(57 days)
The Faller stylet is a surgical tool used to create a subcutaneous tunnel for a peritoneal dialysis catheter, from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.
Faller Stylet
This document is an FDA 510(k) clearance letter for the "Faller Stylet," a surgical tool used to create a subcutaneous tunnel for peritoneal dialysis catheters. As such, it does not contain the kind of detailed performance study information, acceptance criteria, or clinical trial data you are requesting for an AI/ML device.
The questions you've asked (about acceptance criteria, sample sizes, ground truth, expert adjudication, MRMC studies, and standalone performance) are highly relevant for the evaluation of AI/ML-based medical devices. These types of devices require rigorous testing against predefined performance metrics, typically involving clinical validation studies.
This document is for a mechanical surgical tool. Its clearance is based on substantial equivalence to predicate devices, which generally means demonstrating that it has the same intended use, technological characteristics, and safety and effectiveness profiles as legally marketed devices, without introducing new risks or questions of effectiveness. This usually involves:
- Bench testing: To confirm physical properties, strength, etc.
- Biocompatibility testing: To ensure materials are safe for human contact.
- Sterilization validation: To ensure the device can be properly sterilized.
- Performance testing: To confirm it performs its intended mechanical function (e.g., smoothly separates tissue).
Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes for test/training, expert details, adjudication, MRMC, standalone performance, ground truth types) from this specific document because it pertains to a different type of medical device and regulatory pathway.
§ 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.