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This HI-TORQUE guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

The Abbott Vascular 0.014" Hi-Torque Jet (HT Jet) Guide Wire with hydrophilic and hydrophobic coatings is a stainless steel and nitinol steerable guide wire with a maximum diameter of 0.0145", provided in 190 cm extendable, 250 cm, and 300 cm exchange lengths. The distal tip has a radiopaque length of 3.0 cm. The distal tip is straight and shapeable. The HT Jet Guide Wire Family consists of two models with differing flexibility and performance: the HT Jet 15C and the HT Jet 25C. The proximal end of the 190 cm model is plunge ground and coined to fit into the hypotube portion of the DOC® Guide Wire Extension. The HT Jet guide wire family is compatible with devices designed for use with 0.014" guide wires.

The Abbott Vascular Hi-Torque JET Guide Wire Family's acceptance criteria and performance are detailed in the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the in vitro bench tests demonstrated that the Hi-Torque Jet Guide Wire met all acceptance criteria for the following performance aspects:

The overall conclusion is that the device performed similarly to the predicate devices and met all established acceptance criteria, indicating its substantial equivalence.

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

The document does not specify the exact sample sizes used for each of the in vitro bench tests. It simply states that "in vitro bench testing" was conducted.

The data provenance is retrospective, as the tests were performed on the device after its design, and the results are presented as a summary of the outcomes of these tests. The country of origin of the data is not explicitly stated, but the submission is from Abbott Vascular Inc., located in Temecula, CA, USA, suggesting the testing was conducted or overseen in the USA.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the study described is an in vitro bench testing study, not an expert-based clinical or image-based diagnostic study. The "ground truth" for these performance tests is based on objective measurements against predefined engineering and performance specifications.

4. Adjudication Method for the Test Set

The concept of an adjudication method (e.g., 2+1, 3+1) is not applicable here. Adjudication methods are typically used in clinical trials or studies where subjective interpretations (e.g., by experts) need to be reconciled. For in vitro bench testing, acceptance is determined by direct measurement against pre-defined quantitative or qualitative criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic device (often AI-assisted) on human reader performance, typically in medical image interpretation. The device in question is a guide wire, and the testing involved objective in vitro bench tests, not human interpretation tasks.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The study conducted was a standalone performance evaluation in the sense that the device's physical and mechanical properties were tested directly, without human intervention in the 'performance' of the device itself during testing. However, it's important to distinguish that this is not an "algorithm only" study, as the device is a physical medical instrument, not a software algorithm. The tests evaluate the intrinsic performance of the guide wire itself.

7. The Type of Ground Truth Used

The type of ground truth used for the in vitro bench testing is based on engineering specifications and predefined performance criteria. For example:

• Tensile strength: Measured against a minimum required breaking strength.
• Torque strength: Measured against torsional force limits.
• Radiopacity: Assessed against a standard for visibility under fluoroscopy.
• Friction: Measured against specified friction coefficients.

These are objective, quantifiable standards for the device's physical properties.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument (guide wire), not an AI algorithm that requires a "training set" of data.

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

This information is not applicable as there is no "training set" for this physical medical device.

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Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO).

The HI-TOROUE PROGRESS Guide Wire (K091825, cleared Sept. 25, 2009) is an existing family of guide wires, designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires has a maximum diameter of 0.0140" with a stainless steel core and is provided in 190cm extendable and 300cm exchange lengths. The distal core segment of the PROGRESS guide wire family is offered in 5 configurations: PROGRESS 40. PROGRESS 80, PROGRESS 120, PROGRESS 140T and PROGRESS 200T. Each configuration is identical in design except for those design features that impact tip stiffness.

The HI-TOROUE PILOT Guide Wire (K030549/K101116, originally cleared Mav 14, 2003) is an existing family of guide wires constructed using a 304V stainless steel core. HI-TORQUE PILOT Guide Wires have a maximum diameter of 0.0140" and are available in 190cm extendable lengths and a 300 cm exchange length. There are three HI-TORQUE PILOT™ Guide Wire designs with varying tip stiffness (i.e., HI-TORQUE PILOT™ 50, HI-TORQUE PILOT™ 150, and HI-TOROUE PILOT™ 200 Guide Wires). The distal segment of the guide wire includes a series of tapered grinds and a flat section, which reduce the diameter and stiffness of the distal core, thus yielding the desired flexibility and performance.

