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This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use.

This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AL series (Sterilized by Ethylene Oxide) includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure.

The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.

The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only.

These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

This document is a 510(k) clearance letter for "BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop)" and "BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series". It focuses on proving substantial equivalence to a predicate device, rather than providing the detailed acceptance criteria and study results for a new, innovative AI/software device.

Therefore, this document does not contain the information requested regarding acceptance criteria and performance studies for an AI/software device. The questions in the prompt (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance) are relevant to the validation of AI/Software as a Medical Device (SaMD), which is not the subject of this 510(k) clearance.

This submission primarily addresses:

• Device Description: Physical components and intended use of blood tubing lines.
• Technological Characteristics: Comparison of materials, design, and sterilization method to a predicate device.
• Bench Testing: Mechanical and functional performance tests for the physical tubing, such as structural integrity, pump segment performance, and resistance to kinking.
• Biological Safety Testing: Biocompatibility tests for materials in contact with blood.
• Sterilization and Shelf Life: Validation of these aspects.

There is no mention of any AI or software components, nor any studies that would involve human readers, ground truth established by experts, or deep learning models, which are the focus of your prompt's questions.

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This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use.

This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AL series (Sterilized by Steam) includes arterial and venous dialysis blood tubing.

The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System.

The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure.

The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.

The BLOOD TUBING LINES FOR HEMODIALYSIS C18 series is one part of a blood tubing lines for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 PRO Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only.

These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

Based on the provided FDA 510(k) Clearance Letter for "BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) and C18 Series," the device in question is blood tubing lines, not an AI/software device. Therefore, many of the typical acceptance criteria and study components associated with AI-powered medical devices (like those requiring test sets, expert ground truth, MRMC studies, standalone performance, and extensive training data) are not applicable to this product.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through:

• Technological Characteristics: Same intended use, design, configuration, scientific technology, and principles of operation.
• Material Equivalence: Similar materials, with no new or additional materials posing unaddressed risks.
• Performance Testing: Bench testing, sterilization validation, shelf-life testing, and biological safety testing.
• Compatibility: Ensuring compatibility with the intended hemodialysis delivery system.

Given that this is a physical medical device (blood tubing lines) and not a software/AI device, the request for a table of acceptance criteria and study details as typically applied to AI devices cannot be fully fulfilled from the provided document. The document confirms that no clinical performance data and no animal performance data were submitted for this 510(k). This is typical for Class II devices demonstrating substantial equivalence where bench and preclinical testing are sufficient based on established predicate devices and known risks.

However, I can extract the types of performance testing and safety evaluations that were conducted to "prove the device meets acceptance criteria" for a physical medical device:

Acceptance Criteria and Study for BLOOD TUBING LINES FOR HEMODIALYSIS (K242479)

Context: This device is a physical medical device (blood tubing lines) used in hemodialysis, not an AI or software-based device. Therefore, the "acceptance criteria" and "study" described below relate to the physical and biological performance of the tubing lines themselves, demonstrating their safety and effectiveness through substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for each bench, biological, sterilization, or shelf-life test. This information is typically detailed in the full submission, not the summary.
• Data Provenance: The studies are described as "completed" by the submitter, NIKKISO CO., LTD. The typical provenance for such tests would be internal lab testing or accredited third-party labs where the devices are manufactured or tested. No country of origin for the data itself is specified beyond the applicant being from Japan. These are pre-market, prospective tests performed specifically for this 510(k) submission.

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

• Not Applicable. This is a physical device clearance based on engineering performance and biological safety tests, not an AI device requiring expert-labeled medical imaging or clinical data. Ground truth for these types of tests is established through standardized methodologies (e.g., ISO standards, ASTM standards, AAMI standards) and quantitative measurements rather than expert consensus on subjective findings.

4. Adjudication Method for the Test Set

• Not Applicable. As above, no "test set" in the context of expert adjudication for AI models exists for this device. Performance is determined by meeting pre-defined quantitative thresholds and qualitative observations in laboratory settings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

• No. An MRMC comparative effectiveness study is designed to evaluate the impact of an AI system on human reader performance for diagnostic tasks. This device is blood tubing lines, not an AI diagnostic tool.
• The 510(k) summary explicitly states: "No clinical performance data is submitted in this 510(k)." and "No animal performance data is submitted in this 510(k)."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not a software algorithm. The "standalone performance" of the blood tubing refers to its ability to perform its function (e.g., maintain structural integrity, prevent kinking, ensure blood flow pathways) independently, which is covered by the extensive bench testing listed.

