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The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery.

The Entry Needle is an accessory device which is used to gain access to the vein or artery, for placement of the Mini Guide Wire.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery.

The Pinnacle Precision Access System consists of an introducer sheath and a dilator which are packaged together with a metallic entry needle, a mini guide wire and a guide wire inserter, prior to sterilization. The Pinnacle Precision Access System is used to facilitate placing a catheter through the skin into a vein or artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy

The entry needle (cannula) is an accessory device which is used to gain access to the vein or artery for placement of the mini guide wire.

The mini guide wire is an accessory device which is used for placement of the sheath and dilator into the vein or artery. The mini guide wire is offered in two versions, a stainless steel (spring coil) model and a Palladium tipped Nitinol model.

A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.

The provided text describes the Terumo Medical Corporation's Pinnacle Precision Access System and its premarket notification (510(k) summary) to the FDA. This document is for a medical device (catheter introducer) and therefore does not involve AI or machine learning. As such, many of the requested categories related to AI model evaluation are not applicable.

Here's the information that can be extracted or deduced from the provided text, along with an explanation for categories that are not applicable:

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

The acceptance criteria are generally implied by the successful passing of the listed performance tests. The reported device performance is that it "successfully passed all of the following performance tests." Specific quantitative thresholds for "acceptance" are not explicitly detailed in the summary but are inherent in the "pass" result for each test.

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

The document does not explicitly state the sample sizes for each performance test. It mentions "Testing was performed on the worse case configuration of the system" for biocompatibility. The tests are general device performance and biocompatibility tests, not clinical studies with patient data.

• Sample Size for Test Set: Not explicitly stated for each individual test. It mentions "worse case configuration" for biocompatibility testing. These are laboratory/bench tests, not studies on patient data.
• Data Provenance: Not applicable in the context of patient data for a test set. This refers to laboratory and bench testing performed by the manufacturer, Terumo Medical Corporation.

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

This is not applicable. "Ground truth" in this context typically refers to clinical diagnosis or outcomes. The performance tests are objective engineering and biological evaluations, not dependent on expert interpretation of clinical data for a test set.

4. Adjudication method for the test set

This is not applicable. The performance tests are objective measurements against predefined specifications, not subject to adjudication by multiple experts in the way clinical diagnostic interpretations would be.

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

This is not applicable. The device is a medical instrument (catheter introducer), not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

For the performance tests, the "ground truth" refers to established engineering standards, material specifications, and biological testing protocols (e.g., ISO, USP, ASTM standards for biocompatibility and physical properties). For example, for "Needle OD," the ground truth would be the specified diameter range from the design documents. For biocompatibility tests, the ground truth is defined by the limits and criteria set forth in the referenced ISO and ASTM standards.

8. The sample size for the training set

This is not applicable. The device is a physical medical instrument, not an AI model requiring a training set.

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

This is not applicable. The device is a physical medical instrument, not an AI model.

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The GlideCross™ Support Catheter is intended to be used for guide wire support during access of the vasculature allowing for exchange of guide wires and provides for the delivery of saline and/or diagnostic contrast agents. The GlideCross™ Support Catheter is indicated for use in the peripheral vasculature.

The GlideCross Support Catheters are single lumen intravascular catheters designed for use in the peripheral vasculature. The catheters provide support to guide wires during access of the vasculature and allow for exchange of guide wires while maintaining vessel access. The GlideCross Support Catheters are available in 9 models compatible with various guide wire sizes and have a lubricous hydrophilic coating on the distal shaft and a female Luer on the proximal end. The catheters have 3 encapsulated radiopaque marker bands evenly spaced along the distal shaft, with the distal band 3 mm from the tip, to aid in positioning of the catheter tip and in estimating distances.

The provided document describes a medical device, the GlideCross Support Catheter, and its clearance through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove efficacy against specific acceptance criteria in a human study. Therefore, the information typically requested for AI/ML device studies (such as MRMC studies, expert ground truth, sample sizes for training/test sets, etc.) is not applicable in this context.

Instead, acceptance criteria and performance are demonstrated through engineering testing, material comparisons, and biocompatibility assessments to show that the new device is as safe and effective as its predicate.

