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The device is indicated for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

The device is indicated to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device is indicated for use for 6 hours or less.

KIDS Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and they can be used up to 6 hours.

The KIDS Arterial Filters are the modified version of the disposables currently marketed in the D130 PH.I.S.I.O. Dideco Kids Neonatal Arterial Filter (K063255) and the D131 PH.I.S.I.O. Dideco Kids Infant Arterial Filter (K072308).

The provided text is a 510(k) premarket notification for a medical device called "KIDS Arterial Filters." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain any information about acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test or training sets, expert review processes, or any form of AI/ML performance study.

The document explicitly states:

• "No clinical testing was conducted in support of the KIDS Arterial Filters, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use." (Page 7, Section VIII. Clinical Performance Data)
• The performance data is described as "Non-Clinical Performance Data" and states: "Sorin Group Italia S.r.l. has conducted extensive verification and validation testing of the KIDS Arterial Filters... The KIDS Arterial Filters comply with all the applicable voluntary standards related to Arterial Filters. The devices passed all the testing in accordance with national and international standards." (Page 7, Section VII. Non-Clinical Performance Data)

Therefore, based on the provided text, I cannot answer the questions related to the acceptance criteria and the study proving the device meets these criteria in the context of AI/ML device performance or clinical study results.

The device is a physical medical device (an arterial filter), not an AI/ML software device, and its approval is based on substantial equivalence to existing devices through non-clinical testing and adherence to standards, not through clinical performance metrics or AI algorithm validation.

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The devices are recommended for use on 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 may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised.

MICRO Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bvpass.

These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and thev can be used up to 6 hours.

The MICRO Arterial Filters are the modified version of the following currently marketed devices:

a) the D734 Micro 40 included in the Dideco Micro 20 & 40 Adult Arterial Filter (K952270) and in the Dideco MICRO 40 Ph.I.S.I.O. Adult Arterial Filter (K040184); b) the D736 Micro 40 included into the Dideco Newborn/Infant Arterial Filters, 20/40 Micron (K961869) and in the D735 MICRO 20, Dideco D735 Micro 20 Newborn-Infant Arterial Filter with 20 micron screen and for D736 MICRO 40, DIdeco D736 Micro 40 Newborn-Infant Arterial Filter with 40 micron screen (K033987);

c) the D733 Micro 40 included in the D731 Micro 20 and D733 Micro 40 Pediatric Arterial Filters (K041061) and in the D731 MICRO 27 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. Arterial Filters (K112525).

This document is a 510(k) summary for the MICRO Arterial Filters, detailing their substantial equivalence to previously cleared predicate devices. It focuses on the device's technical characteristics and non-clinical performance data, rather than providing specific acceptance criteria and study results in the context of an AI/human reader performance study.

Therefore, most of the requested information regarding acceptance criteria, study design for AI evaluation, sample sizes, expert ground truth establishment, MRMC studies, and training set details for an AI-powered device cannot be extracted from this document because it describes a hardware medical device (a filter), not an AI/software as a medical device (SaMD).

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

Information that CAN be extracted:

• Device Name: MICRO Arterial Filters
• Regulation Number/Name: 21 CFR 870.4260, Cardiopulmonary Bypass Arterial Line Blood Filter
• Regulatory Class: Class II
• Product Code: DTM
• Applicant: SORIN GROUP ITALIA S.R.L.
• Indications for Use: "The devices are recommended for use on 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 may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised."
• Device Description: Single-use, non-toxic, non-pyrogenic fluid path devices, sterile and individually packaged, made of plastic (mainly PVC) and a silicon filtering net. Used for up to 6 hours. Modified versions of existing devices, with changes to tubing material (removal of DEHP) and silicon formulation of the valve's diaphragm. Ethylene oxide sterilized.
• Predicate Devices: Multiple predicate devices listed by 510(k) number and trade name (e.g., K952270 DIDECO ADULT ARTERIAL FILTERS).
• Type of Study (General): Non-clinical performance data (verification and validation testing) was conducted to demonstrate substantial equivalence.
• Clinical Performance Data: "No clinical testing was conducted in support of the MICRO Arterial Filters, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."
• Ground Truth Type (for this device's testing): Implied to be based on adherence to applicable voluntary standards and "proven safety and efficacy" of predicate devices through non-clinical testing.

