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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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Synthesis Mimesys is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 um. Synthesis Mimesys is an adult oxygenator intended for use in operations on adult patients. Synthesis Mimesys must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.

SYNTHESIS MIMESYS Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated is a high efficiency microporous hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter and connected to a hardshell cardiotomy venous reservoir.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Dideco S.p.A. Synthesis Mimesys Hollow Fiber Oxygenator:

Acceptance Criteria and Device Performance

The provided document describes the SYNTHESIS MIMESYS Adult Membrane Oxygenator and its substantial equivalence to predicate devices. The acceptance criteria for this device are primarily demonstrated through in vitro testing and biocompatibility assessments, aligning with established industry standards and FDA guidance. The reported device performance indicates that the SYNTHESIS MIMESYS met these established specifications.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

The provided text describes a submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices. This is not a study designed to prove the device meets pre-defined acceptance criteria in the same way a clinical trial might, but rather to show it performs as safely and effectively as existing devices.

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

   • Test Set (In Vitro): The document references testing performed on the "device aged up to 3 years." It does not specify the exact number of devices tested in the in vitro studies.
   • Data Provenance: The studies are described as "in vitro testing" carried out in accordance with FDA guidance and ISO standards. The location of these labs is not explicitly stated, but the manufacturer is Dideco S.p.A. in Italy, suggesting the primary testing was likely conducted in Europe or by contracted labs. The data is retrospective in the sense that it refers to testing of the manufactured product.

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

   • This type of information (expert review for ground truth) is not applicable to this submission, as it relates to a medical device's engineering and biological performance rather than diagnostic accuracy.

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

   • Not applicable. Adjudication methods are typically employed in clinical studies or imaging-based diagnostic trials where expert consensus is needed to establish ground truth for a subjective assessment. This submission relies on objective, measurable performance characteristics.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools, not for a hollow fiber oxygenator.

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

   • Not applicable. This device is a medical device, not an algorithm. Its performance is assessed independently of human operators for its intrinsic function.

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

   • The "ground truth" for the in vitro tests was established by pre-defined specifications and established scientific and engineering standards (e.g., ISO 10993-1:1995 for biocompatibility, ISO 7199 (1996) and FDA guidances for oxygenators for performance). For biocompatibility, this involves laboratory analysis against toxicity thresholds. For in vitro performance, it involves direct measurement of physical and physiological parameters against engineering targets.

7. The sample size for the training set:

   • Not applicable. This submission is for a physical medical device. There is no "training set" in the context of machine learning algorithms for this product. The design and manufacturing processes are refined through engineering development and testing, not algorithmic training.

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

   • Not applicable for the reasons stated above.

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

The Ideal, System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Holder, Adult Membrane Oxygenator, Heat Exchanger and Arterial Filter is an extracorporeal hemodynamic and gas exchange support system for extracorporeal perfusion. The Ideal consists of a high efficiency, microporous, hollow fiber membrane oxygenator integrated with a heat exchanger and an arterial filter (Synthesis Adult Membrane Oxygenator, K022450), connected to an active venous air removal device (defoamer), a centrifuqal pump (Cobe Revolution Centrifyial Blood Pump. K011835) and a pump bracket.

The provided text describes the Dideco S.p.A. IDEAL System, an extracorporeal hemodynamic and gas exchange support system, seeking 510(k) clearance. The submission focuses on demonstrating substantial equivalence to predicate devices (Synthesis Adult Membrane Oxygenator and Cobe Revolution Centrifugal Blood Pump) rather than establishing new performance criteria or conducting a standalone effectiveness study.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't define explicit acceptance criteria in terms of specific thresholds for the IDEAL system. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices across several characteristics. The reported device performance is primarily a statement of comparability.

