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The MEDOS HILITE 2800 & 2400 LT Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. The 2800 & 2400 LT are pediatric oxygenators intended for use at blood flow rates of 0.5 to 2.8 liters per minute for the HILITE 2800 and 0.5 to 2.4 liters per minute for the HILTE 2400 LT for periods of up to six (6.0) hours.

The MEDOS HILITE 2800 & 2400 LT Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 2800 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 2400 LT hollow fiber membrane consists of a polymethylpentene gas plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to affect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume.

The provided text describes a 510(k) submission for the MEDOS HILITE 2800 & 2400 LT Oxygenator. However, it does not contain the specific detailed acceptance criteria and the results of a study proving the device meets those criteria in the format requested.

The document states that:

• "extensive safety, performance, and validation testing prior to release" was completed.
• "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications" were conducted.
• "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."

It explicitly mentions that the device was found to be "substantially equivalent" to a predicate device (CAPIOX® RX15 Hollow Fiber Oxygenator, K051997) based on this testing and comparison, implying that the performance of the new device was determined to be comparable to the predicate device, which inherently meets an acceptable level of performance.

However, the specific numerical acceptance criteria (e.g., particular oxygen transfer rates, heat exchange efficiency targets, etc.) and the precise reported device performance metrics are not detailed in the provided text. Therefore, I cannot construct the table of acceptance criteria and reported device performance.

Furthermore, details regarding sample sizes for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth used, or training set specifics are not present as this is a medical device submission, not an AI/software submission.

Summary of what can be extracted based on the prompt's request, and what cannot:

1. Table of acceptance criteria and reported device performance: Cannot be provided as specific numerical criteria and results are not detailed. The document only generally states that "functional requirements and performance specifications" were met and it's "substantially equivalent" to the predicate.
2. Sample size for the test set and data provenance: Not applicable/Not provided. This is a physical medical device. Testing involved "various performance tests" and "safety tests," likely in a lab or in vitro setting, but the sample size of tested units or specific data provenance (country, retrospective/prospective) for clinical data (if any) is not mentioned.
3. Number of experts and qualifications for ground truth: Not applicable/Not provided. This is relevant for AI/image analysis. For this medical device, performance is evaluated against engineering specifications and industry standards.
4. Adjudication method: Not applicable/Not provided.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: No. This is not relevant for a physical oxygenator device.
6. Standalone (algorithm only) performance: No. This is not relevant for a physical oxygenator device.
7. Type of ground truth used: Not applicable/Not provided. Performance is against engineering specifications and industry standards.
8. Sample size for the training set: Not applicable/Not provided. This is not an AI/machine learning device.
9. How ground truth for the training set was established: Not applicable/Not provided.

The document primarily focuses on establishing substantial equivalence to a predicate device based on its intended use, technological characteristics, and safety/performance testing in accordance with FDA guidance for cardiopulmonary bypass oxygenators.

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The MEDOS HILITE 1000 & 800 LT Hollow Fiber Oxygenators are indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. The 1000 & 800 LT are neonate, infant oxygenators intended for use at blood flow rates of 0.2 to 1.0 liters per minute for the HILITE 1000 and 0.2 to 0.8 liters per minute for the HILITE 800 LT for periods of up to six (6.0) hours.

The MEDOS HILITE 1000 & 800 LT Hollow Fiber Oxygenators consist of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 1000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 800 LT hollow fiber membrane consists of a polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume.

The provided text describes a 510(k) submission for the MEDOS HILITE 1000 & 800 LT Oxygenators. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through a comparative effectiveness study with human readers or a standalone AI algorithm.

Therefore, many of the requested information points (e.g., acceptance criteria, device performance table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this document, as the submission follows a different regulatory pathway.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable / Not Provided. The document does not describe specific acceptance criteria (e.g., a certain percentage accuracy, sensitivity, or specificity) or present a table of device performance against such criteria. The submission is based on demonstrating equivalence to a predicate device through safety, performance, and validation testing.

