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The membrane oxygenator QUADROX-i Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 – 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and requlates blood temperature. The QUADROX-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

The membrane oxygenator QUADROX-i Small Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 – 5 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates blood temperature. The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 µm. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

The membrane oxygenator QUADROX-iD Adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 I/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide from the blood and regulates the blood temperature. The device's utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.

The QUADROX-i Small Adult / Adult and QUADROX-iD Adult oxygenators are blood-gas exchangers with integrated heat exchanger and optionally integrated arterial blood filter (only available for QUADROX-I Small Adult / Adult). They are used in cardiac surgery, in combination with a heart-lung machine, to oxygenate blood, remove carbon dioxide and adjust blood temperature. The integrated arterial filter is intended to filter out air bubbles and particles larger than 40µm. It is used for removing gaseous embolisms and aggregates from blood components from the arterial blood during extracorporeal circulation. It is a screen filter with pre-post-de-airing mechanic.

The provided text is a 510(k) summary for medical devices, specifically cardiopulmonary bypass oxygenators. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies or acceptance criteria for independent device performance. Therefore, many of the requested details about acceptance criteria, study methodologies, and ground truth establishment are not present in this submission.

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 acceptance criteria in the sense of predefined thresholds for performance metrics. Instead, it describes "performance testing" that demonstrated the modified devices perform "within its specifications and within the acceptable limits of the applied performance standards." The specific performance characteristics tested are listed.

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 the sample sizes used for the "performance testing." It also does not explicitly state the data provenance (country of origin or retrospective/prospective nature). The submitter, MAQUET Cardiopulmonary AG, is based in Germany, and the contact person is in the USA, so the testing could have occurred in either or both regions.

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 is not applicable to the type of testing described. The "ground truth" for mechanical and biological performance of an oxygenator is typically established through standardized laboratory tests and engineering benchmarks, not expert consensus on medical images or clinical outcomes.

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

This is not applicable. Adjudication methods like those described are typically used in clinical studies involving human interpretation or subjective assessments, which are not detailed here.

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

This is not applicable. The device is an oxygenator, not an AI-powered diagnostic tool. No MRMC study involving human readers or AI assistance was conducted or mentioned.

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

This is not applicable. The device is a physical medical device (oxygenator), not a software algorithm.

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

The "ground truth" for the non-clinical tests listed would be established by the physical and chemical properties measured during laboratory testing against defined standards. For example, "Blood Cell Damage" would likely be measured by hemolysis rates, "Stability" by structural integrity under stress, and "Integrity" by leak tests, all compared to pre-defined specifications derived from engineering standards and regulatory requirements.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device and its non-clinical performance testing, not a machine learning model that requires a training set.

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

This is not applicable for the reasons stated above.

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The Antegrade Cardioplegia Cannula acts as an infusion cannula for cardioplegic solutions. The cardioplegic solution is perfused via the aortic root into the coronaries. Furthermore, the Antegrade Cardioplegia Cannula can be used for left ventricular relaxation and aortic arch de-airing during cardiopulmonary bypass. The maximum duration of use is 6 hours.

The Antegrade Cardioplegia Cannula (N-Type) by MAQUET is used to administer cardioplegia solution into the heart in operative procedures where cardiopulmonary bypass is utilized. The cardioplegia solution causes asystole so that the operative procedure can be performed on a still heart.

The Antegrade Cardioplegia Cannula (N-Type) is inserted into the aortic root through a purse-string suture towards the aortic cross clamp. This method allows the cardioplegia solution to flow into the coronary arteries, which is known as antegrade delivery.

This document is a 510(k) premarket notification for a medical device called the "Antegrade Cardioplegia Cannula (N-Type)". This type of document is used to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device to the predicate rather than presenting a standalone study of the new device's absolute performance against acceptance criteria in a detailed clinical study format that would be typical for a novel device.

Therefore, many of the requested elements about detailed study design (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, specific effect sizes, and detailed training set information) are not typically found in this type of FDA submission (510(k) for substantial equivalence), especially for a device like a cannula that's comparing a design change (DEHP replacement and new configurations) to a predicate. The focus is on non-clinical performance and biocompatibility to show it performs "as expected" and comparably to the predicate.

