(94 days)
The NxStage Dialysate Preparation Module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
Device Booonproniment and optional accessory to the NxStage System The NAGtage Dialyone in that mixes with concentrate to produce One that pro treats crequirements of the ANSI/AAMI Standards, RD52:2004 and The dialysate is to be used with the NxStage System One during RD62:2001. hemodialysis therapies.
The provided text describes a 510(k) premarket notification for the NxStage Dialysate Preparation Module, not a study evaluating acceptance criteria or device performance in the typical sense of a clinical or algorithmic study.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a regulatory submission demonstrating substantial equivalence to predicate devices, rather than a detailed performance study with quantifiable acceptance criteria and results.
However, based on the document, I can provide the following:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it states that the device's performance was characterized to enable comparison to predicate devices, focusing on demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adherence to ANSI/AAMI Standards (RD52:2004 and RD62:2001) | The device "pro treats requirements of the ANSI/AAMI Standards, RD52:2004 and RD62:2001." |
| Produces AAMI dialysate from purified AAMI water and AAMI concentrate | The device "uses purified AAMI water that mixes with AAMI concentrate to produce AAMI dialysate." |
| Incorporates proper safety features (conductivity measurement, automatic safety clamp, mix to use timer, ultrafilters and I.V. sterilization filters to insure dialysate purity) | The device "incorporates the proper safety features, such as conductivity measurement, automatic safety clamp, mix to use timer, and ultrafilters and I.V. sterilization filters to insure dialysate purity." |
| Safe for intended use as an optional accessory to the NxStage System One during hemodialysis | "Verification and Validation testing, which includes simulated use testing, sufficiently demonstrates that the Prep Module can be used safely as intended." |
| Substantially equivalent to predicate devices | "Results of the testing presented in this 510(k) have demonstrated that the NxStage Prep Module is substantially equivalent to the predicate devices and is suitable for the labeled indication for use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "Verification and Validation testing" and "simulated use testing," but does not specify sample sizes, specific test sets, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the submission does not detail ground truth establishment by experts. The "ground truth" here is regulatory compliance and functional performance against standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This is not applicable. The device is a medical accessory (Dialysate Preparation Module), not an AI or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a hardware accessory; there is no "algorithm only" performance concept in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" indirectly used here is adherence to industry performance standards (ANSI/AAMI RD52:2004 and RD62:2001) for dialysate quality and the successful functioning of safety features, as well as comparison to legally marketed predicate devices. It is based on engineering and functional testing rather than clinical outcomes or expert consensus on diagnostic interpretations.
8. The sample size for the training set
This information is not provided. This is not an AI/machine learning device, so the concept of a "training set" is not applicable.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this device.
§ 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.