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DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The DualView Catheter is a catheter consisting of two assemblies: the catheter sheath and the imaging core (consisting of lens and transducer). During imaging, the imaging core rotates inside the catheter sheath to obtain a 360°image of the surface layer of the vessel wall by irradiating with near-infrared light and ultrasound. By pulling back the imaging core inside the catheter sheath, an image in the long axis direction can be obtained.

This is a rapid exchange (RX) design (short monorail) catheter, which is used with a 0.014" (0.36 mm) guidewire. The catheter is 2.6 Fr (0.86 mm) in the imaging window section and 3.0 Fr (1.01 mm) in the shaft section with an effective length of 137 cm. The catheter has a 100 cm hydrophilic coating starting from the distal end, which becomes highly lubricious when wet. The catheter has a telescoping section, and the telescoping length is 155 mm. When connected to the OPUSWAVE, the imaging core can be pulled back 150 mm in the catheter sheath. There are two radiopaque markers. The distal radiopaque marker is located 7 mm from the distal end of the catheter sheath, and the sensor radiopaque marker is located where the near-infrared light and ultrasound are emitted. Those markers allow a user to confirm the positional relationship between the distal end of the catheter and the sensor position (imaging point). There are two depth markers, one at 90 cm and the other at 100 cm from the distal end of the catheter sheath, which serves as a guide for insertion.

The transducer has an IPX7 ingress rating in accordance with IEC 60529.

The catheter is stored in the holder tube and is secured to the catheter holder. The catheter comes with the Motor Drive Unit (MDU) Cover and accessories. The MDU Cover consists of an adapter and a plastic cover sheet to maintain the sterility of the catheter and clean field. The catheter accessories consist of a connection tube with a three-way stopcock, a priming syringe, and a reservoir syringe for priming the catheter lumen with heparinized saline solution.

The provided FDA 510(k) Clearance Letter concerns the DualView Catheter, a diagnostic intravascular catheter. This document is a Summary of a Traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing.

Therefore, the submission does not include a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, standalone algorithm performance, or extensive details on ground truth establishment involving human expert consensus for a clinical test set as would be typical for an AI/ML-based device. The clearance is based on direct device performance and safety, primarily through bench testing and animal studies, not a human reader study.

Here's an analysis of the provided information, specifically addressing the questions as much as possible given the nature of this particular 510(k) (a medical device clearance, not an AI/ML algorithm clearance):

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

Since this is a non-clinical device clearance, the "acceptance criteria" are the successful completion of the listed performance and safety tests, demonstrating the device meets its design specifications and is suitable for its intended use. The "reported device performance" is that it successfully met these criteria.

Detailed Study Information (Where Applicable for this Device Type):

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

   • Test Set (Non-Clinical): The document refers to various non-clinical tests (e.g., performance testing, software V&V, electrical safety, biocompatibility, sterilization). The "sample size" for these tests would correspond to the number of catheters or test articles subjected to each specific test. This specific number is not provided in the summary but is assumed to be sufficient for each test type according to relevant standards.
   • Animal Study: A "swine model" was used for both safety and performance animal studies. The specific number of animals is not provided in this summary.
   • Data Provenance: The document does not explicitly state the country of origin for the data (e.g., test labs, animal facilities). This is a traditional 510(k) submission, and the manufacturer is Terumo Corporation (Japan), with manufacturing in Japan. Animal studies were likely prospective.

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

   • Not Applicable in the context of this 510(k). This clearance is for a medical device (catheter), not an AI/ML algorithm that requires human expert consensus for image interpretation ground truth. The "ground truth" for this device's performance is established by direct physical measurements, engineering validations, and physiological outcomes in animal models against predefined specifications and safety standards.

3. Adjudication method for the test set:

   • Not Applicable. Since there's no human interpretation component needing adjudication for ground truth establishment. Test outcomes are determined by objective measurements against acceptance criteria.

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

   • No, an MRMC study was NOT done. The document explicitly states: "This 510(k) does not include data from clinical tests." MRMC studies are typically used to assess the impact of AI algorithms on human reader performance, which is not relevant for this device's non-clinical clearance pathway.

