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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO® GT Crossing14 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) in available lengths of 190cm and 300cm. The outer coil wire diameter has been modified to 0.072 mm. The devices have a solid core with a hvdrophilic coated coil-type distal end. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2 cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300cm. A Torque device is included in the same package.

Here's an analysis of the provided text regarding acceptance criteria and device performance:

It's important to note that the provided document is a 510(k) summary for a medical device (a guide wire), not a publication about an AI/ML medical device. Therefore, many of the requested elements for AI/ML device studies (e.g., ground truth methods, expert qualifications, effect size for human readers with AI assistance) are not applicable to this document. This summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments, not on the performance of a diagnostic or assistive AI system.

Here's the information that can be extracted from the document, with explanations for what cannot be:

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

The document states that "The in vitro bench tests demonstrated that the VASSALLO GT Crossing14 met all acceptance criteria and performed similarly to the predicate devices." However, the specific quantitative acceptance criteria for each test and the corresponding precise device performance values are not explicitly detailed in this 510(k) summary. It only lists the tests performed.

Non-clinical tests performed (details on specific criteria and results are not provided):

• Dimensional Verification
• Visual Inspection
• Tensile Strength / Tip Pull
• Torque Strength
• Torqueability
• Coating Adhesion/Integrity
• Catheter Compatibility / Lubricity
• Corrosion Resistance
• Kink Resistance
• Tip Flexibility
• Radiopacity

Biocompatibility tests performed (details on specific criteria and results are not provided; leveraged from predicate):

• Cytotoxicity
• Sensitization
• Intracutaneous Irritation
• Acute Systemic Toxicity
• Material Mediated Pyrogenicity
• Hemolysis
• Partial Thromboplastin Time
• In Vivo Thromboresistance
• Complement Activation (SC5b-9)

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

The document refers to "non-clinical laboratory testing" and "in vitro bench tests." It does not specify sample sizes for these tests (e.g., how many guidewires were tested for tensile strength). Since these are bench tests, "data provenance" in terms of patient data (country of origin, retrospective/prospective) is not applicable. The tests were performed to support a device manufactured by FILMECC CO., LTD. in Japan.

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

This is not applicable as this is not an AI/ML medical device or a clinical study requiring expert ground truth for interpretation. The "ground truth" for these non-clinical tests would be the physical and chemical properties measured against established engineering and material standards.

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

Not applicable, as this is not an AI/ML medical device or a clinical study involving subjective interpretation requiring adjudication.

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

Not applicable. This document describes a traditional medical device (guide wire) and does not involve AI assistance or human readers.

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

Not applicable. This document describes a traditional medical device (guide wire) and does not involve an algorithm.

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

For non-clinical bench testing, the "ground truth" is defined by established engineering standards, material specifications, and physical/chemical measurements. For biocompatibility, it's defined by biological responses according to ISO standards for biocompatibility testing. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

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

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

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

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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO® GT 018 G12 and G30 Peripheral Guide Wires in this submission are a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) in available lengths of 190cm and 300cm. The devices have a solid core with a hydrophilic coated coil-type distal end. The entire coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2 cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the guide wire with a length of less than 300 cm. A Torque device is included in the same package.

The provided document is a 510(k) summary for the VASSALLO® GT 018 G12 and G30 Peripheral Guide Wires. This type of submission is for medical devices that claim substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information typically requested regarding AI/human reader studies, ground truth establishment for training, and detailed performance metrics as one might find for an AI-powered diagnostic device, is largely not applicable here.

The document describes non-clinical testing performed to demonstrate that the device meets acceptance criteria and performs similarly to its predicate device.

Here's the information extracted from the document:

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

The document states that the VASSALLO GT 018 G12 and G30 met all acceptance criteria for the non-clinical tests performed. Specific acceptance values are not provided in this summary, but the types of tests and the conclusion that the device met the criteria are listed.

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

The document does not specify sample sizes for each non-clinical test. This is typically found in the detailed test reports, not the summary. The tests are non-clinical laboratory tests, meaning they were performed in a controlled lab environment and are not based on human or animal data provenance (e.g., country of origin, retrospective/prospective).

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 tests are non-clinical, mechanical, and material property evaluations. There is no "ground truth" to be established by human experts in the context of diagnostic interpretation.