Information that CANNOT be extracted (as this is not an AI/SaMD submission):

• A table of acceptance criteria and the reported device performance (in the context of AI metrics like sensitivity, specificity, AUC): Not applicable for this hardware device. Acceptance criteria would relate to physical performance (e.g., filtration efficiency, pressure drop, biocompatibility), which are not explicitly detailed here beyond a general statement of compliance.
• Sample sizes used for the test set and the data provenance: Not applicable. Testing was likely bench testing, not a clinical study on human data.
• 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 filter device is based on engineering specifications and material science, not expert image interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While "ground truth" exists for the filter's performance, it's not in the AI/clinical interpretation sense. It's about meeting engineering and biocompatibility standards.
• The sample size for the training set: Not applicable (no AI model).
• How the ground truth for the training set was established: Not applicable (no AI model).

To summarize, this document describes the FDA clearance of a medical device (an arterial filter) based on "substantial equivalence" to existing hardware devices, primarily through non-clinical performance testing (bench-top testing, material compatibility, etc.). It does not involve any AI/machine learning components or associated studies on human or expert annotated data.

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The OCS™ Heart Leukocyte Depleting Filter is indicated for the reduction of leukocytes from donor blood prior to its introduction into the OCS™ Heart System for the preservation of a donor heart from the same donor.

The OCS™ Heart Leukocyte Depleting Filter is a sterile, single-use filter intended for depletion of leukocytes in donor blood prior to its introduction into the OCS Heart system. The polycarbonate housing is 3.2" high and 3.0" in diameter. It has 1/4" fittings and includes a hydrophobic gas-permeable membrane and vent port to allow air to efficiently vent during priming and use. The leukocyte depleting material is a melt blown polyester media supplied by Pall Biomedical (the same material as is used in the predicate device). It has 6 layers, approximately 5 pleats per inch. It includes a polypropylene extruded diamond mesh that provides support for the polyester filter media. The priming volume is 273.5 mL and the anticipated flow rate (associated with gravity feed from a blood collection bag) is 1.9 L/min. During use, the blood enters through the inlet port, flows through the filter media to the interior of the filter element, and then exits through the outlet port. The device is sterilized by ethylene oxide and is provided in a Tyvek pouch packaged in a corrugated box.

This document describes the TransMedics, Inc. OCS™ Heart Leukocyte Depleting Filter, for which a 510(k) premarket notification (K231362) was submitted. The device is a sterile, single-use filter intended to reduce leukocytes from donor blood before it is introduced into the OCS™ Heart System for heart preservation. The submission claims substantial equivalence to the legally marketed predicate device, LeukoGuard BC2 (K902518) by Pall Biomedical.

The document does not contain a table of acceptance criteria or specific reported device performance values for the OCS™ Heart Leukocyte Depleting Filter, nor does it detail a study that explicitly proves the device meets these criteria with quantitative results. Instead, it broadly states that "Bench testing has demonstrated acceptable performance of the device, that it meets all acceptance criteria and that the OCS Heart Leukocyte Depleting Filter is acceptable for clinical use."

However, based on the provided information, we can infer some aspects related to its performance and the studies conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

As mentioned, a direct table is not present. However, the document lists areas of testing that imply acceptance criteria would be related to:

• Leukocyte and platelet depletion: The device is expected to effectively deplete leukocytes (and platelets). It's stated that the proposed device removes more leukocytes and platelets due to its larger size, implying higher effectiveness in this aspect. For the predicate, the acceptance criteria would be established historical performance data.
• Filtration time: The device must filter blood within an acceptable timeframe.
• Hold-up volume, priming volume, and pressure drop: These physical characteristics must be within specifications.
• Maximum flow rate: The device must be compatible with the OCS Heart system's flow requirements (antecedently, 1.9 L/min).
• Structural integrity: The filter must maintain its structural integrity during use.
• Hemolysis: The device should not cause excessive hemolysis.
• Biocompatibility: Meet ISO 10993-1 standards (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility, Genotoxicity, Pyrogenicity, USP Physicochemical Test for plastics).
• Sterility: Achieve a sterility assurance level (SAL) of 10^-6.
• Shelf life: Maintain integrity and performance for 12 months.

