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The NC TREK NEO™ 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 STsegment elevation myocardial infarction
c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)

NC TREK NEO is a Non-Compliant (NC), Rapid Exchange (RX), Coronary Dilatation Catheter (CDC). The catheter is a rapid exchange co-axial design with a balloon at the distal tip. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The outside diameter (OD) of the distal end of the device, including the distal shaft, tip, and the balloon are coated with Hydrophilic Coating.
Radiopaque markers are positioned on the inner member underneath the balloon to provide accurate positioning of the balloon in the artery. The balloon is designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. The Single arm on proximal end of the device provides access to the inflation lumen. It is designed with a Luer-lock fitting to facilitate connection to an inflation device.
The NC TREK NEO™ Coronary Dilatation Catheter will be available in select combinations of 1.50-6.00mm diameters and 6-25mm lengths.

This document concerns the 510(k) premarket notification for the NC TREK NEO™ Coronary Dilatation Catheter (K220634). The information provided does not contain details about acceptance criteria, device performance, and study design typically found in reports for AI/ML-driven medical devices. Instead, it describes a conventional medical device (a PTCA catheter) and establishes substantial equivalence to a predicate device through a comparison of design, materials, manufacturing, sterilization, and non-clinical performance data.

Therefore, many of the requested fields cannot be filled as they are explicitly related to studies and acceptance criteria for AI/ML devices, which are not applicable here.

Here's a breakdown of the available information and what cannot be provided:

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

The document lists various performance tests conducted on the device. However, it does not provide a table with specific quantitative acceptance criteria or the reported device performance values for these tests. It only states that the tests supported a determination of substantial equivalence and raised no new safety or performance issues.

Performance Tests Completed (no specific acceptance criteria or reported values provided in this document):

• Tip dimensions
• Crossing Profile
• Guidewire Lumen
• Shaft Dimensions
• Proximal Shaft Marker Location
• Catheter Length
• Catheter Preparation
• Balloon Inflation/Deflation Time
• Balloon Rated Burst Pressure (RBP)
• Maximum Compliance Label
• Balloon Compliance
• Balloon RBP (In-Stent)
• Proximal Seal Tensile Strength
• Outer Member to Hypotube Seal Tensile Strength (Notch-Seal Tensile Strength)
• Proximal Adaption Tensile Strength
• Catheter Tip Tensile Strength
• Inner Member Lumen Collapse
• Balloon Fatigue Resistance
• Balloon Fatigue Resistance (In-Stent)
• Hydrophilic Coating- Dry Adhesion of Coating
• Hydrophilic Coating- Coefficient of Friction
• Kink/Flex
• Torque
• Particulates
• Finished Good Sheath Removal
• Balloon Preparation, Deployment and Retraction

Biocompatibility and Chemical Characterization Tests Completed:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic & Pyrogenicity
• Hemocompatibility

2. Sample size used for the test set and the data provenance:
Not applicable. This is a conventional medical device, not an AI/ML device relying on a test set of data. The "test set" here refers to the physical devices manufactured for bench and biocompatibility testing. The exact number of devices or components used for each test is not specified in this summary, nor is data provenance 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:
Not applicable. Ground truth and expert consensus are concepts for AI/ML device validation, which is not relevant for this conventional catheter.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device and study.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "truth" for this device's performance is determined by established engineering standards, material properties, and biological compatibility testing, not by expert consensus on clinical data or pathology in the context of an AI/ML algorithm.

8. The sample size for the training set:
Not applicable. This device does not involve a training set for an AI/ML algorithm.

9. How the ground truth for the training set was established:
Not applicable. This device does not involve a training set for an AI/ML algorithm.

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The Viatrac 14 Plus Peripheral Dilatation Catheter is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal, renal arties) or for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.

The Viatrac 14 Plus Peripheral Dilatation Catheter has an integrated shaft system and a balloon near the distal tip. The shaft has a combination of the single lumen and dual lumen tubing. One lumen is used for the inflation of the balloon with a contrast medium. The second lumen in the distal shaft permits the use of a guidewire to facilitate the advancement of the catheter to and through the stenosis to be dilated.

The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length at a specific pressure.

On the 135 cm catheter length, there are two proximal shaft markers (95 cm and 105 cm from the distal tip). On the 80 cm catheter length, there is a single proximal marker (55 cm from the distal tip). Both indicate the relative position of the catheter to the end of a brachial, femoral, or renal guiding catheter. An additional marker is located at the guidewire exit notch and aids in locating the guidewire exit notch.

