(197 days)
The NxStage PureFlow SL module is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
The NxStage PFSL module is an optional accessory to the NxStage System One that is used to treat water for hemodialysis and proportion it with dialysate concentrate to produce dialysate per ANSI/AAMI RD52:2004 and ANSI/AAMI RD62: 2006. The PFSL module consists of the Control Unit (CU), the water Pre-Treatment Unit, the Purification Pack (PAK), and the Dialysate Sack (SAK) with Dialysate Concentrate.
The provided text describes a Special 510(k) submission for a device modification, which primarily focuses on demonstrating substantial equivalence to a predicate device. This type of submission relies on design control requirements and performance testing to ensure the modified device meets design specifications and remains as safe and effective as the original. As such, the information you've requested regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test and training sets, and expert qualifications for ground truth establishment is not typically present in a 510(k) summary for such a modification.
The 510(k) summary focuses on demonstrating that the NxStage PureFlow SL (PFSL) module with modifications is substantially equivalent to the legally marketed predicate device (cleared through K060296).
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with detailed reported performance metrics. Instead, it states:
"Performance, verification and validation testing was conducted to characterize performance of the proposed PFSL to provide a basis of comparison to the predicate device as all features are not identical. Results of this testing have documented that the proposed PFSL module is substantially equivalent to the predicate device and is suitable for the labeled indications for use."
This indicates that internal performance specifications were met to ensure substantial equivalence, but the specific numerical acceptance criteria and results are not disclosed in this summary. The general acceptance criterion is that the modified device performs comparably to the predicate device and meets its design specifications, preparing dialysate per ANSI/AAMI RD52:2004 and ANSI/AAMI RD62: 2006.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any test set or the data provenance. The testing mentioned is "Performance, verification and validation testing," which typically refers to bench testing rather than clinical study data.
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 applicable and not provided. The study described is a non-clinical, bench-testing comparison for substantial equivalence, not a clinical study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. The study described is a non-clinical, bench-testing comparison for substantial equivalence.
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 comparative effectiveness study was not done. This device is an accessory for hemodialysis, and the evaluation is non-clinical, focusing on technological characteristics and performance rather than human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" performance evaluation in the context of an algorithm or AI would not apply here. However, the non-clinical "Performance, verification and validation testing" can be considered a standalone evaluation of the device's functional performance against its design specifications and the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device modification is its design specifications and compliance with relevant industry standards (ANSI/AAMI RD52:2004 and ANSI/AAMI RD62: 2006) for preparing dialysate. The performance was characterized to demonstrate substantial equivalence to the predicate device.
8. The sample size for the training set
This information is not applicable and not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. This is not an AI/ML device that requires a training set.
In summary:
This 510(k) focuses on a "Special 510(k) Device Modification" which primarily relies on demonstrating compliance with 21 CFR §820.30 Design Control Requirements and conducting performance, verification, and validation (bench) testing to confirm that the modified device remains substantially equivalent to its predicate device. This type of submission does not typically involve the detailed clinical study metrics, expert consensus, or AI-specific evaluation criteria often associated with novel medical devices or AI-powered diagnostics.
§ 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.