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This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels).

The CROSSLOOP is steerable guide wire with a maximum diameter of 0.018 inches (0.46 mm) and available in various lengths of 200 cm, 235 cm and 300 cm. The CROSSLOOP consists of a stainless-steel (SUS) core wire with a Pt-Ni alloy coil, soldered with Au-Sn solder. The distal tip is loop-structured. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A silicone and hydrophilic coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

The provided text describes a 510(k) premarket notification for a medical device called "CROSSLOOP," a catheter guide wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval Application).

Therefore, the information you're asking for, such as "acceptance criteria and the study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established," are not directly applicable or available in this document.

This 510(k) summary focuses on non-clinical testing/performance data and biocompatibility to demonstrate that the device is substantially equivalent to existing cleared devices, not that it independently proves clinical efficacy or diagnostic accuracy (as would be the case for an AI-powered diagnostic device, for example).

Here's how to address your points based on the provided text:

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

The document states: "The in vitro bench tests demonstrated the CROSSLOOP met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide a table specifying the precise acceptance criteria or quantitative performance results for each test. It only lists the types of non-clinical 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 for any of the non-clinical tests.
• Data Provenance: The tests are "in vitro bench tests" and "biocompatibility" tests. The manufacturer is ASAHI INTECC CO., LTD. whose global headquarters and R&D center are in Japan. The specific country where the testing was performed is not explicitly stated, but it's likely linked to the manufacturer's R&D facilities. These are laboratory tests, not clinical data, so terms like "retrospective" or "prospective" don't apply in the common clinical sense.

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 applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for imaging devices) is relevant for AI/ML-powered diagnostic tools or clinical studies, neither of which are described here. The "ground truth" for the non-clinical tests would be the established engineering and materials science standards and specifications.

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

This is not applicable. Adjudication methods are typically used in clinical trials involving human observation or interpretation, especially with imaging reads. For bench testing, results are typically quantitative measurements compared against predefined engineering specifications.

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. An MRMC study is designed for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. The "CROSSLOOP" is a physical medical device (catheter guide wire), not an AI/ML software tool.

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The CROSSLOOP is a physical medical device.

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

For a physical device like a guide wire, the "ground truth" for non-clinical testing refers to pre-defined engineering specifications, material properties, and performance standards (e.g., tensile strength required to withstand certain forces, flexibility within a specified range, biocompatibility per ISO standards). This is not derived from expert consensus on clinical cases, pathology, or outcomes data, but rather from material science and mechanical engineering principles.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train AI/ML models. This device is not an AI/ML product.

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

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

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This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.

The CROSSLEAD 0.014inch is steerable guide wire with a maximum diameter of 0.014inch (0.36mm) and available in various lengths of 100cm, 200cm, 235cm and 300cm. This quide wire consists of a hybrid nitinol (Ni-Ti) and stainless-steel (SUS) core wire with a stainless-steel inner coil and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. A hydrophobic coating is applied to proximal portion. The basic structure, construction and materials of the CROSSLEAD 0.014inch are similar to those of previously described in the predicate ASAHI Gladius (K150445/K163426) and references; CROSSLEAD Penetration (K230377), MINAMO (K190176) and Astato XS40 (K153443/K163426).

All sizes are available with a straight and a pre-shaped design.

This document is a 510(k) Premarket Notification for a medical device (CROSSLEAD 0.014inch guide wire) and does not describe a study involving an AI/Machine Learning enabled device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and performance studies for such devices, including details on test sets, expert ground truth, MRMC studies, or training sets.

The document discusses non-clinical bench testing to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not an AI algorithm.

Therefore, I cannot fulfill the request as the provided text does not contain information related to AI/ML device testing and acceptance criteria.

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The indications for use of the FMD Peripheral Guide Wires F-14 and F-18 :

The FMD Peripheral Guide Wires are 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 indications for use of the FMD Guide Wire Extension F-14 EXT :

The FMD Guide Wire Extension 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.