This document is a 510(k) summary for the Viatrac 14 Plus Peripheral Dilatation Catheter, not a clinical study report for an AI/ML medical device. Therefore, the information required for acceptance criteria and study details for an AI system is not present in this document.

The 510(k) summary states that the changes to the device are minimal (a change in resin material source for an inner member material) and do not alter its technological characteristics, design, or manufacturing process. The device's substantial equivalence to the predicate device is demonstrated through:

• Biocompatibility assessment: in accordance with ISO 10993 series of standards (Cytotoxicity, Sensitization, Hemocompatibility, Pyrogenicity).
• Functional testing: (Catheter bend integrity, Inner member lumen collapse, Catheter tensile integrity, Tip tensile).

Since this is a filing for a physical medical device (a catheter) with a minor material change, and not an AI/ML-based device, the concepts of "acceptance criteria for an AI model," "test set and data provenance," "experts for ground truth," "adjudication methods," "MRMC studies," "standalone algorithm performance," "training set," and "ground truth establishment for training set" are not applicable.

Therefore, I cannot provide the requested table and study details regarding AI/ML device performance based on the provided text. The document describes a traditional medical device submission focused on material changes and physical performance, not on the performance of a diagnostic AI algorithm.

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This guide wire is intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA) in arteries such as the femoral, popliteal, and infrapopliteal arteries. 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.

The HI-TORQUE (HT) Proceed Guide Wire Family includes steerable guide wires offered in several tip load and guide wire length configurations.

The HT Proceed Guide Wire Family will be available with the features as listed below:

• 2 tip loads: 11g and 14g
• 1 coating length: Uncoated Tip ●
• 1 tip shape: Pre-shaped, micro-J ●
• 2 lengths: 190 cm, 300cm

The HT Proceed Guide Wires are designed to be compatible with devices designed for use with 0.014" guide wires. The HT Proceed Guide Wire Family has a maximum diameter of 0.0144". The distal tip has a radiopaque length of 3.0 cm.

The provided text describes a 510(k) submission for a medical device, the HI-TORQUE PROCEED Guide Wire Family. This submission focuses on establishing substantial equivalence to a predicate device, the HT InfilTrac Guide Wire.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the subject device (HI-TORQUE PROCEED Guide Wire Family) is "technologically identical" to the predicate device (HT InfilTrac). Therefore, the performance data for the predicate device is leveraged.

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

The document does not explicitly state the sample size for the test set. Instead, it refers to "in vitro bench testing and simulated use testing" performed on the predicate device (HT InfilTrac). The provenance of this data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be laboratory-based testing conducted by the manufacturer (Abbott Vascular).

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

This information is not provided in the document. As this is a 510(k) submission primarily focused on mechanical and functional equivalence for a guide wire, the "ground truth" is established through engineering and performance testing against predefined specifications, rather than expert medical interpretation of clinical data.

4. Adjudication Method for the Test Set:

An adjudication method (e.g., 2+1, 3+1) is not applicable or mentioned in this context. The "ground truth" for this type of device is determined by the objective results of bench and simulated use testing against a set of engineering and performance specifications.

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 typically used for diagnostic imaging devices or AI algorithms where human interpretation is a key component. The HI-TORQUE PROCEED Guide Wire is a physical medical device, and its performance is evaluated through engineering tests, not human reader performance.

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

Not applicable. This device is a physical guide wire, not a software algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is based on predefined engineering and performance specifications derived from industry standards, internal product requirements, and external guidance documents. The text explicitly states: "demonstrate that HT Proceed meets all acceptance criteria requirements as specified in the product specification and external guidance documents."

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI or software-based device that requires a "training set" in the machine learning sense. The performance data is derived from testing the physical properties and functional capabilities of the device (or its identical predicate).

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

Not applicable. As a physical medical device, there is no "training set" or corresponding ground truth establishment process in the context of AI or machine learning. The "ground truth" for the device's performance is established through the engineering specifications and acceptance criteria it must meet, which are determined through design, risk analysis, and regulatory requirements.

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The Hi-Torque Steelcore™ Bare Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not in the cerebral vasculature.

The HT Steelcore Bare Guide Wire is classified under the product code DOX, with the regulation number 21 CFR 870.1330, Catheter guide wire. The HT Steelcore Bare Guide Wire is a steerable wire offered in only one configuration and is designed to be used with devices compatible with 0.018" guide wires.