7. The Type of Ground Truth Used

• For Physical Performance/Bench Testing: Ground truth is defined by objective engineering specifications, performance standards (e.g., ISO, AAMI, ASTM), and quantitative measurements (e.g., tensile strength values, flow rates, volume measurements, pressure limits). These are often derived from predicate device performance and established medical device standards.
• For Biological Safety Testing: Ground truth is established by the results of standardized biological assays conforming to ISO 10993 series and FDA guidance, where specific chemical or biological reactions (e.g., cytotoxicity, hemolysis, pyrogenicity) are measured against predefined safety limits.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of machine learning for this physical medical device. The device itself is manufactured, not "trained."

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

• Not Applicable. As there is no training set for an AI/software model, no ground truth needed to be established for it. The design and manufacturing process for the blood tubing lines are validated through the various tests described above, ensuring they meet the specified performance and safety characteristics.

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This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use. This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AV06C-E includes arterial and venous dialysis blood tubing. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned and reused. They are restricted for sale by or on the order of a physician.

The provided text is a 510(k) summary for a medical device (Blood Tubing Lines for Hemodialysis AV06C-E). It details the device's characteristics, intended use, and comparison to a predicate device, focusing on demonstrating substantial equivalence based on recognized standards and bench testing.

However, the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set information is not present in this document.

This document outlines various tests conducted (sterilization, biological safety, bench performance) to support the device's safety and effectiveness compared to a predicate, but it does not provide explicit acceptance criteria with numerical values or detailed study designs for those criteria as you've requested. It indicates what tests were done (e.g., Cytotoxicity, Structural Integrity, Pump Segment Performance) but not the specific thresholds for acceptance or the methodology of the associated studies in the depth you're looking for.

Therefore, I cannot populate the table or answer most of your detailed questions from the provided text.

Here's what I can extract and state explicitly from the document regarding the information you asked for:

• Acceptance Criteria and Reported Device Performance: Not explicitly stated in the document with specific numerical criteria and outcomes against those criteria. The document states "Sterilization validation and Shelf Life test were completed using the subject device," "Biological safety testing was completed to confirm the safety of the subject device," and "Bench testing was completed to confirm the subject device is substantially equivalent to the predicate device in performance." It then lists the types of tests performed.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this device's evaluation is primarily based on bench testing, sterilization, and biological safety, not expert interpretation of diagnostic images or clinical outcomes.
• Adjudication method for the test set: Not applicable.
• 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 diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithmic device.
• The type of ground truth used: For biological safety, it's based on standard biological safety tests (e.g., cytotoxicity, sensitization, systemic toxicity, hemocompatibility). For bench performance, it's based on engineering and performance standards relevant to blood tubing lines (e.g., structural integrity, pump segment performance, tensile strength, flow dynamics).
• The sample size for the training set: Not applicable (not an AI/learning algorithm).
• How the ground truth for the training set was established: Not applicable.

The document emphasizes that the device is "substantially equivalent" to a predicate device, meaning it has similar intended use, design, configuration, scientific technology, and principles of operation, with only minor differences that do not raise new questions of safety and effectiveness. The demonstration of this equivalence relies on a series of validations and bench performance tests listed by appendix number.

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This device is indicated for hemodialysis prescribed by physicians for adult patients with acute and chronic renal failure, treated in hospitals and dialysis clinics by qualified operators. This device is not indicated for pediatric patients. It is not for home use.

This device is made up of disposable bloodlines intended to provide extracorporeal access to a patient's blood during hemodialysis. It is the responsibility of the physician or other licensed practitioner to ensure compatibility with the available configurations.

The BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) includes arterial and venous dialysis blood tubing.

The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis Delivery System. The components of the device include tubing, drip chambers, infusion tubing, pressure monitoring lines, ports, clamps and filters which are used to pump blood, retain and capture blood debris, infuse medications or fluids, sample blood as well as monitor pressure.

The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

The BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series is one part of a blood tubing lines device for hemodialysis. The devices are packaged together for convenient use during hemodialysis procedures. They are manufactured for application with the DBB-06 Hemodialysis Delivery System. The devices are packaged sterile and labeled for single use only. These devices cannot be cleaned or reused. They are restricted for sale by or on the order of a physician.

