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The product (FineCross M3) is intended to be percutaneously into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.

FineCross M3 is a single use, ethylene oxide sterilized device that is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. FineCross M3 features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyester elastomer and an inner layer of polytetrafluoroethylene. The outer surface of the catheter is coated with hydrophilic polymer.

Here's an analysis of the provided text regarding the acceptance criteria and study for the FineCross M3 device, structured to answer your specific questions.

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a list of performance tests conducted on the FineCross M3 device. For each test, it states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not provide specific numerical or qualitative values for the acceptance criteria, nor does it detail the specific reported device performance values for each test. Instead, it offers a general statement of compliance.

Biocompatibility Testing:

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

The document does not specify the sample sizes used for each of the performance or biocompatibility tests. It only states that tests were performed on "non-aged and accelerated aged samples" for performance testing (except Radio-detectability and Simulated Use Usability) and on "non-aged, sterile, whole device" and "accelerated-aged (2 years), sterile, whole device" for biocompatibility.

The data provenance is industrial (manufacturer-conducted testing) and likely combines both novel testing for this specific device and potentially established testing protocols based on industry standards. It is not patient or clinical data, so terms like "retrospective" or "prospective" are not applicable in this context. The country of origin for the manufacturing and testing is Japan (Ashitaka Factory of Terumo Corporation).

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

This document describes non-clinical performance and biocompatibility testing of a medical device (a microcatheter). It does not involve diagnostic interpretation or patient data where "ground truth" would typically be established by human experts like radiologists. Therefore, this information is not applicable to the provided document. The ground truth for these tests is based on objective, measurable physical and chemical properties and engineering standards.

4. Adjudication Method for the Test Set

As this document describes non-clinical performance and biocompatibility testing, an "adjudication method" in the context of expert consensus (like 2+1 or 3+1 for clinical interpretations) is not applicable. The results of these tests are determined by adherence to pre-defined scientific and engineering protocols and acceptance criteria.

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

There was no MRMC comparative effectiveness study and no AI component mentioned in this 510(k) submission. This K-submission is for a medical device (microcatheter), not an AI/software-as-a-medical-device.

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

This is not applicable as the device is a physical medical instrument (microcatheter), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert concensus, pathology, outcomes data, etc)

For the performance tests, the "ground truth" is defined by engineering specifications, material science principles, and established industry standards. For example, the freedom from leakage is tested against a standard preventing fluid escape, and material biocompatibility is tested against ISO 10993 standards and FDA guidance. This is not a "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

There is no training set in this context. This is a physical medical device, not a machine learning model.

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

This is not applicable as there is no training set mentioned in the document.

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The Progreat is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities and all coronary vessels. The Progreat is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Progreat should not be used in cerebral vessels.

The Progreat catheter consists of metal coil reinforced multi-layer polymer tubing with a hydrophilic coating. The guidewire is comprised of an alloy core wire with radiopaque marker and hydrophilic coating. The subject 2.4 Fr Progreat catheter and 0.018" guidewire will be marketed as a combined unit and will be an extension of the existing Progreat product family. The design and technological characteristics of the subject 2.4 Fr Progreat with 0.018" guidewire are identical to the predicate 2.7 Fr Progreat with 0.021" guidewire.

The Progreat catheter is available with or without accessories. The accessories to the catheter are supplied in different configurations depending on the product code:

• The Guidewire has a super-elastic alloy core and is surface coated with a hydrophilic polymer.
• I The Inserter is used to assist the physician in the placement of the guidewire within the catheter.
• I The Catheter Mandrel (stylet) is used in the shaping of the catheter for procedures that require a catheter with a tip configuration other than straight.
• I The Syringe is used in the priming of the catheter.
• . The Wire Stopper can be clipped onto the guide wire to adjust the length of the guidewire that extends past the catheter tip.
• I The Catheter Stopper S can be clipped onto the catheter to adjust the insertion length of the catheter.
• . The Y-connector can be used to connect a power injector unit to the end of the catheter for infusion of contrast media.

The provided text is a 510(k) summary for the Progreat catheter, which is a medical device. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, many of the requested criteria for AI/ML device studies (such as types of ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract information related to the device's technical specifications and the non-clinical tests performed to assess its performance against predetermined criteria.

