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The Dideco D732 MICRO 27 Ph.I.S.I.O. with 27 micron screen with phosphoryIcholine coating is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The fitter is used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The D732 MICRO 27 Ph.I.S.I.O. is sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 7.0 liters/minute. The D732 MICRO 27 Ph.I.S.I.O. is an Adult Arterial Filter with 27 micron filter screen designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 27 microns from the arterial line perfusate. The D732 MICRO 27 Ph.I.S.I.O. is a modified version of the currently marketed D732 MICRO 20. The modification consists of coating all blood contact surfaces with phosphoryicholine additive that improves the blood compatibility of the substrate materials and change of the pleated polyester filter screen pore size from 20 to 27 micron. Other than this change the D 732 MICRO 27 Ph.I.S.I.O. and the D 732 MICRO 20 are identical in design, materials, and manufacturing processes.

This document is a 510(k) summary for the D732 MICRO 27 Ph.I.S.I.O. adult arterial filter. It focuses on demonstrating substantial equivalence to a predicate device and outlining non-clinical and in vitro test results rather than a detailed study design with acceptance criteria tables.

However, based on the provided text, I can extract the following information about the acceptance criteria and the study that proves the device meets them:

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

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "a complete battery of tests" and that "all tests were performed on sterilized aged devices comparing the D732 MICRO 27 Ph.I.S.I.O. vs. the D732 MICRO 20 non aged unmodified device." This implies multiple units were tested for each characteristic but the exact number is not provided.
• Data Provenance: Not specified. The performing laboratories or country of origin for the data are not mentioned. The document is submitted by an Italian company, but this doesn't confirm where the testing occurred.
• Retrospective or Prospective: These were likely prospective laboratory tests conducted specifically for this 510(k) submission.

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

• This information is not applicable as the described tests are in vitro and biocompatibility tests, not studies requiring expert interpretation of clinical data or images. The "ground truth" is established by adherence to recognized standards and objective laboratory measurements.

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

• This information is not applicable for these types of laboratory performance and biocompatibility studies. Adjudication methods are typically used in clinical trials or studies involving human expert assessment where there might be disagreements in interpretation.

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 an arterial filter, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• This information is not applicable. The device is a physical medical device, an arterial filter, not an algorithm.

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

• The "ground truth" for the performance characteristics and biocompatibility of the device is based on International Standards (ISO 10993-1:1995 and AAMI Standard for filtration efficiency) and FDA Guidance documents ("Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" Final Guidance for Industry, dated November 29, 2000). The product's performance is compared against predefined specifications derived from these standards and guidance.

8. The sample size for the training set:

• This information is not applicable. The device is a physical medical device that undergoes performance and biocompatibility testing, not an AI or machine learning algorithm that requires a training set.

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

• This information is not applicable for the reasons stated in point 8.

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The Dideco D731 MICRO 20 Ph.I.S.I.O., with 20 micron screen with phosphorylcholine coating and the Dideco D733 MICRO 40 Ph.I.S.I.O., with 40 micron screen with phosphorylcholine coating are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. are sterile, non-pyrogenic disposable filters for use in the arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 5.0 liters/minute. The D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. are Pediatric Arterial Filters with 20 and 40 micron filter screens designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 20 and 40 microns respectively from the arterial line perfusate. The D731 MICRO 20 Ph.J.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. are a modified version of the currently marketed D731/D733 MICRO. The modification consists of coating all blood contact surfaces with phosphoryIcholine additive that improves the blood compatibility of the substrate materials. Other than this change the D 731/D733 MICRÓ Ph.I.S.I.O. and the D 731/D733 MICRO are identical in design, materials, and manufacturing processes.

The provided document is a 510(k) summary for a medical device modification, specifically for the D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. Pediatric Arterial Filters. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against specific acceptance criteria.

Therefore, the requested information categories regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies are largely not applicable or explicitly detailed in this type of regulatory submission.