Here's an attempt to extract and infer the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device "met all of the acceptance criteria" for various non-clinical performance tests. However, the specific quantitative acceptance criteria values are not explicitly stated in this summary. The table below lists the performance parameters evaluated and the reported outcome.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: Not specified. The document mentions "non-clinical performance testing" and "biocompatibility testing" but does not provide details on the number of units tested for each parameter.
• Data Provenance: The testing was conducted by MAQUET Cardiopulmonary AG, a company based in Rastatt, Germany. The data is retrospective in the sense that the tests were completed before the submission, but the specific origins of materials or test environments are not detailed beyond the company's location.

3. Number of Experts and their Qualifications for Ground Truth (Test Set)

• Not Applicable. This document describes non-clinical engineering and biocompatibility testing of a physical medical device. It does not involve human interpretation of data where expert consensus for ground truth would be relevant (e.g., radiology images, pathology slides).

4. Adjudication Method for the Test Set

• Not Applicable. As per point 3, this is non-clinical performance testing, not human interpretation requiring adjudication. Decisions are based on objective pass/fail criteria for each test.

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

• No. An MRMC study is not mentioned. Such studies are typically conducted for diagnostic devices or AI systems where human reader performance is a key metric, and comparing performance with and without AI assistance is relevant. This document pertains to a physical cardioplegia cannula.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This device is a physical medical instrument, not a software algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for the non-clinical tests consisted of:

• Pre-defined engineering specifications and standards (e.g., for flow rate, pressure resistance, tensile strength, kink resistance, stress cracking, functional operation, corrosion). These are objective, measurable criteria.
• Biocompatibility standards and protocols (e.g., ISO 10993 series) for evaluating cytotoxicity, sensitization, systemic toxicity, hemocompatibility, and genotoxicity. These results are typically determined by laboratory assays with established pass/fail metrics.

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device; there are no "training sets" in the context of machine learning or algorithms. The device design and manufacturing processes are developed through traditional engineering methods, not machine learning training.

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

• Not Applicable. See point 8. Engineering design and material selection are based on established medical device development practices, material science, and regulatory standards, not on "ground truth" derived for a training set in the AI sense. The "ground truth" during development would be user needs, design requirements, and performance targets based on clinical understanding and predicate device performance.

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The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation, in cardiopulmonary bypass operations on pediatric patients for up to 6 hours. The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

The Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating are developed for surgical procedures requiring cardiopulmonary bypass for pediatric patients. They are used as a blood buffer in the extracorporeal circuit and are used as a collecting and defoaming device for sucked blood. The device is supplied sterile and non-pryogenic.

The provided document describes a 510(k) premarket notification for a medical device modification, specifically for Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) submission.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device submission. The provided information details design verification tests, which are engineering-focused assessments, not clinical performance studies with acceptance criteria as typically understood in the context of AI/ML performance metrics (e.g., sensitivity, specificity).

Here's why the requested information cannot be fully provided from this document:

• Device Type: The device is a "Venous Hardshell Cardiotomy Reservoir," which is a physical medical device used in cardiopulmonary bypass operations, not an AI/ML algorithm.
• Study Type: The submission is a 510(k) for a "device modification," which relies on demonstrating substantial equivalence through non-clinical (i.e., laboratory/benchtop) design verification tests rather than clinical studies.
• Focus: The focus of the 510(k) is on the safety and performance of the modified physical components (defoamer coating, flow rates, volumes), not on the diagnostic or predictive accuracy of an algorithm.

However, I can extract the relevant information regarding the design verification tests performed, which serve a similar function to "proving the device meets acceptance criteria" within the context of hardware modifications:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets for each test, nor does it provide a detailed "reported device performance" table with precise quantitative results. Instead, it indicates that the tests were performed to show the modified device is "as safe and effective as the originally cleared devices" and that the "evaluation and test results do not show any kind of risk potential."

Regarding the specific questions tailored for AI/ML device studies:

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device. The "tests" were design verification tests (benchtop/laboratory), not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance often comes from engineering specifications, established testing protocols, and physical measurements, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set: Not applicable. There is no mention of expert review or adjudication in the context of these engineering design verification 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: Not applicable. This is a physical device, not an AI/ML algorithm used for image interpretation or diagnosis by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the design verification tests listed, the "ground truth" would be established by predefined engineering specifications, performance standards, biological safety standards (e.g., ISO standards for biocompatibility), and comparison to the predicate device's known performance characteristics.

