(158 days)
The Allient® Sorbent Hemodialysis System, including the SORB™ series and HISORB™ series of cartridges, is to be used for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.
The Allient Sorbent Hemodialysis System (Allient System) is intended for the treatment of acute or chronic uremic patients where hemodialysis is prescribed by the physician. The system consists of the Allient hemodialysis machine, SORB™ series of Sorbent cartridges, a single-use, sterile, disposable blood tubing set, a singleuse disposable dialysate set, and various dialysate and infusate chemicals. The system is recommended for use with a variety of dialyzers, access needles or access cannulae, which will be supplied by other manufacturers. The Allient System operates in a similar manner to standard hemodialysis systems currently approved for use. The only significant differences between the Allient System and standard hemodialysis machines are as follows: The Allient System utilizes a Sorbent cartridge to purify dialysate made from potable water. After passing through the dialyzer, the dialysate is recirculated to the dialyzer instead of being disposed of. The Allient System utilizes the Pulsar™ air-activated pump in contrast to the roller-activated pump commonly employed in traditional hemodialysis systems. The Pulsar blood pump is a dual-chamber pneumatically operated pump. All other aspects of Renal Solutions' Allient Sorbent Hemodialysis System process are identical to those employed in the standard "single pass" method of dialysis: there are no significant differences in the technology employed in Sorbent dialysis therapy between the Allient System and traditional methods. The Allient System functions as a traditional recirculating Sorbent hemodialysis system, similar to the REDY 2000 System. Either single-needle or dual-needle access to the patient is permitted. The patient's blood is pumped from the access through a dialyzer and is returned to the patient. Heparin is administered via a flow-controlled heparin pump capable of delivering rates of 0 to 3 milliliter per hour (mL/hr) in 0.5 mL/hr increments as well as an initial bolus of 0 to 10 mL. Blood-flow rates are settable in 10 milliliter per minute (mL/min) increments in the range of 200 to 400 mL/min in the dual-needle mode and 200 to 300 mL/min in the singleneedle mode. The dialysate delivery system consists of a container for dialysate. Sorbent regenerative cartridges, chemical infusion system to replace chemicals removed by the Sorbent cartridges, and an ultrafiltrate control system. The dialysate delivery system operates in a batch recirculating mode and continuously recirculates the dialysate through the cartridge. The cartridge removes dialyzed toxins from the dialysate and buffers the sodium and bicarbonate levels in the dialysate to maintain normal levels in the patient. The Acute mode of operation is intended for use in a hospital, acute or chronic-care facility, or dialysis clinic where the patient is continually monitored. The Acute mode of operation allows the clinician or dialysis technician to enter prescription parameters and machine operating parameters for each patient. The Allient System incorporates a Graphical User Interface (GUI) comprised of a touch-screen display, which controls the System software. The GUI is used to select the mode of operation of the Allient System and enter prescription data and machine control parameters during setup. This information is stored for future reference and verification prior to subsequent treatments. Treatment status and progress, in addition to machine status, is continually collected and displayed on the GUI screen to support treatment. The GUI's touch-screen technology also provides ease of use for Home patients. The Allient System incorporates a control system that contains a number of safety features and audible and visible alert and alarm functions to warn the operator or patient of unsafe conditions.
The provided document describes the "Allient® Sorbent Hemodialysis System" and its substantial equivalence to a predicate device, the REDY 2000. It focuses on the device's specifications and compliance with various domestic and international standards, rather than a clinical study with acceptance criteria in the typical sense of accuracy, sensitivity, or specificity for a diagnostic or AI-driven device.
However, I can extract the relevant information from the document to construct an answer regarding acceptance criteria based on performance specifications and the study that "proves" (or verifies, in this context) the device meets them.
Acceptance Criteria and Device Performance based on provided specifications:
1. Table of Acceptance Criteria and Reported Device Performance
For a medical device like a hemodialysis system, "acceptance criteria" are more about meeting technical specifications and safety standards rather than diagnostic performance metrics (like sensitivity/specificity). The document details various operating parameters, flow rates, and safety features as the de facto acceptance criteria. The "reported device performance" is implicitly stated by saying the system "meets its specifications" and various standards.
