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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 Guide Wires are available in a 0.014" outer diameter, in 175 cm and 190 cm extendable lengths, and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.

The HI-TORQUE BALANCE TREK Guide Wires are available in a 0.014" outer diameter, and in an 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.

The HI-TORQUE BALANCE HEAVYWEIGHT Guide Wires are available in a 0.014" outer diameter, in 175 cm and 190 cm extendable lengths, and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of the adhesive that is used to adhere two core subassemblies.

The HI-TORQUE BALANCE MIDDLEWEIGHT Guide Wires are available in a 0.014" outer diameter, 175 cm and 190 cm extendable lengths, and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the DOC Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J". The change being made is in the formulation of the adhesive that is used to adhere two core subassemblies.

The HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL Guide Wire is a steerable guide wire available in a maximum outer 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 change being made is to the formulation of an adhesive that is used to adhere two core subassemblies.

The HI-TOROUE 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. The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.

The HI-TORQUE BALANCE MIDDLEWEIGHT ELITE Guide Wire is a steerable guide wire available in a maximum outer diameter of 0.014" 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. The change being made is in the formulation of an adhesive that is used to adhere two core subassemblies.

The provided text describes the 510(k) summary for various HI-TORQUE BALANCE Guide Wires by Abbott Vascular. The device is a guide wire used in percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The specific subject of this 510(k) is a change in the formulation of an adhesive used to adhere two core subassemblies within the guide wires.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for the Modified Adhesive Formulation:

Biocompatibility Specific Tests:

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size for the mechanical performance tests or the biocompatibility tests. It only mentions that "In vitro bench testing performance evaluations demonstrated..." and "Bench testing and Biocompatibility testing was conducted...".
• Data Provenance: The studies were retrospective in the sense that they were conducted for the purpose of demonstrating substantial equivalence for a specific change (adhesive formulation) to existing, legally marketed devices. The origin of the data is Abbott Vascular's internal testing facilities, as implied by the submission on behalf of Abbott Vascular. No country of origin for the data (beyond the applicant's location, USA/Germany for contact) is specified, but it's standard industry practice for such testing to be conducted in-house or by accredited labs.

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

• Number of Experts and Qualifications: This information is not provided in the document. For bench and biocompatibility testing, ground truth is typically established by adhering to recognized international standards (e.g., ISO for biocompatibility) and internal company specifications, rather than expert consensus on individual test outcomes. The "experts" would be the engineers, scientists, and toxicologists conducting and interpreting these tests, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not discussed. Since the studies described are bench tests and biocompatibility assessments, not clinical studies or image interpretations, there is no mention of an adjudication method like 2+1 or 3+1. Performance is assessed against pre-defined engineering specifications and standardized biological response criteria.

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 Study: No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (guide wire), specifically addressing a material change (adhesive formulation). It does not involve AI or human readers, so an MRMC study is not relevant.

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

• Standalone Study: No, a standalone algorithm-only study was not done. This submission is for a physical medical device, not an algorithm or AI product.

7. The Type of Ground Truth Used

• Type of Ground Truth:
  • For mechanical integrity (tensile strength, hypotube pull test): The ground truth is defined by engineering specifications and performance criteria designed to ensure the device can withstand normal tensile loading during clinical procedures. This is typically established through risk analysis and functional requirements.
  • For biocompatibility: The ground truth is established by international standards and regulatory guidelines (e.g., ISO 10993 series) for evaluating the biological effects of medical devices. Passing these standardized tests establishes the material's safety for biological contact.

8. The Sample Size for the Training Set

• Sample Size for Training Set: This is not applicable as there is no mention of a training set. This submission is for a physical medical device and its material change, not an AI/machine learning model that requires training data.

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

• Ground Truth Establishment for Training Set: This is not applicable as there is no training set involved.

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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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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.

Ask a specific question about this device

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.

Ask a specific question about this device

To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

The HI-TORQUE BALANCE UNIVERSALIM Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 175 cm, 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrocoat 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 Balance Universal™ Guide Wire is DOC® extendable in the 175 cm and 190 cm lengths.

The provided text describes a 510(k) summary for the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire. However, it does not contain the detailed performance study information required to answer all the posed questions. The text explicitly states:

"In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire may be considered substantially equivalent to the predicate devices."

This is a general statement and lacks the specific details about acceptance criteria, the study design, sample sizes, ground truth establishment, or expert involvement that are typically associated with performance studies involving AI or complex medical device efficacy.