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

This information is not applicable as there is no diagnostic image or data interpretation by experts that would require an adjudication method. The tests are objective measurements of physical properties.

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 information is not applicable. This device is a physical medical device (peripheral guide wire), not an AI diagnostic or assistance tool. Therefore, MRMC studies are not relevant.

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

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

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

This information is not applicable for the non-clinical tests described. The "ground truth" for these tests would be the established engineering specifications, material properties, and performance benchmarks that the device is designed to meet.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this physical medical device.

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

This information is not applicable.

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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO GT 018 Hybrid consists of a hybrid NiTi alloy and stainlesssteel core wire and a coil assembly on the distal end of the device. The coil assembly is soldered to the NiTi alloy portion of the core. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. Coatings are applied on the surface of the VASSALLO GT 018 Hybrid. The proximal portion is coated with PTFE. The distal section is coated with a hydrophilic coating and polyurethane coating. When wet, the hydrophilic coating increases the lubricity of the quidewire surface. The middle portion of the device is coated with PFA and silicone coatings. The VASSALLO GT 018 Hybrid has an outer diameter of 0.018 inches (0.45 mm) and is available in 190cm and 300cm lengths. About 2cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300 cm. A Torque device is included in the same package.

This document describes the VASSALLO® GT 018 Hybrid, a peripheral guide wire. It focuses on non-clinical and biocompatibility testing to establish substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested fields are not applicable (N/A) in this context.

Here's an analysis of the provided text:

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

The document states, "The in vitro bench tests demonstrated that the VASSALLO GT 018 Hybrid met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not explicitly list the quantitative acceptance criteria for each test or detailed performance metrics. It only lists the tests performed.

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

• Sample size: Not specified. The document only mentions "Non-clinical laboratory testing" and "in vitro bench tests."
• Data provenance: The applicant is FILMECC CO., LTD. located in Japan. The tests are non-clinical, so "retrospective or prospective" as generally understood in clinical trials is not applicable. The tests are likely performed in a laboratory setting.

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

This is a non-clinical device submission based on bench testing and biocompatibility. There is no mention of human-expert-established ground truth in the context of radiology or similar fields. The "ground truth" would be the objective results of the engineering and biological tests conducted.

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

N/A. This concept is not applicable for non-clinical bench 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

N/A. This document is for a medical device (guide wire), not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.

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

N/A. This document is for a medical device (guide wire), not an AI algorithm.

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

The "ground truth" for this submission would be defined by the pre-established engineering specifications and industry standards for guide wire performance and safety (e.g., ISO standards for medical devices, ASTM standards for material properties). The tests measure if the device meets these objective standards.

8. The sample size for the training set

N/A. This is not an AI/machine learning device; therefore, there is no "training set."

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

N/A. Not an AI/machine learning device.

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The VASSALLO GT EXT guide wire accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure. This device is intended for peripheral vascular use only.

The VASSALLO GT EXT Guide Wire Extension accessory is used to elongate the working length of compatible peripheral extendable wires. The stainless-steel guide wire extension has an outer diameter of 0.014" (0.36 mm) and a length of 165 cm. The distal end consists of a pipe shaped nitinol-titanium connection port (extension tube). The straight stainless steel wire surface is coated with PTFE. The extension wire is intended to connect with a FILMECC peripheral guide wire shorter than 300 cm. The total length of the system after connection will be 300 cm to 400 cm.

The provided text describes the 510(k) premarket notification for the FILMECC VASSALLO GT EXT guide wire extension. This is a medical device, and the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on performance against specific acceptance criteria for an AI/ML-driven diagnostic or prediction system.

Therefore, the information required to populate the fields related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., sample size, expert ground truth, MRMC study, standalone performance) is not present in the provided document.

The document states:

• Non-clinical testing/performance data: "Non-clinical laboratory testing was performed on the VASSALLO GT EXT to determine substantial equivalence. Testing involved evaluating the joint strength of the extension tube and core wire of extension wire in addition to the joint strength of the extension tube and the core extension wire. The in vitro bench tests demonstrated that the VASSALLO GT EXT met all acceptance criteria and that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device."

This indicates that the acceptance criteria are related to physical performance characteristics (like joint strength) of the guide wire extension and that in vitro bench tests were conducted to demonstrate these. However, the specific quantitative acceptance criteria or the detailed results of these tests (e.g., numerical values for joint strength, performance vs. predicate) are not detailed in this summary.