Here's an analysis of the provided information, framed to address the spirit of your request where applicable, even if direct answers for AI/ML device studies are not available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GlideCross Support Catheter are largely derived from ensuring its specifications and performance are similar to its predicate device (Spectranetics QUICK CROSS CATHETERS, K033678) and that it meets established industry standards for medical devices of its type. The "reported device performance" refers to the results of various engineering and biocompatibility tests.

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

For a traditional medical device (not AI/ML), the "test set" primarily refers to the number of individual devices or components subjected to each specific physical, mechanical, or biological test. The document does not specify exact sample sizes for each test (e.g., how many catheters were tested for trackability or burst pressure). However, it implies that sufficient samples were tested to demonstrate conformity to specifications and substantial equivalence to the predicate.

The data provenance is from Terumo Medical Corporation's in-house testing facilities, likely following established laboratory procedures and standards (e.g., ISO, ASTM, USP) for medical device evaluation. This is a prospective generation of data specifically for this 510(k) submission, comparing the new device's performance against its own pre-approved specifications and in comparison to the predicate device.

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

This concept is not directly applicable to a traditional medical device 510(k) submission concerning physical and mechanical properties. "Ground truth" in this context is established by:

• Engineering specifications and standards: These are the objective benchmarks (e.g., maximum pressure, specific lengths, material properties) that the device must meet.
• Predicate device's performance: The Spectranetics QUICK CROSS CATHETERS (K033678) serves as the established benchmark for "safe and effective" performance through its prior clearance.
• Regulatory standards: ISO, ASTM, and USP standards for biocompatibility and sterilization are the "ground truth" for these aspects.

The expertise lies in the engineers, scientists, and quality assurance personnel who design the tests, conduct them, and interpret the results against these established standards. Their qualifications would typically involve degrees in engineering, materials science, biology, and chemistry, with experience in medical device testing and regulatory affairs. Their 'number' is not specified globally but would involve teams for each testing area.

4. Adjudication Method for the Test Set

Again, this is not applicable in the context of a physical medical device. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews of data (e.g., imaging reads) to resolve disagreements. For engineering tests, the "adjudication" is inherent in:

• Objective measurements: A tensile strength test yields a numerical result. Either it meets the specification or it doesn't.
• Pre-defined pass/fail criteria: Each test has clear parameters for what constitutes a successful outcome.
• Comparison to predicate: Direct comparison of measurements or observations with the predicate device's characteristics.
• Standard compliance: Meeting the requirements of relevant ISO or ASTM standards.

Any discrepancies or failures would lead to investigation, redesign, or retesting, rather than an "adjudication" in the clinical sense.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are clinical effectiveness studies typically used for diagnostic devices (like imaging software) to assess how human reader performance changes with or without AI assistance across multiple cases and readers. The GlideCross Support Catheter is an interventional/support device, and its safety and effectiveness are demonstrated through engineering tests, biocompatibility, and comparison to a predicate device, not through human reader studies.

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

No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not an AI algorithm. Its performance is entirely dependent on the physical properties of the catheter and its interaction with physiological systems and clinicians.

7. The Type of Ground Truth Used

The ground truth used for this device can be categorized as:

• Engineering Specifications/Standards: Detailed quantitative and qualitative requirements for the device's physical and mechanical properties (e.g., dimensions, strength, flexibility, flow rates, coating integrity).
• Predicate Device Performance Profile: The known and accepted performance characteristics of the legally marketed predicate device (Spectranetics QUICK CROSS CATHETERS, K033678). The "substantial equivalence" claim relies on the new device performing similarly.
• International and National Standards: Compliance with recognized standards for biocompatibility (ISO 10993 series, ASTM F756), sterilization (ISO 11135, ISO 10993-7), and endotoxin testing (USP <85>, FDA guidelines). These standards themselves represent established "ground truths" for safety.

8. The Sample Size for the Training Set

No "training set" in the context of machine learning was used. This device is a physical product, not an AI/ML model. Therefore, the concept of a training set is not applicable. The design and manufacturing processes are refined through engineering development and quality control, not iterative training on data.

