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Welch Allyn Connex™ (Vital Solutions Software) is intended for the collection and review of patient data, and also the communication of the data to information systems. It provides notifications when data deviates from ranges, allows manual entry of data, provides a means to identify and manage patients, and provides tools for enhancing productivity.

Health care providers and trained personnel are the intended users of the system.

The Welch Allyn Connex™ (Vital Solutions Software) provides for the collection and review of patient data, and also the communication of the data to information systems. It provides notifications when data deviates from ranges, allows manual entry of data, provides a means to identify and manage patients, and provides tools for enhancing productivity.

In general, Connex™ (Vital Solutions Software) shall serve as an interface between Welch Allyn medical diagnostic vitals devices and user facility information systems. It can be used either with a facility's existing information system or in the absence of an information system.

The provided text is a 510(k) Summary for the Welch Allyn Connex™ (Vital Solutions Software), a device that serves as an interface between Welch Allyn medical diagnostic vital signs devices and user facility information systems.

Based on the provided document, there is no study or specific acceptance criteria reported for the Welch Allyn Connex™ (Vital Solutions Software) regarding its performance in medical diagnosis or patient monitoring accuracy.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Welch Allyn Instrument Interface Module) based on technological characteristics and intended use, rather than clinical performance metrics. It's important to note that this is a 510(k) submission, which often relies on demonstrating equivalence rather than extensive clinical efficacy studies, especially for devices like software interfaces that don't directly make medical diagnoses or provide treatment.

Here's a breakdown of why the requested information cannot be fully provided from the text:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated for performance metrics. The document instead emphasizes that the software "does not set any ranges, tolerances, or accuracy of measurements."
   • Reported Device Performance: Not provided. The submission focuses on functional equivalence and risk management.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned in the document. No "test set" in the context of clinical performance is described.

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 applicable. There is no clinical test set described that would require expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set described.

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 applicable. This device is an interface software, not an AI diagnostic tool that would assist human readers in a diagnostic task.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device's function is to interface and manage data, not to perform standalone diagnostic calculations.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There is no clinical data or diagnostic ground truth mentioned in relation to the device's performance.

8. The sample size for the training set: Not applicable. The document does not describe a machine learning algorithm that would require a training set.

9. How the ground truth for the training set was established: Not applicable. As there's no mention of a training set, the establishment of its ground truth is not discussed.

Summary of Effectiveness (as described in the document):

The document states that the software's "Level of Concern" is Moderate. It also indicates that typical safety concerns (electrical, mechanical, biocompatibility, etc.) are "not applicable." Risk management activities were conducted in accordance with ISO 14971 and would comply with IEC 60601-1-4. Crucially, the software "reads data from Welch Allyn (WA) medical diagnostic vital signs devices and does not set any ranges, tolerances, or accuracy of measurements; therefore, there are no limits and tolerances." This implies the software's effectiveness is tied to its ability to correctly collect, review, and communicate data from existing, approved vital signs devices, rather than establishing its own diagnostic accuracy.

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