Reported Device Performance:
The document states that "The testing demonstrated that the OCS Heart Leukocyte Depleting filter met all specifications and was shown to be equivalent to the predicate device."
Specifically, regarding leukocyte and platelet depletion, it mentions: "The OCS Heart Leukocyte Depleting Filter is larger (273.5 mL priming volume compared to 95 mL priming volume for the LeukoGuard BC2) and therefore removes more leukocytes and platelets than the predicate device." It further clarifies, "an increased level of leukocyte depletion does not raise a different question of safety or effectiveness."

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

• Test Set Sample Size: Not explicitly stated. The testing includes "Bench performance testing" and "Pre-Clinical Validation using the OCS Heart Leukocyte Depleting Filter with the OCS Heart System to preserve swine hearts." The number of "swine hearts" or other samples used for bench testing is not provided.
• Data Provenance: The biocompatibility studies were conducted by NAMSA (Norwood, OH) and Ethide Laboratories (West Warwick, RI), both in the USA. The "Pre-Clinical Validation" using swine hearts suggests an animal model, likely conducted in a controlled laboratory setting. The data is retrospective in the sense that the testing was performed to support the 510(k) submission, not as a continuous monitoring effort.

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

• General Assessment: This information is not applicable in the context of device performance testing for a medical filter. The "ground truth" for the performance tests (e.g., leukocyte count, flow rate, hemolysis level) would be established by scientific measurement techniques and validated laboratory standards, not by expert consensus in the typical sense of diagnostic accuracy studies.
• Biocompatibility Testing: Conducted in compliance with 21 CFR Part 58 (GLPs) and according to ISO-10993-1 and USP standards. Experts involved would be qualified laboratory personnel in toxicology, microbiology, and materials science.

4. Adjudication Method for the Test Set:

• Not applicable. This concept is typically relevant for studies involving human interpretation (e.g., imaging studies) where discrepancies among readers need to be resolved. Performance testing of a filter involves objective measurements against predefined specifications.

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

• No. An MRMC study is not relevant for this device. This type of study assesses diagnostic accuracy and inter-reader variability, usually in imaging or pathology. The OCS Heart Leukocyte Depleting Filter is a physical device with measurable performance characteristics.

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

• Yes, in a sense. The bench testing and pre-clinical validation (swine hearts) represent "standalone" performance evaluations as they assess the device's function directly without human interaction being the primary variable. The device itself does not involve an algorithm or AI.

7. The Type of Ground Truth Used:

• Objective Measurements/Scientific Standards: The "ground truth" for the device's performance is based on objective measurements against established scientific and engineering standards.
  • Leukocyte/Platelet Depletion: Laboratory assays to quantify cell counts before and after filtration.
  • Filtration Time, Flow Rate, Volumes, Pressure Drop: Engineering measurements.
  • Structural Integrity: Physical stress tests and observation.
  • Hemolysis: Laboratory assays to measure hemoglobin release.
  • Biocompatibility: Results from validated in vitro and in vivo toxicological tests (e.g., cytotoxicity, sensitization tests according to ISO 10993-1).
  • Sterility: Microbiological validation tests to confirm SAL.
  • Pre-Clinical Validation (Swine Hearts): Likely physiological measurements of heart function and integrity after blood processing by the device in an isolated organ system.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical filter, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design, materials, and manufacturing process are based on established engineering principles and the performance of the predicate 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 AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. The AF100 with Carmeda BioActive Surface (CB851) is coated with a nonleaching bioactive surface (heparin) to enhance blood compatibility and provide thromboresistant blood-contacting surfaces. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.

The provided text is a 510(k) Summary for a medical device (Affinity® AF100 Arterial Filter with Carmeda® BioActive Surface) seeking a determination of substantial equivalence to a predicate device. This type of regulatory submission in the U.S. FDA context focuses on comparing a new device to an already legally marketed one, rather than presenting a detailed study proving the new device's independent efficacy against acceptance criteria in the way clinical trials for novel devices do.

Therefore, many of the requested elements pertaining to a clinical study (like sample size for test sets and training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of document because it describes pre-clinical bench testing for substantial equivalence, not a clinical effectiveness study.

Here's a breakdown of the information that is available and a note on what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "performance tests" that were conducted to demonstrate substantial equivalence to the predicate device. However, it does not specify quantitative "acceptance criteria" for each test or detailed "reported device performance" against those criteria. It only states that these tests were conducted to "verify the performance characteristics."