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria

This 510(k) submission for the Progreat (2.4 Fr Catheter with 0.018" Guidewire) aims to demonstrate substantial equivalence to its predicate device (K033583, Terumo Progreat). The acceptance criteria for this submission are primarily focused on ensuring that the modified device maintains the safety and effectiveness of the predicate device and conforms to applicable external and internal standards. The study supporting this is a series of non-clinical performance tests.

1. Table of Acceptance Criteria and the Reported Device Performance

The document states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." While the specific numerical acceptance criteria for each test are not explicitly detailed in this summary, the types of performance tests conducted serve as the basis for these criteria.

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

The document does not explicitly state the specific sample sizes for each non-clinical test conducted. It mentions that tests were performed on "non-aged and accelerated aged samples." The provenance of the data is from Terumo Corporation's Ashitaka Factory in Japan, where the device is manufactured and where these non-clinical tests were presumably conducted. This is retrospective in the sense that the testing was performed on manufactured devices to support the 510(k) submission.

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

This information is not applicable as the device is a physical medical instrument, not an AI/ML diagnostic tool requiring expert interpretation for ground truth. Performance was assessed against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

This information is not applicable for a physical device's non-clinical performance testing. Adjudication methods like 2+1 or 3+1 typically apply to human interpretation of diagnostic images or data.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted, and such a study is not applicable for this type of medical device (intravascular catheter). This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks.

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

A standalone algorithm-only performance assessment was not conducted, as this device is a physical catheter and not an algorithm. This criterion is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests effectively refers to predetermined engineering specifications, design requirements, and relevant industry standards for intravascular catheters (e.g., ISO standards for medical devices, internal Terumo specifications). The tests confirm if the device meets these established benchmarks.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" applies to machine learning models, not to the manufacturing and testing of a physical medical device.

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

This information is not applicable for the reasons stated above.

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The R2P (radial to peripheral) SlenGuide is designed for the introduction of interventional and diagnostic devices into the peripheral vasculature of the lower extremities.

The R2P SlenGuide is a single use, ethylene oxide sterilized device that is designed to perform as a guiding catheter for interventional procedures in the peripheral vasculature. It is packaged with a guiding catheter and an inner guide. The guiding catheter features a three-layer construction with a stainless steel mesh, polyamide elastomer, and polytetrafluoroethyelene. The distal end has a hydrophilic coating and a soft-tip visible under fluoroscopy. The inner guide is an accessory device made of polyester elastomer with a flexible distal portion containing tungsten, visible under fluoroscopy.

The provided document describes the R2P SlenGuide, a percutaneous catheter, and its testing to demonstrate substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size for AI assistance. Instead, the "acceptance criteria" here refer to meeting standards for safety and performance characteristics through non-clinical testing.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests performed and states that "Performance testing met the predetermined acceptance criteria." However, it does not explicitly state the numerical acceptance criteria for each test or the specific reported performance results in a detailed, quantitative table. It only confirms that the criteria were met.

For example, for "Peak tensile force," the test procedure is described (measure peak tensile strength), but the acceptable range (e.g., >X Newtons) and the actual measured value are not provided in this summary. The same applies to other tests.

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

• Test Set Sample Size: The document mentions that performance tests were performed on "non-aged and accelerated aged samples." However, it does not specify the number of samples used for each test.
• Data Provenance: The tests are described as non-clinical performance testing conducted by the manufacturer, Terumo Corporation, or its Ashitaka Factory in Japan. The data is retrospective in the sense that it was collected as part of the device development and regulatory submission process.

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

This information is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical medical device (a catheter), not an AI/software device that would require expert-established ground truth for a test set.

4. Adjudication Method

This information is not applicable for the same reason as point 3.

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

This information is not applicable as the device is a physical catheter, not an AI system. There is no mention of human readers or AI assistance in this context.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable as the device is a physical catheter, not an algorithm.

7. Type of Ground Truth Used

This information is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical medical device. The "ground truth" for these tests would be the established scientific and engineering principles and the specific requirements outlined in the referenced ISO and ASTM standards, as well as internal standards.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical catheter, not an AI/machine learning device that would require a training set.

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

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

Summary of Non-Clinical Tests Performed (as a proxy for "study")

The study to demonstrate that the device meets performance requirements involved a series of non-clinical, in-vitro tests based on established international standards (ISO and ASTM) and FDA guidance documents. These tests were categorized into performance testing and biocompatibility testing.

