(102 days)
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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet all design requirements. | "Validation and verification testing was successful in demonstrating that all design requirements have been met." |
| Demonstrate substantial equivalence to the predicate device. | "Bench testing was performed on RenalSoft to support substantial equivalence to the predicate device..." |
| Device operates as intended. | "...as well as demonstrating that the device operates as intended..." |
| Device is safe and efficacious. | "...and is safe and efficacious." |
| Not raise any new safety and effectiveness issues compared to predicate. | "The proposed product does not raise any new safety and effectiveness issues when compared to the predicate product." |
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.
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.