(88 days)
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
| Criterion Description | Acceptance Criteria | Reported Device Performance | Study to Prove Acceptance |
|---|---|---|---|
| Functional Validation | All functions meet their respective required specifications. | All functions were validated as meeting specifications. | "All functions of Renal Link have been tested and validated." (No specific metrics or details provided in this summary.) |
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.
§ 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.