Search Results

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

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.

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), 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.
This product is intended to provide support to facilitate the placement of guide wires in the coronary and peripheral vasculatures, and can be used to exchange one guide wire for another.
This product is also intended to assist in the delivery of contrast media into the coronary, peripheral and abdominal vasculatures, and to assist in crossing de novo coronary chronic total occlusions (CTO).
This device should not be used in neurovasculature.

The ASAHI® PTCA Guide Wires and ASAHI® Corsair® / ASAHI® Corsair® Pro Microcatheters covered by this submission are existing marketed devices. There have been no physical changes to the subject devices as compared to the currently marketed predicate devices except for a change in indication and related clinical information added to the labeling. The designs and performance of the guidewires are unchanged.
The ASAHI® PTCA Guide Wires consist of a core wire and a coil assembly. Depending on the model, the coil assembly could consist of an outer coil soldered to the core wire, or an inner coil and an outer coil, with or without a safety wire, 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 Wires. The coil and distal portion of the quidewire have a hydrophilic outer coating. The proximal portion of the guidewires are coated with PTFE. The ASAHI® PTCA Guide Wires are available in various lengths and tip shapes. The shorter length devices are designed for use with a commercially available Asahi Intecc extension wire.
The ASAHI Corsair / ASAHI Corsair Pro Microcatheter consists of a distal tip and a shaft tube that are inserted into a vascular connector for catheter control and infusion of contrast media. No accessories are part of this device. The ASAHI Corsair has a radiopaque marker coil that is imbedded into the inner layer of resin to facilitate the tip location during angiographic procedures. In addition, the devices have a hydrophilic coating on the outer surface of the shaft tube to provide a smooth transition in blood vessels. The distal tip of the ASAHI Corsair / ASAHI Corsair Pro has a tapered shape and is designed to have increased flexibility towards the distal end. PTFE is applied to the inner lumen of the catheters for the purposes of a smooth transition and exchange of guidewires.
The microcatheters also contain wires to reinforce the distal tip and shaft tube to allow the physician greater control of the device during interventional procedures.

Here's an analysis of the acceptance criteria and study detailed in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 163 subjects
• Data Provenance: Prospective, multi-center, single-arm study. The document does not specify the country of origin of the data, but the applicant's address is in Japan and the US office is in California.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., radiologist with X years of experience). However, the "absence of in-hospital MACE" (Major Adverse Cardiac Events) and "Successful re-canalization" metrics imply adjudication by medical professionals typically involved in cardiac care and angiography. The "Expert Consensus Document from the Society for Cardiovascular Angiography and Interventions (SCAI) published in 2013" is referenced for an alternative MI definition, suggesting expertise from this society would be relevant.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method like 2+1 or 3+1 for establishing ground truth. The MACE definition includes "cardiac death, target lesion revascularization, or postprocedural myocardial infarction (MI)," which would typically involve clinical review and diagnosis by treating physicians or a clinical events committee. The re-canalization success is based on "angiographic visualization," which would involve interpretation by interventional cardiologists.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted or reported. This study evaluates the performance of medical devices (guide wires and microcatheters) directly in human subjects, not an AI-assisted diagnostic tool.

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

No, a standalone algorithm performance study was not done. This study is a clinical trial evaluating the performance of physical medical devices in a clinical setting with human operators, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth is based on clinical outcomes and angiographic visualization, as determined by medical professionals during and after the procedures. Specifically:

• Angiographic visualization of guide wire crossing the target lesion for "successful re-canalization."
• Clinical assessment for "in-hospital major adverse cardiac events (MACE)," which includes cardiac death, target lesion revascularization, and post-procedural myocardial infarction (MI), with two different definitions for MI cited.

8. The Sample Size for the Training Set

This document describes a clinical trial for physical medical devices. There is no mention of a training set as would be applicable to an AI model.

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

As this is not an AI model, there is no training set and therefore no ground truth established for it.

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

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 cerebral blood vessels.

The ASAHI SION blue PTCA Guide Wire is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm lengths. The guide 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 there is a safety wire for which is soldered to the inner and outer coils and the core wire. The distal end of the guide wire has a radiopaque to achieve visibility. The distal end of the coil part is available straight and is made soft to easily bend with the vessel curve, or available as a pre shaped "J ". Silicone and hydrophilic coatings are applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire.

The provided text describes a medical device, the ASAHI SION blue PTCA Guide Wire, and its 510(k) summary for FDA clearance. It outlines the performance data used to demonstrate substantial equivalence to predicate devices, but does not describe an AI medical device or a study involving AI. Therefore, I will extract information related to the device's acceptance criteria and the study proving it meets those criteria, as much as possible for a non-AI medical device.

Key Missing Information for AI Devices:

The document is for a physical medical device (guide wire) and therefore does not contain information about:

• Sample size used for the test set and the data provenance for an AI model.
• Number of experts used to establish ground truth for an AI model's test set.
• Adjudication method for an AI model's test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study for AI.
• Standalone (algorithm only) performance for AI.
• Sample size and ground truth establishment for a training set in AI.

