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The NxStage TPE Cartridge is indicated for use only with the NxStage System One for therapeutic plasma exchange in a clinical environment. All treatments must be administered under a physician's prescription, and must be observed by a trained and qualified person considered to be competent in the use of this device by the prescribing physician.

Device Description

The NxStage TPE Cartridge provides therapeutic plasma exchange therapy when used with a commercially available TPE filter. The blood tubing set is the NxStage TPE Cartridge. The TPE Cartridge is a single use extracorporeal blood circuit and fluid management device available without a pre-attached filter. Therapeutic plasma exchange requires the use of a commercially available Therapeutic Plasma Exchange filter such as such as the Asahi Plasmaflo OP-05W (A) wet filter (PMA P820033 S005 approved on March 16, 2010).

AI/ML Overview

The provided document describes the NxStage Therapeutic Plasma Exchange (TPE) Cartridge and its path to 510(k) clearance. The focus of the study is to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy through a comparative effectiveness study involving human readers or standalone AI performance.

Therefore, many of the requested categories are not applicable to this submission.

Here's the information that can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

Test Method (Acceptance Criteria)	Reported Device Performance (Result)
Pressure leak testing demonstrating the blood tubing can withstand pressures up to 1.5 times the maximum labeled positive and negative pressures	Pass – Results within acceptance criteria
Endurance testing of pump segment at maximum labeled blood flow rates and pressures	Pass - Results within acceptance criteria
Endurance testing under both positive and negative pressures of any injection ports (if applicable) using the largest recommended gauge needle identified in the labeling	Pass - Results within acceptance criteria
Priming volume assessment	Pass - Results within acceptance criteria
Tensile testing of joints and materials of all tubing segments	Pass - Results within acceptance criteria
The ability of pressure transducers to withstand leakage when subject to pressures up to 2 times the maximum labeled pressure e.g. “strikethrough”	Pass – Results within acceptance criteria
Performance testing to evaluate the ability of tubing to resist kinking after repeated clamping, particularly in the post-pump tubing segment	Pass – Results within acceptance criteria
Performance testing of the device's clamps to demonstrate that they can successfully occlude blood tubing	Pass – Results within acceptance criteria
Hemocompatibility (i.e., mechanical hemolysis) for new or significantly altered hemodialysis tubing design that affects the pattern of blood flow	Pass – Results within acceptance criteria
Structural integrity testing on gamma sterilized and thermally stressed samples. ISTA 2A ship testing (Packaging Qualification)	Pass – Results within acceptance criteria
Biocompatibility (Cytotoxicity)	Conclusion: Substantially equivalent
Biocompatibility (Hemolysis)	Conclusion: Substantially equivalent
Biocompatibility (USP Physicochemical)	Conclusion: Substantially equivalent
Biocompatibility (FTIR)	Conclusion: Substantially equivalent

2. Sample size used for the test set and the data provenance

The document specifies "The following tables outline the testing performed on the CAR-510-C to support the determination of substantial equivalence to the predicate device." However, specific sample sizes for each test within the performance and functional tables (Table 2 and Table 3) are not explicitly stated. The testing described appears to be laboratory-based engineering and material testing, not patient data trials. Therefore, data provenance such as country of origin or retrospective/prospective is not applicable in the context of this device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This point is not applicable. The "ground truth" for the tests described relates to engineering specifications and material properties, not diagnostic interpretations from experts. The testing involved measuring physical properties and verifying performance against predefined technical requirements.

4. Adjudication method for the test set

This point is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in clinical studies involving expert interpretation of medical images or patient outcomes. The tests in this document are technical performance evaluations.

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 point is not applicable. This submission is for a medical device (a TPE Cartridge) and is not an AI/CADe/CADx device that involves human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This point is not applicable. This device is a Therapeutic Plasma Exchange Cartridge, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the various performance and functional tests (e.g., pressure leak, endurance, tensile strength, priming volume, hemocompatibility, packaging integrity) was based on pre-defined engineering specifications, regulatory standards, and manufacturing tolerances. For biocompatibility, it was based on accepted biological evaluation standards (ISO 10993).

8. The sample size for the training set

This point is not applicable. This device does not involve a training set as it is not an AI/machine learning device.

9. How the ground truth for the training set was established

This point is not applicable for the same reason as point 8.

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