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

Acceptance Criteria and Device Performance Study

The study, named "EXPERT CTO Guidewire Clinical Trial," was a prospective, multi-center, single-arm study designed to assess the safety and effectiveness of the HI-TORQUE (HT) PROGRESS and HT PILOT guide wires in recanalization of chronic total occlusions (CTO).

1. Table of Acceptance Criteria and Reported Device Performance

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This Hi-Torque Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal and infra-popliteal arteries. This guide wire may also be used with compatible stent devices during therapeutic procedures.

The guide wire may also be used to reach and cross a target lesion, provide a pathway within a vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

The Abbott Vascular 0.014" Hi-Torque Command (HT Command) Guide Wire with hydrophilic and hydrophobic coatings is a stainless steel and nitinol steerable guide wire with a maximum diameter of 0.0145", provided in 190 cm extendable, 250 cm, and 300 cm exchange lengths. The distal tip has a radiopaque length of 3.0 cm. The distal tip is straight and shapeable. The HT Command Guide Wire Family consists of two models with differing flexibility and performance; the HT Command and the HT Command ES. The proximal end of the 190 cm model is plunge ground and coined to fit into the hypotube portion of the DOC® Guide Wire Extension. The HT Command guide wire family is compatible with devices designed for use with 0.014" guide wires.

The provided text describes the Abbott Vascular Hi-Torque Command Guide Wire Family. The information focuses on the device's substantial equivalence to predicate devices based on in vitro bench testing. There is no information about a clinical study, AI/algorithm performance, ground truth establishment for a training set, or expert-based evaluations for this specific medical device submission. The submission relies solely on bench testing to demonstrate substantial equivalence.

Here's a breakdown based on the input requested:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as in vitro bench testing.

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

• Sample Size: Not explicitly stated. The document refers to "in vitro bench testing" without specifying the number of test units.
• Data Provenance: Not applicable in the context of clinical data. These are laboratory bench tests.

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

• Not applicable. The evaluation was based on objective physical and mechanical properties measured during bench testing, not on expert interpretations of data or images.

4. Adjudication method for the test set:

• Not applicable. There was no human interpretation or adjudication involved, as the tests were 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:

• No. This was not an MRMC study. There is no AI component or human reader evaluation described.

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

• No. This device is a physical medical device (guide wire); an algorithm-only performance study is not relevant.

7. The type of ground truth used:

• The "ground truth" for the in vitro bench testing would be the established scientific and engineering principles and standards for evaluating the physical and mechanical properties of guide wires (e.g., standard methods for measuring tensile strength, torque, etc.). The acceptance criteria are based on these predefined thresholds.

8. The sample size for the training set:

• Not applicable. This submission is for a physical medical device and relies on bench testing, not machine learning or AI, so there is no "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

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The device is indicated to dilate stenoses in femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The 2.0 to 4.0 mm balloon diameters are also indicated for postdilatation of balloon-expandable stents up to 40 mm and self-expanding stents up to 80 mm in the vessels listed above.

The Armada 14 PTA Catheter is a standard over-the-wire (OTW) balloon catheter to be used for percutaneous transluminal angioplasty (PTA). It is available in balloon lengths of 20 mm to 200 mm, with nominal diameters of 1.5 mm to 4.0 mm. The balloon has a nominal diameter inflation pressure of 8 atm and a rated burst pressure of 14 atm. Two polymer marker bands mark the working length of the balloons. The catheter shaft has working lengths of 90 and 150 cm. The inner lumen will accept a 0.014" guide wire. The outer shaft has a polycarbonate y-arm fuer adhesively bonded to the proximal end to allow for entry to the guide wire lumen and to allow for connection of the inflation device to the inflation/deflation lumen.

This is a medical device, not an AI/ML device. The provided text is a 510(k) summary for the Armada 14 PTA Catheter, outlining its design, intended use, and performance testing for regulatory clearance. It does not involve AI or machine learning algorithms, and therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable.

