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The Byonyks X-1 APD Cycler is indicated for acute and chronic peritoneal dialysis.

The Byonyks X-1 APD Cycler System includes an Automated Peritoneal Dialysis Cycler and a disposable tubing set. The Byonyks X-1 APD Cycler is intended for acute and chronic peritoneal dialysis. Byonyks X-1 APD Cycler is an automated peritoneal dialysis system that uses a peristaltic pumping mechanism to infuse the dialysate (Dialyzing Solution) into the peritoneal cavity and drain it after the dialysate has dwelled within a patient's peritoneal cavity for a specified amount of time. Byonyks X-1 APD Cycler is a prescription-use-only device and the therapies administered using Byonyks X-1 APD Cycler are prescribed by a physician. The device operates according to a therapy prescription provided by the patient's physician. The device is designed to be used in dialysis clinics, outpatient care areas, and home treatment settings with dialyzing solutions approved for peritoneal dialysis. Dialysate is infused into the patient's peritoneal cavity from a dialysate bag through a surgically implanted catheter which provides a fluid connection to the device's disposable tubing set. The dialysate remains in the peritoneal cavity for the dwell time which is a programmed length of time prescribed by the patient's physician. After the dwell time has elapsed, the fluid is drained from the patient using the device's peristaltic pumping system to extract the fluid from the patient's peritoneal cavity. Peristaltic pumping mechanism of the Byonyks X-1 APD cycler assist the dialysate flow at pre- programmed flowrate up to the volume prescribed by the patient's physicians, device continuously monitors volume of dialysate exchanges along with the fluid pressure external to the cassette of disposable set, fluid pressure detects resistance in dialysate exchanges at which pumping regulates the overall flow.

The Byonyks X-1 APD Cycler System consists of the (i) main control unit (Cycler) and the (ii) disposable set.

The provided 510(k) clearance letter and summary for the Byonyks X-1 APD Cycler focuses on the substantial equivalence of the device to a predicate device, primarily through engineering and bench testing, and does not include an AI/ML component. Therefore, the information required to answer your prompt, such as acceptance criteria for AI/ML performance, study details for AI/ML models (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training data details), is not present in the provided document.

The document details performance testing for the physical cycler device and its disposable set, as well as general medical device requirements like biocompatibility, electrical safety, EMC, and human factors. However, these are evaluations of the hardware and overall system functionality, not specific to an AI/ML algorithm's performance on diagnostic tasks.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML acceptance criteria and performance study details based on the given text.

If this medical device were to incorporate AI/ML, the 510(k) summary would typically include a separate section outlining the AI/ML algorithm, its intended use, performance metrics, and the details of the validation study.

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