(29 days)
The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.
Like the predicate, the modified CRIT LINE Clip (CLiC) Blood Chamber is a non-invasive, disposable, optical cuvette with transparent lenses designed to connect between the arterial bloodline and the dialyzer in the extracorporeal circuit during hemodialysis treatment. The chamber's two (2) clear polycarbonate viewing lenses serve to secure the CLiC Monitor's sensor clip and provide a uniform cross section, allowing a clear view of the blood passage for the CLiC Monitor to transmit light through the blood. The CLiC Monitor uses the principle of light absorption and scattering to measure oxygen saturation (O2 SAT) and hematocrit (HCT) levels in the blood.
The proposed device is the same as the predicate. CRIT LINE Clip (CLiC) Blood Chamber (K141281) with a change only to the internal geometry (taper) of the dialyzer connector (also referred to as the 'female DIN connector').
The provided document is a 510(k) premarket notification for a medical device called the "CRIT-LINE Clip (CLiC) Blood Chamber." This document is a submission to the FDA for a device that is largely the same as a previously cleared device, with a minor modification to the internal geometry of the dialyzer connector.
The document does not describe a study that proves the device meets acceptance criteria in the context of a human-in-the-loop AI system or standalone AI algorithm, as the prompt's questions suggest. Instead, it details engineering verification and validation tests to ensure that the modified physical device (a blood chamber) continues to meet performance and safety standards, particularly concerning its connection integrity.
Therefore, many of the questions asked in the prompt, which are highly relevant for AI/ML device evaluations (e.g., sample size for test/training set, expert qualifications, MRMC studies, ground truth establishment), are not applicable to the content of this document.
However, I can extract information related to the acceptance criteria and the engineering tests performed as described in the document.
Here's the analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document provides a table of "Verification Test" and "Pass/Fail" results, effectively serving as acceptance criteria and reported performance for the engineering changes.
| Acceptance Criteria (Verification Test) | Reported Device Performance (Pass/Fail) |
|---|---|
| Performance Test: Mechanical Characteristic / Structural Integrity per ANSI/AAMI/ISO 8638:2010 (Confirm the bonding between the chamber and the DIN Connector P/N 55-4299) | PASS |
| Dialyzer Connector (Female DIN Connector): Liquid Leakage Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Air Leakage Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Separation Force Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Unscrewing Torque Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Ease of Assembly Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Resistance to Overriding Test per ISO 594-2 | PASS |
| Dialyzer Connector (Female DIN Connector): Stress Cracking Test per ISO 594-2 | PASS |
| Endurance Performance Test per ISO 8368:2010 (Demonstrate the product performs at maximum labeled pressures without resulting in loose connection or leaks) | PASS |
| Bond Strength Test per ISO 8368:2010 (Confirm solvent bonding between the CLiC blood chamber's blue polycarbonate body and clear PVC DIN Connector meet specification) | PASS |
| Blood Pathway Volume (Priming Volume) Test per ISO 8368:2010 (Verify the established the blood pathway volume of the blood chamber meets specification) | PASS |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for each test. It refers to "verification and/or validation testing" but does not give numerical sample sizes for the mechanical and performance tests. The data provenance is implied to be from the manufacturer's internal testing. There is no mention of country of origin of data or whether it was retrospective or prospective, as these are not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device requiring clinical expert ground truth. The ground truth for these engineering tests is established by physical measurement against engineering specifications and international standards (e.g., ISO, ANSI/AAMI).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study requiring adjudication of expert readings.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for these engineering performance tests is based on adherence to established international standards (ISO 8638:2010, ISO 594-2, ISO 8368:2010) and internal product specifications. These are objective engineering measurements, not clinical ground truths.
8. The sample size for the training set
Not applicable. This device does not use a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This device does not use a training set.
§ 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.