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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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