Here's an breakdown of what can be extracted or inferred from the provided text, and what cannot:

1. Table of acceptance criteria and reported device performance:

This document does not provide a table of acceptance criteria with numerical targets. Instead, it states that "The results of the testing met established specifications" for various tests. The performance is reported in terms of "comparable" or "substantially equivalent" to the unmodified predicate devices.

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

• Sample size: Not explicitly stated as a numerical count of devices tested. The document mentions "A complete battery of tests" and "Tests were performed on sterilized aged devices comparing the D731 MICRO 20 Ph.I.S.I.O. vs. the D733 non aged unmodified device and D731 MICRO 40 Ph.I.S.I.O vs. D733 non aged unmodified device". The testing for biocompatibility was performed on the D733 MICRO Ph.I.S.I.O. (accelerated aging) and the data was considered applicable to D731 MICRO 20 Ph.I.S.I.O. There's no specific "test set" size quantified for each parameter.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a regulatory submission, so the data would have been generated internally by the manufacturer or by a contracted lab. It's laboratory-based testing, not clinical data from patients.

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

• Not applicable. The "ground truth" in this context is based on objective, standardized laboratory measurements against established specifications for device performance, not expert human interpretation (like in imaging studies).

4. Adjudication method for the test set:

• Not applicable. See point 3. Testing involves objective measurements, not human 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:

• Not applicable. This document describes a medical device (arterial filter) for mechanical function and biocompatibility, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and "human readers" are irrelevant.

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

• Not applicable. See point 5. This is not an algorithm.

7. The type of ground truth used:

• Objective Laboratory Specifications and Predicate Device Performance: The "ground truth" for the test results is adherence to pre-established scientific/engineering specifications (e.g., ISO 10993 standards for biocompatibility) and performance comparability to the unmodified predicate devices.

8. The sample size for the training set:

• Not applicable. This is not a machine learning model, so there is no "training set."

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

• Not applicable. See point 8.

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The ECC.O is intended for use in patients who undergo surgical procedures requiring extracorporeal gas exchange support and blood temperature control with a maximum blood flow rate of 5 liters/minute. ECC.O must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. ECC.O is intended for use with the Stockert Centrifugal Pump Console.

The ECC.O System with Integrated Venous Air Removal Device, Centrifugal Blood Pump, Pump Bracket. Hollow Fiber Oxygenator and Heat Exchanger is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. ECC.O consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger connected to a venous air removal device (defoamer) (Ideal Mimesys' Venous Air Removal Device, K032040), a centrifugal pump (Ideal Mimesys' Centrifugal Pump, K032040) and a pump bracket.

The acceptance criteria and the study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list a table of acceptance criteria with numerical targets. Instead, it refers to compliance with established specifications and guidance documents. The reported device performance is presented as meeting these specifications.

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

The document does not explicitly state a sample size for the test set in terms of number of devices or data points used for each specific in vitro test. It generally states that "Applicable tests were carried out" and "In vitro testing was carried out."

Regarding data provenance:

• Country of Origin: Not specified for the test data, but the submitter (Dideco S.r.l.) is based in Mirandola (MO), Italy.
• Retrospective or Prospective: The testing described appears to be prospective as it involves new in vitro tests on the ECC.O system, as well as comparative testing with the D 905 EOS assembled with predicate devices. The biocompatibility data from predicate devices are used as a reference, which could be considered retrospective in a way, as it leverages prior testing. The ECC.O devices were "accelerated aged to an equivalent of three years real time aging" for some tests.

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

Not applicable in this context. This submission describes non-clinical (in vitro) testing and substantial equivalence to predicate devices, not studies involving human interpretation or clinical outcomes where expert ground truth would be established.

4. Adjudication Method for the Test Set:

Not applicable, as this is a non-clinical evaluation based on laboratory testing against established specifications and comparative performance with predicate devices.

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

No, an MRMC comparative effectiveness study was not conducted or described in this document. This submission is for a medical device (extracorporeal circulation system), not an AI-powered diagnostic or imaging interpretation tool where such studies would be relevant.