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

Since there was no "training set" for an AI/ML model, this question is not applicable. For physical device development, the "ground truth" (i.e., desired performance and specifications) for the design phase is established through:

• Clinical needs assessment: Understanding the requirements for guide wire support and delivery in peripheral vasculature.
• Benchmarking against existing products: Analyzing the predicate device (Spectranetics QUICK CROSS CATHETERS) and other similar devices to inform design goals.
• Material science: Selecting materials with known properties suitable for the intended use.
• Engineering principles: Applying principles of mechanical engineering and fluid dynamics to design the catheter.
• Regulatory requirements: Ensuring the design inherently meets relevant safety and performance standards.

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Terumo Support Catheters are intended to guide and support a guidewire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or diagnostic contrast agents.

The Terumo Support Catheter is a three-layer construction comprised of a stainless steel braid sandwiched between two layers of polyester elastomer. The polyester elastomer contains tungsten for visibility and contrast under fluoroscopy in the distal portion of the catheter. The most distal tip contains no braid and the tip is available in either straight or curved shapes. The device has three radiopaque markers, the distal one is embedded in the tip wall while the more proximal two are swaged to the outer surface of the catheter. There is a hydrophilic coating on the distal portion of the catheter to enhance lubricity.

The provided text describes a 510(k) premarket notification for the Terumo Support Catheter, which aims to demonstrate substantial equivalence to predicate devices. This type of submission does not typically involve the rigorous clinical trials or complex statistical analyses that would be found in a PMA (Premarket Approval) application for novel, high-risk devices. Therefore, many of the requested elements regarding acceptance criteria, sample sizes, expert ground truth establishment, MRMC studies, and standalone performance for AI/ML devices are not applicable.

The "acceptance criteria" for a 510(k) device primarily revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise any new questions of safety or effectiveness. This is achieved through a combination of design, materials, specifications, and performance testing, often comparing the new device directly to the predicate.

Here's an attempt to extract and present the information based on the provided document, addressing the requested points where possible, and noting when information is not applicable to this type of submission.

Acceptance Criteria and Device Performance for Terumo Support Catheter

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" are generally framed as demonstrating substantial equivalence to predicate devices across various attributes. The performance tests conducted are to ensure the new device meets specifications comparable to or better than the predicates. The text states:

"The Terumo Support Catheter met all performance specifications."

While specific numerical acceptance criteria for each test (e.g., minimum force at break, maximum allowable leakage) are not explicitly detailed in the provided summary, the overarching acceptance criterion is successful completion of all listed performance tests, demonstrating substantial equivalence to the predicate devices. The reported device performance is that it met all specifications.

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

The document does not specify the exact sample sizes (e.g., number of catheters tested) for each performance or biocompatibility test. It indicates that "Testing was performed on nonaged and aged Terumo Support Catheters vs the Spectranetics QUICK CROSS CATHETERS and the Spectranetics QUICK CROSS EXTREME SUPPORT CATHETERS." This implies a comparison study, but the specific N for each test article is not disclosed.

The "data provenance" mentioned in the context of AI/ML (country of origin, retrospective/prospective) is not applicable here as this is a physical medical device. The data comes from in vitro (laboratory) and in vivo (Thrombogenicity Study in Dogs) testing of device prototypes.

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

This section is not applicable. The evaluations are based on objective physical, chemical, and biological tests, not expert interpretation of diagnostic images or patient outcomes. The "ground truth" for parameters like "force at break" is a direct measurement, not an expert consensus.

4. Adjudication Method for the Test Set

This section is not applicable, as there's no subjective interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This is typically relevant for diagnostic imaging AI tools, not for a physical medical device like a catheter seeking 510(k) clearance based on substantial equivalence.

6. If a Standalone Performance Study (Algorithm only without human-in-the-loop performance) was done

This section is not applicable. This is not an algorithm or AI device. The performance tests evaluate the physical device itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (e.g., force at break, burst pressure, flow rate, dimensions) is established through direct physical measurements and standardized test methods. For biocompatibility, the ground truth is determined by the results of specific biological assays (e.g., cytotoxicity, hemolysis, pyrogenicity) against established safety thresholds as per ISO-10993. For sterilization, the ground truth is the demonstration of sterility to a specific SAL (Sterility Assurance Level) through validated processes in accordance with relevant ISO standards.