I'm limited to the information provided and cannot determine the acceptance criteria or reported device performance for NIKKISO Co., Ltd.'s Blood Tubing Lines since the text does not contain such details. The document is a 510(k) summary, which outlines the device description, intended use, and technological characteristics, but does not provide specific performance data or acceptance criteria that a study would prove the device meets. The listed "Test Item" reports are general performance tests and do not include the acceptance criteria or the numerical results that would fulfill the criteria. Therefore, I cannot construct the table you requested.

The document states that no animal or clinical performance data was submitted, so a study with a test set, ground truth, or adjudication methods as requested in your prompt was not provided in this 510(k) submission.

Therefore, for the specific questions:

1. A table of acceptance criteria and the reported device performance: Cannot be provided as this information is not present in the document.
2. Sample sizes used for the test set and the data provenance: Not applicable, as no performance study results were provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study results were provided.
4. Adjudication method for the test set: Not applicable, as no performance study results were provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, no clinical performance data was submitted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a physical medical device (blood tubing lines), not an AI algorithm, so this question is not applicable. No standalone performance study results were provided.
7. The type of ground truth used: Not applicable, as no performance study results were provided.
8. The sample size for the training set: Not applicable, as no AI algorithm is involved.
9. How the ground truth for the training set was established: Not applicable, as no AI algorithm is involved.

The document lists various "Test Item" reports (e.g., Sterilization Barrier System Performance Test, Mechanical Hemolysis, Structural Integrity), but these are general performance tests for the device's functionality rather than a study designed to meet specific clinical acceptance criteria. The submission declares that the device is "substantially equivalent" to a predicate device (K082719) based on similar intended use and technological characteristics, with only minor differences that "do not raise new questions of safety and effectiveness." This indicates that the regulatory clearance relies on equivalence to a previously approved device rather than presenting new performance data against specific acceptance criteria.

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The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician.

The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.

The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K, K2 and T Hemodialysis Machines equipped with Crit-Line hardware.

The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation.

The CombiSet SMARTECH Hemodialysis Blood Tubing Sets (hereinafter referred to as "CombiSet SMARTECH Bloodlines") are the subject of this 510(k) and are available in two (2) configurations:

• CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and ● Integrated Crit-Line Technology (hereinafter referred to as the "Standard bloodline")
• . CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, no Heparin Line (hereinafter referred to as the "No heparin line")

The CombiSet SMARTECH Bloodlines are single-use, ethylene oxide (EO) sterilized blood tubing sets.

The CombiSet SMARTECH Bloodlines are part of the extracorporeal hemodialysis circuit. During hemodialysis, the extracorporeal circuit transports arterial blood from the patient's arterial access (e.g., fistula or catheter), through a hemodialyzer, and back to the patient's venous access. When the CombiSet SMARTECH Bloodlines are used with the Crit-Line Sensing System (which includes the Crit-Line Sensor Clip), the proposed devices will provide a clear viewing surface for the Crit-Line Sensor Clip to transmit light through the blood.

The provided text describes the acceptance criteria and a summary of the performance testing for the CombiSet SMARTECH Hemodialysis Blood Tubing Sets.

Here's the requested information:

1. A table of acceptance criteria and the reported device performance

Please note that for many of the tests, the document states the "objective" or "demonstrate that..." rather than specific numerical acceptance criteria and reported numerical performance. Where specific numerical criteria are given, they are included.

The Study Proving Acceptance Criteria were Met:

The document describes "Performance Testing" which was conducted in accordance with ISO 8638:2010 and the FDA Guidance for Industry and FDA Staff, Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions (April 2008).

2. Sample size used for the test set and the data provenance

• The document does not specify the sample sizes used for each individual test within the "Performance Testing Summary."
• The document does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing. It is implied these were laboratory or bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided in the document. The performance tests appear to be objective measurements against established engineering and performance criteria and standards, rather than requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable/provided. The performance tests are quantitative or pass/fail against engineering standards and do not involve human interpretation or adjudication in the way a clinical study with subjective endpoints might.

