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Renal Therapy Clinical Data Management Software (Renal Link) is designed specifically for nephrology and offers an alternative to the paper medical chart. Renal Link provides the functions of a data repository and data query/reporting system.

Renal Link Clinical Data Management Software (Renal Link) is a software accessory to a medical device based on relational database technology, the same technology as that used by the predicate device.

The provided text is a 510(k) summary for the "Renal Link" clinical data management software. It states that "All functions of Renal Link have been tested and validated. Based on the validation results, all functions meet their respective required specifications." However, it does not provide detailed acceptance criteria or present a study with specific performance metrics against those criteria. It lacks the information needed to fill out most of the requested fields regarding sample sizes, ground truth establishment, or expert involvement.

Here's a summary of the available information and a notation for missing details:

Acceptance Criteria and Device Performance Study for Renal Link

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified. (The 510(k) states "Clinical data: N/A," implying no clinical data was used for validation, but rather functional testing of the software itself.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable, as no external ground truth based on expert review appears to have been established for the functional validation of this software. The validation pertains to the software's ability to perform its specified functions.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Functional validation of software typically involves comparing software output against expected output based on internal specifications, not expert adjudication of clinical outcomes.

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

• MRMC Study: No. This device is a clinical data management software, not an AI-assisted diagnostic or decision support tool for human readers.
• Effect Size: Not applicable.

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

• Standalone Performance: Yes, the validation described is of the software's standalone functions (data repository, data query/reporting). However, no specific metrics for "performance" beyond "meets specifications" are provided.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for this type of software validation would be the pre-defined functional specifications and expected behavior of the software for data management, storage, and retrieval. It is not clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This is not a machine learning or AI algorithm in the traditional sense that requires a training set. It's a relational database software.

9. How the ground truth for the training set was established

• Ground Truth Establishment (Training Set): Not applicable.

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