Search Results

The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

Scientia Vascular's Aristotle Colossus Guidewire is a modification of Scientia Vascular's Aristotle 24 Guidewire. It is a 0.035" diameter, steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a single stiffness profile (standard) and is available in a range of lengths from 150 cm to 300 cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in tortuous vessels.

The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a rotating hemostasis valve (RHV)), and a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use). The shaping mandrel, introducer, and torque device accessories are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The provided text describes a medical device, the Aristotle Colossus Guidewire, and its clearance process with the FDA. It details a comparison to a predicate device and reports on non-clinical performance tests. However, the document does NOT contain information about any study involving human readers, AI assistance, or the establishment of ground truth by experts for such a study. It specifically focuses on the physical and functional characteristics of a guidewire.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and studies that prove the device meets those criteria in the context of an AI/human-in-the-loop performance evaluation. The document describes a traditional medical device clearance process based on material properties, functional performance, and biocompatibility.

Here's a breakdown of why I cannot fulfill your request based on the provided text, and what is present:

Information NOT present in the document which your request asks for:

• A table of acceptance criteria and reported device performance related to AI/human reader performance.
• Sample size used for a test set in the context of AI/human reader performance.
• Data provenance (country of origin, retrospective/prospective) for AI/human reader performance data.
• Number of experts used to establish ground truth for an AI/human reader test set or their qualifications.
• Adjudication method for an AI/human reader test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study (effect size of human readers with/without AI).
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data) in the context of AI interpretation.
• Sample size for a training set (for an AI model).
• How ground truth for a training set was established (for an AI model).

Information that IS present in the document (but is for a physical medical device, not an AI/Software as a Medical Device):

The document describes the acceptance criteria and performance study for the Aristotle Colossus Guidewire, which is a physical medical device (a guidewire for vascular procedures). The studies described are non-clinical (laboratory and simulated use) to demonstrate the device's physical and biological safety and effectiveness.

1. Acceptance criteria and reported device performance (for the physical guidewire):

The document states: "Results of tests performed on the Aristotle Colossus Guidewire demonstrate that it met the test acceptance criteria and meets the requirements of relevant standards and FDA guidance documents."

The "Table 3: Summary of Subject Device Functional Testing" lists the tests performed and consistently reports: "The Aristotle Colossus Guidewires met test acceptance criteria."

Here's a summary of the stated "acceptance criteria" through the lens of successful test outcomes for the physical guidewire:

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

• Sample Size: Not specified quantitatively for each test, but it refers to the physical guidewires tested. Standard engineering and biocompatibility testing typically involves a specific number of units per lot or batch, but these numbers are not detailed in this summary.
• Data Provenance: The studies are non-clinical performance tests conducted in a laboratory setting, likely by or for the manufacturer, Scientia Vascular, Inc. (West Valley City, Utah). They are simulations or bench tests rather than data derived from patients. The studies are prospective in the sense that they were designed and executed to evaluate this specific device for regulatory submission.

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 in the context of this device's testing. The "Usability Evaluation" involved "Physicians [who] evaluated subject and predicate guidewires for various performance characteristics in a human cadaver." The number and specific qualifications of these physicians are not provided. This is a usability assessment, not an expert panel for establishing ground truth for diagnostic accuracy.

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

Not applicable. This is for a physical device, and the "usability evaluation" doesn't describe a ground truth adjudication process in the manner seen for diagnostic AI.

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 guidewire, not an AI diagnostic tool.

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

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

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

The "ground truth" for this device's performance is established by engineering specifications, material science standards, and in vitro/ex vivo (cadaver) performance. For biocompatibility, it's established via standardized biological assays. There is no "ground truth" in the clinical diagnostic sense with expert consensus or pathology involved.

8. The sample size for the training set:

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

Not applicable.

Ask a specific question about this device

PCI Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous coronary intervention (PCI) and percutaneous transluminal angioplasty (PTA), including use in crossing de novo coronary chronic total occlusions (CTO).

The PCI Guide Wires are not to be used in the neurovasculature.

The ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 (Hereafter "ASAHI CONFIANZA PRO 8-20") is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm, 235cm and 300cm length. The extension wire is connected to the end of the guide wire outside the body for 190cm and 235cm wire. The guide wire is constructed from a stainless-steel core wire with a platinum-nickel coil. The coil is soldered to the core wire. The coil has radiopacity 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.

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

Device: ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20

The information provided describes a guide wire, not an AI/ML powered device, so several of the requested sections (MRMC study, standalone AI performance, ground truth for training set, training sample size) are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the ASAHI CONFIANZA PRO 8-20 met all acceptance criteria. However, it does not explicitly list the specific numerical acceptance criteria for each test. It only lists the types of tests performed. Without the specific thresholds for "Tensile Strength," "Torque Strength," etc., a detailed table with specific acceptance criteria is not possible from the provided text.

Here's a table based on the types of tests and the general conclusion:

Note: The document explicitly states: "The in vitro bench tests demonstrated that the ASAHI CONFIANZA PRO 8-20 met all acceptance criteria and performed similarly to the predicate devices." This is the highest level of detail provided regarding performance.

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

The document only states that "in vitro bench tests" were conducted. It does not specify:

• The exact sample size (e.g., number of guidewires tested for each parameter).
• The data provenance (e.g., country of origin for the data).
• Whether the study was retrospective or prospective, although bench testing is typically prospective by nature.

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

This section is not applicable as the study described is non-clinical bench testing, not a clinical study involving experts establishing ground truth for diagnostic or prognostic purposes. The "ground truth" here is determined by objective physical measurements against defined performance specifications.

4. Adjudication Method for the Test Set

This section is not applicable for non-clinical bench testing. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies among multiple human readers or evaluators in clinical studies. For bench testing, 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

This section is not applicable. The device is a physical medical device (guidewire), not an AI-powered diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

This section is not applicable. The device is a physical medical device (guidewire), not an algorithm or AI system.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for the non-clinical testing is based on pre-defined engineering specifications and performance benchmarks established for similar medical devices (the predicate device and industry standards/guidance documents). The tests measure physical and mechanical properties against these objective standards.

8. The Sample Size for the Training Set

This section is not applicable. As a physical guidewire, there is no "training set" in the context of machine learning. The device design and manufacturing processes are developed through engineering and materials science principles, not machine learning training.

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

This section is not applicable for the reasons mentioned in point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.

The ASAHI Neurovascular Guide Wire CHIKAI X 014 soft (hereafter "CHIKAI X 014 soft") is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 200cm length. The extension wire is connected to the end of the guide wire outside the body for 200cm wire. 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 guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration 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 the 510(K) cleared ASAHI Neurovascular Guide Wire CHIKAI with K110584.

This document is a 510(k) Premarket Notification for a medical device called the "ASAHI Neurovascular Guide Wire (CHIKAI X 014 soft)". It describes the device, its intended use, and the testing performed to demonstrate its substantial equivalence to previously cleared predicate devices.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a summary table of non-clinical bench testing. The acceptance criteria for each test were established by prior comparative testing with predicate devices, ASAHI's established guide wire specifications, and clinical experience. The reported device performance indicates that all tested articles met these criteria.

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

• Sample Size: The document does not specify an exact numerical sample size for each test. It uses phrases like "All test articles" or refers to "multiple times" for the bench testing. This typically implies a statistically relevant number of units were tested to ensure consistency and reliability, but the precise numbers are not disclosed.
• Data Provenance: The tests are described as non-clinical bench testing which are performed in a controlled laboratory environment. There is no mention of human subject data, country of origin related to human data, or whether it was retrospective or prospective, as it's a device performance study, not a clinical study.

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

• This information is not applicable to this type of device clearance. The "ground truth" here is the physical performance criteria and specifications of the device, which are established through engineering design, industry standards, and comparison to predicate devices, not through expert human readings or interpretations.

4. Adjudication Method for the Test Set:

• Not applicable. As stated above, this involves physical bench testing against predefined engineering specifications and predicate performance, not human adjudication of observations.

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

• No, an MRMC study was not done. This device is a physical medical instrument (guide wire), not an AI/imaging diagnostic tool that would typically undergo an MRMC study.

