Search Results

The leak detection sensor and tray provide a means of detecting fluid leaks when used as an accessory to the NxStage System One.

The NxStage leak detection sensor and tray is designed for use with the NxStage System One. The plastic tray and leak detection sensor are external devices that are not connected to the NxStage System One. The tray fits under the door area of the NxStage System One cycler. The tray includes a molded area on the left-hand side that holds a commercially available leak detection sensor.

The provided text describes a 510(k) premarket notification for the "NxStage Medical, Inc. Leak Detection Sensor and Tray." It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with performance metrics.

Therefore, many of the requested details, such as specific acceptance criteria, reported device performance metrics, sample sizes, expert qualifications, and ground truth establishment, are not explicitly available in the provided document.

However, I can extract and infer some information:

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

This information is not explicitly provided in the document. The document states: "Performance, verification and validation testing was conducted to characterize performance of the proposed leak detection sensor and tray. Results of this testing have documented that the proposed leak detection sensor and tray is substantially equivalent to the predicate devices and is suitable for the labeled indications for use." This implies that the device met internal acceptance criteria for substantial equivalence, but the specific metrics are not detailed here.

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

• Sample size for test set: Not provided. The document generally mentions "Performance, verification and validation testing" but does not specify the sample size for these tests.
• Data provenance: Not provided. The location or nature (retrospective/prospective) of the data collection is not mentioned. It is implied to be internal testing by NxStage Medical, Inc.

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

• Number of experts: Not applicable/Not provided. For a leak detection sensor, the "ground truth" would likely be objectively determined (e.g., whether a leak actually occurred and was detected) rather than requiring expert consensus interpretation. The document does not mention any expert involvement for ground truth establishment.
• Qualifications of experts: Not applicable/Not provided.

4. Adjudication method for the test set:

• Adjudication method: Not applicable/Not provided. As stated above, the ground truth for a physical leak detection system is typically objective and doesn't involve subjective adjudication by multiple experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• MRMC study: No. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers make subjective judgments. A leak detection sensor is an automatic detection system, so an MRMC study is not applicable.

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

• Standalone performance: Yes, implicitly. The device (Leak Detection Sensor and Tray) is a standalone accessory designed to detect fluid leaks automatically. The performance testing mentioned ("Performance, verification and validation testing was conducted to characterize performance") would inherently be standalone, evaluating the sensor's ability to detect leaks without human intervention in the detection process itself. Human intervention would be in responding to the alarm, not in the detection.

7. The type of ground truth used:

• Type of ground truth: Implied objective/physical ground truth. For a leak detection sensor, the ground truth would be established by physically creating leaks of specified volumes/rates and verifying if the sensor consistently detects them. This would be an objective, experimentally controlled ground truth.

8. The sample size for the training set:

• Sample size for training set: Not applicable/Not provided. This device is a sensor, likely relying on physical principles (e.g., conductivity) rather than a complex algorithm that requires a "training set" in the machine learning sense. The performance is characterized through verification and validation testing against defined specifications.

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

• Ground truth for training set: Not applicable/Not provided. As explained in point 8, a "training set" for an algorithm to establish ground truth is generally not relevant for a simple leak detection sensor. If there were any calibration or development, it would involve empirical testing against known leak conditions.

Ask a specific question about this device