8. The sample size for the training set: Not applicable. This device does not involve machine learning and therefore has no training set.

9. How the ground truth for the training set was established: Not applicable. This device does not involve machine learning and therefore has no training set.

In conclusion: The provided document is for a traditional medical device modification (physical product) and uses design verification testing to demonstrate substantial equivalence, not a clinical study to establish performance metrics for an AI/ML device. Therefore, many of the requested fields are not applicable to this submission type.

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The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport.

The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

The CARDIOHELP System is a compact perfusion system consisting of the following components:

• the CARDIOHELP-i drives suitable disposables using an integrated pump, controls and monitors the extracorporeal circulation and can communicate with other devices
• . the CARDIOHELP Emergency Drive is used in emergencies to manually drive the disposable if the CARDIOHELP-i fails
• different accessories: .
• flow/bubble sensor O
• o level sensor including level sensor pad
• venous probe for blood gas monitoring and measurement of venous temperature o
• external sensors for temperature and pressure O
• different holders o
• connection cables ಂ
• . various disposables, that can be driven by CARDIOHELP-i, including the previously cleared HLS/HIT tubing sets and the Quadrox-iR disposables (part of the predicate CARDIOHELP System (K102726).

This document describes the CARDIOHELP System, a cardiopulmonary support device. The submission is a Special 510(k) for modifications to an existing device (K102726). As such, the focus of the testing is on demonstrating that the modified device is substantially equivalent to the predicate, and much of the information typically found in a clinical study for a novel device is not presented.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit acceptance criteria with specific numerical thresholds for performance metrics. Instead, it broadly states that "Performance testing has resulted in data that demonstrates that the CARDIOHELP System performs within its specifications and within the acceptable limits of the applied performance standards."

The performance characteristics reviewed include:

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

No specific sample size for a "test set" (in the context of clinical data for AI/ML) is mentioned, as no clinical evaluation of the modified device was conducted or required. The assessment relied entirely on non-clinical testing.

The provenance of data is not applicable as the testing was non-clinical and conducted by the manufacturer, MAQUET Cardiopulmonary AG, based in Rastatt, Germany.

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

Not applicable, as no clinical studies with a "test set" requiring expert ground truth were conducted. The device is not an AI/ML diagnostic tool, but rather a medical device with an enhanced user interface and new sensors.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies with a "test set" requiring adjudication were conducted.

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

No MRMC study was mentioned or performed. This is not an AI/ML-driven diagnostic device where human reader improvement with AI assistance would be relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The CARDIOHELP System is a physical medical device for cardiopulmonary support, not an algorithm. Its performance is assessed through hardware, software, and system-level testing, not as a standalone algorithm without human interaction, as a human operator is integral to its function.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established by:

• Requirements specifications: Defining the expected behavior and performance of the device and its components.
• Engineering standards: Adherence to relevant industry and regulatory standards for medical device safety and performance.
• Predicate device performance: The performance of the previously cleared CARDIOHELP System (K102726) served as the benchmark for substantial equivalence comparisons. This acts as a form of "ground truth" for comparative effectiveness.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML medical device that uses a "training set." The development process involved hardware and software engineering, testing, and validation, not machine learning model training.

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

Not applicable, as there is no "training set" for this device.

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The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

The CARDIOHELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for periods up to six hours), e.g. for intra- and inter-hospital transport.

The CARDIOHELP System in configuration with the QUADROX-iR is intended to be used in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery (for periods for up to six hours).

The only modification consists of adding a reusable stainless steel holding clamp as an interim protective safeguard / corrective action to prevent the inlet and/or outlet connector from disconnection. The holding clamp is applied by the perfusionist prior to use.

The holding clamp is applicable to all QUADROX-iR oxygenators which are subject to this submission.

The provided document describes a Special 510(k) submission for a modification to the MAQUET QUADROX-iR Oxygenators. The modification consists of adding a reusable stainless steel holding clamp as an interim protective safeguard. The information provided heavily focuses on design verification testing rather than a clinical study with an acceptance criterion in the traditional sense of a performance metric for a disease. Instead, the "acceptance criteria" are related to the mechanical performance and usability of the new holding clamp.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this submission (a modification to add a holding clamp), the acceptance criteria are based on mechanical and usability performance.

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

The document does not explicitly state numerical sample sizes for the mechanical tests (e.g., number of clamps or oxygenators tested for holding forces, pull-off forces, or vibration tests). It only states "The modified device was subjected to design verification tests."

