FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided text is a 510(k) summary for the Fresenius Sterile Stay Safe® Cap. It establishes substantial equivalence to a predicate device and notes a change in sterility. However, it does not contain the detailed information required to answer your specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth for a performance study.

This document is a regulatory submission focused on demonstrating equivalence and safety, not on providing the results of a specific performance study in the way you've outlined. Therefore, I cannot extract the requested information from the given text.

Here's why and what's missing:

Acceptance Criteria & Reported Performance: The document states "testing of the Fresenius Sterile Stay Safe Cap indicates that the sterile cap is safe and effective for its intended use" (page 2, Section F). However, it does not specify what tests were conducted, what the acceptance criteria for those tests were, or what the quantitative performance results were.
Sample Size (Test Set) & Data Provenance: This information is not present.
Number of Experts & Qualifications: This information is not present.
Adjudication Method: This information is not present.
MRMC Comparative Effectiveness Study: There is no mention of a comparative effectiveness study involving human readers or AI. The submission is about a physical medical device (cap).
Standalone Performance: While it mentions "testing," it does not specify if this was a standalone algorithm performance study (which would be irrelevant for a cap). It's likely referring to physical sterility, integrity, and compatibility testing.
Type of Ground Truth: Not applicable in the context of device performance as usually understood for AI/diagnostic devices. For a cap, "ground truth" would relate to its physical properties meeting specifications.
Sample Size (Training Set): Not applicable, as this is a physical device, not an AI/machine learning model that requires a training set.
Ground Truth for Training Set: Not applicable for the same reason as above.

Summary

Regulation Number and Section

§ 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.