acceptance criteria for patient-related outcomes are not discussed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not found. Since no performance study against specific criteria is reported, there is no mention of a test set, its sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not found. Ground truth establishment, typically relevant for diagnostic accuracy studies, is not applicable or discussed for this software SDK.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not found. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which are not described for this software.
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
- Not found. An MRMC study is not mentioned. The Device Connectivity SDK is a data communication tool, not an AI-assisted diagnostic tool that would directly improve human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not found. While the SDK is a "software only product," the performance evaluation described isn't in terms of a standalone diagnostic algorithm. Its function is to facilitate data transfer. The document states its effectiveness summary is that "patient safety shall not be directly compromised (minor risk)" because it's not an end product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not found. As no diagnostic performance study is described, the concept of ground truth in that context is not relevant to the information provided.
8. The sample size for the training set
- Not found. This is not an AI/ML device that undergoes model training, so there is no mention of a training set or its size.
9. How the ground truth for the training set was established
- Not found. Not applicable, as there is no training set for this type of software product.
Summary of Effectiveness from the Document:
The provided document (K052784, page 5/5) explicitly states the following regarding its summary of effectiveness:
"The Device Connectivity Software Developers Kit (SDK) is a software only product and not an end product; therefore, patient safety shall not be directly compromised (minor risk). The Device Connectivity SDK is non-contact and designed to communicate with and collect data from electronic diagnostic devices to enable an application to request, retrieve and review device data."
"The Device Connectivity SDK reads data from Welch Allyn (WA) electronic diagnostic devices and does not set any ranges, tolerances, or accuracy of measurements; therefore, there are no limits and tolerances."
"Therefore, typical safety areas are not applicable (e.g., electrical, and mechanical, biocompatibility, toxicity, corrosion, explosion, temperature, and fire hazard, EMC). However, risk management (risk, SFMEA and safety analysis) activities will be conducted in accordance with Risk Management (MPD SOP-9067) & Risk Management Policy (MPD SOP-20095, using ISO 14971) and will comply with IEC 60601-1-4 Medical Electrical Equipment Part 1: General Requirements for Safety, Part 4: Programmable Electrical Medical Systems."
This indicates that the assessment of this device's "effectiveness" by the manufacturer and the FDA was focused on its role as a data communication tool with minimal direct patient risk, rather than on specific diagnostic performance metrics. Its substantial equivalence to the predicate device (Welch Allyn Vitals Software Developers Kit, K023495) was based on similar operating principles, intended use, and supported devices, with the new SDK offering expanded operating system compatibility and communication protocols. Risk management measures were deemed sufficient for this product type.
§ 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).