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510(k) Data Aggregation
(94 days)
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
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.
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