For the Usability Test:

• Sample Size: "This test was performed in three hospitals." The number of individual users or attempts is not specified.
• Data Provenance: Prospective (as it was a dedicated test for this modification). The country of origin of the data is not specified beyond "three hospitals," but given the manufacturer's location (Germany) and contact person in the US, it could be either.

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

• Mechanical Tests: The "ground truth" for the mechanical tests is inherent in the objective measurements of forces, vibrations, and secure attachment as per engineering design and risk assessment. No human "experts" in the sense of clinical reviewers are mentioned for establishing ground truth for these physical tests.
• Usability Test: While "three hospitals" performed the test, the number of individuals involved in evaluating the usability, or their specific qualifications (e.g., "perfusionists with X years of experience"), is not specified. The document states it was "evaluated as to whether the clamp could be mounted using the Instruction for Use," implying a practical assessment by users.

4. Adjudication Method for the Test Set

• Mechanical Tests: No adjudication method is mentioned as these are objective measurements against defined engineering specifications.
• Usability Test: No specific adjudication method (like 2+1 or 3+1 consensus) is described. The evaluation seems to be a direct assessment of whether the mounting was successful according to the instructions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is for a mechanical modification (a holding clamp) and not for an AI/imaging diagnostic device that would typically involve a MRMC study. The document explicitly states: "Clinical results are not required for this submission to support substantial equivalence."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a medical device (oxygenator with a holding clamp), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Mechanical Tests: The ground truth is based on engineering specifications and objective measurements (e.g., force required to remove, stability under vibration).
• Usability Test: The ground truth is based on the ability of users to successfully mount the clamp following the provided instructions for use. This is a practical, task-oriented ground truth.

8. The Sample Size for the Training Set

This question is not applicable. This submission is for a physical device modification, not a machine learning model, so there is no "training set."

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

This question is not applicable, as there is no training set for this device.

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The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours.

The membrane oxygenator QUADROX-i Small Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 5 L/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The QUADROX-i Small Adult (HMO 51000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours.

The membrane oxygenator QUADROX-i Pediatric is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The QUADROX-i Pediatric (HMO 31000) model with integrated arterial filter also filters air bubbles and particles larger than 33 um. The utilization period of this device is restricted to six hours.

The membrane oxygenator QUADROX-i Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. It is designed for a blood flow rate of 0.2 - 1.5 Vmin and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature. The QUADROX-i Neonatal (HMO 11000) model with integrated arterial filter also filters air bubbles and particles larger than 33 um. The utilization period of this device is restricted to six hours.

The QUADROX-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide from the blood and regulates the blood temperature. The application duration is limited to 6 hours.

The Diffusion Membrane Oxygenator QUADROX-iD Pediatric is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The oxygenator is designed for a blood flow rate of 0.2 - 2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dicxide and regulates the blood temperature. The utilization period for this device is restricted to six hours.

The only modification consists of adding a reusable stainless steel holding clamp as an interim protective safeguard / corrective action to prevent the inlet and/or outlet connector from disconnection. The holding clamp is applied by the perfusionist prior to use. The holding clamp is applicable to all QUADROX-i / -iD oxygenators which are subject to this submission.

The given submission (K132829) is a Special 510(k) for a device modification of existing MAQUET oxygenators. The modification consists of adding a reusable stainless steel holding clamp. Due to the nature of this submission (a device modification for an existing, already cleared device), the study design and acceptance criteria differ significantly from submissions for novel AI/ML devices or diagnostic tools.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

• The document describes non-clinical mechanical and usability tests for the holding clamp. This is not a study involving human subjects or medical data in the traditional sense of AI/ML device testing.
• Sample Size: The specific number of clamps or oxygenators tested for each mechanical test is not provided in detail. The usability test was performed in "three hospitals," but the number of perfusionists or units tested within those hospitals is not specified.
• Data Provenance: The tests were conducted by the manufacturer, MAQUET Cardiopulmonary AG. The country of origin for the data is implicitly Germany (headquarters of submitter) or potentially associated testing facilities. These are prospective tests performed specifically to support this regulatory submission.