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

• Sample Size for Test Set: Not applicable. Performance was verified through pre-clinical bench testing, not a clinical test set with human data. The document does not specify the number of devices or trials performed for each bench test.
• Data Provenance: Not applicable, as this was pre-clinical bench testing. There is no mention of country of origin or whether it was retrospective or prospective in a clinical sense.

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

• Not applicable. This was pre-clinical bench testing of a physical device, not an AI/diagnostic device requiring expert ground truth for image or data interpretation.

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

• Not applicable. This was pre-clinical bench testing, not a study involving human readers or 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 an arterial filter for cardiopulmonary bypass, 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:

• Not applicable. This device is a physical arterial filter, not an algorithm.

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

• For pre-clinical bench testing, "ground truth" would equate to established engineering and material science standards and measurement techniques for evaluating physical properties (e.g., pressure, filtration size, material strength). The document implies that industry standards and validated methods were used to conduct the described performance tests, but it does not detail them.

8. The sample size for the training set:

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

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

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

Summary of Device Acceptance & Study:

The "acceptance criteria" for this submission are primarily demonstrating substantial equivalence to the predicate device (Affinity Arterial Filter with Carmeda® BioActive Surface (20µm) Model CB353, K001138).

The study that "proves the device meets the acceptance criteria" is a series of pre-clinical bench tests. These tests were conducted to verify that despite a change in housing material (from polycarbonate to Bisphenol A-free (BPA-free) copolyester), the new device maintains similar technological characteristics, operating principles, design features, and performance as the predicate device. The conclusion of the submission states: "Pre-clinical bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence with the predicate devices."

The FDA's letter confirms that based on the provided information, the device is deemed "substantially equivalent" to legally marketed predicate devices, meaning it meets the regulatory requirements for market clearance under the 510(k) pathway.

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The AF100 is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

The AF100 is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery.

The AF100 with Balance Biosurface (BB851) is coated with a nonleaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The AF100 is sterilized by ethylene oxide.

The provided text describes the K122760 submission for the Medtronic Affinity® AF100 Arterial Filter with Balance® Biosurface. Here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets in the provided document. However, the study aimed to verify the performance characteristics through pre-clinical bench testing. The reported "performance" is that the device passed these tests, indicating it met Medtronic's internal criteria for safety and effectiveness, and thus demonstrated substantial equivalence to the predicate device.

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

• Sample Size: Not specified. The document only mentions "Pre-clinical bench testing."
• Data Provenance: The nature of "pre-clinical bench testing" implies that the data was generated in a controlled laboratory environment, likely at Medtronic, Inc. It is not patient data, so "country of origin" is not applicable in the same way as clinical studies. It is implicitly "prospective" bench testing, as it was conducted to verify the device's performance for this submission.

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

This section is not applicable. The device's performance was evaluated through physical and chemical bench tests, not through expert review of data such as medical images or clinical outcomes. Therefore, "ground truth" in the clinical sense, established by medical experts, was not required. The "ground truth" was determined by the objective results of the bench tests against predefined specifications.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments. Since this study involved pre-clinical bench testing with objective measurements, an adjudication method was not needed.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to establish substantial equivalence with the predicate devices."

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

This question is not applicable as the device is a physical medical device (an arterial filter), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth was established through objective measurements and results from pre-clinical bench tests. These tests evaluated the physical and functional properties of the device against internal specifications and engineering standards for blood-contacting medical devices.

8. The Sample Size for the Training Set

This question is not applicable. As the device is a physical medical product, not an algorithm, there is no "training set."

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

This question is not applicable for the same reason as point 8.

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The Terumo® Pall AL20X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 20 microns in size, including gas emboli, fat emboli, and aggregates composed of platelets, red blood cells, and other debris from the arterial line and where the flow rate will not exceed 7 liters per minute. The device may be used in procedures lasting up to 6 hours in duration.

The Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6 Arterial Filter, use the same principles of operation and technology. They perform their functions using two basic forms of technology. As filtration devices, particulates in the blood stream are captured and removed from the blood flow as blood passes through a porous filter material that is contained within the device housing. The filter establishes a physical barrier that entraps particulate matter and prevents it from moving downstream of the arterial filter assembly. As air-removal devices, the Terumo® Pall AL20X Arterial Filter and the predicate device, Terumo® Pall AL6X Arterial Filter, are designed so that air is removed from the blood stream as a result of centripetal force. The blood inlet port of the device is positioned on the upper-side axis of the polycarbonate housing, thereby creating a spiral blood flow pattern as blood enters the device. As the blood flows through the device in a spiral motion, centripetal forces cause the air bubbles to migrate towards the top of the housing assembly - where air can subsequently be purged from the circuit.