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

   • No, not in the sense of an AI algorithm. This device does not appear to involve an AI algorithm whose performance would be assessed in a standalone manner for image interpretation or diagnosis. It is a diagnostic imaging catheter that generates images for human interpretation.

6. The type of ground truth used:

   • Engineering Specifications, Physical Measurements, and Physiological Outcomes (Animal Model):
     • For non-clinical performance tests (e.g., tensile strength, dimensions, imaging quality, etc.), the ground truth is the device's adherence to pre-defined engineering specifications and measurable performance characteristics.
     • For biocompatibility and sterilization, the ground truth is established by adherence to relevant ISO standards and successful completion of validated tests.
     • For animal studies, the "ground truth" relates to the physiological effects observed (e.g., absence of tissue injury, thrombus formation) and the successful performance of the device in a living system as intended by design, compared to predicate devices.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set of data.

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

   • Not Applicable. As no training set for an AI/ML algorithm is involved.

Summary:

The DualView Catheter received 510(k) clearance based on demonstrating substantial equivalence to predicate devices primarily through rigorous non-clinical performance testing and animal studies. This type of submission relies on showing that the new device meets established safety and performance standards equivalent to existing legally marketed devices, rather than a clinical study evaluating an AI algorithm's interpretive accuracy and its impact on human readers. Therefore, many of the questions pertinent to AI/ML device clearances (e.g., human expert ground truth, MRMC studies) are not applicable to this traditional medical device submission.

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The R2P Radifocus Glidewire Advantage 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 subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), are both operated through a manual process. The subject device, R2P Radifocus Glidewire Advantage, and the predicate device, Radifocus Glidewire (K152740), exhibit some differences in design and construction. Terumo has confirmed that these differences don't introduce any new concerns in safety and performance compared to the predicate device.

The provided text is a 510(k) summary for a medical device (guide wire) and does not contain any information about an AI/ML-driven device or study results related to acceptance criteria for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML-driven device meets those criteria based on this document. The document describes traditional performance and biocompatibility testing for a physical medical device.

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The Glidewire GT-R is intended 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 subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are both operated through a manual process. The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are the same design and construction except for Guide wire length. The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are constructed from the same materials. The only material difference lies in the Individual Packaging.

This document is a 510(k) Pre-market Notification for a medical device called Glidewire GT-R. It focuses on demonstrating substantial equivalence to an existing predicate device rather than proving novel performance characteristics through a clinical trial or a deep-dive AI performance study.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device meets these criteria in the context of an AI/human-in-the-loop performance study.

Here's why and what the document does provide:

• Device Type: The Glidewire GT-R is a physical medical device (a catheter guide wire), not a software device or an AI algorithm.
• Purpose of 510(k): The 510(k) submission aims to show that the new device (Glidewire GT-R) is substantially equivalent to a legally marketed predicate device (Glidewire GT). This means it has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate.
• Testing Focus: The "performance testing" described (Section H, Table 3) is engineering performance testing (e.g., Tensile Strength, Torqueability, Lubricity, Kink Resistance, Radiopacity). These tests ensure the physical properties and functionality of the guidewire itself meet established physical and mechanical standards and are comparable to the predicate.
• No AI/Human Reader Study: Since this is a physical guidewire, there is no AI component, and thus no multi-reader multi-case (MRMC) study, human reader improvement, standalone algorithm performance, or ground truth establishment (expert consensus, pathology, outcomes data) as would be relevant for an AI diagnostic device.
• "Acceptance Criteria" in this context: The acceptance criteria here refer to the passing thresholds for the physical performance tests listed in Table 3 (e.g., a certain minimum tensile strength, a maximum friction coefficient for lubricity). The document states, "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not provide the specific numerical acceptance criteria for each test or detailed results beyond this summary statement.

To directly answer your request based on the provided text, while noting the different context:

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

   • Acceptance Criteria: Not explicitly detailed as numerical values in the document. The document states "Performance testing met the predetermined acceptance criteria."
   • Reported Device Performance: The document provides a summary statement that the device met these criteria, but no specific quantitative results for each test item listed in Table 3.