Performance Testing (Guiding Catheter & Inner Guide):

• Standards Referenced: ISO 10555-1:2013, ASTM F640-12, USP , FDA Guidance "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters."
• Tests Included:
  • Radio-detectability
  • Surface quality
  • Peak tensile force
  • Freedom from leakage
  • Hub performance (for Guiding Catheter)
  • Distal tip appearance
  • Particulate evaluation
  • Torque Strength (for Guiding Catheter)
  • Coating lubricity (for Guiding Catheter)
  • Evaluation of flexibility and kink resistance (for Guiding Catheter)
  • Distal tip flexibility (for Guiding Catheter)
  • Kink condition (for Guiding Catheter)
  • Flexural rigidity
  • Distal tip strength (for Guiding Catheter)
  • Cleanliness
  • Product dimensions

Biocompatibility Testing:

• Standards Referenced: ISO 10993-1, FDA General Program Memorandum #G95-1 (5/1/95), Draft Guidance for Industry and Food and Drug Administration Staff - Use of International Standard ISO-10993.
• Classification: Externally Communicating Device, Circulating Blood, Limited Contact (-6.

In essence, the "study" demonstrating the device meets its "acceptance criteria" here refers to the comprehensive non-clinical testing outlined above, which confirmed adherence to recognized standards for safety, performance, and biocompatibility, thereby supporting the claim of substantial equivalence to predicate devices.

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The Glidewire is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The Radifocus Glidewire is a guide wire which is designed to fit inside a percutaneous catheter for the purpose of directing a catheter through the blood vessel. It is provided sterile and is intended for single use only. It consists of a Nickel Titanium alloy core wire; a polyurethane coating (containing tungsten) and a hydrophilic polymer coating are applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled, and two types of flexible part lengths of the tip: 3 and 5cm. The Radifocus Glidewire is packaged in a plastic holder that is contained within an individual package. A guide wire inserter is included within the individual package to assist with the insertion of the guide wire into a catheter.

The provided text describes a 510(k) premarket notification for a medical device called the "Radifocus Glidewire". This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials for a novel device.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD), as implied by the detailed questions about ground truth, expert adjudication, MRMC studies, and standalone performance, does not directly apply to this document.

The document describes performance testing for a physical medical device (a guide wire) to ensure it meets established engineering and material standards and demonstrates substantial equivalence to a predicate device. It does not involve AI or software development that would require an AI-specific validation study as outlined in your prompt.

Here's a breakdown of why the requested information cannot be extracted from this document, and what is provided:

Why the requested information for AI/SaMD is not applicable/available:

• No AI or Software Component: The Radifocus Glidewire is a physical guide wire. There is no mention of any AI algorithm, software, or digital health component.
• No "Acceptance Criteria" for AI Performance: The "acceptance criteria" discussed in the document relate to physical properties and performance tests of the guide wire (e.g., surface, radiodetectability, fracture test, tensile force, torque strength, biocompatibility, sterilization). These are not AI performance metrics like sensitivity, specificity, AUC, or F-measure.
• No "Ground Truth" for AI/Imaging Data: Since there's no AI interpreting images or patient data, there's no need for establishing ground truth through expert consensus, pathology, or outcomes data, nor for training/test sets sourced from specific countries or collection methodologies (retrospective/prospective).
• No "Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study": This type of study is relevant for evaluating human reader performance with and without AI assistance in interpreting diagnostic images. It's not applicable to a physical guide wire.
• No "Standalone (Algorithm Only) Performance": This refers to the performance of an AI algorithm in isolation. It's not relevant here.
• No "Sample Sizes for Training/Test Sets" or "Adjudication Methods" for AI: These concepts are tied to machine learning model development and validation, which is absent from this submission.

What the document does provide regarding "acceptance criteria" and "proof":

The document details the non-clinical tests performed to demonstrate the device's performance and substantial equivalence to the predicate device.

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

   The document provides tables of performance tests based on ISO standards and FDA guidance documents, stating that all samples tested met the standard applicable to each test, and the subject device complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents. It doesn't provide specific numerical values for each test result, but rather a statement of compliance.