The provided text describes a 510(k) submission for a medical device, the Terumo® Pall AL20X Arterial Filter. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for a novel functionality.

Therefore, the requested information regarding "acceptance criteria" for a study that "proves the device meets the acceptance criteria" in the context of AI/ML device assessment (which often involves performance metrics like sensitivity, specificity, AUC) is not directly applicable to this submission. This 510(k) primarily compares the new device to a predicate device based on in-vitro performance evaluations and design characteristics to argue for substantial equivalence.

However, I can extract the closest equivalent information from the provided text, interpreting "acceptance criteria" as the performance measures used to demonstrate equivalence to the predicate device.

Here's the breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" with numerical thresholds in the way a modern AI/ML device might. Instead, it demonstrates performance equivalency to a predicate device through a series of in-vitro tests. The implied "acceptance criterion" is that the performance of the Terumo® Pall AL20X Arterial Filter is not significantly worse than the predicate device (Terumo® Pall AL6X Arterial Filter) for key operating parameters, and for some, it is even improved (e.g., smaller pore size).

Table of Performance Evaluations and Implied Comparison to Predicate:

Key Design Differences & Rationale for Equivalence:

• Filter Pore Size: AL20X has 20µm, AL6X (predicate) has 40µm. Smaller pore size is an improvement for micro-emboli removal. "Filter pore size of 20 um to 40 um for arterial line filters is standard to the industry."
• Maximum Flow Rate: AL20X has 7 L/min, AL6X (predicate) has 8 L/min. This difference is deemed "not clinically relevant" because "A blood flow rate of 7 L/min or less is typically used in Cariopulmonary Bypass procedures and most bypass components are only qualified to a maximum flow rate of 7 L/min."

Other Requested Information (Not directly applicable in the context of this 510(k) for an arterial filter, but addressed based on closest interpretation):

Since this is a submission for a physical medical device (arterial filter) and not an AI/ML diagnostic or prognostic tool, many of the requested fields are designed for AI/ML device evaluation and are not present in this document.

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

   • The document mentions "in-vitro performance evaluations," implying lab-based testing. It does not provide specific sample sizes (e.g., number of devices tested for each evaluation).
   • Provenance: The tests were conducted by Terumo Cardiovascular Systems ("Terumo Cardiovascular Systems conducted the following in-vitro performance evaluations...").
   • Retrospective or Prospective: These would be prospective in-vitro tests performed on manufactured devices.

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

   • Not applicable. This is an in-vitro device evaluation; ground truth would relate to physical measurements and engineering specifications, not expert interpretation of outputs.

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

   • Not applicable. This is an in-vitro device evaluation.

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 not an AI-assisted device requiring human reader interaction.

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

   • Not applicable. This is a standalone physical medical device. The "performance evaluations" are effectively the standalone performance of the device without human interpretation.

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

   • For in-vitro tests, the "ground truth" is based on established engineering and scientific principles, measurement standards for parameters like pore size, flow rate, pressure drop, and material compatibility.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML model requiring a training set. Its design is based on established engineering principles and prior device iterations (predicate).

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

   • Not applicable. No training set for an AI/ML model.

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The D731 MICRO Ph.I.S.I.O. with 27 micron screen with phosphoryIcholine coating and the D733 MICRO Ph.I.S.I.O. with 40 micron screen with phosphoryIcholine 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 may be 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/D733 MICRO Ph.I.S.I.O. Arterial Filters are sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with flow rate not exceeding 6.0 liters/minute. The D731/D733 MICRO Ph.I.S.I.O. are Arterial Filters with 27 and 40 micron filters screen, respectively. The devices are designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris, greater than the pore size, from the arterial line perfusate.

Here's an analysis of the acceptance criteria and study information for the D731/D733 MICRO Ph.I.S.I.O. Arterial Filters, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or detailed reported device performance values in a table format. Instead, it refers to broad compliance with guidance documents and established specifications. The main "acceptance criteria" appear to be meeting the performance of the predicate device and relevant industry standards.