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

• Not Applicable / Not Provided. The document mentions "extensive safety, performance, and validation testing." However, it does not specify the sample size of devices used in these tests, nor does it detail a "test set" in the context of performance metrics that would be used for AI or diagnostic devices. Data provenance (country of origin, retrospective/prospective) is also not specified for these tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable / Not Provided. This information is relevant for studies involving human interpretation or AI performance evaluation where a "ground truth" needs to be established (e.g., by experts reviewing images). For an oxygenator, the "ground truth" during testing would be objective physical measurements of performance (e.g., gas exchange rates, pressure drops) rather than expert consensus on a diagnostic outcome.

4. Adjudication Method for the Test Set

• Not Applicable / Not Provided. Adjudication methods (like 2+1 or 3+1) are typically used when there's disagreement among experts in establishing ground truth for diagnostic studies. This is not relevant for the type of device and testing described.

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

• No, an MRMC study was not done. MRMC studies assess the change in human reader performance (e.g., diagnosis accuracy) with and without AI assistance. This type of study is not relevant for an oxygenator device, which is a therapeutic rather than a diagnostic tool. The document focuses on the physical and functional performance of the oxygenator itself.

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

• Not Applicable. Standalone algorithm performance is relevant for AI or software as a medical device. The MEDOS HILITE oxygenator is a physical medical device. The "performance" here refers to its mechanical and physiological function, not an algorithm's output.

7. The Type of Ground Truth Used

• The "ground truth" for the oxygenator's performance would be objective physiological and engineering measurements. This includes parameters like oxygen transfer rates, carbon dioxide removal rates, pressure drop across the device, heat exchange efficiency, and material compatibility. The document states "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." These specifications are typically derived from industry standards and clinical requirements for oxygenators.

8. The Sample Size for the Training Set

• Not Applicable / Not Provided. The concept of a "training set" applies to machine learning algorithms. For a physical device like an oxygenator, there isn't a "training set" in this context. Device design and development involve engineering principles and testing, not AI training.

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

• Not Applicable / Not Provided. As there is no training set for an AI algorithm, this question is not relevant.

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The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit. The MVC 0730 is a neonate, infant reservoir intended for use in procedures at a maximum flow rate of 1.2 liters per minute for periods up to six hours (6.0) hours.

The MEDOS HILITE MVC 0730 Hardshell Venous Reservoirs are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The MEDOS HILITE MVC 0730 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the 1/4" venous inlet at the bottom section of the reservoir. Venous suctioned blood enters the top section of the defoamer/filter cartridge and passed through a defoamer sponge and 30 micron filter. The maximum venous flow rate is 1.2 lpm. The maximum cardiotomy flow rate is 0.9 lpm.

The provided text is a 510(k) summary for the MEDOS HILITE MVC 0730 Hardshell Venous Reservoir, a medical device, not an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML device evaluation, such as sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, and MRMC studies, are not applicable to this submission.

The document describes a traditional medical device and its predicate comparison, focusing on safety, performance, and validation for its intended use.

Here's the information that can be extracted relevant to the acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific numerical targets. Instead, it broadly states that "the device meets all of its functional requirements and performance specifications" and "complies with applicable industry and safety standards."

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

The document states, "The MEDOS HILITE MVC 0730 Hardshell Venous Reservoir has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system includes various performance tests..."

However, specific sample sizes for testing (e.g., number of units tested, number of in-vitro or in-vivo trials) are NOT provided. The text does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, which are typical considerations for clinical trials, not necessarily for engineering performance validation of a mechanical device like this.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the ground truth concept (e.g., for diagnostic accuracy) is not relevant to the performance validation of a mechanical device like a blood reservoir. The device's performance is assessed against engineering specifications, not clinical interpretations by experts.

4. Adjudication method for the test set

This is not applicable for the same reasons as #3. Adjudication is typically used to resolve discrepancies in expert interpretations or assessments, which is not relevant for the functional and safety testing of this mechanical device.

