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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) and percutaneous transluminal angioplasty (PTA). 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 HI-TORQUE POWERTURN Guide Wire Family has a diameter of 0.014" with a 190 cm extendable length and a 300 cm exchange length. The POWERTURN Guide Wire Family is available in three tip support models and is constructed from a 304V stainless steel core. Over the proximal coined section of the 190 cm model is a Wire Identifier consisting of a black PTFE shrink tube which is removable and is used to help physicians distinguish between two Abbott Vascular wires while being used simultaneously. The distal tip of the guide wire is available as a straight tip that is shapeable or as a pre-shaped "J". The straight shape allows the physician to shape the tip according to his/her preference and the pre-shaped tip provides the physician the convenience of a "J" shape without manual shaping.

This K112957 document describes a 510(k) premarket notification for the HI-TORQUE® POWERTURN Guide Wire Family, a catheter guide wire, by Abbott Vascular. The submission aims to establish substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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." However, the specific quantitative acceptance criteria for each test are not detailed in this summary.

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

The document does not explicitly state the sample size used for the test set for the in vitro bench testing. It only mentions that "in vitro bench testing" was conducted.

The data provenance is from in vitro bench testing, meaning it was conducted in a laboratory setting. There is no information regarding country of origin, retrospective, or prospective nature, as this applies to clinical study data, not bench 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 "ground truth" concept usually applies to clinical studies where expert consensus or pathological findings validate diagnoses or outcomes. For this device, the performance was assessed through in vitro bench testing against predefined engineering and material specifications, not against expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for resolving discrepancies among expert readers/evaluators of medical images or patient data. The evaluation of this guide wire involved direct measurement and observation of physical properties and performance characteristics in a laboratory setting.

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

This information is not applicable. This submission concerns a physical medical device (a guide wire), not a diagnostic algorithm or AI system that assists human readers. Therefore, an MRMC study or evaluation of AI assistance is irrelevant to this device’s clearance.

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

This information is not applicable. As mentioned above, this device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation was based on engineering specifications and established performance benchmarks derived from predicate devices and industry standards for guide wires. The in vitro bench tests measured physical properties and functional performance against these objective criteria.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant to machine learning algorithms, which are not involved in the evaluation of this physical medical device.

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

This information is not applicable, as there was no training set involved in the evaluation of this physical device.

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The NC TREK™ RX Coronary Dilatation Catheter is indicated for:
a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction;
c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

The NC TREK RX Coronary Dilatation Catheter is a rapid exchange co-axial design with a balloon at the distal tip. Balloon diameters from 1.50 mm through 3.25 mm use a single layer design and balloon diameters from 3.50 mm through 5.00 mm use a co-extruded design for both predicate and new sizes. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section to the guide wire notch junction, along with brachial and femoral markers.

The provided text describes a 510(k) premarket notification for the NC TREK™ RX Coronary Dilatation Catheter, a medical device. The document focuses on demonstrating substantial equivalence to a predicate device through in vitro bench testing and biocompatibility testing. It provides detailed information on the performance data but does not contain any information about an AI/ML device or its acceptance criteria or studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving an AI/ML device meets them, as the provided text pertains to a conventional medical device (a coronary dilatation catheter) and its mechanical and physical properties, not software or AI/ML performance.

The information requested in your prompt (sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established) is typically relevant for AI/ML device evaluations and is not found in this document.

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This 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™ ELITE Guide Wire is a steerable guide wire available in a maximum diameter of 0.0145" and in lengths of 190 cm and 300 cm. The distal segment of the guide wire 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 0.0145". The proximal end of the guide wire is coated with hydrophobic coating, which reduces friction of the wire within a catheter. The ELITE Guide Wire is DOC® extendable in the 190 cm lengths. Over the coin DOC is a Wire Identifier to aid in distinguishing between two wires during use.

The provided text describes the 510(k) submission for the HI-TORQUE BALANCE MIDDLEWEIGHT™ ELITE Guide Wire Family. It details the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to predicate devices.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of an AI/algorithm-driven device. The evaluation was based on in vitro bench testing and biocompatibility testing of the physical guide wire. The sample sizes for these physical product tests are not explicitly stated in the provided text. The data provenance is derived from these tests conducted by Abbott Vascular Inc.