6. Standalone Performance:

Yes, a standalone performance evaluation was conducted in the sense that the ECC.O system was subjected to various in vitro tests to assess its algorithm-only equivalent performance (i.e., the device's functional and safety performance without human intervention during the test itself). The results were then compared to established specifications and the performance of predicate devices.

7. Type of Ground Truth Used:

The "ground truth" for this device evaluation is primarily based on:

• Established Specifications: Predetermined performance targets and safety limits derived from regulatory standards (e.g., ISO 10993-1, ISO 7199), FDA guidance documents (e.g., for Cardiopulmonary Bypass Oxygenators, Blood Extracorporeal Blood Circuit Defoamers), and internal validated engineering and design specifications.
• Predicate Device Performance: The functional performance of the predicate devices (D 905 EOS, Ideal Mimesys' Centrifugal Pump, Ideal Mimesys' Venous Air Removal Device) served as the benchmark for demonstrating substantial equivalence.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a "training set." The testing described is for a physical medical device.

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

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

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The Performa Adult Hollow Fiber Membrane Oxygenator is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

The Performa Adult Hollow Fiber Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.

This document describes the Performa Adult Hollow Fiber Membrane Oxygenator, a medical device, and its evaluation for substantial equivalence to a predicate device. The information provided outlines the non-clinical and in vitro testing conducted. It is important to note that this document is a 510(k) summary, which typically focuses on demonstrating equivalence to an already approved device rather than a comprehensive de novo submission requiring extensive proof of safety and effectiveness from scratch.

Here's an analysis of the provided text in the context of acceptance criteria and a study:

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

The document does not provide a specific table of acceptance criteria with numerical targets. Instead, it states that the tests "met established specifications." The "established specifications" likely refer to the requirements outlined in ISO 7199 and the FDA Guidance for Cardiopulmonary Bypass Oxygenators.

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

• Sample Size: The document does not explicitly state the sample size (number of devices) used for the non-clinical and in vitro tests. It refers to "Applicable tests" and "The Performa Oxygenator aged to 3 years was tested," implying that a certain number of devices underwent these evaluations. Without specific numbers, it's impossible to quantify the sample size.
• Data Provenance: The tests seem to have been conducted by Dideco S.r.l., which is based in Mirandola (MO), Italy. The data is in vitro and non-clinical, meaning it's from laboratory testing rather than human subjects. It is prospective testing, as the device was manufactured and then subjected to these tests to assess its performance.

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 section is not applicable to the provided document. The study described is an in vitro and non-clinical engineering and performance evaluation of a device. It does not involve human subjects, expert review of images, or clinical outcomes that would require "ground truth" established by medical experts in the way that, for example, an AI diagnostic device would. The "ground truth" here is the established scientific and engineering principles and the specifications outlined in ISO and FDA guidance documents.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where there are subjective interpretations of data (e.g., medical images, patient symptoms) that require consensus among multiple experts. The tests described are objective, measurable physical and chemical properties of the device, assessed against predefined quantitative 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

This section is not applicable. An MRMC study is relevant for diagnostic or screening devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) with and without the assistance of an AI algorithm. The Performa Adult Hollow Fiber Membrane Oxygenator is a therapeutic device (for cardiopulmonary bypass), not a diagnostic tool, and its evaluation does not involve human readers interpreting cases or AI assistance in that context.

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

This section is not applicable. "Standalone performance" in this context typically refers to the performance of an AI algorithm independent of human intervention. The Performa device is a physical medical device, not an AI algorithm. Its performance is evaluated mechanically, chemically, and biologically through in vitro tests.

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

As mentioned in point 3, the concept of "ground truth" for this type of device evaluation differs from clinical studies involving diagnostic accuracy. The "ground truth" or reference standards used are:

• Established specifications/standards: Primarily the requirements from ISO 10993-1:1997 (for biocompatibility) and ISO 7199 (for in vitro performance characteristics such as gas transfer, pressure drop, plasma leakage, heat exchange, hemolysis, operating blood volume, and mechanical integrity).
• FDA Guidance: The FDA May 1, 1995 Memorandum (for biocompatibility) and the Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions -- Final Guidance for industry and FDA Staff November 13, 2000 provided the framework and specific criteria for the in vitro testing.