The performance data section describes standard tests for a medical catheter (e.g., Simulated Use, Balloon Compliance, Biocompatibility), which are engineering and biological validations, not related to AI/ML model performance.

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This Hi-Torque guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

The Hi-Torque Winn Guide Wire Family is a family of guide wires, designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires have a maximum diameter of 0.0140" with a stainless steel core and are provided in 190 cm extendable and 300 cm exchange lengths. The distal core segment of the Winn is offered in 5 configurations: Winn 40. Winn 80. Winn 120, Winn 140T and Winn 200T. Each configuration is identical in design except for those design features that impact tip stiffness.

This document describes a 510(k) summary for the Hi-Torque Winn Guide Wire Family. The submission leverages performance data from a predicate device, the HI-TORQUE PROGRESS Guide Wire Family, arguing substantial equivalence due to identical materials, design, and manufacturing processes. Therefore, no new performance testing was conducted specifically for the Hi-Torque Winn Guide Wire Family.

Here's an analysis based on the provided text, addressing your questions:

1. Table of acceptance criteria and the reported device performance

Since new performance testing was not conducted for the Hi-Torque Winn Guide Wire Family, the acceptance criteria and reported performance are implicitly those established for the predicate device, the HI-TORQUE PROGRESS Guide Wire Family. The document lists the types of performance characteristics that were tested on the predicate.

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

The document does not specify the sample size used for the test set of the predicate device. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for the tests conducted on the predicate device. The only noted data provenance is the "Pig Aorta" for the Friction/Lubricity Test, indicating an animal model was used for that specific test.

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 and not provided in the document. The performance tests listed are mechanical, chemical, and biological characterization tests, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication method for the test set

This information is not applicable and not provided. Performance tests like tensile strength or biocompatibility do not typically involve adjudication in the way clinical image interpretation studies do.

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 such study was done. This device is a guide wire, a physical medical device, not an AI-powered diagnostic or assistive tool.

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

No such study was done. This device is a physical medical device, not an algorithm.

7. The type of ground truth used

For the performance tests conducted on the predicate device, the "ground truth" would be established by the predefined acceptance criteria for each test (e.g., a specific tensile strength value, acceptable biocompatibility results according to ISO standards). It's based on engineering specifications, regulatory standards, and biological safety profiles.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML device, so there is no concept of a "training set."

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

This information is not applicable, as there is no training set for this type of device.

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To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.

The HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The BMW™ Universal Guide Wire is DOC® extendable in the 190 cm lengths.

The provided text describes a 510(k) summary for the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire Family. This document focuses on demonstrating substantial equivalence to predicate devices through various bench tests and biocompatibility assessments, rather than presenting a clinical study on human diagnostic performance using an AI algorithm.

Therefore, many of the requested points related to AI, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes are not applicable to this submission.

Here's the information that can be extracted from the provided text:

1. Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as a series of "In vitro bench testing" and "Biocompatibility testing." The submission states that these tests "demonstrated that the HI-TORQUE BALANCE MIDDLEWEIGHT™ UNIVERSAL Guide Wire met all acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program..." This indicates that the tests successfully showed the device's performance aligns with acceptable standards and is comparable to previously cleared devices.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document states "In vitro bench testing... were conducted on the subject device," implying a sample was used, but the specific number is not disclosed.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). These are lab-based bench tests and biocompatibility tests, not studies involving human patient data.

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

Not applicable. This is not a study assessing diagnostic performance where expert ground truth would be required. The tests are physical and chemical evaluations of the device's properties.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring expert adjudication of results.

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

No. This type of study is typically done for diagnostic imaging devices involving human readers and AI. This submission is for a guide wire, and the testing involved bench and biocompatibility assessments, not MRMC studies.

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

Not applicable. This device does not involve an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests would be the established engineering specifications and performance characteristics derived from validated test methods, and the performance of the predicate devices. For biocompatibility, it would be the pre-defined safety limits and established biological responses.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI algorithm or a training set in that context.

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

Not applicable. This device does not involve an AI algorithm or a training set.