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 MRMC comparative effectiveness study was done. This device is a blood tubing set for hemodialysis, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a physical medical device (blood tubing set), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the "Functional CLiC Chamber Test - Hematocrit (HCT)" and "Functional CLiC Chamber Test - Oxygen Saturation (O2 Sat)" was based on measurements made using a production blood chamber (CL10041021) as a control.
• For other performance tests (e.g., structural integrity, flow rates, leak tests), the ground truth was based on predefined engineering specifications, international standards (ISO 8638, ISO 80369-7), and FDA guidance documents.

8. The sample size for the training set

• This is not applicable/provided. This device is a physical medical device, not a machine learning or AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

• This is not applicable. As stated above, this device does not involve a training set.

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CAREline Twister: The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the responsibility of the physician. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The Fresenius Access Flow Reversing Connector (AFRC) is for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices during hemodialysis in order to obtain an access flow measurement. The AFRC facilitates the test procedure by eliminating the need to disconnect bloodlines during the test procedure. Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K2 and T Hemodialysis Machines. CAREline Standard: The blood tubing set is indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/ hemodialyzer configuration is the resonsiblity of the physician. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. Blood Tubing Set is intended to be used with the Fresenus Medical Care 2008® Series, K, K.2 and T Hemodialysis Machines.

The CAREline bloodlines are intended for use in acute and chronic hemodialysis therapy. The bloodline is part of the hemodialysis extracorporeal circuit, which transports arterial blood from the patient's arterial access (e.g., fistula or catheter) through a hemodialyzer and back to the patient's venous access.

The provided text describes the 510(k) premarket notification for the CAREline Airless Hemodialysis Blood Tubing Sets. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove device performance against specific acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not explicitly available in the provided document. The document outlines performance testing conducted to support substantial equivalence.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of explicit acceptance criteria with numerical targets. Instead, it lists various performance tests conducted to support substantial equivalence. The "reported device performance" is implied to have met the requirements of these tests, as the FDA concluded substantial equivalence.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each of the performance tests. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The testing was conducted in accordance with ISO 8638:2010.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The performance tests described are primarily engineering and biological safety tests, which typically rely on standardized protocols and instrumental measurements rather than human expert interpretation for "ground truth" in the way a diagnostic AI might.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here for these performance tests.

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 such study was conducted. The device is a physical medical device (blood tubing set) and does not involve AI or human readers in an interpretative capacity.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the listed performance tests, the "ground truth" would be established by the physical and chemical properties measured according to international standards (e.g., ISO 8638:2010) and established biological safety testing methods. For instance:

• Biocompatibility: Ground truth is based on the results of validated assays (e.g., cytotoxicity, sensitization, genotoxicity tests) against predetermined pass/fail criteria specific to those tests, often compared to controls.
• Structural Integrity: Ground truth is based on whether the device withstands specified pressures, pulls, or cycles without failure, as defined by engineering specifications.

8. The sample size for the training set

Not applicable. This is a physical medical device undergoing performance testing, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a physical device.

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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 IV System is used to non-invasively to measure hematocrit, oxygen saturation and percent change in blood volume. The Crit-Line Clip (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 dial. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

The intended use of the Crit-Line IV System is as a continuous real-time blood monitoring system for displaying information measured by the CLiC sensor, including hematocrit, oxygen saturation, and percent change in blood volume. The Crit-Line IV System is comprised of the Crit-Line IV monitor (the subject of this submission), the Crit-Line Clip (CLiC) sensor, and the Crit-Line Clip Blood Chamber. The touchscreen interface and display of the Crit-Line IV monitor is used with the hardware and software of the CLiC sensor, which is a separate component of the Crit-Line Clip (CLiC) Monitor, K121599. Information displayed on the Crit-Line IV monitor may be viewed real-time during a dialysis treatment. There are additional display features incorporated into the Crit-Line IV System, which are similar to that of the Crit-Line III system (K972470) and the 2008T Hemodialysis Machine with (optional) CLiC (K131908). For this reason, the Crit-Line Clip Monitor (CLiC: K121599), is the predominant predicate and the 2008T Hemodialysis Machine with (optional) CLiC (K131908) and the Crit-Line III (K972470) are reference predicate devices.

The provided text describes the Crit-Line IV System, a device used in hemodialysis to non-invasively measure hematocrit, oxygen saturation, and percent change in blood volume. The document is a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to predicate devices. While it generally discusses performance testing, it does not provide explicit acceptance criteria with numerical thresholds or specific reported device performance values in a table format.