   Test Item	Acceptance Criteria	Reported Device Performance
   Dimensional Verification	(Not specified, but assumed to be within manufacturing tolerances for guidewire dimensions.)	"met the predetermined acceptance criteria"
   Visual Inspection	(Not specified, e.g., no defects, smooth coating.)	"met the predetermined acceptance criteria"
   Simulated Use	(Not specified, e.g., successful navigation through a simulated vessel model without kinking or breaking.)	"met the predetermined acceptance criteria"
   Tensile Strength	(Not specified, but would be a minimum force required to break/yield.)	"met the predetermined acceptance criteria"
   Tip Pull	(Not specified, e.g., a minimum force to separate the tip.)	"met the predetermined acceptance criteria"
   Torque Strength	(Not specified, e.g., a minimum torque before a permanent twist.)	"met the predetermined acceptance criteria"
   Torqueability	(Not specified, e.g., the ability to transmit torque from the proximal to distal end smoothly.)	"met the predetermined acceptance criteria"
   Lubricity and Coating Integrity	(Not specified, e.g., a coefficient of friction, or visual assessment after use.)	"met the predetermined acceptance criteria"
   Particulate Evaluation	(Not specified, e.g., maximum number/size of particulates released.)	"met the predetermined acceptance criteria"
   Kink Resistance	(Not specified, e.g., ability to resist kinking at certain bend radii.)	"met the predetermined acceptance criteria"
   Tip Flexibility	(Not specified, e.g., ability to bend to a certain radius and return.)	"met the predetermined acceptance criteria"
   Radiopacity	(Not specified, e.g., visibility under fluoroscopy to a certain standard.)	"met the predetermined acceptance criteria"
   Shaping Test	(Not specified, for shapeable types, ability to hold a formed shape.)	"met the predetermined acceptance criteria"
   Shape Retention	(Not specified, for shapeable types, ability to retain shape after use.)	"met the predetermined acceptance criteria"
   Corrosion resistance	(Not specified, e.g., no signs of corrosion after exposure to specific solutions.)	"met the predetermined acceptance criteria"

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

   • The document does not specify the sample sizes (number of guidewires) used for each performance test.
   • Data Provenance: The tests were conducted internally by Terumo Corporation (Ashitaka Factory, Japan and Terumo Medical Corporation, NJ, USA) on their manufactured devices. The data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device, and the "ground truth" is determined by engineering measurements against pre-defined specifications, not by expert consensus on clinical images/data.

4. Adjudication method for the test set: Not applicable for engineering performance tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI or diagnostic imaging device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable.

7. The type of ground truth used: For the physical performance tests, the "ground truth" is based on engineering specifications and recognized industry standards (e.g., ISO, internal company standards). The predicate device and reference devices informed the establishment of these acceptance criteria.

8. The sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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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 Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for infants aged two months (excluding low birth weight and/or preterm birth) to adults.

The Immucise Intradermal Injection System is a single use, electron beam radiation sterilized device that is designed to be used for intradermal injections of FDA approved drugs. This system consists of an Intradermal Injection Needle and an Immucise Syringe. The system is made of common materials used in needles and syringes. The Immucise Intradermal Injection Needle is comprised of a needle base. The Immucise Syringe is comprised of a barrel, a gasket and a plunger. The sterile Immucise Intradermal Injection Needle and Immucise Syringe are packed separately and assembled prior to use. The Immucise Intradermal Injection System is operated by a manual process.

Here's a breakdown of the acceptance criteria and study information for the Immucise Intradermal Injection System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K181369) for an expanded indication (including infants). Therefore, the "acceptance criteria" are largely implied by meeting the same performance standards as the predicate, or by achieving successful outcomes in functionality tests.

2. Sample Size and Data Provenance for Test Set:

• Bench Test: No specific sample sizes for "non-aged and aged samples" are provided in this document, but it refers to the prior submission K181369. Data provenance is not explicitly stated beyond "performed in K181369."
• Animal Test: No specific sample sizes for the animal study are provided in this document. The data provenance is Terumo (Japan). The study was conducted specifically to support the expanded indication, suggesting it was prospective for this submission, though the methodology was based on a previous study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Neither the bench tests nor the animal studies described in this document involved human experts establishing ground truth in the way a clinical study with image interpretation might.
• For the animal study, the "ground truth" (e.g., successful wheal formation, validated injection depth) would have been assessed by trained personnel through observation and potentially histological analysis. No specific number or qualifications of experts are mentioned.