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

• Sample Size: Not explicitly stated. The document mentions "Applicable tests were carried out," "In vitro testing was carried out," and "Testing supplied... includes performance testing that demonstrates compliance with performance specifications." It does not provide the number of devices tested.
• Data Provenance: The device manufacturer is Sorin Group Italia S.r.l., based in Italy. The tests were likely conducted by the manufacturer or a contract research organization on their behalf. The document does not specify the country of origin of the data beyond the manufacturer's location. The tests are described in the "NON CLINICAL TEST RESULTS" and "IN VITRO TEST RESULTS" sections, suggesting a retrospective approach where existing data or newly generated lab data was compiled for the 510(k) submission, rather than a prospective clinical trial.

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

This information is not provided in the document. The tests described are non-clinical and in-vitro, focusing on device performance specifications rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the described tests are non-clinical and do not involve human interpretation or adjudication in the way a clinical study with expert readers would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The document describes a medical device (arterial filter) and its non-clinical performance, not an AI or imaging device that would involve human readers.

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 arterial filter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be established performance specifications and regulatory guidance.

• For biocompatibility: ISO 10993-1 and FDA May 1st, 1995 Memorandum.
• For in vitro performance: "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" (November 29, 2000), and comparison to the predicate device (AF 620/640 Ph.I.S.I.O. Arterial Filters).
• For sterility and non-pyrogenicity: Effectiveness of production techniques to assure these properties.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, 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. See point 8.

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The AF 620 Ph.I.S.I.O. with 20 micron screen with phosphoryIcholine coating and the AF 640 Ph.I.S.I.O. with 40 micron screen with phosphory choline coating are recommended for use in the arterial line of the extracorporeal nicuti during any procedure that requires cardiopulmonary bypass. The filters, are used to trap and remove gaseous emboli as well as particulate debris that may be 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 AF 620 Ph.1.S.I.O. and 640 Ph.I.S.I.O are sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with flow rate not exceeding 6.0 liters/minute. The AF 620 Ph.I.S.I.O. and 640 Ph.I.S.I.O are Arterial Filters with 20 and 40 micron filters screen, respectively, designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris, greater than the pore size, from the arterial line perfusate. The AF 620 Ph.I.S.I.O. and 640 Ph.I.S.I.O are a modified version of the currently marketed D731 and D733 MICRO Ph.I.S.I.O. The modifications consist of: a different port orientation of the blood outlet port in order to improve the ease of use, ergonomics and fluid dynamics properties; change from polyurethane potting to ultrasonic welding for improved overall biocompatibility; the size of the filter housing has been reduced thus the filter net is double pleated rather than single pleated: the pore size of the filter screen for the AF 620 Ph.I.S.I.O. has been reduced from 27 micron to 20 micron with respect to the D731 MICRO Ph.I.S.I.O. for improved filtration efficiency; a and different formulation of phosphorylcholine monomer has been used to improve wettability. As a consequence of these modifications, the labeling has been updated.

The modified device has unchanged intended use, operating principles, manufacturing, control mechanisms, sterilization process and fundamental scientific technology.

The provided document is a 510(k) summary for a medical device (Arterial Filters), and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than detailing a clinical study with acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI device performance metrics, expert involvement, and ground truth establishment is not applicable or available in this type of submission.

However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and effectiveness, which serves as the "acceptance criteria" for this type of medical device submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" are implied by the established specifications for various in vitro and non-clinical tests, and "reported device performance" refers to the device meeting these specifications and demonstrating substantial equivalence to the predicate.

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

• Test Set Sample Size: Not explicitly stated as a number of devices or cases in a formal statistical sense for a clinical trial. The testing involved multiple units of the AF 620 Ph.I.S.I.O. and AF 640 Ph.I.S.I.O. arterial filters, as well as the unmodified predicate devices (D731/D733 MICRO Ph.I.S.I.O.) for comparative purposes. The number of individual units tested for each specific test (e.g., how many filters were subjected to a pressure drop test) is not provided.
• Data Provenance: The testing was "carried out for the AF 640 Ph.I.S.I.O. Arterial Filter" and states "For comparative purposes all tests, when applicable, were performed on sterilized aged devices comparing the AF 620/640 Ph.I.S.I.O. arterial filters vs. the unmodified devices operated at same max blood flow." This indicates that the data is from in-house laboratory testing (in vitro and non-clinical), likely conducted by or for Sorin Group Italia. It is prospective in the sense that the tests were designed and executed to evaluate these specific modified devices. No country of origin of the data is explicitly stated beyond Sorin Group Italia being the submitter.