The HT Steelcore Bare Guide Wire is developed with 300 cm length and has a maximum diameter of 0.019". The distal tip has a radiopaque length of 5.0 cm. The HT Steelcore Bare Guide Wire will be available with the features as listed below:

• Proximal Coating Single Coat Silicone Based hydrophobic coating. ●
• Distal Coating Dual Coat Silicone Based Hydrophobic Coating. .

This document describes the premarket notification (510(k)) for the HI-TORQUE Steelcore™ Bare Guide Wire. The information provided outlines the device's characteristics, its intended use, and the testing conducted to demonstrate its substantial equivalence to a legally marketed predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "performance testing passed with results meeting acceptance criteria." However, it does not provide a specific table detailing the quantitative acceptance criteria for each test and the corresponding quantitative reported device performance. It generally asserts that the device passed all tests and met acceptance criteria, but lacks specific numerical metrics for these criteria or the test results.

The acceptance criteria are implicitly defined by the chosen performance tests and the relevant FDA guidance and standards. The reported "performance" is the qualitative statement that the device "passed" these tests.

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

The document does not specify the sample sizes used for the performance testing (biocompatibility, sterilization, pyrogen validation, shelf life/packaging, and non-clinical bench testing).

Regarding data provenance:

• Country of origin: Not explicitly stated, but given the submission is to the FDA, it is implied to be relevant to the US regulatory framework.
• Retrospective or Prospective: Not applicable in the context of bench testing. These are controlled laboratory tests, not clinical studies involving patient data.

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

This information is not applicable as the "test set" here refers to physical performance characteristics of a medical device (a guide wire), not a dataset for an AI algorithm or a clinical study requiring expert consensus for ground truth. The "ground truth" is established by the specifications, standards, and validated test methods themselves.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or AI algorithm validation where multiple human readers assess data and discrepancies need to be resolved. For bench testing of a physical device, the "adjudication" is inherent in the adherence to validated test protocols and the objective measurement of physical properties.

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 performance of diagnostic tools or AI systems, often involving human readers' interpretations of medical images. This submission is for a physical medical device (a guide wire) and relies on bench testing and substantial equivalence to a predicate device, not clinical effectiveness in a diagnostic or interpretive context.

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

No, a "standalone" study in the context of an algorithm or AI was not done. This submission is for a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" or reference standard for evaluation was based on:

• Established engineering specifications and design requirements for guide wires.
• Relevant FDA guidance documents: Specifically, "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling: 2019."
• Pertinent consensus standards (though not explicitly listed, implied by "as recommended by the FDA guidance document as applicable").
• Comparison to the predicate device: The device is considered substantially equivalent if its performance demonstrates it is "as safe and as effective" as the predicate.

This is not ground truth derived from expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device where a "training set" would be used to develop an algorithm.

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

Not Applicable. As above, there is no AI/ML training set.

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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 lession, 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 crossing de novo chronic total coronary occlusions (CTO).

The HI-TORQUE (HT) InfilTrac Guide Wire Family includes steerable guide wires offered in several tip load and guide wire length configurations.

The HT InfilTrac Guide Wire Family will be available with the features as listed below:

• 2 tip loads: 11g and 14g
• . 1 coating length: Uncoated Tip
• 1 tip shape: Pre-shaped, micro-J
• 2 lengths: 190 cm, 300cm

The HT InfilTrac Guide Wires are designed to be compatible with devices designed for use with 0.014" guide wires. The HT InfilTrac Guide Wire Family has a maximum diameter of 0.0144". The distal tip has a radiopaque length of 3.0 cm.

The provided text describes a medical device submission (K193126) for the "HI-TORQUE InfilTrac Guide Wire Family." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study to prove the device meets acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested items related to AI/ML studies (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect size, standalone performance, and ground truth establishment for training) are not applicable to this document.

However, I can extract the acceptance criteria and performance data as related to the bench and simulated use testing mentioned.

Here's the information that can be extracted:

1. A table of acceptance criteria and the reported device performance
   The document states: "Results of these tests demonstrated that the HT InfilTrac Guide Wire Family met the functional, dimensional and simulated use testing acceptance criteria requirements as specified in the product specification and external guidance documents. All the outputs tested for HT InfilTrac Guide Wire Family met specification or requirements."

   This is a general statement. Specific acceptance criteria and quantitative performance results are not detailed in this publicly available 510(k) summary. The summary confirms that the device met all unspecified acceptance criteria.

