(88 days)
The CRIT-LINE MONITOR III, (CLM III), is a non-invasive hematocrit, oxygen saturation and percent change in blood volume monitor used in the treatment of hemodialysis patients. In addition, the CLM III estimates access recirculation and access blood flow in hemodialysis patients.
The CLM III consists of a state-of-the-art microprocessor which has all of the chip select logic, serial communication, timing and watchdog circuits incorporated within it. The CLM III is used in conjunction with the In-Line Diagnostics Blood Chamber. The blood chamber is connected to and becomes part of the dialysis tubing circuit. The sensor from the CLM III is connected to the blood chamber which reads critical blood parameters as blood passes through the blood chamber.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
CRIT-LINE MONITOR III (CLM III) with Access Blood Flow (ABF) Feature
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation coefficient value near 1 (i.e., .90 or greater) between CLM III ABF values and Transonic HD01 ABF values | "The results from the two tests indicate that the above described criteria were met." (Implies a correlation coefficient of .90 or greater was achieved) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 44 patients
- 30 patients from the University of Utah Dialysis Program and Veterans Hospital in Salt Lake City, Utah.
- 14 patients from Victoria Hospital South in London, Ontario, Canada.
- Data Provenance: Prospective (described as "during normal dialysis sessions" and "during the study, a formal protocol was followed").
- Country of Origin: USA (Utah) and Canada (Ontario).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The ground truth was not established by human experts in this study. Instead, a predicate device, the Transonic HD01 Monitor, was used as the reference standard for Access Blood Flow (ABF) measurements.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth was based on a predicate device's measurements, not expert adjudication.
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
No, this was not an MRMC comparative effectiveness study. The study focused on demonstrating substantial equivalence of a new feature (ABF calculation) of an existing device to a legally marketed predicate device. There is no mention of human readers or AI assistance effect sizes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this was a standalone performance study. The CLM III, with its built-in capacity to measure hematocrit, was used to calculate ABF values independently. These calculated values were then compared to the ABF values obtained from the predicate Transonic HD01 Monitor. The CLM III itself did not involve human intervention in the ABF calculation process, but rather provided the raw data (hematocrit) from which ABF was calculated using external means (calculator or spreadsheet).
7. The Type of Ground Truth Used
The ground truth used was measurement from a legally marketed predicate device, specifically the Transonic HD01 Monitor.
8. The Sample Size for the Training Set
The document does not mention a separate training set. The study describes the comparison of the CLM III's ABF values to the Transonic HD01 Monitor's values. The ABF calculation method for the CLM III (from real-time hematocrit measurements) already existed, and the purpose of the submission was to claim ABF as an additional feature without hardware or software changes to the current device. Therefore, it appears the "training" was implicitly done during the initial development of the CLM III's hematocrit measurement capabilities, not specifically for the ABF feature using the data from this submission.
9. How the Ground Truth for the Training Set was Established
As no specific training set for the ABF feature is described, the ground truth establishment for a training set is not detailed. The CLM III's core functionality (hematocrit measurement) would have been established through prior validation. The ABF calculation itself appears to be a mathematical derivation from these pre-established hematocrit measurements, rather than requiring a dedicated training set with new ground truth data for the ABF parameter itself.
§ 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.