However, based on the descriptions in the "Performance Data" and "Conclusion" sections, we can infer the approach taken to demonstrate performance.

Here's an analysis of the provided information, addressing your questions to the best of what the text offers:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values for clinical or analytical accuracy. The "Performance Data" section states that "Performance testing requirements were determined through the application of a risk management process and applicable performance standards," and "Performance testing included software verification, electrical safety testing, electromagnetic compatibility (EMC) testing, intentional EM emissions immunity simulation testing, coexistence testing with RFID equipment, ship testing, and usability testing."

The "Conclusion" states, "The information provided in this submission demonstrates the Crit-Line IV System functions as intended and is substantially equivalent to the predicate devices. The test results demonstrate that the proposed device does not raise any new concerns with regard to safety or effectiveness."

This suggests that the "acceptance criteria" were qualitative (e.g., successful software verification, passing electrical safety tests, meeting EMC standards, demonstrating usability), rather than quantitative performance metrics for hematocrit, oxygen saturation, or blood volume changes relative to a gold standard.

Inferred Acceptable Performance Categories:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a sample size for clinical test sets or analytical accuracy studies for the measurement parameters (hematocrit, oxygen saturation, percent change in blood volume). The performance data cited refers to various engineering tests (software verification, electrical safety, EMC, usability) rather than patient or sample-based clinical performance data. Therefore, details regarding data provenance (country of origin, retrospective/prospective) are also not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Given the nature of the described performance data (engineering and usability testing), the concept of "experts establishing ground truth" for specific clinical measurements (like a pathologist for a biopsy) is not directly applicable in the information provided. For usability testing, healthcare professionals (e.g., nurses, technicians operating dialysis equipment) would typically be involved, but their number and specific qualifications are not detailed. For other engineering tests, the "experts" would be engineers and technical personnel conducting the tests, ensuring compliance with relevant standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method is described, as the document does not present results from studies requiring expert interpretation or consensus on clinical findings. The performance tests mentioned (software, electrical safety, EMC, usability) typically involve objective measurements against predefined criteria/standards, rather than subjective interpretation requiring adjudication among experts.

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. The Crit-Line IV System is a monitoring device that provides direct measurements (hematocrit, oxygen saturation, % change in blood volume) to a clinician. It is not an AI-assisted diagnostic imaging device that involves "human readers" interpreting images "with or without AI assistance." Therefore, an MRMC comparative effectiveness study or related effect size is not applicable to this device as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device's core functionality is standalone measurement of physiological parameters (hematocrit, oxygen saturation, % change in blood volume) and display of this information. The algorithms for calculating △BV% and estimating hemoglobin (Hb) are standalone in the sense that they process the data from the CLiC sensor without human intervention in their calculation. However, the system is designed to provide this information for a "clinician/nurse, under physician direction," to intervene in the patient's treatment. So, while the measurement and calculation algorithms operate without human intervention, the overall clinical use of the device is human-in-the-loop, as the data guides clinical decisions.

The document states, "The algorithms used in the proposed monitor software for calculating △BV% and estimating hemoglobin (Hb) are the same algorithms used in the software driver provided with the predicate Crit-Line Clip (CLiC), K121599." This implies that the standalone performance of these algorithms was previously established or is considered equivalent to the predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the core measurements of hematocrit, oxygen saturation, and percent change in blood volume, the ground truth would typically be established by validated laboratory methods (e.g., standard hematology analyzers for hematocrit, blood gas analyzers for oxygen saturation). However, the document does not explicitly state how the ground truth was established for these measurements or if analytical accuracy studies against such ground truth methods were part of this particular submission's performance data. Given the focus on substantial equivalence and engineering tests, it's possible that analytical accuracy was either assumed from the predicate devices or demonstrated in prior submissions for the CLiC sensor itself (K121599), which provides the raw data.

8. The sample size for the training set

Not applicable. This device is a medical monitoring instrument that uses established algorithms for calculation. It is not a machine learning or artificial intelligence device that requires a "training set" in the context of developing a statistical model or neural network. The algorithms for △BV% and estimated Hb are stated to be the same as those in predicate devices, implying they are fixed algorithms rather than adaptable, learned models.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this device in the machine learning sense. The algorithms are based on scientific principles and previously validated methodologies, likely derived from extensive previous research and clinical data during their initial development, but this document does not detail their original establishment.

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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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