Therefore, for many of your questions, the answer will be "Information not provided in the input text."

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

Study Details

Here's what can and cannot be answered based on the provided text:

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

   • Not provided in the input text. The text only mentions "In vitro bench testing performance evaluations."

2. 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 / Not provided in the input text. The study described is "in vitro bench testing," which would not typically involve human experts establishing ground truth in the way described for clinical or imaging data.

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

   • Not applicable / Not provided in the input text. This is not relevant for an in vitro bench testing study.

4. 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. The device is a guide wire, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI-related information is mentioned.

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

   • Yes, in essence. The "in vitro bench testing" represents a standalone evaluation of the physical device's performance against pre-defined criteria, without human intervention in the performance measurement itself (though humans design and conduct the tests). However, this is not an "algorithm" in the context of AI.

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

   • Not explicitly stated in the input text, but inferred from "in vitro bench testing." The "ground truth" would likely be objective measurements of physical properties (e.g., tensile strength, friction, flexibility, torque transmission, coating integrity) against engineering specifications or established industry standards for guide wires, rather than medical "ground truth" like pathology or clinical outcomes.

7. The sample size for the training set

   • Not applicable / Not provided in the input text. The concept of a "training set" is typically for machine learning algorithms, which this device is not. For a physical device, manufacturing and process validation would involve numerous samples, but these aren't "training sets" in the AI sense.

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

   • Not applicable / Not provided in the input text. (See point 7).

In summary, the provided document is a 510(k) summary for a medical device (a guide wire), not for an AI diagnostic tool. Therefore, many of the questions asked, particularly those related to AI performance, human readers, and clinical data/expert consensus, are not applicable or the information is not present in this type of regulatory submission summary. The "study" described is limited to "in vitro bench testing."

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

The HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVESAL™ Guide Wires guide wires with a 0.014'' diameter and available in 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges. The distal tips of the guide wires are available either as a straight tip that is shapeable or as a pre shaped "J".

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the HI-TORQUE BALANCE® guide wires:

It's important to note that the provided text is a 510(k) summary for a medical device (guide wires), not a scientific paper detailing a clinical study for an AI/ML powered medical device. Therefore, many of the requested categories are not applicable or the information is not present within this type of regulatory submission. The "device" in this context is a physical medical instrument, not a software algorithm.

Acceptance Criteria and Reported Device Performance

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

The document states: "The results of the verification testing demonstrate that the HI-TORQUE BALANCE®, BALANCE MIDDLEWEIGHT™, BALANCE HEAVYWEIGHT™, BALANCE TREK™ and BALANCE MIDDLEWEIGHT UNIVERSAL™ Guide Wires meet the established acceptance criteria and performs in a manner equivalent to the predicate device."

However, the specific acceptance criteria (e.g., tensile strength, fracture resistance, lubricity values) and the quantitative reported performance of the device against these criteria are not provided in this 510(k) summary. It only states that the device "meets the established acceptance criteria."

Study Details (as inferable for a non-AI medical device submission)

Given this is a physical medical device and not an AI/ML product, many of the AI-specific questions are not applicable. The "study" here refers to pre-clinical verification testing and a demonstration of substantial equivalence to a predicate device.

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

• Sample Size for Test Set: Not specified. Verification testing would involve testing a certain number of guide wire samples, but the exact quantity is not detailed in this summary.
• Data Provenance: Not applicable in the sense of patient data. The "data" comes from physical engineering and performance tests on the manufactured guide wires. There's no country of origin of "data" in this context, as it's product testing.
• Retrospective or Prospective: Not applicable for device verification testing.

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)

• Number of Experts & Qualifications: Not applicable. For a physical medical device, "ground truth" isn't established by expert consensus on patient data. It's established by engineering specifications, material standards, and performance test protocols. The "experts" would be the engineers and quality assurance personnel performing and validating the tests, but these roles and numbers are not specified.

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

• Adjudication Method: Not applicable. Adjudication methods like 2+1 are used for human review of clinical data, typically in AI/ML validation. For device verification, engineers follow defined test methods and 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

• MRMC Study: No. This is a physical guide wire, not an AI-powered diagnostic or assistive tool.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. There is no algorithm to run in standalone mode.