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

• This is not applicable in the context of this submission. "Ground truth" in the sense of expert consensus on medical images or patient outcomes is not relevant here.
• For the Usability Test, "perfusionists" were involved. While not explicitly defined as "experts" establishing a "ground truth," their feedback on the ability to mount the clamp according to instructions serves as a form of expert user validation for a usability aspect. Their specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set:

• Not applicable as there is no "test set" in the context of expert review of data for a diagnostic or prognostic decision. The non-clinical tests have pass/fail criteria based on engineering and safety standards, not expert adjudication. The usability test likely involved qualitative feedback or direct observation, but no formal adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or screening devices where the performance of human readers with and without AI assistance is compared. The device in this submission (a mechanical holding clamp for an oxygenator) does not involve human readers interpreting medical data or AI assistance.

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

• No, this is not applicable. The device is a mechanical accessory, not an algorithm. The "performance" is its mechanical function and usability, which is inherently tied to human interaction (mounting by a perfusionist) but does not involve an AI algorithm operating independently.

7. The Type of Ground Truth Used:

• For the mechanical tests (Holding Forces, Pull-off Forces, Vibration Tests, Leakage Test): The "ground truth" is derived from predefined engineering specifications, safety requirements, and risk assessment. The tests are designed to demonstrate that the clamp maintains structural integrity, remains securely attached, and does not compromise the primary function or safety of the oxygenator under simulated use conditions.
• For the Usability Test: The "ground truth" is the successful and correct mounting of the clamp by perfusionists following the provided Instructions for Use.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device, so there is no training set in the conventional sense. The "training" for such a device would be its engineering design and iterative development, not data-driven machine learning.

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

• Not applicable, as there is no training set for an AI/ML algorithm. The design and manufacturing processes of medical devices inherently follow quality management systems and engineering principles, but this is distinct from establishing ground truth for machine learning.

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The HLS Cannula from MAQUET is intended for use by trained physicians only. The HLS Cannula may be utilized to cannulate suitable vessels to provide circulatory perfusion of organs and vessels by forming a connection with the extracorporeal circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.

The HLS Cannula from MAQUET is a wire-reinforced, thin-wall cannula made of polyurethane. The transparent proximal section has no reinforcement and can be clamped. Each cannula is supplied with a pre-mounted 3/8" connector and an introducer that allows a guide wire up to 0.038" to be inserted. The cannula is available with an optional percutaneous insertion kit for the Seldinger technique and optional BIOLINE or SOFTLINE Coating. The HLS Cannula comes in a range of sizes and lengths. The HLS Cannula is a sterile and non-pyrogenic device, for single use only and is not to be re-sterilized by the user. The insertion kit from MAQUET comprises various components which permit access to the vessels. One insertion kit is available for the arterial cannula (PIK 100) with a length of 100 cm and one for the venous cannula (PIK 150) with a length of 150 cm. Additionally as accessories to the percutaneous insertion kit, there are two sets with further dilatators available. One set with larger dual step dilatators (18 / 20, 20 / 22, 22 / 24 Fr) for a better vessel dilation in the cases where cannulae are used bigger than 23 Fr. One set contains a smaller dilatator (8 / 10 Fr), dedicated for the insertion of the smaller cannulae like 13 Fr. As further accessories are separately guidewire sets available. These guidewire sets consist of five separately packed quidewires (lengths 100 or 150 cm) which are the identic articles as used in the Percutaneous Insertion Kit itself.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Arterial HLS Cannula 13 Fr non-coated, with BIOLINE Coating and with SOFTLINE Coating (K131666)

1. Table of Acceptance Criteria and Reported Device Performance:

The document is a 510(k) summary for a Special 510(k), which focuses on demonstrating substantial equivalence to a previously cleared device (predicate). Therefore, it doesn't present a table of explicit, pre-defined acceptance criteria with numerical targets and the device's measured performance against those targets in the way a de novo or PMA submission might.

Instead, the "acceptance criteria" for this Special 510(k) are implied by the demonstration of substantial equivalence to the predicate devices. The study essentially aims to prove that the new device's performance is comparable or not inferior to the predicate device for relevant parameters.

Here's how we can infer the acceptance criteria and reported "performance":

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test (Flow Rate, Kink resistance, Pressure resistance, Integrity, Tensile tests). The testing methodologies would typically involve a specific number of units for each test.
• Data Provenance: Not explicitly stated, but given the submitter is MAQUET Cardiopulmonary AG in Germany, it is highly likely the non-clinical testing was conducted in Europe (Germany or within the EU). The study is retrospective in the sense that it relies on previously conducted tests for the predicate devices and then applies additional tests specific to the modified device.

