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The NxStage Travel Warmer and Travel Warmer Disposable Set are accessories to the NxStage System One used to warm dialysate prior to administration.

The NxStage Travel Warmer and Travel Warmer Disposable Set are accessories to the NxStage System One used to warm dialysate. The Travel Warmer is for use with the NxStage System One only and is not used to warm blood or blood products. The Travel Warmer consists of an electro-mechanical warming unit and a single-use disposable.

This NxStage Medical, Inc. K071263 510(k) premarket notification describes the NxStage Travel Warmer, an accessory for the NxStage System One, used to warm dialysate. The submission explicitly states that the device is substantially equivalent to predicate devices (K012832 and K020858) and that non-clinical performance testing was conducted. However, it does not provide specific acceptance criteria or detailed results of these tests, nor does it describe studies involving human readers or ground truth establishment in a medical imaging context.

Here's an analysis based on the provided text, addressing your points where possible, and noting when information is absent for this type of medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not include specific, quantifiable acceptance criteria or detailed reported device performance in a table format. It generally states that "Performance, verification and validation testing was conducted to characterize performance... Results of the all testing have documented that the proposed NxStage Travel Warmer is substantially equivalent to the predicate device and is suitable for the labeled indications for use."

For a device like a dialysate warmer, acceptance criteria would typically involve parameters such as:

• Temperature Range: The ability to heat dialysate to a specific temperature range, typically body temperature (e.g., 36.5°C to 38.5°C).
• Temperature Accuracy: The precision with which the device maintains the target temperature.
• Temperature Uniformity: Ensuring the dialysate is heated uniformly.
• Heating Time: The time taken to reach the target temperature from an initial temperature.
• Safety Features: Over-temperature protection, alarm functions, electrical safety (e.g., leakage current).
• ** biocompatibility**

As these details are missing, a table cannot be constructed from the provided text.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Performance, verification and validation testing" but does not specify sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective). Given this is a hardware device, "test set" would likely refer to the number of units tested, number of warming cycles, or number of disposable sets used in testing, not a dataset of patient images.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this 510(k) submission. This is a medical device for warming dialysate, not an AI or diagnostic imaging device that requires expert ground truth establishment for a medical data set.

4. Adjudication Method for the Test Set

This information is not applicable to this device type. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert readers for diagnostic tasks.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or reported. This type of study is relevant for AI-powered diagnostic tools or imaging systems, not for a dialysate warmer.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the NxStage Travel Warmer is a hardware device, not an algorithm. The "performance testing" referenced would be standalone in the sense that the device's function (dialysate warming) was evaluated independently, but it does not involve algorithms or human interaction in the way medical AI would.

7. Type of Ground Truth Used

The concept of "ground truth" as typically discussed in AI or diagnostic imaging (e.g., pathology, outcomes data) is not applicable here. For a device like a warmer, "ground truth" would be established by physical measurements using calibrated sensors to verify temperature, flow rates, and safety parameters against engineering specifications and regulatory requirements.

8. Sample Size for the Training Set

Not applicable. This is a hardware device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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