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This HI-TORQUE guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

The HI-TORQUE PROGRESS Guide Wire Family is a new family of guide wires. designed to provide improved torque response and crossing while maintaining tactile feedback in stenotic vessels. The subject wire is a core to tip design, where the core material runs through the entire length of the wire. This family of guide wires have a maximum diameter of 0.0140" with a stainless steel core and are provided in 190cm extendable and 300cm exchange lengths. The distal core segment of the PROGRESS is offered in 5 configurations: PROGRESS 40, PROGRESS 80, PROGRESS 120, PROGRESS 140T and PROGRESS 200T. Each configuration is identical in design except for those design features that impact tip stiffness.

The provided text describes a 510(k) summary for the HI-TORQUE PROGRESS Guide Wire Family. It details the device, its intended use, and states that in vitro bench testing was performed to demonstrate substantial equivalence to predicate devices. However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, a detailed study description, sample sizes, ground truth establishment, or expert involvement.

Here's a breakdown of why each requested point cannot be answered from the provided text:

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

   • The document states: "In vitro bench testing performance evaluations demonstrated that the HI-TORQUE PROGRESS Guide Wire Family met the acceptance criteria and performed comparable to the matching predicate devices."
   • Missing Information: It does not provide the specific acceptance criteria (e.g., tensile strength, kink resistance, pushability thresholds) or the measured performance values for the device against these criteria.

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

   • The document mentions "in vitro bench testing" but does not specify the sample size (number of guide wires tested) or the provenance of any data (e.g., country of origin, retrospective/prospective).
   • Missing Information: No details on sample size or data provenance.

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

   • This question is typically relevant for studies involving human judgment (e.g., image interpretation). For a physical medical device like a guide wire, "ground truth" usually refers to objective physical measurements or established engineering standards.
   • Missing Information: The document does not describe any expert involvement in establishing a "ground truth" in the context of human interpretation. The "ground truth" for bench testing would typically be the physical properties measured.

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

   • Adjudication methods are used to resolve disagreements among multiple experts, usually in subjective assessments. Since bench testing is objective and not based on expert interpretation, this concept is not applicable here.
   • Missing Information: Not applicable to this type of testing.

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:

   • MRMC studies are typically for diagnostic AI devices where human readers interpret medical images. This device is a physical guide wire, not a diagnostic AI tool.
   • Missing Information: No MRMC study was done, as it's not relevant for this device.

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

   • This question pertains to AI algorithms. The HI-TORQUE PROGRESS Guide Wire is a physical medical device.
   • Missing Information: Not applicable to this device.

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

   • For a guide wire, the "ground truth" for bench testing would be the objective physical and mechanical properties measured (e.g., tensile strength, flexibility, lubricity, torque response). These are determined by calibrated instruments and established test methods, not expert consensus, pathology, or outcomes data in the typical sense.
   • Missing Information: The document states "in vitro bench testing" which implies objective physical measurements, but it does not explicitly detail the specific ground truth types beyond that.

8. The sample size for the training set:

   • "Training set" is a concept primarily used in machine learning for AI algorithms. This is a physical medical device.
   • Missing Information: Not applicable.

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

   • Again, this relates to AI/machine learning.
   • Missing Information: Not applicable.

In summary, the provided 510(k) summary only states that "in vitro bench testing performance evaluations demonstrated that the HI-TORQUE PROGRESS Guide Wire Family met the acceptance criteria and performed comparable to the matching predicate devices." It lacks the detailed study information, specific acceptance criteria, performance data, sample sizes, and other ground truth establishment methods requested in the prompt, as these details are typically found in the full test reports, not the summary document itself.

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The FoxCross PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.

The FoxCross PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guide wire insertion (max 0.035"). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.

The provided text describes a 510(k) submission for the Abbott Vascular FoxCross PTA Catheter, asserting its substantial equivalence to a predicate device, the FoxPlus PTA Catheter. This document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

Instead, the submission focuses on demonstrating substantial equivalence based on technological characteristics and in vitro bench tests, analyses, and biocompatibility data compared to a previously cleared device. It does not present a clinical study with performance metrics or acceptance criteria for a new device's efficacy or safety.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is absent in the provided text.