Given the nature of the device (a guide wire extension, not an AI/ML diagnostic tool), the typical questions about AI/ML device evaluation (like expert readers, MRMC studies, training/test set ground truth for algorithms) are not applicable to this submission.

In summary, based only on the provided text, I cannot complete the requested tables and information fields because:

• The device is a physical medical device (guide wire extension), not an AI/ML or diagnostic device that would involve typical "acceptance criteria" in terms of classification performance (e.g., sensitivity, specificity, AUC) or human reader performance.
• The "acceptance criteria" mentioned are for engineering/performance bench tests (e.g., joint strength), not diagnostic accuracy.
• The document states "in vitro bench tests demonstrated that the VASSALLO GT EXT met all acceptance criteria," but it does not specify what those criteria are or provide the results of those tests.
• There is no mention of a test set, expert ground truth, MRMC study, or training set in the context of an AI/ML system.

To provide the requested information, the 510(k) submission's detailed test reports for the physical properties of the guide wire extension would be needed, not just this summary.

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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO GT 018 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.018" (0.45mm) and available in lengths of 190cm and 300cm. The device has a solid core with a hydrophilic coated coil-type distal end. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300 cm. A Torque device is included in the same package.

The provided document describes the VASSALLO GT 018 Floppy peripheral guide wire. It does not describe an AI/ML powered device, but rather a medical device that facilitates the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. Therefore, many of the requested elements for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.

However, I can provide information based on the non-clinical testing performed for the device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The in vitro bench tests demonstrated that the VASSALLO GT 018 met all acceptance criteria and performed similarly to the predicate and reference devices." However, specific quantitative acceptance criteria and their corresponding reported device performance values are not detailed in this document. The document only lists the types of tests performed.

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

The document does not specify the sample sizes used for each non-clinical bench test. The data provenance is not explicitly stated in terms of country of origin for the testing, but the applicant company, FILMECC CO., LTD., is based in Japan. These would be considered prospective tests conducted 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. This is a medical device and the tests are non-clinical bench tests (e.g., tensile strength, corrosion resistance). "Ground truth" in the context of expert consensus is not relevant here; the tests have objective physical or chemical measurements.

4. Adjudication method for the test set

Not applicable, as this refers to expert review processes for complex diagnostic outputs, not physical device performance tests.

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

Not applicable. This device is not an AI/ML diagnostic tool.

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

Not applicable. This device is not an AI/ML algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is established by standard engineering and biocompatibility testing protocols and specifications. For example, for "Tensile Strength," the ground truth would be a pre-defined range of acceptable tensile forces according to relevant standards for guide wires. For biocompatibility, the ground truth is the absence of cytotoxicity, irritation, etc., according to recognized international standards (e.g., ISO 10993).

8. The sample size for the training set

Not applicable. This device does not involve machine learning and therefore has no "training set."

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

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

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Intended to facilitate the placement and exchange of diagnostic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO GT Hybrid consists of a hybrid NiTi and stainless-steel core wire and a coil assembly on the distal end of the device. The coil assembly is soldered to the NiTi portion of the core. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. Coatings are applied on the surface of the VASSALLO GT Hybrid to increase lubricity and reduce friction. The proximal portion is coated with PTFE. The distal section is coated with a hydrophilic coating and polyurethane coating. The VASSALLO GT Hybrid has an outer diameter of 0.014 inches (0.36mm) and is available in 190cm and 300cm lengths. About 2cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the guide wire with a length of less than 300 cm. A Torque device is included in the same package.

This document describes a 510(k) premarket notification for the VASSALLO GT Hybrid, a catheter guide wire, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance described by specific metrics (e.g., accuracy, sensitivity, specificity), nor details of any study demonstrating this performance. It's a regulatory submission affirming substantial equivalence based on technical characteristics and bench testing against predicate devices, not a clinical performance validation against specific acceptance criteria for a diagnostic AI/ML device.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided text, as it pertains to a different type of medical device submission (a guide wire, not a diagnostic AI/ML device) and does not include the specific performance metrics or study information requested.