4. Adjudication Method for Test Set:

• This type of information (e.g., 2+1, 3+1) is typically relevant for studies involving subjective human interpretation, such as radiology reads.
• For bench and animal studies (focused on objective measurements and physiological responses), such adjudication methods are not applicable. The assessment would be based on predefined protocols and measurements.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
• This device is a physical medical device (intradermal injection system), not an AI-powered diagnostic tool that human readers would use in conjunction with. The comparative effectiveness focused on technical performance against a reference device, not human reader improvement with AI.

6. Standalone (Algorithm Only) Performance:

• No, standalone performance was not done.
• Again, this is a physical medical device. The concept of "algorithm only" performance is not applicable here as there is no AI algorithm involved in its direct function. The device's performance is its physical function.

7. Type of Ground Truth Used:

• Bench Test: Physical and functional measurements against predefined specifications (e.g., durability, material properties, dimensional accuracy).
• Animal Test: Direct physiological observations (wheal formation) and histological evaluation for injection depth, based on in-house standards designed to confirm intended physiological effects of intradermal injection.

8. Sample Size for Training Set:

• This concept is not applicable for this device. This is a physical medical device, not a machine learning model that requires a training set. The "training" in the context of device development would refer to design iterations and engineering testing, not data used to train an algorithm.

9. How Ground Truth for Training Set Was Established:

• Not applicable, as there is no training set in the context of machine learning. The "ground truth" for the device's design and engineering would be established through established engineering principles, material science, and regulatory standards.

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The Immucise Intradermal Injection System is indicated for intradermal injections of FDA approved drugs. The system is to be used in the deltoid region for adults.

The Immucise Intradermal Injection System is a single use, electron beam radiation sterilized device that is designed to be used for intradermal injections of FDA approved drugs. The system consists of a needle and syringe that are packed separately and assembled prior to use. The Immucise Intradermal Injection Needle consists of a needle tube and needle base, and the Immucise Syringe consists of a barrel, gasket and plunger.

The Immucise Intradermal Injection System, intended for intradermal injections of FDA approved drugs in the deltoid region for adults, did not undergo a comparative effectiveness study with human readers assisted by AI, nor a standalone AI algorithm performance study, as it is a medical device (needle and syringe system) rather than an AI-powered diagnostic or therapeutic tool. Therefore, sections pertaining to MRMC effect size, standalone AI performance, sample sizes for test/training sets, data provenance, number and qualifications of experts, and adjudication methods for AI performance are not applicable.

The device's performance was evaluated through a series of non-clinical tests (bench, animal, human factors, biocompatibility, sterilization, and packaging) to demonstrate substantial equivalence to predicate devices and ensure it met predetermined acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the samples of the device used for the various non-clinical performance evaluations. The provenance of these samples would be the manufacturer's production line in Japan (Kofu Factory of Terumo Corporation). All testing was conducted prospectively as part of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to the evaluation of the medical device's physical and functional properties against established engineering and biological standards, not diagnostic or interpretive tasks requiring expert ground truth in the context of AI studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for establishing ground truth, typically in image interpretation or diagnostic performance studies. The performance of this device was assessed against objective, measurable criteria defined by international standards (ISO, USP) and in-house standards.

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. The Immucise Intradermal Injection System is a medical device (needle and syringe system), not an AI-powered diagnostic or therapeutic tool for which such studies would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Immucise Intradermal Injection System is a medical device, not an AI algorithm. Its performance is inherent to its physical design and manufacturing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance was established by:
* Bench Testing: Adherence to international standards (ISO, USP) and in-house established specifications.
* Animal Study: Direct observation of wheal formation and histopathological evaluation of injection depth.
* Human Factors and Usability Engineering Study: Observation of user interaction to identify potential use-errors that could cause serious harm, as per FDA guidance.
* Biocompatibility: Results of standardized biological tests (e.g., cytotoxicity, sensitization) evaluated against ISO 10993-1 criteria.
* Sterilization: Demonstrated Sterility Assurance Level (SAL) of 10-6 per ISO 11137 standards.
* Packaging: Verification of package integrity against ISTA 3A standards.

