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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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PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA).

The PCI Guide Wires are not intended for use in the neurovasculature.

The basic structure of the MINAMO blue / viola consists of a hybrid stainless steel and nitinol (Ni-Ti) core wire, with a stainless steel distal inner rope coil. Surrounding the inner rope coil and the distal core wire is a radiopaque platinum nickel / stainless steel outer coil. The outer and inner coils are soldered to the tapered core wire. A similar coil design is used with other ASAHI guide wires, such as the predicate MINAMO (K190176). In addition, coatings are applied on the surface of the product. The coil portion is coated with a silicone and hydrophilic coating. The proximal side of the core wire is coated with PFA, silicone and PTFE.

The nominal outer diameter of the MINAMO is 0.36 mm. The devices are available in three lengths: 190 cm, 235 cm and 300 cm.

The MINAMO blue / viola radiopaque distal tip enables the user to view the position of the tip under X-ray fluoroscopy.

All sizes are available with a straight, pre-shape, and J-shape design.

The provided text focuses on the 510(k) premarket notification for the MINAMO blue and MINAMO viola guide wires. It describes the device, compares it to predicate and reference devices, and outlines the non-clinical and biocompatibility testing performed to demonstrate substantial equivalence.

However, the text does not contain the specific information requested regarding acceptance criteria and a study proving the device meets these criteria in the context of an AI/ML-enabled medical device.

The document states that the MINAMO blue and MINAMO viola are catheter guide wires, which are physical medical devices, not AI/ML-enabled software devices. Therefore, the questions related to:

• AI/ML performance metrics (e.g., Sensitivity, Specificity, AUC)
• Sample sizes for test sets in an AI/ML context
• Number of experts for ground truth establishment
• Adjudication methods
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
• Standalone AI performance
• Training set sample sizes and ground truth establishment for training data

are not applicable to the submitted document as it describes a traditional medical device (guide wire) and not an AI/ML product.

The document focuses on demonstrating the substantial equivalence of the guide wires to previously cleared predicate devices through:

• Indications for Use: Same as the predicate.
• Technological Characteristics: Similar materials, design, operating principle, and sterilization.
• Non-Clinical Testing/Performance Data: Bench tests following FDA guidance, demonstrating performance similar to predicate devices and meeting acceptance criteria for physical and mechanical properties (e.g., tensile strength, torque strength, tip flexibility, coating integrity, lubricity, corrosion resistance, kink resistance, radiopacity, dimensional verification, simulated use).
• Biocompatibility: In accordance with ISO 10993.

Based on the provided text, here's what can be extracted and what cannot:

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

The document states: "The in vitro bench tests demonstrated that the MINAMO blue and MINAMO viola met all acceptance criteria and performed similarly to the predicate devices."
However, the specific numerical acceptance criteria and the quantified reported device performance values are NOT provided in the document. It only lists the types of tests performed.

Types of Performance Tests (Implied Acceptance Criteria for these properties):

• Tensile Strength
• Torque Strength
• Torqueability
• Tip Flexibility
• Coating Integrity
• Lubricity
• Visual Inspection
• Corrosion Resistance
• Kink Resistance
• Radiopacity
• Dimensional Verification
• Simulated use in a clinically relevant mode
• Coating Integrity/Particulate Evaluation in a clinically relevant mode

Biocompatibility Tests (Implied Acceptance Criteria: Non-cytotoxic, Non-sensitizer, Non-irritant, Non-toxic, Non-pyrogenic, Non-hemolytic, Not an activator, Thromboresistant):

For all other points (2-9), the information is NOT applicable to this document as it does not describe an AI/ML-enabled device or an AI/ML study.

2. Sample sized used for the test set and the data provenance: Not applicable (not an AI/ML study). The document refers to "bench testing" and "in vitro" tests, implying physical samples of the guide wire.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (not an AI/ML study requiring expert review of data).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 (not an AI/ML study).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the physical device, the "ground truth" would be established by standardized testing protocols and measurements of physical properties. For biocompatibility, it's based on ISO 10993 standards and the biological responses observed in the tests (e.g., no cellular reactivity, no delayed dermal contact sensitization).
8. The sample size for the training set: Not applicable (no AI model).
9. How the ground truth for the training set was established: Not applicable (no AI model).

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ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

The ASAHI PTCA Guide Wire ASAHI Gaia Next (hereafter "ASAHI Gaia Next") is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm length. The extension wire may be connected to the end of the guide wire outside the body. The guide wire is constructed from a stainless-steel core wire with a platinum-nickel and stainless-steel coils. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The distal end of the quide wire has a radiopaque outer coil and inner coil 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. The coil assembly construction is similar to predicate device.