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

This information is not applicable to the provided document. The device is a physical medical device (guide wire), not an AI/software-as-a-medical-device (SaMD) that typically requires expert-established ground truth for performance evaluation. The "ground truth" for this device's performance relies on established scientific and engineering principles for material and mechanical properties, and biological responses, as measured in standard laboratory assays.

4. Adjudication method for the test set

This information is not applicable for the reason stated above.

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 conducted or is relevant for this physical guide wire device. This type of study is for evaluating AI-assisted diagnostic tools that involve human readers.

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

This information is not applicable. The device is a physical guide wire, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation was based on established standards and scientific principles related to:

• Physical and Mechanical Properties: Measured through in vitro bench tests (e.g., tensile strength, torque strength, friction, coating integrity).
• Biocompatibility: Measured through standardized in vitro and in vivo biocompatibility assays as per ISO standards and FDA guidance.

8. The sample size for the training set

This information is not applicable. The device is not an AI/machine learning model that requires a training set.

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

This information is not applicable.

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The TREK™ RX, MINI TREK™ RX, TREK™ OTW, and MINI TREK™ OTW Coronary Dilatation Catheters are indicated for:
a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion;
b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction;
c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

The TREK RX and MINI TREK RX Coronary Dilatation Catheters are a rapid exchange co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section ending distal to the guide wire notch junction, along with brachial and femoral markers.

The TREK OTW and MINI TREK OTW Coronary Dilatation Catheters are an over-the-wire co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. Along the proximal portion of the shaft are brachial and femoral markers to aid in gauging the catheter's position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is located at the proximal end to provide access to the inflation lumen and guide wire lumen and allows connection with an inflation device.

The provided document describes a medical device, the TREK™ RX, MINI TREK™ RX, TREK™ OTW, and MINI TREK™ OTW Coronary Dilatation Catheters, and its substantial equivalence to predicate devices. However, the document does not contain information about an AI/algorithm-driven device or a study involving human readers and AI assistance. Therefore, it is not possible to fill out many of the requested fields related to AI performance, ground truth, and expert evaluation.

Based on the information provided regarding the Coronary Dilatation Catheters:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "The TREK RX, MINI TREK RX, TREK OTW and MINI TREK OTW Coronary Dilatation Catheters were subjected to the following in vitro bench tests..." suggesting that a representative number of units for each catheter type underwent testing.
• Data Provenance: In vitro bench tests. The country of origin for the data is not specified, but the submission is to the FDA in the USA. The tests are "retrospective" in the sense that they are performed on manufactured devices as part of a product release or qualification process.

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 physical medical device, not an AI/algorithm-driven one that requires expert-established ground truth from medical images or data. The "ground truth" for these tests is based on engineering specifications and regulatory guidance.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies (often for AI devices). For physical device testing, performance is objectively measured against predetermined specifications.

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

• Not applicable. This is not an AI/algorithm-driven device.

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

• Not applicable. This is not an AI/algorithm-driven device.

7. The type of ground truth used:

• For the physical tests, the "ground truth" is defined by the acceptance criteria derived from engineering specifications, industry standards, and regulatory guidance documents (e.g., Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010).

8. The sample size for the training set:

• Not applicable. This is not an AI/algorithm-driven device.

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

• Not applicable. This is not an AI/algorithm-driven device.

Summary of the Study:

The study was not for an AI/algorithm. Instead, it was a series of in vitro bench tests and biocompatibility tests conducted on the TREK™ RX, MINI TREK™ RX, TREK™ OTW, and MINI TREK™ OTW Coronary Dilatation Catheters. The purpose of these tests was to demonstrate that the devices met all predetermined acceptance criteria and performed similarly to predicate devices. The acceptance criteria were established based on the requirements outlined in the "Guidance for Industry and FDA Staff - Class II Special Controls for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010" and other relevant engineering and safety standards. The study concluded that the new devices "met all acceptance criteria and performed similarly to the predicate devices," with "no new safety or effectiveness issues...raised." This allowed the FDA to determine that the devices were "substantially equivalent" to legally marketed predicate devices.

