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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.

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.

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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 herapy 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.

The CRIT LINE™ Clip (CLiC) Blood Chamber is a non-invasive, disposable, transparent optical cuvette designed as a connection between the arterial bloodline and the hemodialyzer in the extracorporeal circuit during hemodialysis treatment. The chamber's two (2) polycarbonate viewing lenses serve to secure the CLiC Monitor's sensor clip and provide a uniform cross section, allowing a clear blood passage for the CLiC Monitor to transmit light through the blood. The CLiC Monitor uses the principle of light absorption to measure oxygen saturation (O2 SAT) and hematocrit (HCT) levels in the blood.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CRIT-LINE Clip (CLiC) Blood Chamber, structured according to your request.

Overall Device Context:
The document relates to a 510(k) premarket notification for the CRIT-LINE Clip (CLiC) Blood Chamber, a sterile, single-use, disposable optical cuvette for non-invasively measuring hematocrit, percent change in blood volume, and oxygen saturation during hemodialysis. The goal is to demonstrate substantial equivalence to a predicate device (CRIT-LINE Blood Chamber (K935958)).

Important Note: This document is a 510(k) summary, which typically provides high-level results and conclusions rather than detailed study protocols and raw data. Therefore, some of the requested information (like specific effect sizes for MRMC studies, precise sample sizes for certain tests, or depth of ground truth establishment for training) may not be explicitly present. The information provided is based only on the text given.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list numerical "acceptance criteria" alongside "reported device performance" in a separate table for each test. Instead, it states the "Test Objective" and then reports "Pass - Results within acceptance criteria" or similar conclusive statements for all tests. This indicates that the tests met predefined criteria, but the specific numerical thresholds for these criteria are not provided in this summary.

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

• Test Set Sample Size: The document does not specify exact numerical sample sizes for each test listed (e.g., number of chambers tested for mechanical characteristics, number of blood samples for functional tests). It only states that tests were performed "to support the determination of substantial equivalence."
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device accessory (a blood chamber), the tests are typically internal, in-house laboratory and engineering tests, rather than clinical trials with patient data.

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

• Number of Experts: Not applicable or not specified in the document. The tests performed are primarily engineering and laboratory performance tests, not diagnostic accuracy studies requiring expert interpretation of results for ground truth.
• Qualifications of Experts: Not applicable or not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or not specified. As mentioned, these are laboratory and engineering tests, not studies requiring expert adjudication of clinical outcomes or interpretations.

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

• Was an MRMC study done? No, an MRMC comparative effectiveness study was not performed.
• Effect Size: Not applicable, as no MRMC study was conducted. The device is a physical component (blood chamber) of a hemodialysis system, not a diagnostic imaging algorithm that requires human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? No, a standalone (algorithm only) performance study was not done. The device itself is a blood chamber, an accessory for a monitor, not an algorithm. The "Functional CLiC Chamber Test" evaluates the repeatability of the chamber's ability to allow the monitor to read HCT and O2 Sat, not the standalone performance of an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the various engineering and performance tests, the "ground truth" would be established by:
  • Engineering Specifications/Standards: For mechanical, connector, bond strength, torque, and material property tests. (e.g., ISO 594-2 for connectors).
  • Reference Methods/Instrumentation: For tests like blood pathway volume, functional repeatability (comparison to a known standard or highly precise reference method for HCT and O2 Sat measurement), and mechanical hemolysis (e.g., a standardized hemolysis assay).
  • Regulatory Requirements: For sterilization, bioburden, and pyrogenicity (e.g., sterility assurance level (SAL), non-pyrogenic limits).
  • Usability Best Practices: For human factors testing, evaluating successful vs. unsuccessful completion of tasks according to predefined criteria.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not describe any "training set" in the context of machine learning or AI models. This device is a physical medical accessory, and its evaluation relies on engineering and biological performance testing, not on data-driven algorithm development that typically involves training sets.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The Crit-Line Clip Monitor (CLiC) is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. CLiC measures hematocrit, percent change in blood volume and oxygen saturation in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

The intended use of the Crit-Line III (CLM III) Monitor is as a continuous real-time monitor for non-invasive hematocrit, oxygen saturation, and percent change in blood volume measurement. The CLM III is used primarily as a monitor for dialysis treatments.

The CLM III uses the principle of light absorption and scattering through the blood under test to measure oxygen saturation (O2 SAT) and hematocrit (HCT). The HCT values are then used to calculate the related Blood Volume (BV) percentage change relative to the starting BV based on the beginning HCT.

The CLM III consists of a microprocessor-controlled main circuit board located within the display housing. The display housing contains the sensor clip driver measurementcalculation circuitry and display screen circuitry. The sensor clip with optical system (LED array and a photodetector array) is tethered to the main housing and circuit board by a multi-conductor cable. The cable connects to a single-use, sterile cuvette (K935958) installed in-line with the arterial line of the dialysis tubing set.