Here's a breakdown of why each specific point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not available. The document states "Summary of Substantial Equivalence: The FoxCross PTA Catheter...is substantially equivalent to the FoxPlus PTA Catheter...as demonstrated by the results of the in vitro bench tests, analyses, and biocompatibility data." No specific criteria or performance values are given.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available. The testing mentioned is "in vitro bench tests," which typically refers to laboratory testing, not human subject data. Therefore, details like data provenance or sample size of a test set are not applicable in the context of clinical data.
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): Not applicable, as there's no clinical test set or ground truth established by experts mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set or adjudication process is mentioned.
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 PTA catheter, a physical medical device, not an AI software or a device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth is established or discussed.
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. There is no mention of a "training set" or ground truth for it.

In summary, the provided documentation is a 510(k) summary for a physical medical device, focusing on substantial equivalence to a predicate device via bench testing. It does not provide the type of performance study details requested for AI or diagnostic devices.

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The Fox Plus PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the expansion or delivery of stents.

The Fox Plus PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.035"). The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The balloon material expands to a known diameter at specific pressures.

This document is a 510(k) summary for the Fox™ Plus PTA Catheter. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market. It typically does not involve clinical studies designed to prove performance against specific acceptance criteria in the way that novel devices might. Instead, the focus is on demonstrating equivalence to an existing, legally marketed device.

Therefore, many of the requested elements of your query are not applicable to a 510(k) submission for substantial equivalence based on identical technological characteristics and aging tests.

Here's the breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

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: Not applicable/not provided. The document primarily relies on demonstrating identical technological characteristics and aging test results, not a clinical test set in the traditional sense.
• Data provenance: Not applicable/not provided.

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)

• Not applicable. Ground truth for a clinical test set is not established in this type of submission. The "ground truth" here is the predicate device's established safety and effectiveness.

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

• Not applicable. There is no clinical test set requiring adjudication.

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 catheter, not an AI-powered diagnostic device. 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 physical medical device, not an algorithm.

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

• The "ground truth" in this context is the safety and efficacy profile of the previously cleared predicate device, to which the subject device is deemed substantially equivalent. The substantial equivalence is demonstrated through identical technical characteristics and performance in non-clinical tests (like aging tests).

8. The sample size for the training set

• Not applicable. There is no training set as this is not an AI/machine learning device.

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

• Not applicable.

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This HI-TORQUE Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may also be used with compatible stent devices during therapeutic procedures.

The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire is a steerable guide wire available in a diameter of 0.0140" and in lengths of 190 cm DOC extendable length and a 300 cm exchange length. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The distal segment of the guide wire is coated with a new lubricious coating to improve guide wire movement in the catheter. The proximal end of the guide wire utilizes SMOOTHGLIDE coating technology.

Here's a breakdown of the acceptance criteria and study information for the HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II Guide Wire, based on the provided text:

Acceptance Criteria and Device Performance (Based on provided text)

The provided text does not contain a detailed table of specific acceptance criteria with numerical targets. Instead, it states a general conclusion about meeting acceptance criteria and performance comparability.

Study Details:

1. Sample sizes used for the test set and data provenance:

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: The study was "in vitro bench testing," meaning it was conducted in a laboratory setting, not with human or animal subjects. Therefore, there is no information about country of origin or whether it was retrospective or prospective in the clinical sense.

2. Number of experts used to establish the ground truth for the test set and their qualifications:

   • Not applicable/Not specified. This was an in vitro bench test, not an evaluation relying on expert interpretation of clinical data or images.

3. Adjudication method for the test set:

   • Not applicable/Not specified. This was an in vitro bench test, not a study requiring adjudication of expert opinions.

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

   • No. This device is a guide wire, not an AI-powered diagnostic or assistive technology. The study was an in vitro bench test.

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

   • Not applicable. This device is a physical medical instrument (guide wire), not an algorithm. The study was an in vitro bench test of its physical properties and functionality.

6. The type of ground truth used:

   • The "ground truth" for this in vitro bench testing would be established engineering specifications, performance standards, and the performance characteristics of the predicate device. The text indicates the device "met the acceptance criteria" and "performed comparable to the predicate device."

7. The sample size for the training set:

   • Not applicable. This was an in vitro bench test of a physical device, not an AI model that requires a training set.

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

   • Not applicable. As noted above, this was not an AI study requiring a training set with established ground truth.

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