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

• This question is not applicable as this is a medical device (arterial filter) and not an AI or imaging device where human experts establish ground truth for image or data interpretation. The "ground truth" here is the physical and biological performance of the device against established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not applicable. This relates to human interpretation of data/images, which is not relevant for this device. The "adjudication" is implicitly done by the test results meeting pre-defined quantitative or qualitative specifications in a laboratory setting.

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

• No. This is a medical device, not an AI or imaging device that involves human readers interpreting cases.

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

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

7. The type of ground truth used

• Laboratory-established specifications and regulatory standards: The "ground truth" for this device is its performance against established engineering specifications (e.g., flow rate capacity, pressure drop, filtration efficiency, structural integrity, sterility, ETO residuals) and biological safety standards (e.g., ISO 10993 for biocompatibility). The claim of substantial equivalence is also a key "ground truth" for these types of submissions, showing that the modified device performs similarly to or better than previously cleared predicate devices.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

• Not applicable. See point 8.

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The QUART Arterial Filter with SOFTLINE COATING is designed for use in an extracorporeal circulation system during surgical procedures involving a cardiopulmonary bypass. Within the cited flowrates, the arterial filter removes particulate and gaseous micro-embolisms from the extracorporeal circulation system. The eliminated gas can be removed via the purge line. The max. flow rate of the QUART Arterial Filter is 71/min.

The decision regarding the method in which the arterial filter is to be employed rests solely with the treating physician.

The unit may not be continuously employed for more than 6 hours. We do not recommend longer contact with the blood.

The QUART Arterial Filter serves as a filter during extracorporeal circulation procedures to safely remove gaseous embolisms and aggregates from blood components in the arterial blood line.

Utilization of the QUART Arterial Filter therefore reduces the patient risk of injury from a micro-embolism resulting from gases or solids.

This 510(k) summary describes a device modification rather than the development of a new AI/ML device. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device submissions, are not applicable here.

The submission focuses on demonstrating substantial equivalence of the modified device (QUART Arterial Filter with SOFTLINE COATING) to its predicate devices by comparing technical characteristics and performance based on standard medical device testing, not AI/ML algorithm validation.

However, I can extract the relevant information presented in the document regarding the device modification and the testing performed to demonstrate substantial equivalence.

Device Description:
The QUART Arterial Filter serves as a filter during extracorporeal circulation procedures to safely remove gaseous embolisms and aggregates from blood components in the arterial blood line, reducing patient risk from micro-embolisms.

Device Modification:
The QUART Arterial Filter with SOFTLINE COATING is identical to the QUART Arterial Filter with Safeline Coating, with the only exception that it has been coated with SOFTLINE. The SOFTLINE COATING is the same as that used with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with SOFTLINE COATING. Besides this difference, both QUART Arterial Filters are the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology.

Acceptance Criteria and Reported Device Performance (as implied by the substantial equivalence determination):

The submission does not list specific numerical acceptance criteria in a table format, as would be expected for AI/ML performance metrics. Instead, it asserts that the modified device's performance aligns with the predicate devices through evaluation and testing. The "reported device performance" is essentially that it meets the expected standards for an arterial filter and is substantially equivalent to the predicate devices.

Study Information (for a device modification, not an AI/ML algorithm):

1. Sample sizes used for the test set and the data provenance: Not applicable. This submission concerns a physical device modification, not a software algorithm tested on data sets. The "testing" refers to bench testing and material compatibility, not analysis of a data set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is relevant for diagnostic AI/ML algorithms, not for evaluating a physical device modification.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in AI/ML studies to resolve disagreements among experts in ground truth labeling.
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 a physical medical device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in this context would relate to the physical properties and biological interactions of the device materials and function, assessed through standard engineering and biological testing (e.g., biocompatibility testing, flow rate performance, particulate removal efficiency against a known standard).
7. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML algorithm.
8. How the ground truth for the training set was established: Not applicable. This pertains to AI/ML algorithm development.

Conclusion stated in the 510(k):
"The data given demonstrate that the QUART Arterial Filter with SOFTLINE COATING is substantially equivalent to the named predicate devices which hold currently market clearance."

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