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Renal Soft is designed specifically for nephrology and offers an electronic alternative to the paper medical chart. RenalSoft provides the functions of a data repository and data query/reporting system. This software is not intended to be a substitute for good clinical management practices nor does its operation create decisions or treatment pathways.

RenalSoft is designed specifically for nephrology and offers an electronic alternative to the paper medical chart, in accordance with local regulations. RenalSoft provides the functions of a data repository and data query/reporting system. RenalSoft is a clinical tool that organizes dialysis therapy data to facilitate clinician decision-making and patient care.

This document is a 510(k) Premarket Notification for RenalSoft version 2.0. The device is a "Renal Therapy Clinical Data Management Software" and is substantially equivalent to a predicate device, Renal Link (K990953).

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific quantitative acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that:

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

The document does not specify a sample size for any test set related to clinical performance. The "Clinical Data" section explicitly states "NA" (Not Applicable). The study mentioned is "Bench testing," which typically refers to internal engineering or software testing, not clinical studies with patient data.

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

Since there is no mention of a clinical test set or clinical data, there is no information provided on experts used to establish ground truth or their qualifications.

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

With no clinical test set or expert evaluation, no adjudication method is 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:

No MRMC comparative effectiveness study was done. The device (RenalSoft) is described as a "data repository and data query/reporting system" and a "clinical tool that organizes dialysis therapy data to facilitate clinician decision-making and patient care." It explicitly states that "This software is not intended to be a substitute for good clinical management practices nor does its operation create decisions or treatment pathways." Therefore, it's not an AI-assisted diagnostic or decision-making tool in the way an MRMC study would typically evaluate improvements in human reader performance.

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

The device is a data management system, not an algorithm that performs a standalone diagnostic or interpretive task. Therefore, a standalone performance study in the context of an algorithm's diagnostic accuracy was not performed or is not applicable. The "bench testing" mentioned assessed its functional operation, not clinical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Given the nature of the device as a data management system, there is no concept of "ground truth" related to a diagnostic or clinical outcome. The "ground truth" for this type of software would revolve around whether the data is correctly stored, retrieved, and presented according to its design requirements and specifications. The document implies that the "ground truth" for the bench testing was the pre-defined design requirements and expected operational behavior.

8. The Sample Size for the Training Set:

The device is a data management system, not a machine learning model that requires a "training set" in the conventional sense of AI. Therefore, a training set size is not applicable and not provided.

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

As there is no training set for an AI/ML model, this question is not applicable to the RenalSoft device.

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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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cyberREN is a clinical data management system, designed specifically for nephrology, to replace the paper medical chart. Full chart replacement, i.e. a conversion from a paper medical record to an electronic medical record is at the option of the client. The cyberREN electronic chart essentially provides the functions of a data repository and data query / reporting system.

cyberREN is a clinical data management system designed for nephrology. It functions as a data repository and data query/reporting system, intended to replace paper medical charts. It is a multiuser, multidisciplinary system accessible via standard Windows 95 based computers. It saves, calculates, displays, and reports clinical information. Data is primarily entered manually by caregivers, but can also be received from networked systems like laboratory computers and dialysis machines (specifically the Fresenius 2008H). It calculates values such as weight gain, protein catabolic rate, percent urea reduction, KT/V dialysis efficacy index, and nutrition parameters. It supports general charting functions like patient demographics, problem lists, orders, medications, progress notes, consultations, and laboratory results reporting. It also supports charting for hemodialysis (treatment orders, session charting, access charting, scheduling) and peritoneal dialysis (orders, session charting, peritonitis charting, access charting). It can also be used to document transplant status and workup activities. cyberREN does not alter entered information, make treatment recommendations, influence dialysis machine operation, or provide diagnoses.

The provided text describes the "cyberREN" device, a clinical data management system for nephrology. However, the document is a 510(k) clearance letter from the FDA, and it primarily focuses on the device's "Indications for Use" and its substantial equivalence to previously marketed devices. It does NOT contain the details required to answer your specific questions about acceptance criteria, device performance study details, sample sizes, expert qualifications, or ground truth establishment.

The document states that cyberREN is intended to:

• Replace paper medical charts in nephrology.
• Function as a data repository and data query/reporting system.
• Save and display clinical information (manually entered, from labs, or directly from Fresenius 2008H dialysis machines).
• Calculate a limited number of values (weight gain, protein catabolic rate, urea reduction, KT/V dialysis efficacy index, nutrition parameters).
• Report clinical information.
• Support general charting functions (patient demographics, problem lists, orders, medications, progress notes, consultations, laboratory results reporting, billable services, nutrition).
• Support hemodialysis management (treatment orders, session charting, access charting, schedule).
• Support peritoneal dialysis management (orders, session charting, peritonitis charting, access charting).
• Support transplant management (status, workup).

It explicitly states what cyberREN does not do:

• Logically alter information entered or imported.
• Make recommendations for treatment.
• Influence the operation of the Fresenius 2008H dialysis machine.
• Provide a diagnosis or selection of possible diagnoses.

Since the document is a regulatory clearance letter, it assumes the device manufacturer has performed these studies, but the details of those studies are not typically included in the public FDA 510(k) summary or this type of letter.

Therefore, I cannot provide the requested information based on the given text.

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