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 a hardshell venous reservoir, a mechanical component of a cardiopulmonary bypass circuit. It is not an AI-driven diagnostic or assistive technology, and therefore, human reader improvement or MRMC studies are entirely irrelevant.

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

This is not applicable. The device is a mechanical blood reservoir, not an algorithm.

7. The type of ground truth used

For a mechanical device like this, the "ground truth" is typically defined by engineering specifications, design requirements, and applicable industry or regulatory standards. Performance tests verify if the device meets these pre-defined physical and functional parameters (e.g., flow rates, filtration efficiency, defoaming capability, material compatibility, sterile barrier integrity). There is no "expert consensus," "pathology," or "outcomes data" in the sense of clinical diagnostic accuracy for this type of device's core validation.

8. The sample size for the training set

This is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This is not applicable as the device is not an AI/ML algorithm.

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The MEDOS HILITE MVC 4030 Hardshell Venous Reservoir is indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to seven (7.0) liters per minute for periods up to six hours (6.0) hours.

The MEDOS HILITE MVC 4030 Hardshell Venous Reservoirs are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The MEDOS HILITE MVC 4030 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the 1/2' venous inlet at the center top section of the lid. Venous suctioned blood enters the top section of the defoamer/filter cartridge and passed through a defoamer sponge and 30 micron filter. The maximum venous flow rate is 7 lpm. The maximum cardiotomy flow rate is 4 lpm.

The provided text describes a medical device submission (K083131) for the Medos Hilite MVC 4030 Hardshell Venous Reservoir. This is a conventional 510(k) submission for a Class II medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific acceptance criteria in the manner of AI/software devices. The submission focuses on device characteristics, intended use, and performance tests related to its manufacturing quality and functional requirements.

Therefore, many of the requested points, especially those related to AI/algorithm performance (e.g., sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, training set details), are not applicable to this type of traditional medical device submission.

Here's the information that can be extracted and inferred from the provided text, addressing the applicable points:

1. Acceptance Criteria and Reported Device Performance

The submission states that the device was "subjected to extensive safety, performance, and validations prior to release." It also mentions "various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications" and "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."

While specific quantitative acceptance criteria are not detailed in the summary, the general areas of performance and safety are highlighted. The reported "performance" is that the device meets these functional requirements and specifications.

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

This is not applicable as this is not a study evaluating an algorithm on a "test set" of data in the AI sense. Performance testing would have involved physical units of the device. The text does not provide details on the number of physical units tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable. Ground truth in this context refers to established functional parameters and safety standards for the device's physical operation. It does not involve expert review or consensus of interpretable data like medical images.

4. Adjudication method for the test set

This is not applicable. Regular engineering testing and validation procedures would have been followed, not adjudication in the context of expert review.

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. This device is a hardware component for cardiopulmonary bypass and does not involve AI or human-in-the-loop performance for image reading or diagnosis.

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

This is not applicable. This is a physical medical device, not a software algorithm.

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

The "ground truth" for this device's performance would be derived from:

• Engineering specifications and design requirements: These define what the device should do (e.g., flow rates, filtration efficiency).
• Established industry standards: Pertaining to biocompatibility, sterilization, materials, and mechanical integrity for blood-contacting devices.
• Comparability to the predicate device: The predicate device (Gish CAPVRF45 Hardshell Venous Reservoir, K964973) serves as a benchmark for performance and safety.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

This is not applicable. No training set exists for this type of device.

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The MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to seven (7.0) liters per minute for periods of up to six (6.0) hours.

The MEDOS HILITE 7000 & 7000 LT Oxygenator consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The MEDOS HILITE 7000 hollow fiber membrane consists of a polypropylene gas permeable mat. The MEDOS HILITE 7000 LT hollow fiber membrane consists of a Polymethylpentene plasma tight mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a polyester non-porous hollow fiber configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood around the outside of the fibers while water flows through the inner lumen of the fibers and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible and coated with a proprietary coating. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifugal pump connected through the tubing. The MEDOS HILITE 7000 Oxygenator may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

The provided text describes the MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or any of the specific details requested regarding sample sizes, ground truth, experts, or AI-related aspects.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive performance studies with specific acceptance criteria and detailed quantitative results.