Calculations performed on the main circuit board within the display housing yield the hematocrit, oxygen saturation and the related value of blood volume measurement results and are displayed on the LCD display screen.

Modifications to the previously cleared Crit-Line III Monitor include:

3. Miniaturization/Re-packaging

The CLiC Monitor incorporates all hardware/electronic components - miniaturized and contained within the sensor clip housing, for measuring indicated parameters (HCT O2 SAT). The primary modification of the device involves integrating a miniaturized microprocessor with the required electronic circuitry and software to drive the existing optical system (LED and photo-detector array) within the plastic sensor clip housing. The CLiC utilizes the same, previously cleared Crit-Line technology (K972470), sensor clip and optical system. The operating principles and fundamental measurement methods of the CLiC are the same as the predicate device.

4. Distributed Process Technology

A standard USB cable replaces the tethering multi-conductor cable used in the CLM III Monitor. USB-compatible hardware and software are incorporated in the CLiC housing. The CLiC can be hosted on a medical grade computer system (Windows OS) that can interface with, power a USB peripheral and operate supporting drivers. CLiC interlocks with a singleuse, sterile cuvette (K935958) which is located in-line with the arterial line of the dialysis tubing set for indicated measurements. The lightwave measurements are performed autonomously by the CLiC. Blood parameters are then calculated and transmitted to the host computer display microprocessor in text format by means of the USB interface. The accompanying display software installed on the host computer system facilitates the display of measured parameters: hematocrit, oxygen saturation and blood volume changes on the display screen.

Here's a summary of the acceptance criteria and the study details for the CLiC Monitor (K121599) based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary for the CLiC Monitor focuses on demonstrating substantial equivalence to its predicate device, the Crit-Line III Monitor (K972470), rather than establishing new, specific numerical acceptance criteria for its performance metrics (hematocrit, oxygen saturation, and percent change in blood volume).

The key "acceptance criteria" presented are:

• The CLiC Monitor's accuracy is equivalent to the predicate device specifications for both hematocrit and oxygen saturation measurements.
• The percentage blood volume comparisons are also equivalent due to the equivalence in hematocrit.
• The device functions as intended and met pre-determined acceptance criteria (though these specific criteria are not quantitatively laid out in the summary).
• The modifications did not affect the essential performance of the device.

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

The document mentions "performance testing (in vitro bench testing), safety testing and usability testing," and "System verification and validation testing." However, no specific sample sizes for test sets (e.g., number of patients, number of blood samples, specific data points) are provided. The data provenance (country of origin, retrospective/prospective) is also not specified. The focus is on demonstrating equivalence to the predicate device through technical evaluation rather than large-scale clinical trials.

3. Number of Experts and Qualifications for Ground Truth:

The document does not mention using experts to establish ground truth for a test set in the context commonly associated with AI/algorithm performance studies. The evaluation is against the performance of a known predicate device and compliance with engineering standards.

4. Adjudication Method:

Given that there's no mention of experts establishing a ground truth for a test set, an adjudication method (like 2+1 or 3+1) is not applicable and therefore not mentioned in this 510(k) summary.

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

No MRMC comparative effectiveness study was done or mentioned. This submission is for a device based on an existing technology (Crit-Line III) with modifications related to miniaturization, distributed process technology, and software, rather than a novel AI diagnostic algorithm requiring human-in-the-loop performance evaluation.

6. Standalone Performance:

The 510(k) summary describes the standalone performance of the CLiC Monitor relative to its predicate. The CLiC performs the lightwave measurements autonomously and transmits blood parameters for calculation and display. The core measurement functions (hematocrit, oxygen saturation, blood volume changes) are evaluated based on their equivalence to the predicate device's established performance specifications. The "algorithm" in this context refers to the inherent calculations performed by the device, and its stand-alone accuracy is assessed against the predicate's known accuracy.

7. Type of Ground Truth Used:

The ground truth used for performance validation is implicitly the established performance specifications and measurements of the legally marketed predicate device, the Crit-Line III Monitor. The CLiC Monitor is evaluated to ensure its measurements of hematocrit, oxygen saturation, and calculated blood volume changes are equivalent to those obtained from the predicate device under similar conditions. This involves direct comparison to a validated, previously cleared device, likely through in vitro bench testing (as mentioned).

8. Sample Size for the Training Set:

This device is not presented as an AI/machine learning device that requires a "training set" in the conventional sense. It uses existing, cleared technology and optical principles. Therefore, no specific sample size for a training set is applicable or mentioned.

9. How the Ground Truth for the Training Set was Established:

As this is not an AI/ML device with a training set, the question of how ground truth was established for a training set is not applicable. The device functions based on established light absorption and scattering principles and signal processing, akin to an updated version of an existing physical measurement device. Its performance is validated against the known performance characteristics of its predecessor.

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