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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.

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The ASAHI PTCA Guide Wire, Fielder FC 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 is 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 available straight and is made soft to easily bend with the vessel curve. And there is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The provided text describes a medical device, the ASAHI PTCA Guide Wire, Fielder FC, which is a steerable guide wire used in percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

The information focuses on establishing substantial equivalence to predicate devices based on:

• Materials: Stating it uses the same materials as predicate devices.
• Dimensional specifications and design: Ensuring compatibility for the intended use.
• Performance Data: "This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI ASAHI PTCA Guide Wire, Fielder FC performs as intended."

Crucially, there is no mention of:

1. AI/ML components: The device is a physical medical instrument, not a software algorithm.
2. Acceptance criteria (quantitative metrics): The document generally states "performs as intended" without providing specific pre-defined thresholds for performance.
3. Specific study details: While "mechanical and functional bench testing" is mentioned, no details are provided regarding:
   • Test protocols
   • Specific parameters measured (e.g., tensile strength, friction, torque, tip flexibility, navigation capabilities)
   • Numerical results
   • Sample sizes for these tests
   • How ground truth was established (as it's a physical device, functional tests would be against engineering specifications or established physical properties).
   • Any multi-reader multi-case (MRMC) studies or standalone performance evaluations as these are irrelevant for a physical guide wire.
   • Number or qualifications of experts.
   • Adjudication methods.
   • Training set information.

In summary, the provided document does not align with the request for information on acceptance criteria and study details for an AI/ML device because the device in question is a physical medical guide wire and not an AI/ML product.

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The ASAHI PTCA Guide Wire, Fielder 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 J shape is 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 available as a pre shape "J" and made flexible to bend easily at the vessel curve. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.

The provided document describes a medical device, the ASAHI PTCA Guide Wire, Fielder J, and its substantial equivalence to predicate devices, supported by bench testing. However, it does not contain the level of detail requested for a comprehensive description of acceptance criteria and the study proving it.

Based on the provided text, here's what can be extracted and what is missing:

Description of Acceptance Criteria and Study Findings for ASAHI PTCA Guide Wire, Fielder J

The provided 510(k) summary indicates that the ASAHI PTCA Guide Wire, Fielder J demonstrated substantial equivalence to predicate devices through mechanical and functional bench testing. The acceptance criteria are implicitly met by demonstrating that the device "performs as intended" and its "characteristics are substantially equivalent to the specified predicate devices." No specific quantitative acceptance criteria or detailed study results are provided in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but generally, bench testing data would be generated in a laboratory setting, likely at the manufacturer's location in Japan, or a designated testing facility. This is a retrospective analysis of the device's physical properties.

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

• Number of Experts: Not applicable, as this was mechanical and functional bench testing, not a clinical study involving human assessment.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Not applicable, as this was mechanical and functional bench testing, not a study requiring adjudication of expert opinions.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed based on the provided document. The submission relies solely on bench testing for substantial equivalence.

6. Standalone (Algorithm Only) Performance

• No, this refers to a medical device (guide wire), not an algorithm or AI. Therefore, standalone algorithm performance is not applicable.

7. Type of Ground Truth Used

• Bench Testing Standards/Specifications: The ground truth for the bench testing would be established by pre-defined engineering and performance specifications and standards for guide wires, which dictate acceptable mechanical and functional properties (e.g., tensile strength, flexibility, lubricity, torque transmission, etc.). Comparison to predicate devices also serves as a "ground truth" for substantial equivalence.

8. Sample Size for the Training Set

• Not applicable. This submission is for a physical medical device (guide wire), not an AI algorithm that would require a training set.

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

• Not applicable. (See point 8)

Summary of Limitations Based on Provided Text:

The document serves as a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence to predicate devices through bench testing. It does not provide the detailed level of information (e.g., specific quantitative ranges for performance metrics, detailed study protocols, sample sizes for specific tests, or clinical data) that would be present in a comprehensive study report or a publication detailing a clinical trial. The "acceptance criteria" are implied by the claim of functioning as intended and substantial equivalence.

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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 is steerable guide wire with a maximum diameter of 0.36mm (0.014 inches) and available in 180 cm and 300 cm length. 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 flexible to bend easily at the vessel curve. There is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.

The provided text describes a 510(k) premarket notification for the Asahi PTCA Guide Wire Fielder. It states that "Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the Asahi PTCA Guide Wire Fielder met the acceptance criteria and performed equivalent to the predicate devices." However, it does not provide a table of acceptance criteria or specific reported device performance metrics. It also does not detail the methodology of the study or the provenance of data, only that testing was conducted.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's a summary of what can be extracted and what cannot:

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

• Cannot be provided. The text states that "bench and biocompatibility testing...met the acceptance criteria and performed equivalent to the predicate devices" but does not explicitly list the criteria or the specific device performance results.

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

• Cannot be provided. The text mentions "bench and biocompatibility testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

• Cannot be provided. There is no mention of expert involvement in establishing ground truth for any testing described.

4. Adjudication method for the test set

• Cannot be provided. There is no mention of an adjudication method.

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

• Cannot be provided. The device is a PTCA Guide Wire, not an AI or imaging device that would typically involve human reader studies.

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

• Cannot be provided. The device is a medical instrument, not an algorithm.

7. The type of ground truth used

• Cannot be explicitly stated based on the text. For "bench and biocompatibility testing," ground truth would typically be established through standardized methods, specifications, and laboratory measurements. However, the text does not detail how the acceptance criteria for these tests were set or what constitutes "ground truth" for them.

8. The sample size for the training set

• Not applicable. The device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, there is no "training set" for a physical device.

Summary of available information:

• Study Type: Bench and biocompatibility testing.
• Conclusion: The device "met the acceptance criteria and performed equivalent to the predicate devices." This implies the study aimed to demonstrate substantial equivalence through these tests.
• Predicate Devices: JoWire Neo's PTCA Guide Wire (K022762) and JoWire Asahi PTCA Guide Wire (K031277).
• No new safety or effectiveness issues were raised during the testing.

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