Here's a breakdown of what can be extracted and what is missing:

The device is a blood oxygenator indicated for extracorporeal oxygenation and carbon dioxide removal from human blood at blood flow rates of 1.0 to 7.0 liters per minute for up to 6.0 hours.

Missing Information:

• Acceptance Criteria Table: The document does not specify any quantitative acceptance criteria or report specific device performance metrics against such criteria (e.g., oxygen transfer rate, CO2 removal rate, pressure drop, hemolysis rates, etc., with specific thresholds).
• Sample Size for Test Set and Data Provenance: This information is not provided. The summary mentions "extensive safety, performance, and validations" and "final testing for the systems," but no details on sample sizes or the nature (retrospective/prospective, country of origin) of the data from these tests are given.
• Number of Experts and Qualifications: Not applicable, as no expert-derived ground truth or review process is detailed concerning a test set.
• Adjudication Method: Not applicable for the same reason as above.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is entirely irrelevant to this type of medical device (a physical blood oxygenator) and is not mentioned. There is no AI component involved.
• Standalone Performance (Algorithm Only): Not applicable, as this is a physical medical device, not an algorithm.
• Type of Ground Truth Used: Not explicitly stated in terms of a "ground truth" as might be used in an AI or diagnostic imaging study. The "test data" likely involved laboratory measurements and possibly animal or human studies to compare to the predicate device's performance.
• Sample Size for Training Set: Not applicable or mentioned, as there is no AI algorithm being trained.
• How Ground Truth for Training Set was Established: Not applicable.

What the document does state regarding testing:

• "The MEDOS HILITE 7000 & 7000 LT Oxygenator has been subjected to extensive safety, performance, and validations prior to release."
• "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."
• "Safety tests have further been performed to ensure the device complies with applicable industry and safety standards."
• "A review of literature pertaining to the safety and effectiveness has been conducted."
• The conclusion is based on "testing and comparison to the predicate device," asserting equivalence in safety and effectiveness.

In summary, this document is a regulatory submission for a physical medical device (blood oxygenator) focusing on substantial equivalence to a predicate device, not on detailed performance studies with specific statistical acceptance criteria as would be found for a diagnostic or AI-driven device. Therefore, most of the requested specific information is not contained within this text.

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The Gish CAPVRF44 Hardshell Venous Reservoirs are indicated for use during cardiopulmonary bypass surgery as a storage reservoir for gravity and augmented venous return blood and to filter and defoam intrathoracic suctioned blood prior to its return to the extracorporeal circuit at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six hours (6.0) hours. The Gish CAPVRF44 Hardshell Venous Reservoirs are also indicated for the collection and autotransfusion of the same patient's postoperative shed blood with the addition of the Postoperative Conversion Pack with water seal/manometer.

The Gish CAPVRF44 Hardshell Venous Reservoirs with hyaluronan based coating (HA Coating) are sterile, non-pyrogenic, single use, disposable, device designed for collection, storage and filtration of blood during cardiopulmonary bypass. The Gish CAPVRF44 has a clear polycarbonate shell and an internal defoamer filter cartridge. Venous drainage enters the ½" venous inlet where it is directed to the bottom of the device and passes through a 160 micron screen filter. Intrathoracic suctioned blood enters the top section of the defoamer/filter cartridge and passes through a defoamer sponge and 20 micron depth filter. The maximum venous flow rate is 8 lpm. The maximum cardiotomy flow rate is 4 lpm.

This document describes a 510(k) submission for the Gish CAPVRF44 Hardshell Venous Reservoir with HA Coating, a medical device used during cardiopulmonary bypass surgery. It is a traditional 510(k) submission, indicating that the device demonstrates substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding performance metrics. Instead, it relies on the concept of "functional requirements and performance specifications" and "applicable industry and safety standards," along with comparison to predicate devices, to establish safety and effectiveness.

