(29 days)
The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Moda-flx Hemodialysis System ™
The Moda-flx Hemodialysis System™ Cartridge is a single use blood tubing set that provides extracorporeal access during hemodialysis and is only compatible with Moda-flx Hemodialysis System™
The provided text is a 510(k) Summary for the Moda-flx Hemodialysis System™ Cartridge. It describes the device, its intended use, and comparability to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics in a table, sample sizes, information about expert-established ground truth, adjudication methods, or MRMC study details. The document states that "No animal or clinical studies were required to support this submission," which implies that a standalone performance study as typically understood for AI/ML devices involving human-in-the-loop or standalone algorithm performance was not conducted.
Therefore, many of the requested details about acceptance criteria and study particulars cannot be extracted from this document.
Here's a summary of what is available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests that were conducted but does not provide specific acceptance criteria or quantitative performance results in a table format. It only states that the tests supported the substantial equivalence determination.
2. Sample size used for the test set and the data provenance:
Not explicitly stated. The tests performed are engineering/performance verification tests of the device's physical components and functionality, not clinical test sets with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this is not a diagnostic device relying on expert-established ground truth from clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is not a diagnostic device relying on expert adjudication of clinical data.
5. 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:
No, an MRMC study was not done. The document explicitly states: "No animal or clinical studies were required to support this submission." This type of study is relevant for diagnostic devices, particularly those incorporating AI, which this device is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone performance study for an algorithm was not done. This device is a physical hemodialysis cartridge, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of clinical ground truth. The "ground truth" for the performance tests would be established by engineering specifications and industry standards for medical device functionality and safety.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML model.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis 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 an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.