The FMD Peripheral Guide Wires F-14 and F-18 are designed to facilitate the placement of interventional peripheral devices such as dilating balloon catheters, stent delivery systems and other peripheral artery diagnostic or therapeutic devices. The guide wires are available in nominal diameters of 0.014 (F-14) and 0.018 (F-18) inches and nominal lengths from 190cm to 300cm. The F-14 and F-18 guide wires with a length of less than 300 cm are compatible exclusively with the FMD Guide Wire Extension F-14 EXT, which can extend the guide wire length allowing for exchange of Over-The-Wire systems. The guide wires are composed of a stainless-steel core wire and a stainless steel and platinum nickel coil assembly on the distal end of the device. The coil assembly is soldered to the core. The Pt-Ni radiopaque coil allows for visualization while using fluoroscopy. The proximal portion is coated with PTFE. The distal section is coated with hydrophilic coating. All wires are available in a straight tip configuration.

The FMD Guide Wire Extension F-14 EXT is composed of a stainless steel core wire coated with PTFE. It has an outer diameter of 0.014" (0.36 mm) and a length of 165cm. Its distal end contains a connecting hypotube that is compatible with guide wires less than 300cm of both the F-14 and F-18 series.

Attachment of the FMD Guide Wire Extension F-14 EXT to FMD's extendable guide wire creates an extended guide wire that can be used to exchange out a percutaneous transluminal angioplasty (PTA) catheter without removing the original guide wire from the artery. When the exchange is complete, the FMD Guide Wire Extension F-14 EXT can be detached, and the original guide wire can be used in a conventional manner.

This document describes the premarket notification for the FMD Peripheral Guide Wires F-14 and F-18, and the FMD Guide Wire Extension F-14 EXT. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis based on your request:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a detailed quantitative manner. Instead, it broadly states that "The in vitro bench tests demonstrated that the FMD Peripheral Guide Wires F-14 and F-18 met all acceptance criteria and performed similarly to the predicate and reference devices." and for the biocompatibility tests, it indicates "The following biocompatibility tests were completed".

Here's a summary based on the listed tests:

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

The document does not specify the exact sample sizes used for each non-clinical bench test. The data provenance is from non-clinical laboratory testing performed on the FMD Peripheral Guide Wires F-14 and F-18 and FMD Guide Wire Extension F-14 EXT. The country of origin of the data is not explicitly stated, but the applicant and contact information are for FMD Co., Ltd. located in Japan. All data would be considered prospective as it's 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

This information is not applicable as the study described is a series of non-clinical bench tests and biocompatibility tests, not a clinical study involving human data or expert review of images for ground truth. The "ground truth" for these tests would be the established scientific and engineering principles and standards for medical device performance.

4. Adjudication method for the test set

This information is not applicable as the described study involves non-clinical bench testing and biocompatibility assessments, not a clinical trial requiring adjudication of patient outcomes or expert consensus. Decisions would be based on quantitative measurements and established pass/fail criteria for each test.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes the premarket notification for physical guide wires and guide wire extensions, which are mechanical devices, not AI-powered software or diagnostic tools that would involve human readers or AI assistance. The document explicitly states "Clinical evaluation was not required for this device."

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

A standalone performance study of an algorithm was not done. This submission is for mechanical medical devices, not an algorithm or AI.

7. The type of ground truth used

The ground truth used for this submission is based on established engineering principles, international and national standards (e.g., ISO, ASTM), and the performance characteristics of legally marketed predicate devices. For biocompatibility, the ground truth is based on the results of validated in vitro and in vivo toxicology tests as per relevant standards (e.g., ISO 10993 series).

8. The sample size for the training set

This information is not applicable. The submission is for physical medical devices and does not involve an AI algorithm or a "training set" in the context of machine learning.

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

This information is not applicable, as there is no "training set" in the context of an AI algorithm described in this submission.

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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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