Here's the information extracted from the provided text, focusing on the acceptance criteria and the study performed for the ASAHI SION blue PTCA Guide Wire:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in this summary. The text mentions "in vitro bench testing" and "particulate evaluation was conducted with a combination assessment with the subject device itself and data leveraged from the predicate devices." For biocompatibility, testing was "leveraged from the predicate devices."
• Data Provenance: The company, Asahi Intecc Co., Ltd., is based in Japan. The testing described (in vitro bench testing) would likely have been conducted by the manufacturer or a contract lab. The data related to predicate devices are from previously cleared 510(k) devices by Asahi Intecc. This would be considered retrospective for the predicate data and likely prospective for the specific bench tests conducted on the ASAHI SION blue device. The country of origin of the data is not specified beyond the company's location.

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

• Not applicable. This summary describes a physical medical device and its performance in bench testing, not an AI model requiring expert ground truth or interpretation of images/data. The "truth" in this context is based on engineering specifications and established test methodologies.

4. Adjudication Method for the Test Set

• Not applicable. This is a physical device tested against engineering and biocompatibility standards, not an AI model where human adjudication of results is typical.

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

• No such study was done or described. This is a premarket notification for a physical medical device, not an AI-assisted diagnostic or therapeutic tool.

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

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

7. The Type of Ground Truth Used

• For mechanical/physical tests: The ground truth is the established engineering specifications and performance standards for guide wires, and comparison to the performance of equivalent predicate devices.
• For biocompatibility: The ground truth is established biocompatibility standards for medical devices and successful use of identical materials and manufacturing processes in previously cleared predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This summary is for a physical medical device, not an AI model that uses a training set. The term "training set" is not relevant here.

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

• Not applicable. As above, there is no "training set" in the context of this device.

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 cerebral blood vessels.

The ASAHI SION J PTCA Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm lengths. The guide 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 there is a safety wire for which is soldered to the inner and outer coils and the core wire. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available as a pre shaped "J". A hydrophilic coating is applied to the distal portion of the guide wire. The proximal section of the guide wire is coated with PTFE. The extension wire is connected to the end of the guide wire outside the body for 180 cm wire.

The submission for the ASAHI SION J PTCA Guide Wire (K122469) primarily relies on demonstrating substantial equivalence to a predicate device (ASAHI SION PTCA Guide Wire - K100578) through characterization of its technical features and performance in bench and biocompatibility testing. The acceptance criteria are essentially that the device performs similarly to or better than the predicate device in these tests, and that its materials are biocompatible, especially given its intended use.

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

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

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

The document does not specify the exact sample sizes used for each in vitro bench test or for the biocompatibility leveraging. It broadly states that "Enclosed within this submission is performance data" and "In vitro bench testing...were conducted." For biocompatibility, it states it "was leveraged from the predicate devices."

Therefore:

• Sample Size: Not explicitly stated for specific tests.
• Data Provenance: The bench testing appears to be prospective testing conducted directly on the ASAHI SION J PTCA Guide Wire. The biocompatibility data is retrospective, leveraged from previously 510(k) cleared Asahi Guide Wire products (predicates). The testing was presumably conducted by Asahi Intecc Co., Ltd. (Japan), but the specific country of origin for the leveraged data is not stated, though the predicate device (K100578) was also from Asahi Intecc.

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

This type of information is generally not applicable to a submission for a guide wire, which primarily involves objective engineering and biological tests rather than interpretation by human experts to establish "ground truth" for diagnostic or clinical decision-making. No experts were used in this manner for the described tests.

4. Adjudication method for the test set

Not applicable. The tests described are objective, quantitative/qualitative bench tests and biocompatibility assessments, not subjective assessments requiring adjudication by multiple experts.

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

Not applicable. This device is a medical instrument (guide wire), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies involving human readers or AI assistance are irrelevant to its evaluation.

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 or software. Its performance is evaluated through physical and biological testing.

7. The type of ground truth used

The "ground truth" for the performance tests is based on:

• Engineering Specifications/Standards: Predetermined performance criteria likely derived from internal specifications, relevant industry standards, or regulatory guidelines for guide wires.
• Benchmarking against Predicate: The performance is implicitly compared to the predicate device, where the predicate's established performance acts as a de facto "ground truth" for acceptable levels.
• Established Biocompatibility Standards: The biocompatibility evaluations rely on the well-established safety of the materials in previously cleared devices, which have met regulatory biocompatibility standards.

8. The sample size for the training set

Not applicable. This device is a medical instrument, not a machine learning model. There is no concept of a "training set" in its evaluation.

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

Not applicable for the same reason as above.

Ask a specific question about this device

The ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon rilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and thatator outhers wantely (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.