8. The Sample Size for the Training Set

This section is not applicable. There is no AI/ML model being "trained" for this device. The development process involves design, prototyping, testing, and refinement, but not in the sense of a machine learning training set.

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

This section is not applicable, as there is no training set in the context of this device's development or regulatory submission.

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The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery.

The Glidesheath is comprised of an introducer sheath and a dilator. The Glidesheath is coated with a hydrophilic coating to reduce the frictional resistance of the sheath when inserting or removing the sheath from the patient's blood vessel. The Sheath and Dilator contain bismuth, making these devices visible under fluoroscopy. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.

The Entry Needle is an accessory device which is used to gain access to the vein or artery including but not limited to the radial artery, for placement of the Mini Guide Wire.

The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to straighten out the wire.

Accessories to the Glidesheath are the metal entry needle and the mini guide wire. Both the metal entry needle and the mini guide wire are packaged with the Glidesheath in a pouch prior to sterilization.

The provided text describes the 510(k) summary for the Glidesheath introducer sheath, comparing it to a predicate device (K082644) to demonstrate substantial equivalence. The information focuses on the device's design, materials, specifications, and performance testing, which is largely bench testing and biocompatibility studies.

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

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail threshold manner for each performance test. Instead, it lists the performance tests that were successfully passed. The implication is that passing these tests constitutes meeting the acceptance criteria for a medical device of this type.

Table of Acceptance Criteria and Reported Device Performance:

Study Details for Acceptance Criteria Proof:

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

   • The document does not specify sample sizes for individual performance tests (e.g., how many needles were tested for joint strength).
   • It also does not indicate the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of bench testing, it's typically performed in a laboratory setting by the manufacturer.

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

   • This information is not provided. For mechanical and biocompatibility testing, ground truth is typically established by adhering to recognized international standards and internal quality control specifications, rather than relying on expert consensus in the way clinical studies do. The "experts" would be the engineers and scientists performing and interpreting the standardized tests.

3. Adjudication method for the test set:

   • This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective interpretations (e.g., image reading). The listed performance tests are primarily objective, quantitative, or qualitative assessments against defined standards.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices or devices where human interpretation is a key component, often comparing human performance with and without AI assistance. This document describes a physical medical device (introducer sheath) that does not involve diagnostic interpretation or AI.

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

   • No, a standalone algorithm performance study was not done. This device is a physical mechanical instrument and does not incorporate an AI algorithm.

6. The type of ground truth used:

   • The ground truth for most performance tests (Needle, Guide Wire, Dilator, Sheath, Inserter, System) would be based on engineering specifications, material science standards, and functional requirements for similar medical devices.
   • For Biocompatibility, the ground truth is established by international biological evaluation standards (ISO 10993), which define acceptable thresholds for biological responses (e.g., absence of cytotoxicity, genotoxicity, etc.).
   • For Sterilization, the ground truth is based on sterilization validation standards (ANSI/AAMI/ISO 11135) to achieve a defined Sterility Assurance Level (SAL) of 10^-6.

7. The sample size for the training set:

   • This is not applicable. The Glidesheath is a physical medical device, not an AI or machine learning model that requires a "training set."

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

   • This is not applicable for the same reason as point 7.

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The Pinnacle® Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.

The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (Devices with TBV Valve only).

The provided document is a 510(k) summary for the Pinnacle® Destination® Peripheral Guiding Sheath. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance as would be expected for a novel device.

Therefore, many of the requested details regarding acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment are not applicable or not provided in this document because it's a submission for a substantially equivalent medical device, not a new clinical trial of a diagnostic or AI-driven aid.

Here's a breakdown of the available information:

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)

• The document mentions "bench and vessel model testing" but does not specify sample sizes for these tests.
• Data provenance is not specified. These would typically be laboratory-based tests.