   Test	Standard / Acceptance Criteria (Implicitly Met)	Reported Device Performance
   ISO 11070:2014-based Tests:
   Surface	Section 4.3 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
   Radiodetectability	Section 4.5 of ISO 11070:2014 & ASTM F640-12	Met the standard applicable to the test. Only non-aged sample was tested.
   Fracture Test	Section 8.4 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
   Flexing Test	Section 8.5 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
   Peak Tensile Force of Guidewire (ISO)	Section 8.6 of ISO 11070:2014	Met the standard applicable to the test. No new issues of safety and effectiveness were raised.
   FDA Guidance & In-house Standard-based Tests:
   Peak Tensile Force of Guidewire (FDA/In-house)	3.a of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Torque Strength	3.b of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Torqueability	3.c of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Tip Flexibility	3.d of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Sliding Resistance/Coating Integrity	3.e of Coronary and Cerebrovascular Guidewire Guidance, January 1995 & In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Particulate Evaluation	VIII.A.13 of Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010; USP; In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Product Dimension	In-house Standard	Complies with the acceptance criteria established based on the predicate device and/or the FDA guidance documents.
   Biocompatibility	ISO 10993-1:2009 (Externally Communicating Devices, Circulating blood, Limited Contact

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The Radifocus Optitorque Angiographic Catheter is indicated for use in cardiac and vascular procedures. It is designed to deliver radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The different shapes are designed to selectively engage arteries from access sites such as the femoral, radial, and brachial artery.

The Radifocus Optitorque Angiographic Catheter is comprised of a two-layer construction featuring stainless steel mesh sandwiched between layers of polyurethane and polyamide elastomers. The shaft inner layer and outer layer contain barium sulfate for visibility and contrast under fluoroscopy. A soft tip is attached to the distal portion of some 4 Fr and all 5 Fr and 6 Fr catheters except those with a pigtail design; a soft tube is attached to the distal portion of 5 Fr and 6 Fr catheters with a pigtail design; the 4 Fr products are available with or without a soft tip. Constructed of flexible, supple polyurethane that is permanently welded to the catheter shaft, the soft tip and soft tube are designed to minimize trauma to the vessel wall. There is no change to the design of the device as a result of this submission.

The device is offered in lengths of 65-120 cm. French sizes and shaft inner diameters are as follows:

It is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.

The provided 510(k) summary describes a medical device, the Radifocus Optitorque Angiographic Catheter, and its performance testing. However, it does not include information about AI/ML device performance, human reader studies, or ground truth establishment relevant to AI/ML. The entire document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing for a material change.

Therefore, many of the requested items related to AI/ML device performance, sample sizes for test/training sets, expert qualifications, and ground truth establishment cannot be extracted from this document.

Here's the information that can be extracted, along with explanations for the missing items:

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

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

This document describes non-clinical performance and biocompatibility testing for a physical medical device. It does not refer to "test sets" in the context of AI/ML models or clinical data. The testing was performed on "samples" of the device, both non-aged and accelerated aged (3 years). The exact number of samples for each test is not specified, only that "All samples tested met the standard applicable to each test."

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

This is not applicable to the information provided. The document concerns a physical medical device and its non-clinical performance, not an AI/ML device that requires expert-established ground truth from clinical images or data.

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

This is not applicable to the information provided. The document concerns a physical medical device and its non-clinical performance, not an AI/ML device that requires adjudication of expert labels.

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 such study was conducted or reported in this document. This filing is for a conventional medical device, not an AI/ML diagnostic aid. The document explicitly states: "This 510(k) does not include data from clinical tests."

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

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

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

For the non-clinical performance tests, the "ground truth" or acceptance criteria were derived from recognized consensus standards (ISO, ASTM, USP) and the manufacturer's own internal standards for device functionality and safety. For biocompatibility, it was based on ISO 10993 standards and FDA G95-1 guidance.

8. The sample size for the training set

This is not applicable. There is no AI/ML model or "training set" relevant to this device.

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

This is not applicable. There is no AI/ML model or "training set" relevant to this device.

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The Capiox FX Hollow Fiber Oxygenator and Arterial Filter is intended to be used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery.

The integrated arterial filter is intended to filtrate non-biologic particles and emboli and to facilitate air bubble removal from the blood flowing through the cardiopulmonary bypass circuit.

The integrated heat exchanger is used to warm or cool blood and/or perfusion fluid as it flows through the device.

The hardshell reservoir is used to store blood during extra-corporeal circulation from the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The 3-liter and 4-liter reservoirs may be used for Vacuum Assisted Drainage procedures and Post Operative Chest Drainage Procedures.

