(13 days)
The Vitals Software Developer's Kit (SDK) is an Original Equipment Manufacturer (OEM) software product that will be licensed to Computerized Patient Record (CPR) manufacturers who will integrate it with and sell it as part of their CPR system. The SDK is designed to communicate with and collect data from diagnostic instruments using an instrument specific interface that is compatible with the instrument's existing communications capability. Existing instruments will not have to be changed. The data that is collected will be displayed for the user to verify before it is sent to the CPR where it is saved as part of the CPR's database.
For access by the CPR, the data is translated from its original form into industry standard software object form (XML, Active X, COM). The SDK also provides sample program software that demonstrates how to display the data in the appropriate form.
The SDK is required for both the collection and the retrieval/review of data. The SDK will also provide the necessary set-up or configuration guidelines and help files that will allow the user to designate which instruments are connected to a personal computer (PC) at a specific location.
The Welch Allyn Vitals Software Developer's Kit (SDK) is strictly a software product. It is designed to work with Microsoft Window 98, NT, 2000 and XP. It communicates with the VSM 5200 series and the SPOT 4200 series medical devices via an RS232 cable in one configuration and an Infrared dongle in the other both are standard synchronous RS-232 serial interfaces.
Once integrated with a third-party computerized patient record, the SDK will provide the CPR the ability to request, receive and parse alphanumeric observational data, and error messages from these medical devices. It will provide the user with the ability to configure to a single device. It will also display information to the user, using and ActiveX display control, in a manner that is consistent with the medical device used to capture the data.
1. Acceptance Criteria and Reported Device Performance:
The provided document describes a software product (Welch Allyn Vitals Software Developers Kit - SDK) and does not specify quantitative acceptance criteria in terms of accuracy or clinical metrics. Instead, the "effectiveness" is described in terms of its functional capabilities and user satisfaction.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Communicates with and collects data from diagnostic instruments | Designed to communicate with VSM 5200 series and SPOT 4200 series devices via RS232 or Infrared dongle. Collects alphanumeric observational data and error messages. |
| Translates data into industry standard software object form | Translates data into XML, ActiveX, COM. |
| Provides ability for CPR to request, receive, and parse data | Provides CPR ability to request, receive, and parse data. |
| Displays information consistent with the medical device | Displays information to the user, using an ActiveX display control, consistent with the medical device. |
| Allows user to configure to a single device | Provides the user with the ability to configure to a single device. |
| Provides necessary set-up/configuration guidelines and help files | Provides necessary set-up/configuration guidelines and help files. |
| Meets the needs and expectations of practitioners | "The results of the testing and evaluations indicate that the Welch Allyn Vitals Software Development Kit (SDK) meets the needs and expectations of the practitioners who will be using this software device." |
| Operates with specified Windows operating systems | Designed to work with Microsoft Windows 98, NT, 2000, and XP. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a "test set" with a specific sample size. The description of effectiveness relies on:
- Proven Windows technology and tools: This implies general computing infrastructure, not a medical dataset.
- Specific medical devices noted: Refers to the VSM 5200 series and SPOT 4200 series for compatibility, but no data sample size from these devices is mentioned.
- Vendors who supply CPR systems: Suggests interaction with real-world CPR systems, but no details on the number of systems, patients, or data records used for testing are provided.
Therefore, no information on data provenance (e.g., country of origin, retrospective/prospective) for a distinct "test set" is available.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided. Given the nature of the device (software interface for data collection and display, not a diagnostic device), the concept of "ground truth" as typically applied to diagnostic performance (e.g., presence/absence of a disease) does not directly apply. The "ground truth" for this device would relate to the accurate transmission and display of data as generated by the source medical devices. The document mentions "practitioners" whose "needs and expectations" were met, implying their input was considered, but no details on their number or specific qualifications are given.
4. Adjudication Method for the Test Set:
Not applicable, as no formal "test set" with adjudicated ground truth for diagnostic performance is described. The evaluation appears to be based on functional verification and user feedback.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices to assess the impact of AI on human reader performance. The SDK is a software interface, not a diagnostic tool that interacts with human readers in the same way.
6. If a Standalone Study was done:
Yes, in essence, the evaluation performed was a standalone assessment of the SDK's functionality. The SDK itself (the algorithm/software) was tested for its ability to communicate, collect, translate, and display data as intended. The "effectiveness" summary discusses the SDK's capabilities on its own, independent of a specific human-in-the-loop scenario.
7. The Type of Ground Truth Used:
The "ground truth" for this device's effectiveness is primarily functional correctness and adherence to specifications. This means:
- Data integrity: Ensuring the data received by the SDK matches the data sent by the medical device.
- Protocol compliance: Verifying that communication protocols (RS232, Infrared) are correctly implemented.
- Data translation accuracy: Confirming that data is accurately converted to XML, ActiveX, COM.
- Display accuracy: Checking if the displayed information is consistent with the source device.
- User expectations: Satisfying the functional requirements of CPR manufacturers and end-users (practitioners).
There is no mention of pathology, outcomes data, or expert consensus in a diagnostic sense.
8. The Sample Size for the Training Set:
Not applicable. The Welch Allyn Vitals SDK is a software product designed for communication and data handling, not a machine learning or AI model trained on a dataset. Therefore, there is no "training set" in the context of supervised learning.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
§ 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).