These standards serve as the objective "ground truth" against which the device's performance is measured.

8. The sample size for the training set

This section is not applicable. A "training set" refers to data used to train a machine learning or AI model. The Performa oxygenator is a physical medical device, not an AI algorithm, and therefore does not have a "training set."

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

This section is not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply here.

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The Dideco D 905 EOS Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy Reservoir is intended for use in patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation with a maximum blood flow rate of 5 liters /minute. It provides oxygenation and carbon dioxide removal from venous blood. The integrated heat exchanger provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from patient's veins (gravity or vacuum assisted) during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for 6 hours or less.

The D 905 EOS Hollow Fiber Oxygenator With Integrated Hardshell Venous/Cardiotomy Reservoir (hereafter referred to as the D 905 EOS) is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and connected to an hardshell venous/cardiotomy reservoir. The device is a modified version of the currently marketed D 903 Avant 2 Ph.I.S.I.O (K033323) predicate device (hereafter referred to as the Avant Ph.1.S.I.O.). The modification is limited to an overall reduction in the size of the device. The reduction in size enables the device to be better suited for the pediatric and small adult patient population.

Here's an analysis of the provided text regarding the D 905 EOS Oxygenator, extracting information relevant to acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a dedicated table. Instead, it states that the test results "met established specifications" and that the device is "substantially equivalent" to predicate devices. The performance is reported in relation to these comparisons.

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

The document does not specify a distinct "test set" sample size for each performance characteristic. Instead, it refers to in-vitro testing performed on the "D 905 EOS" (the device itself) and, "for comparative purposes," on the "D 903 Avant 2 Ph.I.S.I.O." and the "Cobe Optimin predicate device."

• Sample Size: Not explicitly stated as a number of devices or data points for the in-vitro tests. It refers to testing the device and predicate devices.
• Data Provenance: Retrospective for the predicate devices as they are "legally marketed." Prospective for the D 905 EOS, as the testing was conducted to support its 510(k) submission. There is no mention of country of origin for the data collection, but the submitter is Italian (Dideco S.r.l.).

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

This information is not provided in the document. The studies described are in-vitro tests, which typically rely on standardized laboratory measurements and comparison to objective specifications and predicate device performance, rather than expert judgment for "ground truth."

4. Adjudication Method for the Test Set

Not applicable. As described above, the studies are in-vitro tests with objective measurements, not studies requiring expert 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

Not applicable. This device is a medical oxygenator, not an AI-based diagnostic or assistive technology that would involve "human readers" or "AI assistance" in the context of imaging or similar interpretation tasks.

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

Not applicable. The device itself is a standalone medical device. The "standalone" concept typically applies to software or AI algorithms operating independently of human intervention. Here, the device's performance was evaluated in various standalone in-vitro tests.

7. The Type of Ground Truth Used

The "ground truth" for the in-vitro performance characteristics was established by:

• Established Specifications: These would be pre-defined numerical or qualitative criteria based on regulatory guidelines, engineering principles, and clinical requirements for oxygenators.
• Predicate Device Performance: The functional parameters of the D 903 Avant 2 Ph.I.S.I.O. and Cobe Optimin served as benchmarks for demonstrating substantial equivalence.

There is no mention of pathology, outcomes data, or expert consensus (in the context of clinical interpretation) as ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not a software algorithm that would require a "training set" in the context of machine learning. The term "training set" refers to data used to train an AI model.

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

Not applicable, for the same reasons as point 8.

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The Dideco D731 MICRO 20 with 20 micron screen and the Dideco D733 MICRO 40 with 40 micron screen are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that maybe intrough the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The D731 MICRO 20 and D733 MICRO 40 are sterile, non-pyrogenic disposable filters for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 5.0 liters/minutes. The D731 MICRO 20 and D733 MICRO 40 are Pediatric Arterial Filters with 20 and 40 micron filter screens designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 20 and 40 microns respectively from the arterial line perfusate. The maximum blood flow rate has been increased to 5.0 liters/minute.