The Capiox FX15 is for use with patients when the required blood flow rate will not exceed 5.0 L/min. when used with a 4 Liter Reservoir; and when the required blood flow rate will not exceed 4.0 L/min. when used with a 3 Liter Reservoir.

The Capiox FX25 is for use with patients when the required blood flow rate will not exceed 7.0 L/min.

The Capiox FX Oxygenator/Reservoir/Arterial Filter assemblies can be used in procedures lasting up to 6 hours.

The modified Capiox® FX15 and FX25 Oxygenator utilizes porous fiber technology to facilitate the transfer of gases between a blood-phase environment and a gas-phase environment for the intent of satisfying the gas exchange needs of a patient during cardiopulmonary bypass surgery. A fiber bundle offers the porous membrane surface to sufficiently permit the movement of gases through the walls of the hollow fibers via diffusion.

The modified Capiox® FX15 and FX25 device has an integrated heat exchanger that is comprised of stainless steel encased in a polycarbonate housing. The stainless steel acts as a heat transfer material that permits heat that is generated from a temperature controlled external water bath to transverse across the walls of the stainless steel to effect the necessary temperature change upon circulating blood.

With respect to the filtration of arterial blood, the modified Capiox® FX15 and FX25 Oxygenator/Reservoir relies upon mechanical entrapment of particulates and emboli within the filter mesh as a means to remove those particulates from the blood.

The subject of this Special 510(k) is a modification being made to the detachable Hardshell Reservoir. The design of the Hardshell Reservoir component remains identical to the design of the original reservoir that was cleared by FDA with K071494 -- except that a positive pressure relief valve will be included on the lid of the reservoir.

The materials that are used in the construction of the Capiox® FX15 and FX25 Oxygenator/Reservoir, but are not limited to, nylon, polycarbonate, stainless steel, polyvinyl chloride, polyurethane, polyester, polypropylene, polyethylene terephthalate, polyethylene and X-Coating™. The positive pressure relief valve that is included with the modified reservoir is constructed of polycarbonate and nylon.

The provided text describes a 510(k) summary for modifications to the Capiox® FX15 and FX25 Oxygenator/Reservoir. This document is a regulatory submission for medical devices, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed scientific study with specific acceptance criteria, experimental results, and statistical analyses typically found in research papers.

Therefore, many of the requested elements (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth data for training sets) are not applicable or extractable from this type of regulatory document.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes "Performance Evaluations" as a demonstration of "substantial equivalence" to the predicate device, implying that the modified device should perform comparably to the original. Explicit numerical acceptance criteria are not detailed, but the evaluations are qualitative in nature to confirm the safety and effectiveness of the modification (the pressure relief valve).

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 (Test Set): Not specified. The performance evaluations are described as "in-vitro," implying laboratory testing, but the number of units tested is not provided.
• Data Provenance: The studies are described as "in-vitro performance evaluations," which are laboratory tests. The manufacturer is Terumo Corporation (Ashitaka Factory) in Fujinomiya City, Shizuoka Pref., Japan, suggesting the testing likely occurred in-house or by a contracted lab in Japan. The nature of the tests (e.g., pressure, sterilization) would be considered prospective for the specific purpose of this submission.
• Retrospective or Prospective: Prospective, as these evaluations were conducted to support the 510(k) submission for the device modification.

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):

• Number of Experts: Not applicable. These were in-vitro engineering and performance tests, not clinical studies requiring expert interpretation of patient data to establish "ground truth."
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This refers to consensus methods for expert interpretation of data, which is not relevant for in-vitro engineering tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study: No, an MRMC study was not done. This device is an oxygenator/reservoir, not an AI-powered diagnostic tool, so such a study would not be relevant.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is not an algorithm or AI system; it's a medical hardware device. The performance evaluations assess the device's physical and functional properties, which is its "standalone" performance in a laboratory setting.

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

• Type of Ground Truth: For the in-vitro performance evaluations, the "ground truth" would be established engineering specifications, validated test methods, and industry standards for medical device performance (e.g., pressure measurements, sterility levels, biocompatibility standards).

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable. This is not an AI/machine learning device that requires a training set. The device's design and materials are based on established engineering principles and prior validated devices.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device. The "ground truth" for the device's design and manufacturing is based on established medical device standards and the performance of its predicate device.

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