The provided text describes the 510(k) premarket notification for the ASAHI PTCA Guide Wire ASAHI Gaia Next. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting results from a study proving device performance against specific acceptance criteria for a new, novel technology. Therefore, many of the requested categories (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not available from this regulatory submission. This document details non-clinical bench testing to show the device performs similarly to a predicate.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of precise quantitative acceptance criteria (e.g., "tensile strength must be >X Newtons") or specific numerical performance results for each test. Instead, it states that the device "met all acceptance criteria" and "performed similarly to the predicate devices" in bench testing.

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

• Sample Size for Test Set: Not specified. The document refers generally to "bench testing" without providing the number of units tested for each non-clinical performance test.
• Data Provenance: The tests are described as "in vitro bench tests." This implies tests were conducted in a laboratory setting. The country of origin of the data is not explicitly stated, but the applicant is ASAHI INTECC CO., LTD from Japan.

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

• Not Applicable. This device is a guide wire, and the evaluation involves non-clinical engineering and biological performance testing, not diagnostic interpretation requiring expert consensus on "ground truth."

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

• Not Applicable. As mentioned above, this is non-clinical bench testing. Adjudication methods are relevant for human-read diagnostic studies.

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 is a medical device (guide wire), not an AI-powered diagnostic tool. No MRMC study was conducted.

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

• Not Applicable. This is a medical device (guide wire), not an AI-powered diagnostic tool. No standalone algorithm performance was evaluated.

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

• For the non-clinical bench tests, the "ground truth" or reference for acceptance is against established engineering and material science standards and performance specifications for guide wires, and comparison to the predicate device. For biocompatibility, it's against established biological safety standards.

8. The sample size for the training set

• Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for a physical medical guide wire.

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

• Not Applicable. See point 8.

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ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal anqioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

ASAHI PTCA Guide Wire ASAHI SION (hereafter "ASAHI SION"), ASAHI PTCA Guide Wire ASAHI SION blue (hereafter "ASAHI SION blue") and ASAHI PTCA Guide Wire ASAHI SION J (hereafter "ASAHI SION J") are steerable guidewires with a maximum diameter of 0.014 inches (0.36mm) and available in 180cm. 190cm and 300cm lengths. The quide wire is constructed from stainless-steel core wire with platinum-nickel and stainless-steel coils. The coils assembly consists of an inner coil and an outer coil, as well as a safety wire which is soldered to the inner and outer coils and the core wire. The distal end of the quide wire has a radiopaque tip to achieve visibility and is available in a straight (ASAHI SION) and shaped "J" (ASAHI SION blue, ASAHI SION J) and Pre-Shape (ASAHI SION and ASAHI SION blue) to easily bend with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire (ASAHI SION and ASAHI SION J). A silicone and hydrophilic coating are applied to the distal portion of the guide wire for (ASHI SION blue). The proximal sections of the ASAHI SION Series are coated with PTFE.

The provided document is a 510(k) Pre-market Notification from the FDA for the Asahi PTCA Guide Wire Asahi SION Series. It describes non-clinical testing performed to establish substantial equivalence to predicate devices. However, it does not include information about any studies that would involve AI or human readers.

Here's the breakdown of the information provided for the device's acceptance criteria and studies, as requested, focusing on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that non-clinical laboratory testing was performed and that the device met all acceptance criteria. However, the specific quantitative acceptance criteria values for each test are not explicitly detailed. The performance is reported as meeting these (unstated) criteria and being similar to predicate devices.

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

The document mentions "non-clinical laboratory testing" and "in vitro bench tests." It does not specify the sample sizes used for these tests. The data provenance is described as non-clinical laboratory testing, implying controlled lab environments, not patient data from specific countries. It is retrospective, as it's testing a finished product against established standards.

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

Not applicable. This is a non-clinical device performance study, not involving human interpretation of data where expert ground truth would be established. The acceptance criteria are based on engineering and material science standards.

4. Adjudication Method for the Test Set:

Not applicable. This is a non-clinical device performance study.

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

No, an MRMC comparative effectiveness study was not conducted or described in this document. This filing is for a physical medical device (guidewire), not a software or AI-based diagnostic tool that would typically involve human readers or AI assistance.

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

No, a standalone algorithm performance study was not conducted or described. The device is a physical guidewire, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests is established by industrial standards and pre-defined specifications for medical devices (e.g., ISO 10993 for biocompatibility, and unspecified internal criteria for mechanical properties like tensile strength, torque strength, coat adhesion, and particulate matter).