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

• Sample Size: The document does not explicitly state numerical sample sizes for the "in vitro test results." It mentions that "the device aged up to 3 years was tested for operating blood volumes, hemolysis/cell depletion, mechanical integrity and air handling characterization." It also states "the same testing, when applicable, has been conducted also on the Synthesis and Revolution predicate" for comparative purposes. This implies tests were performed on at least one IDEAL device and comparable predicate devices, but exact numbers of units tested are not provided.
• Data Provenance: The testing was carried out in vitro, following FDA guidance documents and ISO standards. The country of origin of the data is not specified beyond the manufacturer being Dideco S.p.A. (Italy). The data is presumably prospective for the IDEAL system tests performed for this submission, although some reference is made to "previous in-vitro data" for the Synthesis predicate.

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

This type of information is not applicable to this submission. The "ground truth" for this device is based on physical and chemical performance measurements (e.g., blood volumes, hemolysis, air removal) against established engineering specifications and comparison to predicate devices, not on expert interpretations of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" concept is typically used in clinical studies or studies involving human readers, where discrepancies in interpretation need to be resolved. This submission describes in-vitro performance testing, which does not involve human readers for ground truth establishment or adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with and without AI assistance, which is irrelevant for a device like the IDEAL system.

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

Yes, a standalone study (in vitro testing) was done. The entire "In Vitro Test Results" section describes the performance of the IDEAL device itself (without human intervention in its function) against specific standards and in comparison to predicate devices. This testing evaluated the device's functional performance directly.

7. The Type of Ground Truth Used

The ground truth for the in-vitro performance tests was based on:

• Established specifications derived from relevant FDA guidance documents ("Guidance for Cardiopulmonary Bypass Oxygenators," "Guidance for Blood Extracorporeal Blood Circuit Defoamer," "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter") and ISO 7199 (1996) standard.
• Performance data from the legally marketed predicate devices (Synthesis Adult Membrane Oxygenator and Cobe Revolution Centrifugal Blood Pump), which served as the benchmark for "substantial equivalence."

8. The Sample Size for the Training Set

Not applicable. This device is a medical mechanical/biological system, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of AI model development.

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

Not applicable. As stated above, there is no training set for this type of device.

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The Dideco DHF Hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.

The Dideco DHF Hemoconcentrator is a hollow fiber type hemoconcentrator consisting of an external transparent housing with two filtrate ports on the cylindrical body and a fiber bundle. These fibers are bonded within the housing with polyurethane. A transparent blood header cap with a male Pos-Lock port is bonded to each end of the housing.

The provided document is a 510(k) premarket notification for a medical device, the Dideco DHF Hemoconcentrator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with specific acceptance criteria and detailed performance metrics as one might find for a novel AI/software medical device.

Therefore, many of the requested points regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies are not applicable or
not explicitly detailed in this type of submission. The 'acceptance criteria' here refer to the performance specifications the device must meet to be considered equivalent to existing devices and safe for its intended use.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance for Dideco DHF Hemoconcentrator

The Dideco DHF Hemoconcentrator underwent non-clinical and in vitro testing to demonstrate compliance with safety and effectiveness requirements and substantial equivalence to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific numerical values or ranges. Instead, it states that the results of the tests "met established specifications" and showed "comparable or even better performances" with respect to the predicate devices. The types of performance criteria evaluated are listed.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact number of devices or repeat tests performed for each in vitro and non-clinical test. It states "The results of these tests carried out on the DHF 0.6 and DHF 0.2 Hemoconcentrators aged to 5 years met established specifications." This implies multiple units of each model were tested.
• Data Provenance: Not explicitly stated, but based on the submitter's location (Italy) and adherence to international (ISO, EN) and US (FDA) standards, the testing was likely conducted in a laboratory setting, potentially in Italy or a contracted facility. The data is retrospective in the sense that the tests were performed before the 510(k) submission.

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

N/A. This is a medical device (hardware) submission focused on physical and biological performance characteristics, not an AI/software device requiring expert interpretation for ground truth establishment. The "ground truth" here is determined by objective measurements and standardized test methods.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like '2+1' or '3+1' are typically used for establishing ground truth in image interpretation or diagnostic studies, which is not applicable to the in vitro and non-clinical testing of a hemoconcentrator.