   Acceptance Criteria Type	Reported Device Performance
   Functional requirements	Met specifications
   Dimensional requirements	Met specifications
   Simulated use testing	Met specifications

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   Not applicable, as this is for a guide wire and involves in-vitro bench and simulated use testing, not clinical data sets for AI/ML.

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 (no AI/ML study).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   Not applicable (no AI/ML study).

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 (no AI/ML study).

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   Not applicable (no AI/ML study).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   For the physical device testing, the "ground truth" or "specifications" were established by the "product specification and external guidance documents." These would likely include engineering design specifications and relevant international standards for medical devices.

8. The sample size for the training set
   Not applicable (no AI/ML study).

9. How the ground truth for the training set was established
   Not applicable (no AI/ML study).

In summary: The provided document is a 510(k) submission for a physical medical device (guide wire). It states that the device successfully met "functional, dimensional and simulated use testing acceptance criteria requirements as specified in the product specification and external guidance documents." However, it does not provide the detailed acceptance criteria or the specific performance results, nor does it involve the type of AI/ML studies typically associated with the other questions.

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The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the site of the Filtration Element should be between 2.5 and 7.0 mm.

The Emboshield NAVO Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during interventional procedures within carotid arteries or atherectomy in the arterial vasculature of the lower extremity. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element and RX Retrieval Catheter and ancillary items which include loading funnel, flushing syringes, introducer tool and torque devices.

Here's an analysis of the provided text, outlining the acceptance criteria and the study proving the device meets them, based on the requested categories.

Important Note: The provided text is a 510(k) summary for a medical device (Embolic Protection System), not an AI/ML device. Therefore, many of the requested categories related to AI model development, such as training sets, expert adjudication of ground truth, and MRMC studies, are not directly applicable or discussed in this document. The focus of this submission is on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and clinical data on safety and efficacy in an expanded indication for use.

Acceptance Criteria and Device Performance for Emboshield NAV6 Embolic Protection System (K191173)

1. Table of Acceptance Criteria and Reported Device Performance

• Deployment and Retrieval Force
• Simulated Use | The assessment concluded these tests should be performed, and the overall conclusion states the device met all acceptance criteria. (Specific pass/fail results for individual non-clinical tests are not detailed in this summary.) |
  | Technological Equivalence | Show substantial equivalence to predicate in:
• Intended Use
• System Components
• Technological Characteristics
• Sterilization
• Materials and Biocompatibility | "The conclusion of the comparison analysis is that the subject Emboshield NAV6 EPS is substantially equivalent to the predicate device." |
  | Safety - Filter Specific | Low occurrence of events directly reflecting filter performance (distal embolization, perforation at filter level, unplanned amputation) | One case of distal embolization, no cases of perforation at the level of the filter, and no unplanned amputations among MAEs. |
  | Overall Safety & Effectiveness | No new safety or effectiveness issues raised. | "The clinical and non-clinical data demonstrate that the subject Emboshield NAV6 EPS met all acceptance criteria and performed similarly to the predicate device and that no new safety or effectiveness issues were raised." |

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

• Sample Size for Clinical Study: n=162 patients.
• Data Provenance: Retrospective clinical data from a "real-world population" of peripheral arterial disease (PAD) patients treated at the Mount Sinai Health Center (USA, implied by FDA submission context, though not explicitly stated as country of origin). The data represents routine clinical practice.

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

• This document does not describe the use of experts to establish a "ground truth" for the clinical test set in the way it would be for an AI/ML diagnostic device. The clinical outcomes (MAE) were observed clinical events, not interpretations by experts for the purpose of a ground truth.
• The MAE definition is a composite of clinical events (death, MI, thrombosis, dissection, distal embolization, perforation, unplanned amputation, TVR). These are typically determined by clinical observation and data collection according to study protocols, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

• Not applicable in the context of this device. The clinical events (MAE) are observed outcomes, not interpretations 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 not an AI/ML device. The study evaluates the performance of a medical device (embolic protection system) in a clinical setting, not how human readers' diagnostic accuracy changes with AI assistance.

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

• Not applicable. This is not an AI/ML algorithm. The device's performance is measured in its intended use during a clinical procedure.

