(62 days)
The HomeChoice Automated Personal Cycler Peritoneal Dialysis System is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
The HomeChoice Automated Personal Cycler, version 8.9 software is used for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis therapy. The HomeChoice Automated Personal Cycler automatically cycles peritoneal dialysis fluid in the amounts and time prescribed by a clinician.
The provided text describes a 510(k) premarket notification for the HomeChoice Automated Personal Cycler, version 8.9 software. However, it does not contain the specific details required to complete your request regarding acceptance criteria and a study proving device performance in the context of an AI/ML device.
Here's why and what information is missing:
- Device Type: The HomeChoice Automated Personal Cycler is a medical device for peritoneal dialysis, specifically its software version 8.9. This document is a regulatory submission, not a study report for an AI/ML diagnostic or predictive algorithm.
- Absence of AI/ML Specifics: The document primarily focuses on demonstrating substantial equivalence to a predicate device (K923065 and K012988) and confirming that the design requirements for controlling dialysate solution exchanges are met. There is no mention of AI, machine learning, image analysis, or any other features that would require the kind of performance metrics you've requested (e.g., sensitivity, specificity, AUC).
- "Clinical Data: N/A": This explicitly states that clinical data was "N/A," which means no clinical study, in the typical sense of evaluating patient outcomes or diagnostic performance, was deemed necessary for this particular submission. This further supports that it's not an AI/ML device requiring such studies.
- "Validation and Verification testing was successful in demonstrating that all design requirements have been met. Bench testing was performed...": This describes the type of testing done, which is functional verification and validation for a control system, not performance evaluation against ground truth data for an AI model.
Therefore, I cannot provide the requested information because the input text does not describe an AI/ML device or its performance study. The questions you've asked are pertinent to AI/ML device evaluations, which are not detailed in this 510(k) summary.
§ 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.