Search Results

OneView is an optional computer-based interface to be used with the NxStage System One to provide on-line instructions for use, summarized system information, and remote access.

OneView is contraindicated as the sole method of monitoring a patient during treatment.

OneView is an optional computer-based interface accessory to the NxStage System One to provide on-line instructions for use, summarized system information, and remote viewing of treatment information. OneView consists of software, a flat panel touch screen display, and a central processing unit (CPU).

The provided text is related to a 510(k) premarket notification for the NxStage OneView Interface, a hemodialysis accessory. It describes the device, its intended use, and states that performance testing was conducted to demonstrate substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or detailed results of a study that proves the device meets those criteria, nor does it provide information on reader studies, sample sizes, ground truth establishment, or expert qualifications.

The content focuses on regulatory submission details and general statements about performance testing. Therefore, based on the provided text, I cannot complete the table or answer most of the questions as the information is not present.

Here's what can be extracted from the given input:

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

The document states: "Performance testing was conducted to characterize performance of the proposed NxStage OneView Interface to provide a basis of comparison to the predicate devices. Results of the performance testing have documented that the proposed NxStage OneView Interface is substantially equivalent to the predicate devices and is suitable for the labeled indications for use."

However, no specific acceptance criteria or quantitative performance metrics are provided in the document. Therefore, this table cannot be filled out.

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.

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 in the document.

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

This information is not provided in the document.

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 information is not provided in the document. The device is an interface accessory, not an AI for interpretation.

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

The device is an interface accessory and not an algorithm for standalone diagnostic performance. The document explicitly states: "OneView is contraindicated as the sole method of monitoring a patient during treatment." This implies it's designed to assist, not replace, human monitoring.

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

This information is not provided in the document. The device is for displaying information and instructions, not making diagnostic or therapeutic decisions independently.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Ask a specific question about this device