The provided document describes the Dideco D731 MICRO 20 and D733 MICRO 40 Pediatric Arterial Filters. Based on the information, here's an analysis of the acceptance criteria and the study performed:

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

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it states that "The results of the testing met established specifications" and "The results of these tests met established specifications." The reported device performance is described as comparable or substantially equivalent to the predicate devices.

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 provide a specific sample size for the "in vitro test results." It mentions that "Testing was performed on the D731 MICRO 20 and of the D733 MICRO 40 (accelerated aging)" and that "all tests were performed on sterilized aged devices." The provenance of the data is not explicitly stated, but the submission is from Dideco S.p.A. in Italy, suggesting the primary data generation might have occurred there. The testing described is prospective, as it involves evaluating the new devices against established protocols.

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 section is not applicable. The study is an in vitro and biocompatibility assessment of a physical medical device (arterial filter), not an AI or diagnostic device that requires expert ground truth establishment for patient data.

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

This is not applicable since the study is not based on human judgment or interpretation of data needing adjudication. Performance is assessed through objective laboratory 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

This is not applicable. The device is an arterial filter, not an AI-assisted diagnostic tool.

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.

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

The "ground truth" for this device's evaluation is based on pre-established specifications and validated laboratory test methods for physical and mechanical properties (e.g., structural integrity, flow rates, filtration efficiency) and ISO 10993 standards for biocompatibility. The new device's performance is then compared to these specifications and to the predicate devices.

8. The sample size for the training set

This is not applicable. The device 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 for the reasons mentioned in point 8.

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The Dideco D 903 Avant Adult Hollow Fiber Oxygenator with Integral Hardshell Venous Reservoir is intended for use in adults who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation. It provides oxygenation and carbon dioxide removal from venous blood. The integrated on other provides blood temperature control and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. The venous reservoir with cardiotomy filter is intended to collect blood aspirated from the operating field during surgical procedures and the blood from to tient's veins (gravity or vacuum assisted) during normal operation to assure the proper oxygenation capability of the device. The device is intended to be used for six hours or less.

The D 903 AVANT and D 903 AVANT 2 Ph.I.S.I.O, hereafter referred to as the AVANT, are hollow fiber membrane oxygenators with integral heat exchanger and a hardshell cardiotomy/venous reservoir. The D 903 AVANT 2 Ph.I.S.I.O. is the phosphorylcholine coated version of the same AVANT oxygenator. The change covered by this submission is limited to extending the intended use of the AVANT (uncoated and coated versions) in order to allow the use of active venous drainage with vacuum. No modifications are being made to the devices themselves except an addition to the indications for use and instructions for use.

This is a 510(k) premarket notification for a medical device, the D 903 AVANT Adult Hollow Fiber Oxygenator. These notifications are about demonstrating substantial equivalence to a predicate device, not necessarily defining or proving new acceptance criteria through a clinical study in the way an AI/ML device submission would. Therefore, many of the requested categories for AI/ML study details (like sample size for test sets, number of experts, MRMC studies, training set details) are not applicable here.

Here's a breakdown of the available information in the context of your request:

Acceptance Criteria and Device Performance

The "acceptance criteria" here are implicitly defined by the performance characteristics of the predicate devices and the relevant standards. The "reported device performance" is a demonstration of substantial equivalence to these predicate devices.

• Performance characterization
• Physical effectiveness characterization/integrity |
  | Blood Compatibility (for coated version) | "Blood compatibility characterization and stability of the coating were performed on the AVANT Ph.I.S.I.O. predicate device (K020351)." This included "hemolysis/cell depletion characterization, microembolic activity characterization, and reservoir housing integrity during active venous drainage." "The results of these tests met established specifications." |
  | Intended Use with Vacuum Drainage | The submission specifically addresses the extension of intended use to include active venous drainage with vacuum. The above tests (e.g., reservoir housing integrity during active venous drainage) would cover this. "functional tests demonstrate that the AVANT is equivalent to the predicate devices, with respect to its intended use with vacuum drainage." |
  | Equivalence to Predicate Devices | "The results of the study showed the device characteristics of the modified AVANT and predicate devices are comparable." "The results of in vitro studies demonstrate that the AVANT Adult Hollow Fiber Membrane Oxygenator performs in a manner substantially equivalent to the predicate device." |

