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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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