8. The Sample Size for the Training Set:

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable. As there is no training set mentioned, there is no corresponding ground truth establishment process for it.

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Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.

The Fixed Core Wire Guides, subject of this submission, are Class II devices according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a core mandril, a spring coil anchored over the mandril, and an inner safety wire. The Fixed Core Wire Guides are available with outside diameters ranging from 0.015 inches to 0.052 inches and lengths ranging from 15 centimeters to 480 centimeters. The flexible tip portion of the wire guides is either straight or J-tipped. The Fixed Core Wire Guides will be uncoated or coated with Polytetrafluoro-ethylene (PTFE). The Fixed Core Wire Guides are packaged, sterile devices intended for single use.

The document describes the premarket notification (510(k)) for the Fixed Core Wire Guides. However, it does not pertain to an AI/ML medical device. Therefore, much of the information requested in your prompt (e.g., patient data, training/test sets, expert consensus, MRMC studies, standalone performance, etc.) is not applicable to this submission, as it is for a physical medical device (wire guides).

The "study that proves the device meets the acceptance criteria" refers to the various engineering and biological tests conducted on the physical device.

Here's an attempt to answer the prompt based on the provided document, acknowledging the non-AI nature of the device:

Device: Fixed Core Wire Guides (K171764)
Device Type: Physical Medical Device (Catheter Guide Wire)
Regulation: 21 CFR 870.1330 (Catheter Guide Wire)

Given that this is a 510(k) submission for a physical medical device (wire guide) and not an AI/ML-driven device, many of the standard questions regarding AI/ML acceptance criteria and study design are not relevant or applicable. The "acceptance criteria" here refer to the passing thresholds for various physical and biological performance tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria values or detailed performance results for each test. Instead, it states that "The pre-determined acceptance criteria were met" for all listed tests.

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

For a physical device, "sample size" typically refers to the number of device units tested. The document does not specify the exact sample sizes (number of units) used for each of the performance tests (e.g., biocompatibility samples, number of wires for tensile testing, etc.).

• Data Provenance: The tests are laboratory and animal studies, not human clinical data.
  • Biocompatibility, Corrosion, Flexing, Fracture, Tensile, Tip Flexibility, Torque Strength: Performed in a laboratory setting.
  • Acute Performance Evaluation: Performed in an animal model.
• Retrospective or Prospective: These would be considered prospective tests performed specifically for this 510(k) submission.

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

This question is not applicable. For physical device performance testing, "ground truth" is established by the test procedures themselves (e.g., measuring force, observing breakage, biological reactions) and assessed by qualified laboratory personnel and engineers, not clinical experts for diagnostic accuracy.

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

Not applicable. This concept is relevant for human interpretation of data, not for material or mechanical performance testing of a physical device.

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 is for AI/ML devices where human readers interact with AI. This device is a physical wire guide.

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

Not applicable. This pertains to AI/ML software performance.

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

For this physical device, the "ground truth" for demonstrating performance is derived from:

• Standardized industry and international test methods (e.g., ISO, FDA guidance documents).
• Quantitative measurements (e.g., force, elongation, cycles to failure).
• Qualitative observations (e.g., absence of corrosion, successful access in animal model).
• Biocompatibility assessments based on established biological endpoints.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling from patient data. The "training" for such a device would be the design and manufacturing processes.

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

Not applicable. See point 8.

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Fighter™, Marvel™, Samurai™, and Samurai™ RC Guidewires:

Boston Scientific Fighter™, Marvel™, and Samurai™ RC Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during percutaneous transluminal coronary angioplasty (PTCA) or other intravascular interventional procedures. These guidewires are not intended for use in the cerebral vasculature.

Stretch Extension Wire:

Attachment of the Stretch Extension Wire to a Boston Scientific extendable guidewire creates an extended guide wire that can be used to exchange out a percutaneous transluminal coronary angioplasty (PTCA) or percutaneous transluminal angioplasty (PTA) catheter without removing the original guide wire from the exchange is complete, the Stretch Extension Wire can be detached and the original guide wire can be used in a conventional manner.