Here's a breakdown of what can be inferred from the document regarding the closest analogous information, and what is explicitly missing for your request:

What can be inferred (closest analogies):

• "Acceptance criteria" and "reported device performance": The document states, "The in vitro bench tests demonstrated that the VASSALLO GT Hybrid met all acceptance criteria and performed similarly to the predicate and reference devices." and "Performance data demonstrate that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate devices." While this confirms tests were performed and criteria met, the actual criteria (e.g., specific tensile strength in Newtons, specific coating adhesion force) and the numerical performance results against those criteria are not provided. The bench tests listed are:
  • Dimensional Verification
  • Visual Inspection
  • Simulated Use
  • Tensile Strength / Tip Pull
  • Torque Strength
  • Torqueability
  • Coating Integrity
  • Coating Adhesion
  • Catheter Compatibility / Lubricity
  • Corrosion Resistance
  • Kink Resistance
  • Tip Flexibility
  • Radiopacity
• "The study that proves the device meets the acceptance criteria": This refers to "Non-clinical laboratory testing" and "Biocompatibility testing."
• "Type of ground truth used": For the guide wire, the "ground truth" is typically defined by engineering specifications, material properties, and established medical standards for guide wire performance (e.g., ISO standards for tensile strength, elongation, etc.), as well as in-vitro performance models that simulate use. These are not explicitly detailed but are inherent in the types of non-clinical tests performed.

What is explicitly missing from the provided text for your request (and why):

1. A table of acceptance criteria and the reported device performance: While criteria were met, the specific metrics and values are not given.
2. Sample size used for the test set and the data provenance: Not applicable in the context of bench testing for a guide wire in the way it would be for an AI/ML diagnostic. Bench tests typically use a pre-production sample of devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for engineering bench tests. "Ground truth" is based on objective measurements against engineering specifications.
4. Adjudication method for the test set: Not applicable. Bench test results are typically objective measurements.
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 medical instrument, not an AI diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: As mentioned above, it's engineering specifications and in-vitro performance models, not expert consensus, pathology, or outcomes data in the sense of a diagnostic interpretation.
8. The sample size for the training set: Not applicable. This device does not use a training set as it's not an AI/ML product.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a 510(k) submission for a physical medical device (a guide wire), not an AI/ML diagnostic device. The regulatory pathway involves demonstrating substantial equivalence through comparison of technological characteristics and non-clinical bench testing to predicate devices, rather than establishing clinical performance against human expert ground truth using AI-specific metrics.

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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO® GT Peripheral Guide Wires in this submission are steerable guide wires with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm and 300cm lengths. These devices have a solid core with a hydrophilic coil-type distal end. When wet, the hydrophilic coating increases the lubricity of the quidewire surface. Some models also include silicone coating on the distal tip. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300 cm. A Torque device is included in the same package.

This document is a 510(k) summary for the VASSALLO® GT Guide Wire. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, based on non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The in vitro bench tests demonstrated that the VASSALLO GT met all acceptance criteria". However, it does not provide a specific table of acceptance criteria with corresponding performance values. It only lists the types of tests performed.

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

The document does not specify the sample size used for each non-clinical test.
The data provenance is from non-clinical laboratory testing performed on the VASSALLO® GT. The country of origin for the manufacturing company (Filmecc Co., Ltd.) is Japan. The type of study is bench testing (in vitro), not human subject testing (prospective or retrospective).

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

This question is not applicable as the study described is non-clinical bench testing, not a clinical study involving expert interpretation of data or images. Ground truth for non-clinical tests is established by adhering to testing standards and specifications.

4. Adjudication Method for the Test Set

This question is not applicable as the study described is non-clinical bench testing. Adjudication methods are typically relevant for clinical studies where human interpretation or consensus is required.

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 done. This document focuses on non-clinical bench testing of a guide wire, not an AI-assisted diagnostic device. Therefore, there is no discussion of human readers, AI assistance, or effect sizes in that context.

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

This question is not applicable. The device is a medical guide wire, not an algorithm or software requiring standalone performance evaluation.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" or reference for evaluating performance would be predefined engineering specifications, international standards, and performance characteristics of predicate devices. The document states that the device "met all acceptance criteria" and "performed similarly to the predicate and reference devices," implying comparison against these types of benchmarks.

8. The Sample Size for the Training Set

This question is not applicable. There is no mention of a "training set" as this is a physical medical device undergoing bench testing, not an AI/machine learning model.

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

This question is not applicable as there is no training set for a guide wire.

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