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)

• Not applicable / not provided. The testing described (bench and vessel models, biocompatibility, sterilization) does not involve expert interpretation or ground truth establishment in the way a diagnostic imaging study would.

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

• Not applicable / not provided. Adjudication is relevant for interpreting subjective assessments, which is not the primary mode of testing for this type of device (an introducer sheath).

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

• Not applicable. This device is a manual catheter introducer, not an AI-assisted diagnostic or interventional tool. Therefore, an MRMC study with AI assistance is entirely irrelevant.

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

• Not applicable. This device is a physical medical instrument operated manually, not an algorithm.

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

• For performance testing (bench and vessel models), the "ground truth" would be established engineering and biomechanical specifications and measurements compared to the predicate device's performance.
• For biocompatibility, the ground truth is established by the results of standardized biological tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993.
• For sterilization, the ground truth is established by microbiological challenge testing validating the sterilization cycle to achieve the specified SAL.

8. The sample size for the training set

• Not applicable / not provided. No "training set" is relevant for a device like this, which is compared to a predicate based on physical and material properties and performance in bench/vessel models.

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

• Not applicable / not provided. As there is no training set for this type of device, ground truth establishment for it is not relevant.

In summary: The document is a 510(k) submission for a substantially equivalent medical device. The "study" described is a series of bench and vessel model tests, along with biocompatibility and sterilization validations, to demonstrate equivalence to a previously cleared predicate device. It does not involve human readers, AI algorithms, or extensive clinical trials with detailed statistical endpoints that would require the typical "acceptance criteria" breakdown seen for diagnostic devices or AI-driven systems.

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The TERUMO Hybria Closed System Safety I.V. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. The needle shield feature and the needleless access port aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.

The TERUMO® Hybria™ Closed System Safety I.V. Catheter is a device consisting of an over-the needle, peripheral intravascular catheter made of a slender, flexible, radio-opaque, plastic catheter, integrated extension tubing with a Y or I adaptor (needleless access port and/or filter cap available) and one touch clamp, and a passive needle-shielding mechanism.

The design of the TERUMO® Hybria™ Safety I.V. catheter can be described as a closed system since it protects clinicians and patients from blood exposure during the catheter insertion procedures. Since the needle is withdrawn through a septum that seals after the needle has been removed and ports of the Y or I adapter attached to pre-connected tubing to the IV catheter are closed, blood remains within the TERUMO® Hybria™ Safety I.V. catheter during catheter insertion.

The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The one touch clamp on the integrated extension tubing is provided to minimize blood exposure when connecting with an infusion set.

The provided text describes a 510(k) premarket notification for the TERUMO® Hybria™ Closed System Safety I.V. Catheter. This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or a performance table in the typical sense of a clinical or analytical study. Instead, it relies on demonstrating that the new device's specifications (dimensions, flow rates, etc.) are comparable to its predicate devices, implying that if the predicates met their performance criteria, this device would as well. The provided tables (pages 4-6) list the physical specifications of various configurations of the Terumo Hybria catheter, including gauge, length, outer diameter, inner diameter, cannula gauge, tube length, tube OD/ID, adaptor type, connector type, wing type, flow rate, priming volume, and lumen volume. These are design specifications, not performance criteria with associated pass/fail thresholds.

For example, a "flow rate" is listed, but there's no defined acceptance criterion like "Flow rate must be ±X% of predicate device" or "Flow rate must exceed Y ml/min for Z application."

Therefore, a table of explicit acceptance criteria and corresponding performance cannot be constructed from this document. The "performance" assessment is described as "bench tests and simulated use study" which demonstrated "substantial equivalence."

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

The document does not specify the sample sizes used for the "bench tests and simulated use study." It also does not explicitly state the data provenance (e.g., country of origin of the data, retrospective or prospective). Given that it's a 510(k) for a device with a physical function, these studies would typically be conducted in a laboratory setting.