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

• Type of Ground Truth: For this type of device, the "ground truth" would be defined by the pre-established engineering specifications, material properties, and functional performance benchmarks (e.g., specific thresholds for torqueability, tip flexibility, lubricity, radiopacity, tensile strength, etc.) that the device must meet.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth for Training Set: Not applicable. There is no training set for this 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 equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic procedures.

The HI-TORQUE BALANCE TREK™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a steerable guide wire with a maximum diameter of 0.014″ and available in: 175 cm and 190 cm extendable lengths and a 300 cm exchange length. The proximal end of the 175 cm and 190 cm models are tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension. The distal end of the guide wire has a radiopaque tip that are available either as a straight or as a preshaped J. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with polytetrafluoroethylene.

Here's an analysis of the provided text regarding the acceptance criteria and study for the HI-TORQUE BALANCE TREK™ Guide Wires:

There are no specific acceptance criteria or performance metrics quantified in the provided text. The document describes a medical device submission (510(k)) where the focus is on demonstrating "substantial equivalence" to a predicate device, rather than proving a device meets specific quantitative performance targets.

The study described is not a typical clinical trial or AI performance study. It's a series of in vitro bench tests and in vivo performance evaluations designed to show the new device performs similar to a predicate device.

Here's a breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document does not provide numerical acceptance criteria (e.g., "distal tip pull strength must be >X Newtons") nor does it provide quantitative results from the tests (e.g., "distal tip pull strength measured Y Newtons"). The primary "acceptance criteria" is stated as performing "similar to" or "equivalent to" the predicate device.

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

• Sample Size: The document does not specify the sample size used for the in vitro bench testing or in vivo performance evaluations.
• Data Provenance: The data provenance is not specified (e.g., country of origin, retrospective or prospective). Given it's a 510(k) submission focused on bench and "in vivo performance evaluations," it's likely a mix of laboratory testing and potentially animal studies or early human use if the "in vivo performance evaluations" refer to that, though details are absent. It is not explicitly stated as retrospective or prospective human patient data.

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

• Number of Experts: Not applicable. This study focuses on device engineering performance, not interpretation of clinical data by experts.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "tests" are functional engineering performance tests, not clinical assessments 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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable. This is not an AI-assisted device.

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

• Standalone Performance: Not applicable. This is a physical medical device (guide wire), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" here is the functional performance of the predicate device and established engineering specifications for guide wires. The new device's performance was compared against the predicate's performance in specific functional tests. The goal was to show similarity/equivalence.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Ground Truth for Training Set: Not applicable.

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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 equipment such as atherectomy and compatible stent devices during other diagnostic and therapeutic procedures.

The ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is a guide with a 200 cm exchange length and lengths of 175 cm and 190 cm and 190 and lengths of 175 cm and 190 cm extendation of the are a soland tapered so that it has The proximal end of the 175 cm and 190 cm models and one Wire Extension. This enables the physician to extend the working length of this guide wire to facilitate catheter exchanges.

The ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating is constructed from astable wire consists of an HYDROCOAT™ Hydropinne Coating is course in consists of the wire consists of an ewith a nominal oute with a nominal outer diameter of 0.017 . The wire is coated with polytetrafluoroethylene (PTFE) and the distal, segment of the wire is coated with HYDROCOAT™ Hydrophilic Coating.

The distal tip coil has a radiopaque length of 4.5 cm. The distal end of the guide wire is available either as a straight tip that is shapeable, or as a pre-shaped "J". The 190 cm and 300 cm guide wires have markers located 90cm and 100 cm from the distal tip.

The provided 510(k) summary for the ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating describes the performance data and conclusions based on bench testing. However, it does not include information related to human user studies, expert involvement, or training data for an AI/algorithm-based device. This is because the device described is a physical medical device (a guidewire), not an AI/software-as-a-medical-device (SaMD).

Therefore, the requested information elements related to AI/SaMD studies (sections 2, 3, 4, 5, 6, 7, 8, 9) are not applicable to this submission.

Here's the breakdown of the available information:

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

The document states: "The results from the bench tests showed that the new ACS HI-TORQUE BALANCE HEAVYWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed in a manner equivalent the predicate ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire."

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

This information is not applicable as this is a physical medical device. The "test set" refers to the guidewire samples used in the bench tests. The document does not specify the number of guidewires tested for each bench test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. Ground truth is not established by human experts for the performance evaluation of this physical device in bench testing. Performance is measured against engineering specifications and comparison to a predicate device.