The Fighter™, Marvel™, Samurai™, and Samurai™ RC Guidewires are designed to facilitate the placement of interventional coronary devices such as dilating balloon catheters, stent delivery systems and other coronary artery diagnostic or therapeutic devices. The guide wires are available in a nominal diameter of 0.014 inches and nominal lengths of 190 cm and 300 cm. The 190 cm quide wires are compatible exclusively with the Stretch Extension Wire which can extend the quide wire length allowing for exchange of Over-The-Wire systems. The guide wires are composed of a stainless steel core wire which tapers at the distal end. The tapered distal end of the quide wire is covered with a proximal stainless steel coil and a distal platinum/nickel radiopaque coil that allows for visualization while using fluoroscopy. The proximal end of the guide wire contains a polytetrafluoroethylene (PTFE) coating and the distal portion of the wire is coated with a hydrophilic coating. All wires are available in a straight tip configuration. The Marvel and Samurai wires are available in an additional J-tip configuration.

The Stretch Extension Wire is composed of a stainless steel core wire coated with PTFE and contains a hypotube that is compatible with the 190 cm Fighter, Marvel, Samurai, and Samurai RC Guidewires.

The provided document is a 510(k) premarket notification for guidewires and an extension wire. It describes the design verification and biocompatibility testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving a device meets specific acceptance criteria with reported performance metrics. Therefore, most of the requested information regarding acceptance criteria and study particulars cannot be extracted directly from this document in the manner typically associated with clinical performance studies for AI/medical imaging devices.

However, I can extract information about the types of tests performed and the overall conclusion of substantial equivalence.

Here's a breakdown of the information that can and cannot be found in the provided text:

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

This document does not provide a table of acceptance criteria or specific reported device performance metrics in the format requested. It lists various tests performed (e.g., Dimensional Evaluation, Coating Durability, Tensile) but does not provide quantitative acceptance criteria or results. The conclusion states that the tests provide "reasonable assurance that the proposed devices have been designed and tested to assure conformance to the requirements for its intended use" and "no new safety or performance issues were raised."

2. Sample sized 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. The document describes design verification and biocompatibility testing, not clinical studies with patients. Therefore, terms like "test set" in the context of clinical data are not applicable here.

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. No ground truth establishment by experts is mentioned, as this is a materials/engineering performance evaluation, not expert-based assessment.

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

This information is not applicable. No adjudication method is mentioned as this is a materials/engineering performance evaluation.

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 document is for medical devices (guidewires and extension wires), not an AI/imaging device. No MRMC study or AI assistance is mentioned.

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

This information is not applicable. This document is for medical devices (guidewires and extension wires), not an AI/imaging device.

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

This information is not applicable. The "ground truth" in this context would be the pass/fail criteria for the engineering and biocompatibility tests performed.

8. The sample size for the training set

This information is not applicable. No training set is mentioned as this is a medical device performance evaluation, not a machine learning model.

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

This information is not applicable. No training set is mentioned.

Summary of what is available from the document:

This submission details the design verification and biocompatibility testing for Fighter™, Marvel™, Samurai™, Samurai™ RC Guidewires, and the Stretch™ Extension Wire. The purpose of these tests was to demonstrate substantial equivalence to legally marketed predicate devices.

Tests Performed:

The following performance tests were completed:

• Dimensional Evaluation
• Tip Flexibility
• Tensile
• Device Compatibility
• Coating Lubricity
• Master Shipping Carton/Condition
• Label Adhesion and Print Quality
• Sterile Barrier Integrity
• Coating Durability
• Wire Flex
• Combined Load
• Torque Response
• Wire Fracture
• Pouch Seal Strength
• Shelf Carton Condition
• Visual Sterile Barrier Integrity
• Radiodetectability
• Particulate Evaluation
• Corrosion Testing
• Exchange Connect
• Exchange Tensile
• Carrier Tube Assembly
• Withdrawal from Carrier Tube

The following biocompatibility tests were completed:

• Cytotoxicity
• Sensitization
• Intracutaneous Reactivity
• Acute Systemic Injection
• Natural Rubber Latex
• Ames Mutagenicity
• Mouse Lymphoma
• Hemolysis Direct Contact
• Hemolysis Extract Method
• Partial Thromboplastin Time
• In vitro Hemocompatibility
• Materials Mediated Pyrogen
• In Vivo Thrombogenicity
• USP Physicochemical
• Complement Activation C3a and SC5b-9

Conclusion of the Study:

"Based on the indications for use, technological characteristics, safety and performance testing, the Fighter, Marvel, Samurai, and Samurai RC Guide Wires are appropriate for the stated intended uses and are considered to be substantially equivalent to the ChoICE Guide Wire (K143587) and the Stretch Extension Wire is considered to be substantially equivalent to the AddWire Extension Wire (K030617)."

Clinical Testing:

• "Clinical evaluation was not required for this device."

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