(270 days)
The Voyager Peritoneal Dialysis System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis.
All therapies using the Voyager Peritoneal Dialysis System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about peritoneal dialysis.
The Voyager Peritoneal Dialysis (PD) System is used for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis therapy. The Voyager Peritoneal Dialysis (PD) System automatically cycles peritoneal dialysis fluid in the amounts and time prescribed by a clinician.
This device is a Peritoneal Dialysis (PD) System, not an AI/ML device, therefore most of the requested information (sample sizes, ground truth establishment, MRMC studies, etc.) is not applicable. The document assesses the device's conformance to design specifications and industry standards rather than its performance in an AI/ML context.
Here's an overview of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Specifications | Met: The Voyager Peritoneal Dialysis System has been evaluated for conformance to its design specifications. Full system validation and software regression testing were performed to ensure the device functions as intended and that all design requirements have been met. |
| Applicable Industry Standards for Software Development | Met: The device has been evaluated for conformance to applicable industry standards for software development. |
| System Compatibility | Met: The device is verified for system compatibility with the devices with which it communicates. |
| Hardware Certification | Met: Device hardware is certified to applicable safety standards. |
| Electromagnetic Compatibility (EMC) | Met: EMC testing was conducted according to IEC 60601-1-2. The device was found to meet the requirements defined in that document. |
| Electrical Safety | Met: Electrical safety testing was conducted according to IEC 60601-1. The device was found to meet the requirements put forth in that document. |
| Human Factors | Met: Human factors testing was performed. The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria. |
| Overall Functionality | Met: Full system validation and software regression testing were performed to ensure that the device functions as intended. Bench testing, simulated use testing, and human factors testing were performed to support substantial equivalence to the predicate device and demonstrate that the device performs as intended and is as safe and effective as the predicate device. The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria. Validation and Verification testing was successful in demonstrating that all design requirements have been met. |
Study Information (Based on the context of a non-AI medical device submission):
-
Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of data for an AI/ML model. Instead, the testing described refers to verification and validation activities for a physical medical device and its software.
- The provenance of data (e.g., country of origin, retrospective/prospective) is not applicable or provided, as the studies are focused on product-based engineering assessments (bench testing, simulated use testing, human factors testing, etc.) rather than clinical data analysis for an AI model.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the device is not an AI/ML diagnostic tool requiring expert-established ground truth from a "test set" of cases. The validation relies on engineering and regulatory standards.
- The document implies that "a physician who is familiar and well informed about peritoneal dialysis" is responsible for prescribing and performing therapies using the device, but this is for clinical use, not for establishing ground truth for a test set.
-
Adjudication method for the test set:
- Not applicable, as there is no "test set" in the context of an AI/ML model for which adjudication would be needed.
-
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:
- Not applicable. This is not an AI-assisted diagnostic or decision-support tool. Therefore, MRMC studies evaluating improvement in human readers with AI assistance were not performed.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable, as this is a physical medical device with integrated software, not a standalone AI algorithm. The performance evaluation is of the complete system ("algorithm only" performance is not a relevant concept for this device type).
-
The type of ground truth used:
- For this device, "ground truth" is established by adherence to predefined engineering specifications, regulatory standards (e.g., IEC 60601-1-2, IEC 60601-1), functional requirements, and the successful outcome of various performance tests (software validation, EMC, electrical safety, human factors, bench testing, simulated use testing). There is no "pathology" or "outcomes data" in the AI/ML sense for ground truth.
-
The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML device that learns from data. The software is developed and validated, not trained.
-
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of device.
§ 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.