Search Results

The NxStage System One Low Volume Cartridge Express is indicated for use only with the NxStage System One in a chronic care dialysis facility or acute care unit. It is indicated for use in adult patients for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration.

All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The NxStage System One Low Volume Cartridge Express is a single-use extracorporeal blood circuit and fluid management device with a pre-attached high flux (permeability) hollow-fiber filter that mounts integrally within the NxStage Cycler.

The provided 510(k) summary for the NxStage System One Low Volume Cartridge Express details non-clinical bench testing to demonstrate substantial equivalence to predicate devices. However, it does not explicitly define specific quantitative acceptance criteria or provide the detailed results of each test in a table format as requested. Instead, it offers a general statement that "All predetermined acceptance criteria were met."

Therefore, I cannot populate a table with specific acceptance criteria and reported device performance directly from the provided text. I can only infer the types of testing performed and the general outcome.

Here's a breakdown of the information that can be extracted based on your request:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text mentions "Performance, verification and validation testing was conducted" and refers to "bench" testing. It does not specify the sample size for any of the tests, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective study design). This appears to be non-clinical, in-vitro testing.

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 section is not applicable. The study described is a non-clinical bench test of a medical device (dialysis cartridge), not a study involving expert assessment of patient data or images to establish a ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods are typically associated with studies requiring human interpretation or subjective assessment. The tests performed are objective, quantitative bench tests.

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 section is not applicable. An MRMC study is not mentioned as this submission is for a medical device (dialysis cartridge), not an AI-assisted diagnostic tool or an imaging device requiring human interpretation.

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

This section is not directly applicable in the context of an "algorithm only" performance because the device is a physical medical component, not a software algorithm. However, the bench testing conducted can be considered "standalone" in that it evaluates the device's performance independently, without human interaction during the test itself (though humans operate the testing equipment).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the bench tests would be the established scientific and engineering principles, material specifications, and regulatory standards for a high permeability hemodialysis system. For instance, for "priming volume assessment," the ground truth would be the accurately measured volume according to standardized procedures. For "pressure drop," the ground truth is the physically measured pressure differential. These are objective physical measurements rather than subjective assessments.

8. The sample size for the training set

This section is not applicable. The device is a physical medical device, not a machine learning model, so there is no training set.

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

This section is not applicable as there is no training set for this type of device submission.

Ask a specific question about this device