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

This information is not provided in the document. For a physical device like an IV catheter, "ground truth" often refers to engineering specifications, established testing standards, or performance in simulated use protocols rather than expert clinical consensus on an output like image interpretation.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies where human interpretation of data is being assessed, such as medical imaging. For a physical device, testing against predefined engineering specifications is more common.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described or mentioned in this document. MRMC studies are generally relevant for evaluating the impact of AI algorithms or diagnostic tools on human reader performance, which is not applicable to a physical medical device like an IV catheter.

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

No, this question is not applicable as the device is a physical IV catheter and not an algorithm or AI system.

7. The Type of Ground Truth Used

The types of "ground truth" implicitly used for this device would be:

• Engineering Specifications: The design parameters (e.g., catheter gauge, length, flow rate) listed in the tables are the 'ground truth' for manufacturing.
• Performance Standards: The "bench tests and simulated use study" would have been conducted against established performance standards for IV catheters, likely related to patency, insertion force, flow continuity, and the integrity of the needle safety mechanism.
• Biocompatibility Standards: Biocompatibility was evaluated in accordance with ISO 10993-1, which provides the 'ground truth' for material safety. Sterility was validated according to ISO 11135-2007, and EtO residuals to ISO 10993-7.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical IV catheter and not an AI/algorithm that requires a training set.

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

This question is not applicable as the device is a physical IV catheter and not an AI/algorithm that requires a training set.

Summary of the Study and Evidence Presented:

The study described is a set of "bench tests and simulated use study" ([7]) conducted on the TERUMO® Hybria™ Closed System Safety I.V. Catheter. The purpose of these tests was to demonstrate substantial equivalence to predicate devices. This means the study aimed to show that the new device performs comparably to devices already on the market (K991406 TERUMO® SURFLASH® I.V. Catheter, K923702 Becton Dickinson Saf-T-Intima Closed I.V. Catheter System, K032843 Becton Dickinson Nexiva Closed IV Catheter System) in terms of intended use, design, technology/principles of operation, materials, and performance.

Specific details about the methodology, sample sizes, or outcome thresholds for these bench and simulated-use tests are not provided in this 510(k) summary. The document relies on the assertion that these tests were performed and demonstrated equivalence, alongside adherence to relevant ISO standards for biocompatibility and sterilization. The core argument for acceptance is the demonstrated equivalence to already approved devices, indicating that the new device does not raise "any new issues of safety or effectiveness."

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The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system. It is also used to lead a guide wire or a catheter into the target site.

The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) is a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. There is a hydrophilic coating on the distal portion of the device. The length of the coating is determined by the product code number.

This document describes a 510(k) premarket notification for a medical device, the RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP). Given the nature of a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to prove performance against specific acceptance criteria through a clinical study in the way one might for a novel device requiring a PMA.

Here's an analysis of the provided text in response to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria in the way a clinical trial might for a new device's performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it focuses on demonstrating that the device's performance characteristics are substantially equivalent to the predicate device.

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

The submission does not describe a test set or data provenance in the context of a clinical study or a performance evaluation against a specific set of clinical data. This is because the submission is for a 510(k) where substantial equivalence is being claimed with a predicate device with no changes in design or materials. The "performance" section refers to a risk/hazard analysis and a justification of equivalence, not a new comparative study using a clinical test set. The biocompatibility and sterilization validation are described, which would use specific samples for those tests, but not a general "test set" for overall device performance in a clinical sense.

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

This information is not applicable and not provided. As explained above, there was no clinical "test set" requiring ground truth established by experts for performance evaluation in this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the same reasons as #3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI

This information is not applicable and not provided. This device is a manual, physical catheter; it does not involve AI or any software requiring a multi-reader multi-case study.

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

This information is not applicable and not provided. This device is a medical catheter and does not involve any algorithms.

7. The Type of Ground Truth Used

This information is not applicable and not provided for a clinical performance test set. The "ground truth" here is essentially the already-cleared performance and characteristics of the predicate device (K915414, the Terumo Angiographic Catheter) against which the current device is deemed substantially equivalent due to being the same design and materials.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Since there's no machine learning or AI algorithm involved, there's no concept of a "training set."

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

This information is not applicable and not provided for the same reasons as #8.

