(434 days)
- Indicated for treatment of the chronic or acute uremic patient where hemodialysis, including high flux dialysis, is prescribed by the physician.
- Indicated for hemodialysis in a variety of environments, to include acute care facility, chronic dialysis facility, self care facility, or home setting, where the patient has been trained and certified to be competent in the use of this device by the attending physician.
The PHD Personal Hemodialysis System is an automated high flux hemodialysis system using a double needle configuration. It is designed to perform safe and effective personal hemodialysis as prescribed by the patient's physician, while minimizing the time and effort to perform each treatment. A computer-like touch screen prompts the operator through each step of the procedure. The PHD System consists of several components that combine to deliver hemodialysis and perform ultrafiltration. These include the PHD Instrument (PHDi), the PHD Water Pre-Treatment System (WPS), the PHD Blood Tubing Set (BTS), the PHD Chemical Concentrate Bottles (CCBs), and the PHD Transducer Protector (TP). The PHD Instrument orchestrates and performs the entire pre-treatment, treatment, and post treatment cycle. It accomplishes this by working in conjunction with the WPS (or equivalent), BTS, CCBs, TP, and a commercially available hollow fiber membrane dialyzer. Between treatments, the system automatically cleans and disinfects the blood tubing set, dialyzer, and all other components in the fluid pathway. Also, the machine checks the efficiency and integrity of the dialyzer. The PHD Instrument electronically stores information about the patient, prescription, treatment schedule, and machine set-up while allowing for updates according to individual needs.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aksys PHD® Personal Hemodialysis System:
The document is a 510(k) summary for the Aksys PHD Personal Hemodialysis System. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through extensive clinical trials with predefined, quantitative acceptance criteria for device performance.
Therefore, many of the specific details requested in your prompt (like MRMC studies, sample sizes for training/test sets, expert qualifications for ground truth) are not present in this type of regulatory submission. This document highlights a predicate pathway, where the new device is compared to existing, legally marketed devices.
Let's break down what information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of clearly defined acceptance criteria with specific thresholds, the document states general equivalency.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Efficacy | Substantially equivalent to conventional hemodialysis equipment | "Clinical data has shown the PHD System is substantially equivalent to conventional equipment in terms of efficacy." |
| Accuracy (Kt/V) | Substantially equivalent to conventional hemodialysis equipment | "Parameters used to establish the substantial equivalence of the PHD clinical study were accuracy of delivered Kt/V..." |
| Accuracy (Ultrafiltration) | Substantially equivalent to conventional hemodialysis equipment | "...accuracy of ultrafiltration..." |
| Safety / Adverse Events | Comparable incidence of adverse events to conventional hemodialysis equipment | "...and incidence of adverse events." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Twenty-three (23) patients
- Data Provenance: The document does not specify the country of origin. It indicates data was collected from "3 sites." It is a prospective study as it's described as a "clinical study" designed to "establish the substantial equivalence."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the 510(k) summary. Given the nature of hemodialysis output (Kt/V, ultrafiltration measurements), the "truth" is likely derived from the machine's own measurements or standard clinical assessments rather than expert consensus on images.
4. Adjudication Method for the Test Set
This information is not provided. For parameters like Kt/V and ultrafiltration, it's unlikely that a traditional expert adjudication method (e.g., 2+1) would be used. The "truth" would be objective measurements. Adverse events would be recorded and reviewed by the clinical study team and potentially a data safety monitoring board, but not "adjudication" in the sense of resolving conflicting interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC study was not done. MRMC studies are typically for diagnostic imaging devices where human readers interpret images. This device is a treatment system, and the study focused on clinical outcomes and machine performance. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance" to report. The PHD System is a standalone treatment device, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself operates in an "algorithm only" mode for delivering treatment parameters once programmed by a clinician and operated by a trained user. The clinical study assessed the performance of the entire system (device + intended use) against conventional methods. It's not a diagnostic algorithm that would typically have a "standalone" performance evaluation separated from human interpretation. The system performs its functions autonomously once set up.
7. The Type of Ground Truth Used
The ground truth implicitly used for the clinical study's parameters (Kt/V accuracy, ultrafiltration accuracy, adverse events) would be:
- Kt/V and Ultrafiltration: Clinical measurements and calculations performed by the device and/or standard clinical protocols, compared against expected or benchmark values from conventional systems.
- Adverse Events: Documented clinical observations and patient outcomes.
8. The Sample Size for the Training Set
This information is not provided. The PHD System is a medical device, not a machine learning algorithm in the modern sense that requires a "training set" of data to learn from. Its operational parameters are based on engineering design, physics, and medical principles, not on iterative learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of a machine learning algorithm, this question is not applicable. The device's functionality is designed and validated through engineering principles and testing, not by training on patient data.
In summary: The provided 510(k) summary describes a traditional medical device submission for a hemodialysis system, demonstrating substantial equivalence to existing predicate devices. It does not contain information about AI/ML algorithm development, reader studies, or detailed performance metrics and ground truth establishment typically found in submissions for AI-powered diagnostic tools. The clinical study was primarily designed to show that the new device performs comparably to established hemodialysis equipment in terms of safety and efficacy parameters relevant to hemodialysis treatment.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”