8. The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. As the device is not an AI algorithm, there is no training set or associated ground truth.

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The NaviCross 0.018" is intended to guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

The NaviCross 0.018" is a single use, ethylene oxide sterilized device that is intended to guide and support a guide wire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

NaviCross 0.018" features a three-layer construction, which consists of a stainless steel mesh braid sandwiched between an outer layer of polyamide and an inner layer of polytetrafluoroethylene. It has a distal tip that is comprised of a polyamide. It also has a hydrophilic coating over the distal 40 cm of the catheter.

The device is offered in effective lengths of 65, 90, 135 and 150 cm.

The provided text describes a 510(k) submission for the NaviCross 0.018" catheter. It details the device's technical specifications, comparison to predicate and reference devices, and non-clinical performance testing. However, it explicitly states that no clinical tests were performed or included in this 510(k) submission.

Therefore, I cannot provide information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment based on the provided text, as these typically pertain to clinical studies.

The document focuses on demonstrating substantial equivalence through non-clinical performance testing and biocompatibility testing.

Here's a breakdown of what is available in the document regarding non-clinical performance:

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

The document lists various performance tests conducted. While it states that "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life," the specific numerical acceptance criteria and the exact reported performance values for each test are not detailed in the provided text. The table (Table 5.4) only lists the Test Items.

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

• Sample Size: The document does not specify exact sample sizes for each non-clinical test. It states that tests were performed on "non-aged and accelerated aged samples."
• Data Provenance: The device manufacturer and sterilization facility are the Ashitaka Factory of Terumo Corporation in Japan (Fujinomiya, Shizuoka 418-0015, Japan). The testing was conducted as part of their 510(k) submission for the US market. The testing is pre-market, laboratory-based performance and biocompatibility testing, not human data.

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

This is not applicable as the testing described is non-clinical performance and biocompatibility testing, not clinical data requiring expert ground truth or interpretation of images/patient outcomes.

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

Not applicable for non-clinical performance testing.

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. No clinical studies, especially MRMC studies comparing human performance with and without AI assistance, were performed or referenced in this document.

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

Not applicable. This device is a medical catheter, not an AI algorithm.

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

For the non-clinical tests, the "ground truth" or reference for acceptance is established by predefined engineering and material science standards (e.g., ISO standards, internal specifications for dimensions, strength, leakage, etc.). It's based on physical and chemical measurements rather than clinical ground truth types.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. No training set for an algorithm is mentioned.

In summary, the provided document details non-clinical performance and biocompatibility testing for a medical device (catheter) to establish substantial equivalence. It explicitly states that no clinical tests were included in this 510(k) submission. Therefore, most of the questions relating to clinical study design, expert involvement, and AI performance are not applicable to the information given.

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The Glidewire® GT 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 Glidewire® GT is a guide wire which is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. The Glidewire® GT consists of a core wire of a Nickel Titanium superelastic alloy and has a flexible radiopaque gold coil around the distal tip of the core wire. The Glidewire® GT is offered with two distal tip types: Shapeable and Preshaped. The wire distal segment comes in angled or straight configurations. Physicians choose the guide wire types depending upon their personal preference and the type of interventional procedure being performed. Other considerations may include: anatomy, difficulty of access, and the interventional device used for procedure. The device is packaged in a plastic holder that is contained within an individual package. A guide wire inserter, torque device and mandrel (Shapeable type only) are contained within the individual package to assist with the manipulation of the guide wire. Following the guide wire insertion, the guide wire inserter is removed from the proximal portion of guide wire.

The provided document is a 510(k) summary for the Glidewire GT and describes non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets an acceptance criterion for an AI/ML device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several performance tests. It states that "All samples tested met the applicable acceptance criteria, and no new issues of safety and effectiveness were raised by the testing performed." However, it does not explicitly list the specific quantitative acceptance criteria alongside the reported performance for each test. Instead, it refers to ISO standards, FDA guidance documents, and in-house standards.

General Summary of Performance Testing:

Biocompatibility: The device is classified as Externally Communicating Devices, Circulating blood, Limited Contact (

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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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