7. The Type of Ground Truth Used

• The "ground truth" for the clinical study was the occurrence or non-occurrence of predefined clinical events (Major Adverse Events - MAE) in real-world patients. This can be considered a form of "outcomes data."
• For non-clinical testing, the "ground truth" relies on predefined engineering specifications and simulated use outcomes.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device or an algorithm that requires a "training set" in the machine learning sense. The clinical data was used to demonstrate the device's performance in a real-world setting.

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

• Not applicable, as there is no "training set" for this type of medical device submission.

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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 STsegment elevation myocardial infarction; c) balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

The NC TREK OTW 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 STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm - 5.00 mm only)

The TREK RX 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 STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation.

The TREK OTW and MINI TREK OTW 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 STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm -5.00 mm only).

The MINI TREK RX 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 STsegment elevation myocardial infarction; c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only); d) Balloon dilatation of de novo chronic total coronary occlusions (CTO).

The MINI TREK II OTW 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 STsegment elevation myocardial infarction (MI); c) Balloon dilatation of a stent after implantation (balloon models 2.00 mm only); d) Balloon dilatation of de novo chronic total coronary occlusions (CTO).

The NC TREK RX Coronary Dilatation Catheter (CDC) is a medical device that is intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. The catheter is a rapid exchange co-axial design with a balloon at the distal tip. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon has radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. An adaption arm is provided on the proximal end of the catheter to provide access to the inflation lumen. It is designed with a Luer - lock fitting for connection with an inflation device.

The NC TREK OTW Coronary Dilatation Catheter (CDC) is a medical device that is intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. NC TREK OTW is an over-the-wire co-axial design with a balloon at the distal tip. The outer lumen provides for inflation of the balloon with contrast medium. The inner lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The device has dual radiopaque markers to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at specified pressures. The annular space between the outer member and the inner lumen provides a fluid path from the side arm adaptor to the balloon. The distal portion of the catheter is coated with a hydrophilic coating. The inner lumen of the inner member is coated with Microglide. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter position relative to the guiding catheter tip when introducing the catheter through the guiding catheter. A side arm adaptor is provided on the proximal end of the catheter to provide access to the inflation lumen and the guide wire lumen. It is designed with a luer - lock fitting for connection with an inflation device.

The TREK and MINI TREK RX (CDC) are medical devices intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. They are both rapid exchange coaxial designs with a balloon at the distal tip. The MINI TREK sizes range from 1.20x6mm through 2.00x30mm. The TREK sizes range from 2.25x6mm through 5.00x15mm. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Balloon markers aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter's position relative to the guiding catheter tip when introducing the dilatation catheter through the guiding catheter. An adaption arm is provided on the proximal end of the dilatation catheter to provide access to the inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device. The annular space between the distal outer member and the central distal lumen provides a fluid path from the proximal lumen to the balloon. The shaft of the catheter, the tip, and tapers of the balloon are coated with a hydrophilic coating. The inner lumen of the inner member is coated with Microglide.

The TREK OTW, MINI TREK OTW, and MINI TREK II OTW Coronary Dilatation Catheters (CDC) are medical devices intended for use in percutaneous transluminal coronary angioplasty (PTCA) to treat patients with coronary artery disease as specified in the indications section of the instructions for use. The TREK OTW family are over-the wire co-axial design catheters with a balloon at the distal tip. The MINI TREK OTW sizes range from 1.20x6mm through 2.00x30mm. The MINI TREK II OTW sizes range from 1.20x6mm through 2.00x20mm. The TREK™ OTW sizes range from 2.25x6mm through 5.00x15mm. The outer lumen provides for inflation of the balloon with diluted contrast medium. The inner lumen permits the guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Balloon markers aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at specified pressures. Proximal shaft markers located on the outer shaft aid in gauging the dilatation catheter's position relative to the guiding catheter tip when introducing the dilatation catheter through the guiding catheter. An adaption arm is provided on the proximal end of the dilatation catheter to provide access to the inflation lumen and the guide wire lumen. It is designed with a luer-lock fitting for connection with an inflation device. The annular space between the outer member and the inner lumen provides a fluid path from the side arm adaptor to the balloon. The outer shaft of the catheter, the tip, and tapers of the balloon are coated with a hydrophilic coating. The inner of the inner member is coated with Microglide.

This document is a 510(k) summary for the Abbott Vascular TREK Coronary Dilatation Catheters. It asserts substantial equivalence to previously cleared predicate devices and focuses on changes to labeling and Instructions For Use (IFU) rather than device design or performance. Therefore, it primarily discusses the justification for these labeling changes, rather than presenting a performance study with acceptance criteria for a new device.