However, based on the description, we can infer some performance aspects:

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It broadly states that "extensive safety, performance, and validations" were conducted.

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

This type of information is not applicable to this device. This is a medical device (a blood reservoir), not a diagnostic or AI-powered device that requires expert interpretation to establish ground truth for a test set. The validation would have involved engineering tests, material compatibility tests, and performance demonstrations against specifications.

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a human-in-the-loop diagnostic or interpretive component requiring adjudication.

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 information is not applicable. The device is a physical blood reservoir, and an MRMC study related to AI assistance for human readers is not relevant to its evaluation.

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

This information is not applicable. The device does not involve an algorithm or AI component.

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

The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. The "ground truth" for this device would be established by:

• Engineering specifications and test methods: Verifying that the device meets defined physical dimensions, material properties, flow rates, filtration efficiency, and other operational parameters.
• Biocompatibility testing: Demonstrating that the materials are safe for contact with blood, often using established standards and lab tests.
• Sterility and pyrogenicity testing: Ensuring the device is sterile and non-pyrogenic according to recognized standards.
• Comparison to predicate devices: Demonstrating that the new device performs equivalently or better than previously cleared devices for its intended use.

8. The sample size for the training set

This information is not applicable. The device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable. The device does not involve a "training set" or corresponding ground truth establishment in the context of machine learning or AI.

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The Gish Soft Venous Reservoir with HA Coating is indicated for use collecting systemic venous and cardiotomy return blood during cardiopulmonary bypass procedures. It is designed to operate at flow rates of one (1.0) to eight (8.0) liters per minute for periods up to six (6.0) hours.

The Gish Soft Venous Reservoirs with HA Coating consist of a bag with three fluid ports and two aspiration ports and are intended to prevent venous air from entering the extracorporeal circuit. The design of the Soft Venous Reservoir reduces blood stagnation and will collapse if emptied; a built in safety mechanism that minimizes accidental air delivery to the oxygenator. Each Soft Venous Reservoir contains one ½" venous inlet (blue) with integral temperature port and luer port, one 3/8" cardiotomy inlet (white), one 3/8" arterial outlet (red) and two 1/8" aspiration ports with attached 3-way stopcocks. The components of this system which have contact with the fluid path are sterile and non-pyrogenic. All materials of the Soft Venous Reservoirs are biocompatible and coated with a proprietary coating. The Gish the Soft Venous Reservoirs with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

Here's a breakdown of the acceptance criteria and study information for the Gish Soft Venous Reservoir (SVR) with HA Coating, based on the provided 510(k) summary:

The provided document is a 510(k) summary for a medical device (Gish Soft Venous Reservoir with HA Coating). These types of submissions primarily demonstrate substantial equivalence to a legally marketed predicate device rather than presenting detailed "acceptance criteria" and "study results" in the way one might expect for a novel AI/software product or a clinical trial. Instead, the "acceptance criteria" are implied by the performance of the predicate devices and the "study" is a series of engineering and performance tests to ensure the new device functions similarly and safely.

Therefore, I will interpret your request within the context of a 510(k) submission for a physical medical device.

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • The document does not specify a sample size for a "test set" in the context of clinical data or patient outcomes. The "test set" here refers to the actual physical devices (Gish SVR with HA Coating) that underwent "various performance tests" and "validations". The number of devices tested is not explicitly stated.
   • Data Provenance: The testing was conducted by Gish Biomedical, Inc. This is internal company testing, likely done in a laboratory or simulated environment, rather than involving human clinical data from a specific country or being retrospective/prospective in a clinical study sense.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This concept is not applicable in this 510(k) submission. "Ground truth" established by experts is typically relevant for diagnostic devices or AI algorithms where interpretation is involved. For a physical blood reservoir, engineering specifications and established test methodologies serve as the "ground truth" or benchmarks. Product specifications and performance standards are typically set by internal R&D, engineering, and regulatory teams, often informed by industry standards and regulatory guidance.

