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The Finesse Injectable™ PTA Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Finesse InjectableTM PTA Balloon Dilatation Catheter is an over-the-wire balloon catheter for peripheral indications. The device features a semi-compliant balloon combined with a low-profile tip. The catheter is compatible with 0.014" (0.36 mm) guidewires and has a hydrophilic coating over its distal coaxial segment to facilitate advancement of the catheter to the treatment site. The Finesse Injectable™ PTA Balloon Dilatation Catheter has a working length of 150 cm, and is available with balloon working lengths of 20, 40, 60, 100, and 225 mm. There are two radiopaque marker bands located within the balloon working length (one proximal and one distal). These radiopaque marker bands, in conjunction with fluoroscopy, aid in the placement of the catheter's balloon segment. There is one additional radiopaque marker located distal of the exit holes to aid in locating their position relative to a guiding sheath distal tip. The catheter construction consists of a catheter shaft with two independent lumens extending along its length. One lumen is for inflation and deflation of the angioplasty balloon. The other lumen is for placement of the guidewire and injection of fluids via the catheter's exit holes that are positioned proximal to the balloon. The proximal portion of the catheter comprises a hub that includes an extension tube with a female luer-lock port connected to a balloon inflation/deflation lumen, and a stopcock with female luer-lock port for fluid/contrast injection attached to the side port of a Touhy-Borst adapter that is in communication with the guidewire lumen.

The Finesse™ Injectable PTA Balloon Dilatation Catheter is intended for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria for each test. However, it states that "Results from all tests were acceptable" and that the data "demonstrate that the Finesse Injectable™ PTA Balloon Dilatation Catheter is substantially equivalent to the predicate devices."

Based on the information provided, a table of acceptance criteria and reported device performance would look like this:

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

The document does not explicitly state the sample sizes used for each specific test mentioned under "Performance Data." It refers to "Design verification and validation" and "the following tests were conducted," implying a series of laboratory and bench tests.

• Sample size: Not specified.
• Data provenance: The performance data is generated through "Design verification and validation" testing. This typically implies prospective, internal laboratory testing conducted by the manufacturer (Summa Therapeutics, LLC). There is no indication of country of origin for the data or if it was retrospective.

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. The study is a device performance evaluation (bench testing and biocompatibility), not a clinical study involving the establishment of ground truth by experts for diagnostic or treatment effectiveness.

4. Adjudication method for the test set:

This information is not applicable, as it is a device performance study and not a study requiring expert adjudication of clinical outcomes or images.

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. This is a 510(k) submission for a physical medical device (balloon catheter), not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

This information is not applicable, as the device is not an algorithm or AI system.

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

This information is not applicable in the context of this device performance study. The "ground truth" for this device's evaluation is defined by engineering specifications, material standards, and established test methodologies for evaluating the physical and mechanical properties of balloon catheters and their biological safety.

8. The sample size for the training set:

This information is not applicable. This is a device performance study, not a machine learning or AI algorithm development that would involve training sets.

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

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

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The ComboCath™ OTW PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The ComboCath™ OTW PTA Dilatation Catheter is an 0.014" (0.36mm) guidewire compatible balloon angioplasty catheter with an effective working length of 150cm. The angioplasty catheter includes a semi-compliant distal Balloon of known diameter and length when inflated to recommended pressures.

The device construction consists of a catheter shaft with two independent lumens extending along its length. One lumen is for inflation and deflation of the angioplasty balloon. The other lumen is for placement of the quidewire and injection of fluids via the catheter's Exit Holes that are positioned proximal to the Balloon.

The proximal Hub includes an Inflation Port used for inflation of the Balloon and a standard Touhy-Borst valve with a side port terminated by a Stopcock that permits injection of fluids.

The catheter includes three radiopaque markers to aid angiographic placement of the device.

This document is a 510(k) summary for the ComboCath™ OTW PTA Dilatation Catheter, seeking to demonstrate substantial equivalence to a predicate device. This type of regulatory submission does not typically involve clinical studies with human participants or a "test set" of patients to evaluate performance against specific acceptance criteria for diagnostic accuracy or effectiveness in the way an AI/ML device would. Instead, "performance" here refers to functional and material equivalence to a legally marketed predicate device.

Therefore, many of the requested categories are not applicable to this submission. I will address the applicable sections and indicate where information is not relevant to this type of device submission.

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

For this medical device (a balloon catheter), "acceptance criteria" and "performance" are framed in terms of substantial equivalence to a predicate device, focusing on design, materials, and functional characteristics rather than diagnostic accuracy or clinical outcomes from a study with a test set.

Study Proving Acceptance Criteria:
The study proving the acceptance criteria for this device is a benchtop (functional) and materials comparison study, along with biocompatibility testing. This is not a clinical study with patients or an AI performance study.

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 applicable. This 510(k) submission does not describe a "test set" in the context of clinical data for diagnostic or therapeutic efficacy. Performance was evaluated through bench testing and material comparisons.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth, in the sense of expert consensus on clinical cases, is not relevant to this type of device submission. Performance is validated through engineering bench testing and material science.

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

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

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

• Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

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

• Not applicable. This is not an AI/ML device.

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

• The "ground truth" for this submission is related to engineering specifications, material science standards, and established functional performance requirements for similar medical devices. For example, the ground truth for guidewire compatibility is the standard diameter of a 0.014" guidewire, and the ground truth for biocompatibility is compliance with ISO 10993-1.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, and there is no "training set."

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

• Not applicable.

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