Here's an analysis based on the provided text, addressing your questions where possible and indicating when information is not available:

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

This document does not contain a table of acceptance criteria and reported device performance. The submission is for updates to Instructions For Use (IFU) and labeling, not a new device or significant design change. The filing states: "No safety or effectiveness issues were raised by this change, as the change modifies and adds content to the IFU. The performance data that supports the predicate devices remains the same." This implies that the performance data for the predicate devices, which the current devices are asserted to be identical to, would hold any such acceptance criteria. However, those specific criteria are not detailed in this document.

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

Not applicable. This submission is for labeling and IFU changes, not for a new device or a clinical performance study requiring a test set of 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. This submission does not involve establishing ground truth for a test set through expert review. The changes relate to aligning existing labeling information and incorporating updates based on a "Risk Master List (RML) for CDC products" and a "review of literature."

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

Not applicable, as no test set requiring ground truth adjudication is described.

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 a study involving AI or human reader performance.

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

Not applicable. This is not a study involving algorithms.

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

Not applicable. The document refers to updates based on a "review of literature" and a "Risk Master List (RML) for CDC products," which are sources of information for regulatory compliance and safety profiles, not ground truth in the context of a diagnostic performance study.

8. The sample size for the training set

Not applicable. This submission does not involve a training set for an algorithm.

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

Not applicable. This submission does not involve a training set or ground truth establishment in this context.

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

This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and /or reuse.

The HI-TORQUE (HT) TurnTrac Guide Wire Family includes steerable guide wires offered in several configurations by various support levels, tip loads, hydrophilic coating lengths, tip shape and guide wire lengths.

The HT TurnTrac Guide Wire Family will be available with the features as listed below:

• 2 tip loads: 0.6g and 0.9g ●
• 2 support levels: HT TurnTrac Moderate Support (MS) and HT TurnTrac Extra . Support (ES)
• 2 coating lengths: Fully Coated (HC), Uncoated Tip (pHC) ●
• 1 tip shape: Straight ●
• 2 lengths: 190 cm, 300cm ●

The HI-TORQUE TurnTrac Guide Wire Family has a maximum diameter of 0.0142" or 0.0145" depending on the support level and is compatible with devices designed for use with 0.014" guide wires. The HI-TORQUE TurnTrac Guide Wire Family includes a shaping tool, which is clipped on to the outer packaging coil after the final assembled product has been inserted into the packaging coil. This accessory is to aid the physician in shaping the distal portion of the guide wire, if desired.

The provided text describes a 510(k) submission for a medical device, the HI-TORQUE® TurnTrac Guide Wire Family. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive clinical trials.

Therefore, the information you're asking for, which is typical for demonstrating safety and efficacy of new and complex medical devices, especially AI/ML-driven ones, is largely not present or not applicable in this 510(k) summary. This submission primarily relies on bench testing to show the device performs similarly to its predicate.

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

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

The text states: "The results from the in vitro bench tests demonstrated that the HI-TORQUE TurnTrac Guide Wire met all acceptance criteria and performed similarly to the predicate device."
However, the specific acceptance criteria values (e.g., minimum tensile strength in Newtons) and the actual reported performance values are not explicitly listed in a table within this document. The document only confirms that the criteria were met.

We can infer the categories of tests conducted:

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

• Sample Size for Test Set: Not specified. The document only mentions "in vitro bench testing" was conducted on the "modified device." It doesn't provide the number of units tested.
• Data Provenance: Not applicable in the context of patient data (e.g., country of origin, retrospective/prospective). These are entirely bench tests conducted in a lab setting, not clinical data from patients.

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

Not applicable. For a guide wire, "ground truth" for bench testing is established by engineering specifications and quantitative measurements (e.g., force transducers, microscopes, specialized test equipment), not by human expert opinion like radiologists for image interpretation.

4. Adjudication method for the test set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or annotators, typically in clinical studies or image interpretation tasks. This is a bench test, and results are quantitative.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. An MRMC study is relevant for AI-assisted human performance in tasks like interpreting medical images. This 510(k) is for a physical medical device (a guide wire), and the testing described is purely in vitro bench testing.

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

Not applicable. This is not an AI/ML algorithm. It is a physical medical device.