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

   • Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical trials or studies to resolve discrepancies in expert interpretation, particularly in diagnostic contexts. For physical device performance testing, results are typically objective measurements against predefined specifications; there is no "adjudication" between expert opinions on the performance data itself.

4. 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. This is a physical medical device (blood reservoir) and not an AI or imaging diagnostic device. Therefore, an MRMC study is completely irrelevant and was not performed.

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

   • Not applicable. This is a physical blood reservoir, not an algorithm.

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

   • The "ground truth," while not referred to as such, is based on engineering specifications, performance standards, and comparison to the predicate devices' established safety and effectiveness. The device's ability to meet its functional requirements (flow rates, volume, air prevention, etc.) and demonstrate biocompatibility and sterility are the "truths" being validated.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable for the same reason as above.

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The Vision Hollow Fiber Oxygenator with HA Coating is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to eight (8.0) liters per minute for periods of up to six (6.0) hours.

The Gish Vision Hollow Fiber Oxygenator with hyaluronan based coating (HA), Coating consists of a hollow fiber membrane oxygenator and extracorporeal heat exchanger. The hollow fiber membrane consists of a polypropylene gas permeable mat. The unique mat design increases the interaction between blood and gas, creating a highly efficient blood oxygenator. The heat exchanger consists of a one piece, stainless steel bellows confiqured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the outside convolutions of the stainless steel bellows, and therefore effects heat exchange while minimizing priming volume. All materials of the heat exchanger are biocompatible and coated with a proprietary coating. The device allows for trapping and removal of air. Oxygenated blood is delivered to the patient through the tubing and appropriate cannula. Blood flow is driven by a roller pump or centrifugal pump connected through the tubing. The Gish Vision Hollow Fiber Oxygenator with HA Coating may be purchased separately or preconnected with tubing and other components of an extracorporeal circuit.

Here's an analysis of the provided text regarding acceptance criteria and study details:

This document describes a medical device submission (510(k)) for a blood oxygenator. It does not describe an AI/ML-based medical device. Therefore, many of the questions regarding AI/ML-specific study design (like ground truth establishment, training sets, multi-reader studies, effect sizes) are not applicable to this document.

However, I can extract the information relevant to a traditional medical device submission for the Vision Hollow Fiber Oxygenator with HA Coating.

Acceptance Criteria and Device Performance for Vision Hollow Fiber Oxygenator with HA Coating

Evaluation Summary:
The provided document is a 510(k) summary for a traditional medical device, the Gish Vision Hollow Fiber Oxygenator with HA Coating. It outlines the device's characteristics, intended use, and a generic statement about safety, performance, and validation testing. It does not provide specific numerical acceptance criteria or detailed results of tests performed to demonstrate compliance. Instead, it relies on demonstrating substantial equivalence to predicate devices (Vision Hollow Fiber Oxygenator, K961530, and Vision Hollow Fiber Oxygenator with Guardian Coat, K023381).

In the context of the provided document, the "acceptance criteria" are implied to be that the new device performs equivalently to the predicate devices and meets its functional requirements and performance specifications, without introducing new safety concerns.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "extensive safety, performance, and validations" and "various performance tests." However, specific sample sizes for these tests (e.g., number of devices tested, number of in-vitro runs, number of animal studies if applicable) are not provided.
• Data Provenance: Not specified. The document states "Final testing for the systems includes various performance tests." It does not mention clinical data, country of origin, or whether the data was retrospective or prospective. Given the device type and 510(k) pathway, it's highly likely that the "testing" refers to bench testing, in-vitro studies, and potentially pre-clinical animal studies, rather than human clinical trials for a blood oxygenator, especially if substantial equivalence is claimed to existing predicate devices.

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

• Not Applicable. This is a traditional medical device submission, not an AI/ML device requiring human expert annotation for ground truth. The "ground truth" for this type of device is established through objective engineering and biological performance metrics (e.g., oxygen transfer efficiency, pressure drop, hemolysis rates) and comparison to established predicate device performance.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human experts establishing ground truth via consensus, there is no adjudication method in the sense of AI/ML evaluation. Device performance is determined by objective measurements against specifications.

