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The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing hemodialysis treatment. The device includes a blood sensor incorporated into a sensor patch. The sensor monitors potential blood leakage from the venous needle blood access via a light signal and will alarm if blood leakage is detected by the device's sensor.

Redsense Medical provides a system for monitoring the blood access during haemodialysis consisting of an alarm unit and a sensor connected to a specifically developed patch. The Redsense Patch uses integrated optic fibers to detect blood leakage from wounds. The optic fiber is connected to the sensor and alarm unit. If blood leakage occurs during haemodialysis, the patch surrounding the vein needle registers the event and changes a light signal to the alarm unit. This immediately activates a light and an alarm signal. Thus if a vein needle comes out of place extensive blood leakage is prevented.

Acceptance Criteria and Device Performance Study for Redsense Alarm System

The Redsense Alarm System (K130554) is a device intended to monitor for potential blood loss from the hemodialysis access site during hemodialysis treatment. The device includes a blood sensor incorporated into a sensor patch that detects blood leakage via a light signal and alarms if detected.

1. Acceptance Criteria and Reported Device Performance

The core functional acceptance criteria for the Redsense Alarm System are primarily based on sound output level and compliance with relevant electrical and EMC standards. The device's ability to detect blood is validated through non-clinical testing.

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

The provided document does not describe a specific test set with human subjects for the K130554 device's performance evaluation. The device's performance for blood detection was validated in "nonclinical test." The clinical evidence for the intended use and safety for the subject device (K130554) relies on previous clinical data from a predicate device (K071013).

Regarding the "user evaluation" mentioned:

• Sample Size: Not specified.
• Data Provenance: Not specified, but based on "user feedback," it is likely retrospective or observational use of the predicate device (K071013) that informed design changes for K130554, and potentially some limited prospective evaluation for the K130554 to confirm users "can handle the device and understand its use."

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

This information is not provided as the primary performance validation for blood detection was non-clinical. For the "user evaluation," no details are given about experts or their role in establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided as there is no detailed description of a clinical test set for K130554's performance.

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

There was no MRMC comparative effectiveness study described for the Redsense Alarm System (K130554) or its predicate devices. The device is an alarm system, not an interpretive diagnostic tool that involves human readers.

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

The device's core function is an automated alarm for blood leakage. The "ability to detect blood is validated in nonclinical test." This suggests a form of standalone performance evaluation for the sensor and alarm mechanism without direct human intervention as part of the detection process. However, the details of this non-clinical test are not provided.

7. Type of Ground Truth Used

• For blood detection (non-clinical test): The "ground truth" would have been established by controlled simulations of blood leakage under laboratory conditions, using known quantities and types of blood or blood-like substances to trigger the device's sensor.
• For the clinical evidence (derived from K071013): This would have involved actual patient outcomes and observations of blood loss instances in a clinical setting.

8. Sample Size for the Training Set

This information is not provided. The Redsense Alarm System appears to be based on a deterministic optical principle rather than a machine learning model that typically requires a "training set." The development of its algorithm would be based on engineering specifications and empirical testing.

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

As noted above, the concept of a "training set" in the context of machine learning does not readily apply to the described device. The "ground truth" for the device's development and validation would have been established through:

• Engineering specifications and physics: Understanding the optical properties of blood and how light interacts with it.
• Empirical testing and calibration: Testing the sensor's response to various concentrations and types of blood in a controlled environment to calibrate its sensitivity and alarm thresholds. This would involve creating controlled blood leakage scenarios and confirming the device's triggering mechanism.

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