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

• Not applicable. This is a hardware device, not a software algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance evaluation is based on:
  • Prior comparative testing with predicate devices: Directly comparing the new device's performance to that of legally marketed and accepted similar devices.
  • ASAHI's established guide wire specifications: Internal engineering and design specifications for their devices.
  • Clinical experience: Implicitly, the understanding of performance requirements derived from the real-world use of similar guide wires.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI model that requires a "training set."

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

• Not applicable. As above, no training set for an AI model is involved.

Ask a specific question about this device

This product is intended for use in the percutaneous introduction of catheters. Not for use in the coronary arteries or intracranial vessels.

The ASAHI Silverway consists of a one-piece core wire and a coil assembly that extends the entire length of the device. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. In addition, coatings are applied on the surface of the ASAHI Silverway. The distal and proximal sections are coated with silicone. The intermediate section is coated with hydrophilic coating. The ASAHI Silverway has a nominal outer diameter of 0.89mm (0.035in) and is available in various lengths from 150cm to 300cm and tip shapes.

This document describes the premarket notification (510(k)) for the ASAHI® Silverway® guidewire. The acceptance criteria and study details are focused on non-clinical performance given the type of device and the 510(k) pathway, which establishes substantial equivalence rather than independent safety and effectiveness.

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

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

The document states that the ASAHI Silverway "met all acceptance criteria" and "performed similarly to the predicate devices." While specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, maximum torque to twist in degrees) are not explicitly listed in the public summary, the general categories of tests performed indicate the areas for which acceptance criteria would have been established.

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

• Sample Size: The document does not explicitly state the specific number of units tested for each non-clinical test. It generally refers to "non-clinical laboratory testing."
• Data Provenance: The tests were "non-clinical laboratory testing" presumably conducted by or for ASAHI INTECC CO., LTD. Given the company's address (Japan), the testing was likely performed in Japan or by a qualified lab contracted by them. The studies are by nature prospective in that new guidewires were manufactured and then tested according to predefined protocols.

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

This section is not applicable to this type of regulatory submission. For a guidewire, "ground truth" is typically defined by engineering specifications, material properties, and performance benchmarks established through industry standards (e.g., ISO, ASTM) and comparison to predicate devices, rather than expert human interpretation of complex data (like medical images).

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

Not applicable. As this is non-clinical laboratory testing against pre-defined engineering and material standards, there is no need for expert adjudication in the way it might be applied to, for example, classifying medical images. Test results are 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 guidewire, not an AI/imaging device. Therefore, no MRMC study or AI assistance evaluation would be relevant or expected.

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

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)

The "ground truth" for this device's performance is based on:

• Engineering specifications and design requirements: Did the device meet its designed dimensions, material properties, and functional characteristics?
• International standards: Adherence to relevant ISO (e.g., ISO 11070 for catheter guidewires, ISO 10993 for biocompatibility) and ASTM standards.
• Performance of predicate devices: Substantial equivalence is demonstrated by performing "similarly to the predicate devices." The predicates themselves would have established a benchmark for acceptable performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense. The "training" in manufacturing comes from process validation and quality control, but not a data-driven model training.

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

Not applicable for the same reason as point 8.

Ask a specific question about this device

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). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

The ASAHI® PTCA Guide Wire ASAHI Gladius Mongo consists of a one-piece core wire and a distal coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI® PTCA Guide Wire ASAHI Mongo. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE only. The ASAHI® PTCA Guide Wire ASAHI Mongo is available in various lengths. The shorter length device is designed for use with a commercially available ASAHI INTECC extension, wire.

The provided text describes the 510(k) premarket notification for the "ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES." This document pertains to a medical device (a guide wire), not an AI algorithm or a diagnostic tool. Therefore, the questions regarding acceptance criteria and studies for an AI/ML powered device, specifically those requiring information on human readers, ground truth establishment for AI training/test sets, and expert adjudication, are not applicable to this document.

The document focuses on demonstrating substantial equivalence of the new guide wire to a legally marketed predicate device (ASAHI® Fielder XT-A). It primarily relies on non-clinical testing/performance data to show that the new device functions as intended and has a similar safety and effectiveness profile.