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/ML device.

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

• Not Applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

• Objective Performance Metrics and Comparison to Predicate Devices. The "ground truth" for this device's performance and safety is based on:
  • Engineering Specifications: Meeting predefined performance characteristics (e.g., blood flow rates, oxygen transfer efficiency, pressure drop).
  • Biocompatibility Standards: Adherence to established standards for material safety.
  • Predicate Device Performance: The primary "ground truth" for substantial equivalence is the established safety and effectiveness profile of the legally marketed predicate devices, against which the new device is compared. This comparison implies the new device must perform at least as well as, and not worse than, the predicate devices without raising new questions of safety or effectiveness.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. This is not an AI/ML device.

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The Gish Vision Blood Cardioplegia System with HA coating is indicated for use in applications that require control of fluid temperature, such as blood or cardioplegia, typically in an extracorporeal circuit The device may be used for normothermic or hypothermic applications It is designed to operate at flow rates of one hundred (100) to six hundred (600) milliliters per minute for periods up to six (6 0) hours

The Gish Vision Blood Cardioplegia System with hyaluronan based coating (HA coating) consists of an extracorporeal heat exchanger and fluid administration set The heat exchanger consists of a one piece, stainless steel bellows, configured heat exchanger as the primary element to effect heat exchange This element is encased by a polycarbonate housing, which directs the blood through the outside convolutions of the stainless steel bellows, and therefore effects heat exchange while minimizing priming volume All materials of the heat exchanger are brocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air Additionally, the device includes an integral bubble trap, gross particulate filter (105 u) and pressure relief device designed to open in the event of excessive fluid pressure (600 mmHq) during use Solutions are delivered to the patient through the extension line and appropriate cannula Blood flow is driven by a roller pump connected through an extension line. The components of this system which have contact with the fluid path are sterle and nonpyrogenic. All blood contact materials of the Vision Blood Cardioplegia System with HA coatung are biocompatible and coated with a proprietary coating.

This document describes a 510(k) submission for the Gish Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger with HA Coating. It is a medical device, and the submission focuses on demonstrating its substantial equivalence to previously cleared predicate devices rather than proving its effectiveness through a new clinical study with specific acceptance criteria as you might see for a novel device.

Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typical for studies evaluating diagnostic accuracy or clinical outcomes of a novel device) is not explicitly present in this type of regulatory submission. The goal of a 510(k) is to show that the new device is as safe and effective as a legally marketed predicate device, often relying on engineering and performance testing.

However, I can extract the relevant information about the "Test Data" and "Comparison" sections to infer what the manufacturer claims regarding device performance and how it meets its functional requirements.

Here's an attempt to answer your questions based on the provided text, acknowledging the limitations inherent in a 510(k) summary for a "substantially equivalent" claim:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the format typically seen for rigorous clinical studies. Instead, it states that the device was subjected to various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications.

The functional requirements and specifications are implied by the device's intended use and comparison to the predicate devices. The key performance aspects mentioned are:

2. Sample size 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 "test set" in the context of a clinical study or a specific number of devices tested. The testing mentioned appears to be engineering and performance validation rather than clinical trial data.

• Sample Size: Not specified. It refers generally to "the systems."
• Data Provenance: Not specified, but likely refers to internal testing conducted by Gish Biomedical, Inc. in the USA.
• Retrospective or Prospective: Not applicable in the context of device performance/engineering testing described.

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)

Not applicable. The testing described is performance and functional verification, not a clinical study requiring expert ground truth establishment for a diagnostic output.

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

Not applicable. This is not a clinical study involving human assessment or adjudication of outcomes for a test set.

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 device is a cardiopulmonary bypass heat exchanger, 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 device is not an algorithm.