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The NC TREK™ RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perforusion; b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segement elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

The NC TREK RX Coronary Dilatation Catheters is a rapid exchange co-axial design with a balloon at the distal tip. The balloon segment expands to a known diameter and length at a specific inflation pressure and has radiopaque marker(s) under the balloon to aid in positioning the balloon in a stenosis. The coaxial shaft consists of a tubular inner and outer member. The inner member permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outer lumen provides for inflation and deflation of the balloon with contrast fluid. The proximal shaft consists of a hypotube with a hub on the proximal end, a tapered distal section ending distal to the guide wire notch junction, along with brachial and femoral markers.

The provided text describes a medical device, the NC TREK™ RX Coronary Dilatation Catheter, and its clearance process. However, it does not include information relevant to an AI/ML device and its associated studies (e.g., test set, training set, ground truth, expert adjudication, MRMC studies).

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them in an AI/ML context from this document.

The document discusses in vitro bench and biocompatibility tests conducted according to specific guidance for Class II medical devices, and these tests demonstrated that the device "met all acceptance criteria and performed similarly to the predicate devices." This implies the acceptance criteria were related to the physical and biological performance characteristics of the catheter, not diagnostic accuracy or output from an AI model.

The questions you asked are highly geared towards AI/ML device evaluations. Since the provided document is for a physical medical device (coronary dilatation catheter) and not an AI/ML diagnostic or assistive tool, the requested information is not present.

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The HI-TORQUE PILOT Guide Wire Family is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The guide wire is also intended to facilitate the placement of compatible stent devices during therapeutic intravascular procedures.

The HI-TORQUE PILOT™ Guide Wire with Hydrophilic Coating is a guide wire with a maximum diameter of 0.0140" and is available in a 190 cm extendable length and a 300 cm exchange length.

There are three HI-TORQUE PILOT Guide Wire designs with varying tip stiffness, the HI-TORQUE PILOT 50, HI-TORQUE PILOT 150, and HI-TORQUE PILOT 200 Guide Wires.

The distal tip of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The straight shape allows the physician to shape the tip according to his/her preference; the J shapes provide the physician the convenience of a J shape without manual shaping. Brachial and femoral markers are located on the proximal segment of the 190 cm and 300 cm guide wires to indicate when the tip of the guide wire is about to exit the guide catheter.

The proximal section of the wire is coated with polytetrafluoroethylene (PTFE). The distal, polyurethane-covered area of the wire is covered with a hydrophilic coating.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested format:

Acceptance Criteria and Device Performance Study

The information provided describes a 510(k) premarket notification for a medical device (HI-TORQUE PILOT™ Guide Wire Family with Hydrophilic Coating). As such, the "acceptance criteria" are not reported as specific numerical thresholds, but rather as showing that the device is "substantially equivalent" to a predicate device. The performance data is primarily focused on demonstrating this substantial equivalence through various in vitro and biocompatibility tests.

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 exact sample sizes used for each in vitro bench test or biocompatibility test. It generally states that "in vitro bench testing" and "biocompatibility testing" were conducted.
• Data Provenance: The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. As these are bench and lab tests, the "provenance" would typically refer to the internal lab where the tests were performed.

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

This section is not applicable as the provided document describes testing of a physical medical device (guide wire) through in vitro bench tests and biocompatibility tests, not an AI/software device that requires expert-established ground truth for a test set. The "ground truth" here is the physical performance and biological response measured in a controlled laboratory setting against predefined standards or predicate device performance.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image analysis or diagnostic studies with human interpretation, not for objective physical and chemical testing.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for AI/software devices for diagnostic or interpretive tasks. The submitted device is a physical guide wire.

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

This section is not applicable. The device is a physical guide wire, not an algorithm, so "standalone performance" in the context of AI is not relevant. The performance reported is inherently "standalone" in the sense that it's the device's intrinsic mechanical and biocompatible properties.

7. The Type of Ground Truth Used

The "ground truth" for the tests conducted includes:

• Predicate Device Performance: For mechanical and biocompatibility tests where new testing wasn't performed, the performance of the predicate device (HI-TORQUE PILOT Guide Wire, K030549) served as the reference.
• Defined Acceptance Criteria/Standards: For the new coating-related tests (adherence, integrity, friction) and the biocompatibility tests, the device was tested against established acceptance criteria, which would be based on recognized standards or internal specifications to ensure safety and effectiveness.

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical guide wire; there is no "training set" as would be found in AI/machine learning development.

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

This section is not applicable for the same reason as point 8.

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