| Feature / Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Dialysate Flow Rate | 0 to 400 +/- 10% mL/min (into 25 psi max back pressure from Sorbent cartridge); Measuring Tolerance: +/- 10% of set point; Increment: 10 mL/min (200-400 mL/min range) | "The Allient System has been tested to verify that it meets its specifications as listed above." (Implicitly, the device performs within these specified tolerances.) |
| Infusate Flow Rate | 0 to 3 mL/hr against +/- psi back pressure; Measuring Tolerance: +/- 10% of set point | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Heparin Flow Rate | 0 to 3 mL/hr; Measuring Tolerance: +/- 0.1mL/hr (1 mL/hr); Increment: 0.25 mL/hr; Accuracy: 10% of set point | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Blood Flow Rates | Single Needle: 150-200 mL/min; Dual Needle: 150-400 mL/min | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Air Detectors | Detection Range: > 1.0 ml bubble or microbubbles > 1.5 ml | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Dialysate Temperature | Control Range: 34°C to 37°C | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Blood Leak Detector | Leak Detection Range: 0.35 ml/min of 0.25% hematocrit Blood in dialyzer output flow | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Saline Flow Rate | Controlled at 200 mL/min; Measuring Tolerance: +/- 10% of set point | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Net Ultrafiltration | Min. 20g/hour to 2000 g/hour (based on acceptable Dialyzer); Measuring Tolerance: +/- 20 g/hr or 5% (whichever is greater) | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Degassing Flow Rate | 750 mL/min (with SORB cartridge bypassed) | "The Allient System has been tested to verify that it meets its specifications as listed above." |
| Compliance with Standards | ANSI/AAMI RD17, ANSI/AAMI RD5, EN 556, IEC 60529, IEC 60601 series, ISO 10993 series, ISO 11135, ISO 8638 | "The Allient System has also been tested and meets the following domestic and international standards." |
| Substantial Equivalency | To predicate REDY 2000 system | "All testing performed on the Allient Sorbent Hemodialysis System verifies the substantial equivalency of the Allient System to the predicate REDY 2000 system." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" for a test set in the traditional sense of a clinical trial with patient data. The "testing" referred to is engineering verification and validation against technical specifications and recognized standards. This typically involves testing multiple units of the device and its components in a controlled laboratory environment.
- Test Set Sample Size: Not specified as a number of patients or cases. It would refer to the number of devices or components tested.
- Data Provenance: The testing is internal (by Renal Solutions Inc.) for verification and validation against engineering specifications and international standards (e.g., IEC, ISO, AAMI). This is a technical validation, not clinical data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This concept is not applicable to the type of device and study described. For a hemodialysis machine, the "ground truth" is defined by the physical laws of operation and the engineering specifications that ensure safety and effectiveness. Experts (e.g., engineers, quality control personnel) would be involved in designing, measuring, and verifying these specifications against established benchmarks and regulatory requirements. There is no "ground truth" established by clinical experts reading or interpreting output in the way one would for an AI-driven diagnostic device.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials or studies where there is subjective interpretation (e.g., image reading) and a need to resolve disagreements among multiple experts to establish a definitive ground truth. For the Allient System, performance is measured against objective, quantifiable engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done, and the document does not mention any clinical trials comparing human performance with and without AI assistance. This type of study is typically for evaluating diagnostic accuracy or decision support systems, which the Allient System is not.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The Allient System is a physical medical device, not an algorithm or AI system. Its performance is inherent in its electromechanical and chemical operations. Therefore, the concept of "standalone" performance for an algorithm is not applicable here. Its operation is standalone in the sense that it performs its function (dialysis) according to its design.
7. The Type of Ground Truth Used
The "ground truth" for the Allient System is based on:
- Engineering Specifications: Quantifiable parameters and tolerances for flow rates, temperatures, leak detection, etc.
- Compliance with Recognized Standards: Adherence to established domestic and international standards for medical devices (e.g., ANSI/AAMI, IEC, ISO) which define safety, electrical, biological, and sterilization requirements.
- Predicate Device Performance: The predicate device, REDY 2000, serves as a benchmark for "substantial equivalency," implying its established safety and effectiveness forms part of the "ground truth" or acceptable performance standard.
8. The Sample Size for the Training Set
This concept is not applicable. The Allient System is not an AI/ML algorithm that requires a "training set" of data. Its design and operational parameters are determined through engineering principles, bench testing, and adherence to established medical device standards.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no "training set" for this type of medical device. The "ground truth" for its design and verification is established through a combination of engineering design principles, regulatory requirements, and established industry standards for hemodialysis systems.
§ 876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
(a)
Identification. A sorbent regenerated dialysate delivery system for hemodialysis is a device that is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a sorbent cartridge and the means to circulate dialysate through this cartridge and the dialysate compartment of the dialyzer. The device is used with the extracorporeal blood system and the dialyzer of the hemodialysis system and accessories (§ 876.5820). The device includes the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate, and alarms to indicate abnormal dialysate conditions. The sorbent cartridge may include absorbent, ion exchange and catalytic materials.(b)
Classification. Class II (performance standards).