Here's a breakdown of the relevant information provided, responding to the spirit of the request where applicable to a traditional medical device:

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

The document lists the following non-clinical tests performed, implying that internal acceptance criteria were met. However, the specific quantitative acceptance criteria and the exact reported performance results (e.g., specific tensile strength values or torque strength ranges) are not detailed within this public summary. The statement is qualitative: "met all acceptance criteria and performed similarly to the predicate device."

Regarding the other questions, they are not directly applicable to this type of device submission:

• 2. Sample sized used for the test set and the data provenance: This refers to data for an AI model. For this physical device, "sample size" would refer to the number of devices tested for each non-clinical test. This specific number is not provided in the summary. Data provenance is not relevant for a physical device's bench testing.
• 3. Number of experts used to establish the ground truth... and qualifications: This is for AI performance evaluation. Not applicable.
• 4. Adjudication method... for the test set: This is for AI performance evaluation. Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: This is for AI performance evaluation. Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is for AI algorithm performance. Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This is for AI ground truth. For this device, "ground truth" would be established by validated test methods and engineering specifications.
• 8. The sample size for the training set: This is for AI model training. Not applicable.
• 9. How the ground truth for the training set was established: This is for AI model training. Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device (a guide wire), and the questions posed are primarily designed for the evaluation of AI/ML-powered medical devices. Therefore, most of the specific details requested regarding AI acceptance criteria, ground truth, and study design are not found within this document. The core of this submission is demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical bench testing.

Ask a specific question about this device

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). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

The ASAHI® PTCA Guide Wire ASAHI SION black consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire, and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI® PTCA Guide Wire ASAHI SION black. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE. The ASAHI® PTCA Guide Wire ASAHI SION black is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available ASAHI INTECC extension wire.

This document describes the premarket notification for the ASAHI® PTCA Guide Wire ASAHI SION black. It does not contain information about an AI/ML powered device, therefore no information regarding acceptance criteria or a study that proves the device meets acceptance criteria related to AI/ML device performance can be extracted.

The document discusses non-clinical laboratory testing performed on the guide wire to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-based one. The types of tests conducted are standard for guide wires (e.g., tensile strength, torqueability, tip flexibility, etc.) and the conclusion is that the device met all acceptance criteria and performed similarly to predicate devices.

Ask a specific question about this device

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). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire. and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® PTCA Guide Wire: ASAHI SUOH® 03. The distal portion of the guidewire has a hydrophilic coating, and the proximal portion of the guidewire is coated with PTFE. The ASAHI® PTCA Guide Wire: ASAHI SUOH® 03 is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available Asahi Intecc extension wire.

The provided document is a 510(k) Summary for a medical device (Asahi PTCA Guide Wire Asahi SUOH 03) and focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML medical device. Therefore, the information typically requested in an AI/ML context regarding acceptance criteria and study details (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this document.

The document outlines the device's technical specifications and compares them to predicate devices, along with non-clinical performance testing to ensure safety and effectiveness.

Here's a breakdown of the non-clinical performance data and acceptance criteria as presented in the document, which primarily revolve around engineering and material properties, rather than diagnostic accuracy or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the device "met all acceptance criteria" and "performed similarly to the predicate devices" for the listed tests. Specific numerical values for the criteria or performance are not provided in this summary but would have been part of the full 510(k) submission.

Regarding the AI/ML specific questions (2-9):

This document is for a conventional medical device (a guide wire), not an AI/ML-driven device. Therefore, the following information is not applicable and cannot be extracted from the provided text:

2. Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to physical guide wire samples for bench testing, not a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. Ground truth for an AI model is not relevant to guide wire physical testing.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size: Not applicable. This type of study is for evaluating human performance with/without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" for a guide wire's performance is its physical properties meeting engineering standards.
8. The sample size for the training set: Not applicable. There is no AI model to train.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.

The ASAHI CHIKAI Black 14 Soft Tip neurovascular guide wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and length of 200cm. The quide wire is constructed from a stainless steel core wire with 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 coil assembly construction is similar to that of the 510(k) cleared ASAHI CHIKAI black neurovascular guide wire (K141751). The distal end of the guide wire has a radiopaque tip to achieve visibility. A hydrophilic coating is applied to the distal portion of the guidewire. This change introduces a soft tip version of the round curve tip configuration.