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

N/A. This type of study is relevant for AI-assisted diagnostic tools where human reader performance is a key metric. The Dideco DHF Hemoconcentrator is a physical device used during cardiopulmonary bypass; it is not an AI/software tool, and human interpretation of outputs in the clinical context is not evaluated in this way in this submission.

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

N/A. The device is a physical hemoconcentrator. The tests performed are "standalone" in the sense that they evaluate the device's inherent properties and performance without human interaction as part of the test itself (though a human operates the test equipment).

7. Type of Ground Truth Used

The "ground truth" for the performance characteristics was established through:

• Established Specifications/Standards: Reference to ISO 10993-1:1997, FDA May 1, 1995 Memorandum, FDA "Guidance for the Content of Premarket Notifications for Conventional and High permeability Hemodialyzers" (1998), and EN 1283:1996 when applicable. These documents define the accepted test methods and, implicitly or explicitly, the performance thresholds for safety and effectiveness.
• Predicate Device Performance: The primary comparative "ground truth" was the established performance of the legally marketed predicate devices (Cobe HC 700 Midi Hemoconcentrator (K003023) and Hemocor HPH 400 Hemoconcentrator (K923139)). The new device was deemed acceptable if its performance was "comparable or even better" than these predicates.
• Objective Measurements: Laboratory measurements of physical properties (priming volume, pressure drop, ultrafiltration rate, sieving coefficient, mechanical integrity) and biological indicators (plasma free hemoglobin, index of hemolysis) against predefined limits.

8. Sample Size for the Training Set

N/A. This submission does not involve a "training set" as it is not an AI/machine learning device. The tests are for device validation, not model training.

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

N/A. See point 8.

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The Synthesis is intended for use in cardiopulmonary bypass circuits as substitute for the lungs (transfer of oxygen and removal of carbon dioxide), to control the arterial/venous temperature, and as venous blood reservoir and filter element to eliminate gas emboli and remove blood component aggregates larger than 40 um. The Synthesis is an adult oxygenator intended for use in operations on adult patients. Synthesis must not be used for longer than 6 hours. Contact with blood for longer periods is inadvisable.

The Synthesis Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir Mimesys treated is a high efficiency microporous hollow fiber membrane oxygenator integrated with an heat exchanger and with an arterial filter and connected to a an hardshell venous/cardiotomy reservoir.

The provided text discusses the SYNTHESIS Adult Membrane Oxygenator With Integrated Arterial Filter and Hardshell Venous/Cardiotomy Reservoir, hereafter referred to as "the device." The information describes its characteristics, indications for use, and the studies conducted to demonstrate its substantial equivalence to predicate devices.

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

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

The document does not explicitly list "acceptance criteria" in a typical quantitative pass/fail table format. Instead, it states that various tests "met established specifications" and that the device was found to be "comparable to the predicate devices concerning with all characteristics" and "substantially equivalent" in relevant functional parameters.

Therefore, the "acceptance criteria" are implied to be the established specifications and performance characteristics of the predicate devices. The "reported device performance" is that it met these specifications and demonstrated substantial equivalence.

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 specify the exact numerical sample sizes for the "test set" for any of the in vitro or biocompatibility tests. It states that "A complete battery of tests were carried out" and "In vitro testing were carried out."
• Data Provenance: The studies were performed by the manufacturer, Dideco S.p.A., located in Mirandola (MO), Italy. The tests were conducted according to US FDA guidance documents and international ISO standards. The data is prospective, as it describes a series of tests performed on the device.

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 product is a medical device (oxygenator, filter, reservoir) for cardiopulmonary bypass. The evaluation of its performance relies on objective laboratory testing and adherence to published performance standards and guidance documents, not on human expert interpretation of data like in an imaging study. Therefore, the concept of "experts used to establish ground truth" with specific qualifications in the context of interpretation (e.g., radiologists) is not applicable here.