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

For the performance tests, the "ground truth" would be the engineering specifications and established standards for heat exchangers in cardioplegia systems. For biocompatibility, it would be compliance with relevant biocompatibility standards.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model that requires a training set.

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

Not applicable. This device is not an AI/machine learning model.

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The Gish Tubing and Connectors with HA Coating are indicated for use in Surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit It is designed to operate at flow rates of one (1 0) to six (6) liters per minute for periods up to six (6) hours

The Gish Tubing and Connectors with HA Coating are used in surgical procedures to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass cırcuit - Specifically they are used in connecting oxygenators, reservoirs, filters, heat exchangers and other devices used in surgical procedures The tubing is polyvinyl chloride (PVC) The connectors are polycarbonate of various configurations such as straight, "Y", Luer and reducer types. The components of this system which have contact with the fluid path are sterle and nonpyroqenic. All materials of the Gish Tubing and Connectors are biocompatible and coated with a proprietary coating. The Gish Tubing and Connectors with HA Coating may be purchased separately or pre-connected with tubing and other components of an extracorporeal circuit.

The provided text describes the Gish Tubing and Connectors with HA Coating, a medical device used in cardiopulmonary bypass procedures. However, the text explicitly states that "The Gish Tubing and Connectors with HA Coating has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications." It further concludes that "The conclusion drawn from these tests is that Gish Tubing and Connectors with HA Coating is equivalent in safety and efficacy to its predicated devices."

Despite these statements, the document does not provide any specific acceptance criteria or detailed results of the studies conducted to demonstrate that the device meets those criteria. It mentions "extensive safety, performance, and validations" and "various performance tests" but does not enumerate the criteria, the reported device performance against them, or the methodology of these tests.

Therefore, I cannot fully complete the requested table and answer the study-related questions based solely on the provided text.

Here's an attempt to answer based on the available information, with specific notes about what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only generally refers to "extensive safety, performance, and validations prior to release."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided. The device is a physical tubing and connector system, and "ground truth" would likely refer to objective performance metrics (e.g., burst pressure, flow rate, biocompatibility) rather than expert interpretation of images or data.

4. Adjudication method for the test set

• Not applicable/Not specified. Given the nature of the device (physical components), an adjudication method as typically used for expert consensus on diagnostic interpretations is unlikely. Performance tests would likely involve objective measurements.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices where human interpretation is involved. This device is a cardiopulmonary bypass tubing and connector system, not an AI or diagnostic tool.

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

• No, this is not applicable for this device. This term is relevant for AI algorithms. The Gish Tubing and Connectors with HA Coating is a physical medical device. The "standalone" performance would refer to the device's inherent physical and functional properties, which the text states were "subjected to extensive safety, performance, and validations."

7. The type of ground truth used

• Implicitly, the ground truth would be objective performance specifications and safety standards. For example, tests would likely establish metrics such as:
  • Biocompatibility (e.g., according to ISO standards)
  • Flow rates (specified as 1 to 6 liters per minute)
  • Pressure resistance
  • Tensile strength
  • Leak integrity
  • Sterility
  • Non-pyrogenicity
  • Durability for up to six hours of operation.
• The document states "All materials of the Gish Tubing and Connectors are biocompatible and coated with a proprietary coating." This indicates biocompatibility testing was a factor.

8. The sample size for the training set

• Not applicable/Not specified. This device is not an AI algorithm that requires a "training set." The development process would involve iterative design, testing, and validation of physical prototypes, not machine learning training.

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

• Not applicable. (See answer to #8).

Summary of what the document does state regarding studies:

• "The Gish Tubing and Connectors with HA Coating has been subjected to extensive safety, performance, and validations prior to release."
• "Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."
• "A review of literature pertaining to the safety and effectiveness has been conducted."
• "The conclusion drawn from these tests is that Gish Tubing and Connectors with HA Coating is equivalent in safety and efficacy to its predicated devices."

The document focuses on declaring equivalence to predicate devices and adherence to internal specifications rather than detailing the specific acceptance criteria and study results.

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