Asahi PTCA Guide Wiles are steerable gulde with a maximaling to wire 114 inches (0.56mm) and available in Too children wire is constructed from the more is constructed from connected to the end of the guide wille batside the body. The wild besign. The with the stight stainless steel core with varying core ichgitis and diamotors for backless of the dights innd or wire and coil are soldered or welded depending upon specific encluded at onl of ewire and coll are soldered of welded deportung upon open open on and is and is and is a radiopaque tip to achieve visibility, and is available straight and is made soft to easily bend with the vessel curve or, available as are shaped " "The ade soit to easily bend with the vooool ed to the distal portion of the guide wire. The mating (nydropmine and Silicone) is applica to the title guilter of the galler series noximal section of the galde wire is outlou with hydrophilic coating applied to the distal there is poryal and the proximal section of this guide wire is coated with PTFE.

The provided text describes a medical device, the ASAHI PTCA Guide Wire, and its 510(k) submission to the FDA. It details the device's design, indications for use, and a summary of performance testing.

Here's an analysis of the provided information against your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the sample size used for the bench testing. It only mentions "mechanical and functional bench testing."
• Data Provenance: The study was conducted by Asahi Intecc Co., Ltd. in Japan (applicant address provided). The data is retrospective in the sense that it's bench testing conducted by the manufacturer for regulatory submission.

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

• This information is not provided in the document. The testing described is mechanical and functional bench testing, not clinical studies involving expert interpretation of data or images. Therefore, the concept of "ground truth established by experts" as typically applied to AI/imaging studies does not directly apply here. The "ground truth" for this device would be its physical specifications and performance metrics against engineering standards.

4. Adjudication Method for the Test Set:

• This information is not applicable/provided. Since the testing is mechanical and functional bench testing, there's no mention of an adjudication method among experts. Performance is likely measured against predefined engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The document describes mechanical and functional bench testing only. This is a physical medical device (a guide wire), not a diagnostic or AI-driven system that would typically undergo MRMC studies to assess human reader improvement with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable/No. This device is a physical guidewire, not an algorithm or AI system. The concept of "standalone performance" for an algorithm doesn't apply. The "standalone" performance here refers to the guidewire's inherent mechanical and functional characteristics during bench testing.

7. Type of Ground Truth Used:

• The ground truth for this device's performance would be engineering specifications and established performance standards for guide wires. The document states that the "dimensional specifications and design... ensures compatibility for the intended use" and that "bench testing demonstrates that the device functions as intended." This implies that the device's performance was compared against predetermined technical criteria.

8. Sample Size for the Training Set:

• This information is not applicable/provided. The device is a physical guidewire, not an AI model requiring a training set.

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

• This information is not applicable/provided. As explained above, this device does not involve an AI model or a training set in the conventional sense.

Ask a specific question about this device

The ASAHI PTCA Guide Wire, Fielder FC J is 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 cerebral blood vessel.

The Asahi PTCA Guide Wire, Fielder FC J is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 180cm wire. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is made soft and easily bendable with the vessel curve, and is provided in a pre-shaped J configuration. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire and dimethylpolysiloxane (silicone oil - not contacting blood) is applied to gape space in spring-coil in the tip part. The proximal section of this guide wire is coated with PTFE.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Asahi PTCA Guide Wire, Fielder FC J:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not explicitly list quantitative acceptance criteria or specific performance metrics with target values (e.g., minimum tensile strength of X N, maximum friction of Y mN). Instead, it relies on the concept of substantial equivalence to predicate devices. The "acceptance criteria" are therefore implicitly tied to demonstrating that the new device is as safe and effective as the previously cleared predicate devices for the same indication. The reported performance confirms this equivalence and that the device functions as intended through bench testing.

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

• Sample Size for Test Set: Not specified. The document only mentions "mechanical and functional bench testing." It does not provide details on the number of wires tested or the specific tests conducted.
• Data Provenance: Not specified. The testing described is "bench testing," which implies laboratory testing. There is no mention of clinical data or data from a specific country or population. It's a pre-market submission for a medical device, so the data would have been generated by the manufacturer (Asahi Intecc Co., Ltd., Japan). The study is not a retrospective or prospective clinical study but rather bench-top engineering testing.

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

• This information is not applicable to this submission. The device is a physical medical instrument (guide wire), and the testing described is mechanical and functional bench testing. "Ground truth" in this context would typically refer to objective measurements of the device's physical properties or performance in a controlled environment, not expert interpretation of data.

4. Adjudication Method for the Test Set

• Not applicable. As the testing is mechanical and functional bench testing, there would be no need for expert adjudication in the way it's used for AI/diagnostic studies (e.g., resolving discrepancies in expert interpretations). The results would be objective measurements against predefined engineering specifications.

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

• No, an MRMC comparative effectiveness study was not done. The submission describes mechanical and functional bench testing, not a clinical trial involving human readers or cases.

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

• Not applicable. This device is a physical guide wire, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm doesn't apply.

7. The Type of Ground Truth Used

• For the bench testing, the "ground truth" would be objective engineering measurements and specifications. For example, measurements of tensile strength, torque transmission, coating integrity, lubricity, radiopacity, and dimensions would be compared against predefined internal specifications or industry standards. There is no mention of expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

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

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

• Not applicable. As there is no training set for an AI model, this question is not relevant to this medical device submission.

Ask a specific question about this device