Summary of the Study Proving Acceptance Criteria (Substantial Equivalence):

The "study" in this context is the 510(k) submission itself, which argues for substantial equivalence to a predicate device (K915414, the Terumo Angiographic Catheter).

• Proof of Equivalence: The key "proof" lies in the explicit statement: "The RADIFOCUS® Glidecath® (or RADIFOCUS Glidecath XP) in this submission is the same device that was cleared under K915414, the Terumo Angiographic Catheter. There are no changes in the design or materials."
• Risk Analysis: A risk/hazard analysis (according to EN ISO 14971) was performed to ensure that the identical device (now with a slightly different name/marketing) still meets safety standards and that its performance characteristics remain acceptable and equivalent to the already-cleared predicate.
• Biocompatibility Testing: Blood contacting materials were tested according to ISO 10993 to confirm biocompatibility.
• Sterilization Validation: Sterilization processes were validated according to EN ISO 11135-1 to ensure sterility.
• Manufacturing Controls: Ongoing manufacturing controls (visual, functional, dimensional, sterility tests) are in place to ensure consistent quality.

Conclusion:

This 510(k) submission represents a situation where the device is claimed to be identical in design and materials to a previously cleared predicate device. Therefore, the "acceptance criteria" are largely met by demonstrating that the device is the predicate device, and the "study" is the documentation proving this identity and confirming standard manufacturing and biological safety aspects. No new clinical performance studies comparing it to a control or evaluating its accuracy against a ground truth dataset were required or performed because the device itself is not new.

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The Pinnacle® ROII Introducer Sheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

The PINNACLE R/O II Introducer Sheath is comprised of an introducer sheath and a dilator. The introducer sheath has a radiopaque marker that is highly visible under fluoroscopy. The marker is a band that is located approximately 5 mm from the sheath's distal tip. The introducer sheath consists of 2 pieces of ETFE tubing -- a long segment and a short tip segment. The band is sandwiched between the two segments and fused together. The band is completely encapsulated within the tubing wall. The PINNACLE R/O II Introducer Sheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the device. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer. The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The PINNACLE R/O II Introducer Sheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Dilator maintains the integrity of the Sheath and dilates the blood vessel while the Introducer Sheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed. The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.

The KOR2847 document describes the "Pinnacle® ROII Introducer Sheath," a medical device designed to facilitate placing catheters into veins or arteries.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the performance of the Pinnacle® ROII Introducer Sheath is substantially equivalent to the performance of its predicate device (K003424). It doesn't list specific quantitative acceptance criteria for this device (like tensile strength values or flow rates) but rather relies on the equivalence to the predicate.

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

• Sample Size: The document does not explicitly state the sample size used for the bench testing.
• Data Provenance: The testing was conducted as "bench testing" by the manufacturer, Terumo Medical Corporation. The country of origin of this data is not specified, but the manufacturer is based in Elkton, MD, USA. The testing is considered prospective as it's part of the pre-market notification process for the new device.

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

This information is not provided in the document. The study involved bench testing rather than clinical performance evaluation that would typically involve expert assessment against ground truth. The "ground truth" here is adherence to engineering specifications and performance parameters set to achieve substantial equivalence.

4. Adjudication method for the test set:

This information is not provided. As it was bench testing, there was likely no "adjudication" in the sense of expert consensus on clinical outcomes.

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

No. This study is not a multi-reader multi-case comparative effectiveness study. It's a 510(k) submission for a non-AI medical device, focusing on substantial equivalence to a predicate device through bench testing. There is no AI component involved.

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

No. This device is a manual introducer sheath, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

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

The "ground truth" for this submission is based on engineering specifications, regulatory standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135-1994 for sterilization), and the established performance characteristics of the predicate device (K003424). The testing aims to demonstrate that the new device meets these specifications and performs equivalently to the predicate.

8. The sample size for the training set:

Not applicable. This submission is for a physical medical device (introducer sheath), not an AI/machine learning algorithm that requires a training set.

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

Not applicable. As above, no training set is relevant for this device.

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The product (Finecross™ MG) 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 the purpose of angiography.