Study Details (as applicable to a 510(k) for a non-AI/ML device)

1. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device. This submission focuses on in vitro and biocompatibility testing of a physical medical device. The "test set" would refer to the physical samples of the oxygenator or its materials subjected to various tests. The provenance is the manufacturer's testing facilities (Dideco S.p.A., Italy).
2. 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 is established by standardized laboratory measurements and compliance with ISO standards, not expert consensus in the diagnostic sense.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for subjective assessments or discrepancies in diagnostic interpretations, not for objective measurements of physical device performance.
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: Not applicable. This is for a physical medical device, not an AI/ML diagnostic algorithm.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is compliance with established international standards (ISO 10993-1:1995, ISO 7199 (1996)) and FDA guidance documents, as well as objective measurements of physical and chemical properties of the device and its materials.
7. The sample size for the training set: Not applicable. This is for a physical medical device, not an AI/ML device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) premarket notification demonstrates substantial equivalence for a physical medical device based on in vitro performance data and biocompatibility testing, not an AI/ML diagnostic product, so many of the requested AI/ML-specific details are not present.

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The Dideco D735 MICRO 20 with 20 micron screen and the Dideco D736 MICRO 40 with 40 micron screen are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

The D735 MICRO 20 and D736 MICRO 40 are sterile, non-pyrogenic disposable filters for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 2.5 liters/minute. The D735 MICRO 20 and D736 MICRO 40 are Newborn-Infant Arterial Filters with 20 and 40 micron filter screens designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 20 and 40 microns respectively from the arterial line perfusate. The bypass connector has been eliminated in the modified versions of the D736 predicate devices resulting in enhanced ergonomics. In addition, the maximum blood flow rate has been increased to 2.5 liters/minute, in order to be consistent with the maximum flow rate of the cleared D736 MICRO Ph.I.S.I.O. modified device (K002493).

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify exact sample sizes for each in-vitro test. However, it states that "all tests were performed on sterilized aged devices" comparing the D735 MICRO 20 (operated at 2.5 LPM) against its D735 predicate device (operated at 2.0 LPM), and the D736 MICRO 40 (operated at 2.5 LPM) against its D736 predicate device (operated at 2.0 LPM).

The data provenance is retrospective, as the testing was performed on aged devices, and the entire document is a 510(k) submission, which is a premarket notification process based on demonstrating substantial equivalence to a legally marketed predicate device. The country of origin for the submitter is Italy (Dideco S.p.A., Mirandola, MO, Italy).

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

Not applicable. This device is a medical filter, and its performance is evaluated through objective physical and biological in-vitro tests, not through expert-based assessment of diagnostic images or clinical outcomes. Therefore, there is no "ground truth" established by experts in the typical sense of a clinical study.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation relies on objective in-vitro test results against established specifications, not human adjudication of subjective data.

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 a diagnostic device involving human readers or AI.

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

Not applicable. This is not an algorithmic device. The device itself is a physical filter.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of this medical device is based on pre-defined, objective experimental specifications for physical and biocompatibility characteristics, aligned with relevant guidance documents (e.g., "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" and ISO 10993-1:1995). The comparison is against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable, as there is no training set.

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The MVR 1200 PC is intended for use as a storage reservoir for blood in an extracorporeal bypass circuit for periods up to six hours.

Sorin Monolyth Venous Reservoir 1200 PC with Phosphorilcholine coating (hereafter referred to as the MVR 1200 PC) is a soft, flexible polyviny chloride plastic bag designed for use during extracorporeal bypass surgery as in-line venous bag reservoir. Blood contact surfaces of the MVR 1200 PC have been coated with phosphorylcholine (PC) coating improves blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.