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

This information is not applicable as the studies are entirely non-clinical (bench testing). There is no "ground truth" derived from expert consensus on medical images or clinical outcomes in this context. The "truth" is established by direct physical measurements according to specified test standards or protocols.

4. Adjudication Method for the Test Set:

This information is not applicable as the studies are entirely non-clinical bench testing, not involving human interpretation or clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study investigates human reader performance, often in image interpretation, and is not relevant for the non-clinical bench testing described for this device.

Effect Size: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This concept is not applicable as the device is a physical medical device (cannula), not software or an AI algorithm. The performance described refers to the physical attributes and function of the cannula itself, not an algorithm's output.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is established by:

• Bench Testing Measurements: Direct physical measurements (e.g., flow rate in L/min, pressure in mmHg, force in N for tensile strength) under controlled laboratory conditions, following established test protocols and standards.
• Comparison to Predicate: The ultimate "ground truth" for substantial equivalence is demonstrating that these measured characteristics are comparable or "essentially the same" as those demonstrated for the already cleared predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of physical medical device bench testing or a 510(k) submission for a non-AI/software device.

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

This information is not applicable as there is no "training set" or corresponding ground truth for this type of submission.

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The HCU 40 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.

The Heater-Cooler Unit HCU 40 is used to supply temperature-controlled water to regulate the patient temperature during extracorporeal circulation (ECC). Further application areas are warming and/or cooling therapies. The device can also be used to control the temperature of a cardioplegia solution. Therefore the Heater-Cooler Unit HCU 40 contains two independent water circuits. One circuit (main circuit) can be connected to the blood heat exchanger (part of the oxygenator) and/or to the warming/cooling blanket. The other circuit (cardioplegia circuit) can be connected to the cardioplegia heat exchanger. The use of an UV treatment does significantly enhance the water quality between the water change intervals. The heat exchange with the patient and the cardioplegia fluid occurs when the water passes the heat exchangers and/or the blanket. The water temperature of the main and the cardioplegia circuit can be regulated independently from each other.

Here's an analysis of the provided text regarding the MAQUET HCU 40 Heater-Cooler Unit, focusing on the acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device. This type of submission primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than conducting extensive clinical efficacy studies as one might find for a novel drug or a high-risk Class III device. Therefore, the information regarding acceptance criteria and performance studies will be different from what you might expect for an AI/ML-based diagnostic device.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, the "acceptance criteria" for the HCU 40 are primarily demonstrated through its substantial equivalence to its predicate device, the HCU 30. The performance is assessed through non-clinical tests verifying that the device meets its design requirements and is safe and effective.

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

This document describes a medical device (Heater-Cooler Unit), not an AI/ML diagnostic system. Therefore, the concept of a "test set" in the context of an algorithm's performance is not applicable here.

• Test Set Sample Size: Not applicable. The device undergoes engineering verification and validation testing, not a "test set" of patient data for AI model evaluation.
• Data Provenance: Not applicable in the AI/ML sense. The non-clinical tests are performed on the device itself and its components. The device manufacturer is MAQUET Cardiopulmonary AG, located in Rastatt, Germany, and the contact person is in Wayne, NJ, USA.

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

Not applicable. This is not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" for this device's performance would be derived from engineering specifications, established medical device standards, and the performance characteristics of its predicate device as verified through non-clinical testing.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of human-reviewed cases for AI ground truth adjudication. Non-clinical testing results would be reviewed and accepted by internal engineering and quality personnel according to established protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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. No MRMC study was conducted or is relevant for this type of device submission. The document explicitly states: "No clinical evaluation of the modified device was conducted or required."

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

Not applicable. This device is not an algorithm. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device is effectively its ability to meet engineering specifications, safety standards, and functional requirements as verified through laboratory and bench testing, and its equivalence to a legally marketed predicate device. This is primarily based on:

• Engineering Specifications: The design requirements for temperature control, flow rates, safety features, etc.
• Regulatory Standards: Compliance with relevant national and international medical device standards.
• Predicate Device Performance: The HCU 30's established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI algorithms, so there is no "training set."