The acceptance criteria and study proving the device meets them are described for the ASAHI Neurovascular Guide Wire: ASAHI CHIKAI Black 14 Soft Tip, a catheter guide wire used in neurovasculature.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document states "All test articles met established acceptance criteria" for Tensile Strength, Torque Strength, Torqueability, and Tip Flexibility tests, and "Test results on all test articles confirmed guide wire performance" for the Bench (Simulated) Testing. However, the exact sample size ("N") for the test set is not explicitly specified in the provided text. It refers to "all test articles" without quantifying them.
• Data provenance (country of origin, retrospective/prospective): Not explicitly stated in the provided text. The applicant is ASAHI INTECC CO., LTD. in Japan, so the testing was likely conducted by or for them. The nature of these bench tests suggests they are prospective (i.e., 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:

• This information is not applicable in the context of this device and these tests. The tests are purely performance-based bench tests comparing the physical properties and functional performance of the device against predefined specifications and predicate devices. There is no "ground truth" established by human experts in the way it would be for, say, an AI diagnostic algorithm.

4. Adjudication method for the test set:

• This information is not applicable for these types of bench tests. Adjudication methods like 2+1 or 3+1 are typically used for subjectively interpreted data or ground truth establishment by multiple human readers, which is not the case here. The results are objective measurements of physical properties.

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 mentioned or indicated in the provided text. This type of study is more relevant for diagnostic devices that involve human interpretation of images or data, where AI might assist. The device described is a physical guide wire.

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 (a guide wire), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply.

7. The type of ground truth used:

• The "ground truth" for the performance tests relies on pre-established specifications and comparative performance to predicate devices and industry standards (FDA guidance document). For example:
  • Tensile strength is measured against "ASAHI's established tensile strength specifications."
  • Bench testing evaluates whether the guide wire "reached target area and microcatheter was successfully advanced."
  • The overall conclusion states, "Performance data demonstrate that the device functions as intended, and has a safety and effectiveness profile that is similar to the predicate device."
• There's no external "gold standard" ground truth like pathology or outcomes data mentioned for these specific physical performance tests.

8. The sample size for the training set:

• Not applicable. This device is a physical medical instrument, not a machine learning model that requires a training set.

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

• Not applicable. As it's not an AI/ML device, there's no training set or associated ground truth establishment process.

Ask a specific question about this device

ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.

The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16. The coil and taper core wire of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is soft in order to easily bend in accordance with the vessel curve. The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is available in various lengths and tip shapes. Accessories such as a Torque device, Shaping device and Inserter are included in the packaging of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16.

This document is a 510(k) Summary for the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16, submitted by ASAHI INTECC CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated study for a new clinical indication.

Therefore, many of the requested categories regarding acceptance criteria and study design for a new device or algorithm are not directly applicable or available in this document. This document describes the testing performed to show the new device is as safe and effective as a previously cleared device.

Here's the information extracted and organized as requested, with notes where information is not applicable or present in the provided text:

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, it does not explicitly list the specific quantitative acceptance criteria for each test. Instead, it generally states that the device "performed similarly to the predicate devices" and "functions as intended."

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

The document mentions "non clinical laboratory testing" and "in vitro bench tests." These are likely physical tests on device samples. The sample size for these tests is not specified in the provided text. The data provenance is laboratory testing (bench tests). There is no mention of patient data (country of origin, retrospective/prospective) as this is a physical device equivalence submission, not a clinical study of an AI/software 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 applicable to this type of device submission. Ground truth for physical device performance is typically established through standardized testing methods, not expert human assessment in the way it's used for AI diagnostic tools.

4. Adjudication method for the test set

This information is not applicable as there are no expert readers or interpretations for physical bench testing 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

This information is not applicable. This document describes a physical medical device (guide wire), not an AI algorithm, and therefore, an MRMC study or AI assistance is irrelevant.

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

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

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by objective measurements and predefined pass/fail criteria based on engineering specifications and comparison to the predicate device's established performance, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable as this document does not describe an AI/ML algorithm that requires a training set.

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

This information is not applicable as this document does not describe an AI/ML algorithm that requires a training set.

Ask a specific question about this device