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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 NC TREK™ OTW Coronary Dilatation Catheter is indicated for:

• balloon dilatation of the stenotic portion of a coronary artery or . bypass graft stenosis for the purpose of improving myocardial perfusion;
• balloon dilatation of a coronary artery occlusion for the purpose ● of restoring coronary flow in patients with ST-segment elevation myocardial infarctions;
• balloon dilatation of a stent after implantation (balloon models 2.0 mm - 5.0 mm only).

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

The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML medical device. The document is a 510(k) summary for a non-AI medical device, specifically the NC TREK™ OTW Coronary Dilatation Catheter, which is a balloon catheter used for coronary artery procedures.

The information provided relates to:

• Device Description: An over-the-wire co-axial design with a balloon at the distal tip for coronary dilation.
• Indications for Use: Balloon dilation of stenotic coronary arteries/bypass grafts, coronary artery occlusions (for ST-segment elevation myocardial infarctions), and balloon dilation of stents after implantation.
• Technological Characteristics: Claims substantial equivalence to predicate devices in product performance, design, and intended use.
• Performance Data:
  • Biocompatibility Testing: Included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, complement activation, and pyrogenicity according to ISO 10993-1:2009 and FDA guidance.
  • In Vitro Bench Testing: Included catheter preparation, balloon inflation/deflation, catheter shaft fatigue/rupture, distal/proximal adaption tensile, inner member collapse, kink and flexibility, torque, and catheter coating particulate/integrity.
  • Conclusion: Stated that the device "met all acceptance criteria and performed similarly to the predicate devices" and that "no new safety or effectiveness issues were raised."

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and an AI/ML-related study as those details are not present in the provided text. The document describes a traditional medical device submission (a PTCA catheter) and its associated non-AI performance testing.

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