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

This information is not applicable. Adjudication methods are relevant for human interpretation tasks, not for bench testing of a physical device.

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

This information is not applicable as this is a physical medical device and not an AI/SaMD.

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

This information is not applicable as this is a physical medical device and not an AI/SaMD.

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

The "ground truth" for this device's performance is based on engineering specifications and performance equivalence to a legally marketed predicate device as demonstrated through bench testing. There is no biological or clinical "ground truth" as would be found in diagnostic AI studies (e.g., pathology, outcomes).

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI/SaMD based on machine learning.

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

This information is not applicable. There is no "training set" in the context of this device.

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The HI-TORQUE BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating have the following intended uses:

• 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 equipment such as . atherectomy, IVUS and compatible stent devices during other diagnostic and therapeutic intravascular procedures.

The HI-TOROUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating are steerable guide wires with a nominal diameters of 0.014" and two lengths: a 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models are tapered to fit into the hypotube portion of the ACS DOC Guide Wire Extension (K902755, approved September 4, 1990).

The wires are constructed from a stainless steel proximal shaft and a distal superelastic ELASTINITE Shaft for flexibility and performance. The distal end of this guide wires have radiopaque tips that are available either as a straight, shapeable configuration or as a preshaped J configuration. The guide wires have proximal markers at 90 and 100 cm from the distal tip. The hydrophilic coating is applied to the distal portion of the wire guide wire. The proximal shaft of the guide wire is coated with polytetrafluoroethylene.

The provided 510(k) summary (K973494) describes the performance testing for the HI-TORQUE BALANCE™ Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating.

Here's an analysis of the acceptance criteria and study findings based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Bench testing was performed to demonstrate that the HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating met the acceptance criteria and performed similar to the predicate HI-TORQUE BALANCE® Guide Wire." Similarly, for in vivo testing, it states "The results showed that the new wires performed in an equivalent manner to the predicate devices." And finally, "The results from the bench tests plus the animal testing showed that the new HI-TORQUE BALANCE® Guide Wire with HYDROCOAT™ Hydrophilic Coating and the ACS HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire with HYDROCOAT™ Hydrophilic Coating met acceptance criteria and performed in a manner equivalent the predicate HI-TORQUE BALANCE® Guide Wire and the HI-TORQUE BALANCE MIDDLEWEIGHT™ Guide Wire."

However, the specific quantitative acceptance criteria or detailed numerical performance results for each test were not explicitly provided in the summary. The acceptance criterion appears to be general equivalence or similarity to the predicate device.

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

Test Set Sample Size: The document does not specify the exact number of units or animals used in the bench tests or the in vivo animal testing. It generally refers to "bench testing" and "in vivo animal testing in a canine model."

Data Provenance:

• Bench tests: Not explicitly stated, but typically conducted internally by the manufacturer.
• In vivo animal testing: Performed in a "canine model," which implies an experimental, prospective study. The country of origin is not specified but is presumably where the manufacturer (Guidant Corporation) is based or where their testing facilities are located.

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

This question is not applicable to the provided document. The performance testing described (bench tests and animal studies) involves physical and mechanical properties, not interpretation or diagnosis requiring human experts or ground truth in the context of diagnostic accuracy. The "ground truth" here is the objective measurement of physical properties or observed physiological responses in the animal model.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., image reading) to establish a consensus ground truth. The device's performance was evaluated through objective bench tests and animal studies, not through human interpretation 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

This question is not applicable. The device is a medical guidewire, not an AI or imaging device that would be subject to MRMC studies or human reader comparisons. Performance was assessed through physical testing and animal models, not human interpretation.

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

This question is not applicable. The device is a physical guidewire, not an algorithm, so standalone algorithm performance is not relevant. The performance tests described (bench and animal) are inherently "standalone" in the sense that they evaluate the device itself.

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

For the bench tests, the "ground truth" would be the objectively measured physical properties and performance characteristics against predefined engineering specifications (implied to be equivalent to the predicate device). For the in vivo animal testing, the "ground truth" would be the observed physiological responses, device maneuverability, and safety outcomes within the healthy coronary arteries of the canine model, compared to the predicate device.

8. The sample size for the training set

This question is not applicable. The device is a physical guidewire, not a machine learning model, so there is no "training set."

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

This question is not applicable as there is no training set for a physical medical device.

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