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The MAQUET Hemoconcentrators are used to remove excess fluid from the blood or to concentrate highly diluted blood solutions. They are only intended for use for blood concentration during and/or following cardiopulmonary bypass procedures. The maximum duration of use is 6 hours. The physician in charge of treatment has sole responsibility for decisions concerning use of the hemoconcentrator.

BC 60 plus, BC 140 plus Hemoconcentrators are used to remove excess fluid from the blood during and/or following cardiopulmonary bypass procedures. Hemoconcentrators are ready for use after they have been filled and vented as the membrane contains no stabilizers. The type of Hemoconcentrator used is determined by the protocol used.

This document describes a 510(k) premarket notification for the MAQUET BC 60 plus and BC 140 plus Hemoconcentrators. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, many of the requested items (e.g., acceptance criteria table with reported performance, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, specific training set details, and type of ground truth used) are not applicable or not provided in this type of regulatory submission.

Here's a breakdown of what can be extracted based on the provided text:

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

This information is not explicitly provided in the format of acceptance criteria and reported performance values. The submission states that the devices met the requirements of ISO standards and that evaluation and testing demonstrated substantial equivalence. However, the specific quantitative acceptance criteria or the reported performance data against those criteria are not detailed in this public FDA summary. The assessment revolves around equivalence to predicate devices, not the new establishment of performance criteria for this specific device.

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

This information is not provided. The submission states that "evaluation and testing on safety and effectiveness was executed" and lists general areas (Integrity, Performance, Biocompatibility, Sterility) that were tested/evaluated. However, details about sample sizes, study design (retrospective/prospective), or data provenance are absent.

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 is not applicable/not provided. This type of information is typically relevant for studies evaluating diagnostic or AI-driven devices where human expert consensus forms a "ground truth" for comparison. Hemoconcentrators are physical medical devices, and their performance is assessed through engineering and biological testing, not through expert interpretation of data points that require "ground truth" establishment in the way an image analysis algorithm might.

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

This is not applicable/not provided for the same reasons as item 3. Adjudication methods are used in studies involving human interpretation or subjective assessments to resolve discrepancies, which is not the primary method for evaluating the performance of a physical device like a hemoconcentrator.

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

This is not applicable/not provided. MRMC studies are specific to diagnostic devices where human readers (e.g., radiologists) interpret images or data, and their performance is compared with and without AI assistance. This device is a hemoconcentrator, not a diagnostic imaging or AI system.

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

This is not applicable/not provided. This question pertains to AI algorithms. The MAQUET Hemoconcentrators are physical devices that perform a function and are not AI algorithms.

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

As noted previously, the concept of "ground truth" in the context of expert consensus or pathology is not directly applicable to the evaluation of a hemoconcentrator. The "truth" in this context would be the objective measurements of the device's technical performance and biological safety as defined by the relevant ISO standards and predicate device performance. For biocompatibility, established biological endpoints and validated testing methods would constitute the "ground truth."

8. The sample size for the training set

This is not applicable/not provided. This question applies to machine learning models. The MAQUET Hemoconcentrators are physical medical devices, not an AI algorithm that requires a training set.

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

This is not applicable/not provided for the same reason as item 8.

Summary of the Study and Device Evaluation:

The study proving the device meets criteria for substantial equivalence (which is the regulatory standard for this 510(k) submission) is based on non-clinical testing.

• Acceptance Criteria/Performance Standards: The devices were tested to and met the requirements of:

  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing. (This implies meeting established biocompatibility endpoints).
  • ISO 8637: Cardiovascular implants and extracorporeal systems - Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators. (This implies meeting established performance and safety requirements for these types of devices).
  • The overall "acceptance criteria" were demonstrating substantial equivalence in safety and effectiveness to the predicate devices: Hemocor HPH® 700 (K983085) and Hemocor HPH® 1400 (K923139). This equivalence was assessed across the "principals of operation, performance and indications for use."

• Areas Tested/Evaluated:

  • Integrity
  • Performance
  • Biocompatibility
  • Sterility

Limitations of the provided text: This 510(k) summary is a high-level overview. It confirms that testing was done and standards were met, but it does not provide the detailed results, specific test protocols, or quantitative data that would fulfill many of the requested items (e.g., exact performance numbers, sample sizes, or specific ground truth methodologies for each test). The purpose of this summary is to demonstrate regulatory compliance through substantial equivalence, not to provide a detailed scientific publication of a study's methodology and results.

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