The "ground truth" for device performance is defined by the established specifications and requirements outlined in the relevant guidance documents and ISO standards (e.g., ISO 10993-1, ISO 7199, FDA guidances for oxygenators, defoamers, and arterial filters). The experts involved would be the engineers, scientists, and technicians who designed the tests, performed them, and analyzed the results according to these standards, but their number and specific qualifications are not detailed.

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

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where subjective expert opinion is used to establish ground truth from complex medical data (e.g., images for diagnostic AI). For this device, the tests are primarily objective laboratory measurements against predefined performance metrics and specifications. Therefore, an adjudication method in the sense of resolving conflicting expert opinions is not applicable. The results are either within specifications or they are not.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study design is used for evaluating diagnostic or interpretive AI systems that assist human readers (e.g., radiologists interpreting images). The device in question is a mechanical medical device, not an AI system.
• Effect Size of Human Readers with/without AI: Not applicable, as there is no AI component or human reader interaction with an AI system described for this device.

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

No, a standalone (algorithm only) performance study was not done. This concept is typically relevant for AI algorithms. The studies performed were in vitro laboratory tests evaluating the device's physical and functional performance (e.g., gas transfer, filtration, biocompatibility) as a standalone medical product. While these tests evaluate the device without a human "in-the-loop" in the sense of interpretation, it's not an "algorithm only" study as understood in the context of AI.

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

The "ground truth" for the performance of this medical device is established by:

• Referenced Standards and Guidances: Adherence to established international standards (ISO 10993-1, ISO 7199) and US FDA guidance documents for cardiopulmonary bypass oxygenators, defoamers, and arterial filters. These documents define the accepted performance metrics and test methodologies.
• Predicate Device Performance: The functional and safety characteristics of the legally marketed predicate devices (D 903 Avant 2 Ph.I.S.I.O. and D 734 Micro 40u Arterial Filter) served as the benchmark for substantial equivalence. The "ground truth" is that the new device must perform comparably or equivalently to these established devices across all functional parameters.
• Established Specifications: The document repeatedly refers to "established specifications" for various tests, which represent the target performance metrics that the device must meet.

8. The sample size for the training set

This device is a physical medical device, not an AI model. Therefore, the concept of a "training set" (used to train a machine learning algorithm) is not applicable.

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

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

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The Dideco electa is indicated for intraoperative and postoperative recovery of blood, washing of the processed blood, and pre-operative sequestration (with indirect and direct patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.

The Dideco electa consists of hardware and disposables. It is the next generation of the Dideco autotransfusion device family. The main elements of the hardware include the centrifuge, blood pump, automatic clamps, control and monitoring sensors, and a user interface (display panel and keyboard). The modifications to the disposables are the addition of a bar code to the addition of a tubing cassette to simplify disposables installation.

The provided submission for the Dideco electa autotransfusion device is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics through detailed studies against acceptance criteria. Therefore, the document does not contain the specific information requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement in a multi-reader multi-case (MRMC) study.

The submission primarily relies on a side-by-side comparison of features and intended uses to establish equivalence.

Here's a breakdown of what the document does state in relation to your request, and where it falls short:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of quantitative acceptance criteria for the electa's performance (e.g., specific hematocrit recovery rates, wash efficiency, or red blood cell viability). Instead, it provides a "Side-by-Side Comparison of the electa and Predicate Devices" (Table I-1 in section 6 and continued in section 7). This table compares various characteristics such as:

• Intended Use: Identical to predicate devices (Pre-operative Sequestration, Intraoperative/Postoperative recovery, PPP, PRP, etc.)
• Typical Clinical Applications: Mostly identical, with some predicates "not specified" for certain surgical specialties where the electa is indicated.
• Operating Modes: All devices (electa and predicates) have Automatic, Semi-automatic, and Manual modes, and are pre-programmed and reprogrammable.
• Processing Phases: All devices perform Prime (Fill), Wash, Empty, Return, and Concentrate.
• Disposables: electa uses 55, 125, 175, and 225 mL bowl sizes, similar to Dideco ABMS, but different from COBE BRAT II (135, 250 mL). All are sterile, single-use, and disposable.
• Features: The electa has additional features compared to its direct predicate (Dideco ABMS) and some features not present in COBE BRAT II (e.g., Cardiotomy weighing system, Hematocrit sensor, Free hemoglobin sensor, Pressure occlusion sensor, Blood loss sensor, Bar code reader, Level sensor, Smart card, Continuous operation capability). It also shares features like Air bubble sensor, Buffy coat sensor, and Vacuum pump with some predicates.
• Operating Parameters:
  • Centrifuge speeds (RPM): electa (1500-5600) is identical to Dideco ABMS, and wider than COBE BRAT II (4400).
  • Pump speeds (mL/min): electa (25-1000) is identical to Dideco ABMS, and within the range of COBE BRAT II (25-1300).
  • Blood source for PPP/PRP: All devices can use Patient or bag.
  • PPP collection parameters: Similar to Dideco ABMS and COBE BRAT II (50 mL/min, 5600 RPM or 4400 RPM for COBE).
  • PRP collection parameters: Similar to Dideco ABMS and COBE BRAT II (50 mL/min, 2400 RPM or 4400 RPM for COBE).
  • Vacuum level: electa (0 to 300 mmHg) is comparable to COBE BRAT II (50-300 mmHg).

The document states, "Dideco S.p.A. believes that the electa is substantially equivalent to the Dideco ABMS, COBE Brat II, and other currently marketed automated autotransfusion devices, that any differences are minor, and raise no new issues of safety and effectiveness."

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

• The document mentions "performance testing that demonstrate compliance with performance specifications" (Section 7). However, it does not provide any specific sample sizes for this testing, nor does it detail the nature of the "test set" (e.g., patient samples, simulated blood, etc.).
• There is no information on data provenance (e.g., country of origin, retrospective or prospective).

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 in the document. As performance data itself is not presented in detail, the method of establishing ground truth for such data (if any was used for comparison) is absent.

4. Adjudication method for the test set:

• This information is not provided in the document.

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 an autotransfusion device, not an AI diagnostic imaging or analysis tool. Therefore, an MRMC study and the concept of "human readers improving with AI assistance" are not applicable to this type of device and are not mentioned in the submission.

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

• As above, this is an autotransfusion device, not an AI algorithm. The concept of "standalone algorithm performance" is not applicable and not mentioned. The device's performance would be evaluated in the context of its function in processing blood, typically by comparing output parameters (like hematocrit) to established standards.

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

• The document does not specify the type of ground truth used for any performance testing. For an autotransfusion device, ground truth would typically refer to gold standard measurements of blood components (e.g., laboratory analysis of hematocrit, red blood cell count, hemolysis) of the processed blood, and possibly clinical outcomes related to re-infusion. This level of detail is absent.

8. The sample size for the training set:

• As this is not an AI/ML device, the concept of a "training set" in that context is not applicable. The device's operation is based on established engineering principles and pre-programmed parameters, not a learned model from a training set.

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

• Again, not applicable as it's not an AI/ML device with a training set.

In summary:

The provided 510(k) summary for the Dideco electa focuses on demonstrating substantial equivalence to predicate devices based on design characteristics and intended use, rather than presenting detailed performance study results against specific acceptance criteria. Consequently, most of the specific questions about study design, sample sizes, ground truth, and expert involvement for a performance study are not addressed in this document. The "testing" section (Section 7) is very brief, stating only that electrical testing, electromagnetic compatibility testing, and performance testing were supplied to demonstrate compliance with performance specifications, without providing specifics of those tests or their results.

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