The provided text describes the submission of a 510(k) premarket notification for the "MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with phosphorylcholine coating". This is a medical device, and the information focuses on demonstrating its substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and performance against those criteria in the way one might for a diagnostic AI/ML device.

Therefore, many of the requested categories for AI/ML device studies (like expert-established ground truth, MRMC studies, sample sizes for training/test sets, adjudication methods, and effect sizes) are not applicable to this type of device submission.

However, I can extract the relevant "acceptance criteria" and "device performance" in the context of this traditional medical device submission, which primarily revolves around biocompatibility, functional equivalence, and safety.

Here's a breakdown of the available information structured to best answer your query given the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials or AI/ML datasets. The testing involved various in vitro and biocompatibility tests on the device itself.
• Data Provenance: The device tested was the MVR 1200 PC, which was subjected to accelerated aging up to three years. The data provenance is from tests conducted on this manufactured device. There is no mention of "country of origin of the data" in terms of patient data, nor is it retrospective or prospective in the clinical trial sense. The studies were laboratory-based.

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

• Not Applicable. This is a physical medical device. "Ground truth" in this context refers to the defined specifications and standards (e.g., ISO 10993-1995, FDA guidance documents) against which the device's physical and biological performance is measured. It does not involve expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

• Not Applicable. As above, the tests are laboratory-based measurements against established technical and biological specifications, not qualitative assessments 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

• No. This is not an AI/ML device involving human readers or comparative effectiveness studies of that nature.

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

• No. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this device's performance is established by well-defined international standards (ISO 10993-1995) and FDA guidance documents for biocompatibility and in vitro functional testing of blood-contacting medical devices. The device's performance is assessed against these established specifications and against the performance of predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that uses a "training set."

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

• Not Applicable. No training set was used.

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Ideal Mimesys is intended to be used in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control. Ideal Mimesys must not be used longer than 6 hours. Contact with blood for longer periods is inadvisable. Ideal Mimesys is intended for use with the Stöckert Centrifugal Pump Console.

IDEAL MIMESYS System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter Mimesys Treated (PhosphoryIcholine coating hereinafter called PC coating) is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. IDEAL MIMESYS consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter (Synthesis Mimesys Adult Membrane Oxygenator, K031223) connected to an active venous air removal device (defoamer), a centrifugal pump (Cobe Revolution Centrifugal Blood Pump with PC coating, K030462) and a pump bracket.

The provided text describes the 510(k) summary for the IDEAL MIMESYS System. Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided document, but rather are implicitly defined by meeting established specifications and demonstrating substantial equivalence to predicate devices. The reported device performance is described qualitatively.

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

The document does not explicitly state the numerical sample size for the test set. It mentions that "a complete battery of tests were carried out" and "in vitro testing were carried out."

• Data Provenance: Not explicitly stated regarding country of origin. The studies appear to be prospective in nature, as they involve performing tests on newly manufactured devices (including aged devices) to evaluate their performance against established specifications and predicate devices.

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

This information is not provided in the document. The studies are primarily focused on in vitro and biocompatibility testing of the medical device itself, rather than diagnostic interpretation requiring expert human assessment to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The studies involve laboratory and engineering testing, not human interpretation that requires 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 and therefore not provided. The device is an extracorporeal blood circuit system, not an AI-assisted diagnostic tool.

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

This information is not applicable and therefore not provided. The device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is based on:

• Established Specifications: Compliance with pre-defined performance and safety parameters.
• Predicate Device Performance: Demonstrating substantial equivalence to the performance of legally marketed predicate devices through comparative testing.
• Regulatory Guidance Documents: Adherence to requirements outlined in FDA guidance documents (e.g., "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions") and international standards (e.g., ISO 10993-1:1995, ISO 7199 (1996)).

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. As this is a medical device and not an AI/machine learning algorithm, there is no "training set" in the conventional sense. The development of the device would involve engineering, design, and manufacturing processes, with validation through the described testing.

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

This information is not applicable and therefore not provided for the same reason as point 8.

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