(112 days)
Gambro PrismaSate solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.
Gambro PrismaSATE solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags.
The provided text is a 510(k) summary for a medical device (PrismaSATE Dialysis Solutions). It describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria in the way typically expected for a diagnostic or machine learning-based device.
The "Testing, and Recognized Standards" section mentions:
- Expiration Dating: Stability studies were performed and results provided.
- Sterilization: Validation methods followed ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 11138-3.
- Biocompatibility: Primary packaging material was tested per Gambro's procedure for physico-chemical and biological evaluation.
These are compliance activities related to manufacturing and material safety, not performance criteria for a diagnostic or AI-driven system. The core of this 510(k) is based on substantial equivalence to predicate devices due to having the same intended use, indication for use, chemical concentration range, and packaging characteristics, with "no significant technological changes."
Therefore, I cannot populate the requested table and study information because the provided text does not contain a performance study with acceptance criteria for a device that would typically involve such metrics (like sensitivity, specificity, AUC, etc.). The "performance" here is demonstrating chemical and physical equivalence and safety.
Here's a breakdown of why the requested information cannot be extracted:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on chemical composition, packaging, and safety/sterilization standards rather than a quantifiable performance metric (e.g., accuracy for a diagnostic).
- Sample size used for the test set and the data provenance: Not applicable in the context of this submission. The "tests" mentioned are for stability, sterilization validation, and biocompatibility, not for a "test set" of patient data for a diagnostic algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for an AI/diagnostic device is not discussed.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. The "ground truth" here is adherence to specified chemical concentrations, sterility, and biocompatibility standards.
- The sample size for the training set: Not applicable. There is no "training set" for an AI/ML algorithm mentioned.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a medical device (dialysis solutions) that is a consumable and is cleared based on substantial equivalence to existing products, as well as adherence to manufacturing and safety standards. It is not a diagnostic device or an AI-powered system that would typically undergo the kind of performance study outlined in your request.
§ 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.