(191 days)
The Redsense device is intended to monitor for potential blood loss from the hemodialysis access site in hemodialysis patients undergoing continuous hemodialysis treatment up to 5 hours in the clinical setting. The device includes a blood sensor incorporated into an adhesive sensor patch. The sensor monitors potential blood leakage from the venous needle puncture site via an infrared light and will alarm if blood leakage is detected via absorption onto the device's sensor patch.
Redsense is a system for monitoring the vein or arterial needle during hemodialysis. Redsense consists of an alarm unit and infrared sensor incorporated into an adhesive patch. The patch with the sensor is placed around the vein or arterial needle and detects any blood that drips onto the patch if the needle has been accidentally pulled out or if there is leakage during dialysis. If blood loss is detected, the device will alarm.
Here's a summary of the acceptance criteria and study information for the Redsense device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria for the Redsense device's performance. Instead, it indicates that "Verification testing has been performed to verify that the Redsense device fulfills the Requirement Specifications" and "Results showed the device functioned successfully in the clinical environment."
Based on the device's functional description, the primary performance metric would be its ability to detect blood leakage and alarm. The closest stated performance characteristic is:
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Blood amount for detection | Not explicitly stated as acceptance criteria, but mentioned as device capability | Approximately 2 ml |
| Functionality in clinical environment | Device functions successfully in the clinical environment. | Device functioned successfully in the clinical environment. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated. The document mentions "clinical testing was conducted" but does not specify the number of patients or cases.
- Data Provenance: Prospective (clinical testing).
- Country of Origin: Sweden (Departments of Nephrology/Medicine at Eksjö, Halmstad, Hässleholm, Skövde, and Varberg Hospitals).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study involved clinical testing in hospitals, implying medical professionals were involved in observing and confirming events, but the specific number or qualifications of experts establishing ground truth are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document describes a study to verify the Redsense device's functionality, not a comparative effectiveness study involving human readers with and without AI assistance.
- Effect Size of human readers improvement with AI vs without AI assistance: Not applicable, as no MRMC comparative effectiveness study was performed.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study (clinical testing) was performed. The provided text describes the Redsense device, which includes a sensor and an alarm unit, as a standalone system designed to detect blood leakage. The clinical testing was conducted to verify that "the Redsense device fulfills the Requirement Specifications" and "functioned successfully in the clinical environment." This implies the device's performance was evaluated independently.
7. Type of Ground Truth Used
The ground truth for the clinical testing would have been clinical observation of actual blood leakage and confirmation by medical staff during hemodialysis treatments. This is inferred from the description of the device's purpose and the clinical study setting.
8. Sample Size for the Training Set
This information is not provided in the document. The Redsense device is described as a sensor-based system, and there is no mention of an "AI" or "algorithm" that would typically require a training set in the context of machine learning. The "Verification testing" and "Clinical testing" refer to the testing of the final, built device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is likely not applicable, as the device is not described as utilizing a machine learning algorithm that requires a training set with established ground truth. It appears to be a direct physical sensor detecting infrared light absorption by blood.
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.