7. The type of ground truth used

For the bench tests, the "ground truth" would be the engineering specifications and validated measurement techniques (e.g., calibration standards for tensile strength, precise measurements of torque, particulate counts verified against specific thresholds). It's not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. There is no AI/ML model for which a "training set" would be required.

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

Not applicable, as there is no training set.

In summary:

This 510(k) submission, typical for Class II devices like guide wires, focuses on demonstrating substantial equivalence through in vitro bench testing rather than extensive clinical studies or AI/ML model performance validation. The criteria and studies requested in your prompt are largely geared towards software as a medical device (SaMD) or other complex clinical applications, which do not apply to this specific device submission.

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The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray that is individually pouched in a Tyvek/Nylon corner peel pouch, heat-sealed one time, and the single sealed pouch is placed into a cardboard nest and top-loading box.

The subject 510(k) pertains to a design change to the Steerable Guide Catheter. The proposed change to the Steerable Guide Catheter consists of a design and processing modification to the internal feature of the tip ring component at the distal tip.

This document describes K172394, the Steerable Guide Catheter, which is a design modification to an existing device. The performance data section is brief, focusing on a single test.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the tensile strength evaluation or the process validation. It also does not mention the country of origin of the data or whether it was retrospective or prospective.

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

This information is not applicable and not provided in the document. The study involved physical testing of a medical device, not interpretation of data by human experts to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. The study involved physical testing of a medical device, not expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study described is a physical performance test (tensile strength and process validation) of a medical device.

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

This is not applicable as the device is a physical catheter, not an algorithm or AI system. The performance testing was of the physical device itself.

7. The Type of Ground Truth Used

For the tensile strength evaluation, the "ground truth" would be the measured tensile strength values compared against predetermined engineering specifications (though these specifications are not explicitly stated in the provided text). For process validation, the "ground truth" would be consistent manufacturing output that meets specified performance metrics.

8. The Sample Size for the Training Set

This is not applicable, as there is no "training set" for physical device testing in the context of an algorithm or AI.

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

This is not applicable, as there is no "training set."

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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 the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

The Abbott Vascular Hi-Torque (HT) Command 18 Guide Wire with hydrophilic coating is a guide wire with a maximum diameter of 0.0180" and is provided in 210 cm and 300 cm lengths.

The Abbott Vascular HT Command 18 Guide Wire consists of a 304V stainless steel proximal core and a nitinol distal core. The distal core is attached to the stainless steel proximal core using a dissimilar metal solid-state resistance weld. The core wire at the tip is flattened to provide optimize flexibility, steering, and tip shaping. There are four nitinol lengths of the HT Command 18 family, each having multiple tip load options. The HT Command 18 has a straight (shapeable) tip.

The distal portion of the wire is covered with a polyurethane jacket and a hydrophilic coating. The proximal section of the wire is coated with polytetrafluoroethylene (PTFE) and a single coat of a silicone-based hydrophobic coating. Brachial and femoral markers are located on the proximal segment of the 210 cm and 300 cm guide wires.HT Command 18 Guide Wire is offered in two (2) packaging configuration options: With Accessory Devices (Torque Device and Guide Wire Introducer) and Without Accessory Devices.

The provided document is a 510(k) summary for a medical device (Hi-Torque Command 18 Guide Wire). It describes the device, its intended use, and states that functional and dimensional testing was performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the detailed study information typically associated with AI/ML device evaluations.

Therefore, many of the requested sections regarding acceptance criteria, study design, ground truth, and expert involvement are not applicable or cannot be extracted from this document, as this is a traditional medical device submission, not an AI/ML device submission.

Here's what can be extracted based on the provided text, with notes on what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests performed and states that the device "successfully met functional and dimensional acceptance criteria" and "met all acceptance criteria." However, it does not provide the specific numerical or qualitative acceptance criteria for each test, nor does it report the specific performance metrics (e.g., actual measured friction force, tensile strength values) for each test.

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

This information is not provided in the document. The testing described is for the physical and mechanical properties of a guide wire, not for an AI/ML algorithm that processes data.

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

Not applicable. This is a physical device, and its performance is evaluated against engineering specifications and predicate device equivalence, not against expert-established ground truth on a dataset.

4. Adjudication Method for the Test Set

Not applicable.

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 document describes a physical medical device (guide wire), not an AI-enabled device.

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

Not applicable.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, material properties, and comparison to a predicate device's established performance characteristics, as measured by standard laboratory tests. It's not based on expert consensus, pathology, or outcomes data in the context of an AI/ML algorithm.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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