FINECROSS MG consists of a catheter shaft, a hub and an anti-kink protector. The catheter shaft has reinforcing braided mesh, thus achieving the high shaft strength and anti-kink characteristics. The shaft has gradual hardness change from the proximal to the distal portion. This is achieved by joining outer layers of material with different hardness. By using polytetrafluoroethylene (PTFE) as the inner layer, high inner face mobility has been achieved. The outer surface of the catheter is coated with a hydrophilic polymer, therefore, it demonstrates a high lubricity upon moistening.

The provided text describes a 510(k) premarket notification for the FINECROSS™ MG Coronary Micro-Guide catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics typically associated with AI/software as a medical device (SaMD) clearances.

Therefore, many of the requested elements for an AI/SaMD study, such as sample size for test and training sets, expert qualifications, and adjudication methods, are not applicable or explicitly mentioned in this document. The device is a physical medical instrument, not an AI algorithm.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for a physical medical device, specific "acceptance criteria" and "device performance" in the context of an AI algorithm's metrics (e.g., sensitivity, specificity) are not present. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various specifications and bench testing.

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

Not applicable for this type of device. The "test set" in this context would refer to physical prototypes undergoing bench testing, not a dataset for an AI algorithm. The document states "bench testing" was performed, but does not specify sample sizes or data provenance for these physical tests.

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

Not applicable. "Ground truth" in the context of AI refers to expert-labeled data. For a physical device, testing is typically against engineering specifications and predicate device performance, not expert-established ground truth in the AI sense.

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

Not applicable. This is a method for resolving discrepancies in expert labeling for AI ground truth.

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

No. This device is a physical catheter, not an AI or software assistant for human readers. Therefore, an MRMC study related to AI assistance would not be performed for this product.

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

Not applicable. This is not an AI algorithm.

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

For this physical device, the "ground truth" would be established by engineering specifications, validated test methods, and direct comparison to the performance characteristics of the legally marketed predicate devices, rather than expert consensus on medical images or pathology.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for this physical device.

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The Radifocus Optitorque Angiographic Catheter is intended for 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 a two-layer construction comprised of a stainless steel mesh sandwiched between layers of polyurethane polyamide elastomer. The polyurethane polyamide elastomer contains barium sulfate for visibility and contrast under fluoroscopy. The Catheter has a "soft-tip" whose purpose is to minimize trauma to the vessel wall. The soft-tip is a flexible, supple polyurethane tip that is permanently welded to the catheter shaft.

The provided text is a 510(k) summary for the Radifocus® Optitorque™ Angiographic Catheter. It states that the device is substantially equivalent to a previously cleared device (K992051) and thus does not contain a typical study with acceptance criteria and performance metrics for a new device. Instead, the justification for substantial equivalence relies on the fact that the device is identical in design, materials, and principle of operation to the predicate device, and a risk/hazard analysis was conducted.

Therefore, many of the requested details about acceptance criteria, performance, sample sizes, expert involvement, and ground truth establishment are not applicable or cannot be extracted from this document, as a new clinical performance study was not required or submitted for this specific 510(k).

Here's an attempt to address the points based on the provided text, indicating where information is not available:

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 information is not provided as a formal performance study on a test set (clinical or otherwise with specific sample sizes) for this new 510(k) was not conducted. The submission relies on substantial equivalence to a predicate device.

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

This information is not provided as a specific clinical performance study requiring expert ground truth establishment for this 510(k) was not conducted.

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

This information is not provided as a specific clinical performance study requiring adjudication for this 510(k) was not conducted.

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

An MRMC study was not conducted, as this is a medical device (angiographic catheter), not an AI-assisted diagnostic tool.

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

This is not applicable as the device is an angiographic catheter and does not involve an algorithm. The "Principle of Operation / Technology" states it "is operated manually or by a manual process."

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

This information is not applicable to this type of device submission. The performance justification relies on compliance with standards for material safety, sterility, and mechanical/physical specifications rather than a comparative ground truth for diagnostic accuracy.

8. The sample size for the training set

This information is not applicable as this is a medical device (angiographic catheter) and does not involve a "training set" in the context of an algorithm or AI model development.

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

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

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