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The SoloPath® Re-Collapsible Access System is indicated for percutaneous insertion into the femoral artery over a guidewire and, once expanded, to provide a guide for catheters and/or devices introduced into the femoral artery. The device may also be used to expand femoroiliac artery lesions to facilitate its use as an Access System.

The SoloPath Re-Collapsible Access System is a sterile, single-use device that consists of a flexible, reinforced polymer sheath and specially folded, radially-collapsed distal end (the Sheath) pre-mounted over a central balloon dilatation catheter (the Expander), and equipped with a proximal hub assembly incorporating a hemostasis valve.

The SoloPath assembly is inserted percutaneously over a guidewire, with the deflated Expander in place. Once positioned into the vasculature and inflated with liquid, the Expander balloon exerts a controlled radial force, enlarging the folded distal region of the Sheath and surrounding anatomy. The Expander balloon is deflated and the Expander is removed leaving a central lumen extending from the proximal end to the distal end of the Sheath, which maintains its expanded size by means of malleable distal reinforcement.

The SoloPath Re-Collapsible Access System features an integrated external collapsible outer jacket which is pressurized with liquid under low pressure prior to removal, collapsing the outer sheath diameter for ease of removal. The Sheath is designed: 1) as a guide for catheters and/or devices introduced into the femoral artery and 2) to dilate stenosed femoro-iliac vessels as an adjunct to its primary function.

The principles of operation for the subject SoloPath Re-Collapsible Access System are identical to those of the currently cleared SoloPath Re-Collapsible Access System (K121404). There are no changes to the insertion, deployment, or removal of the device as a result of this secondary indication.

This submission is a 510(k) for the SoloPath Re-Collapsible Access System, which is an intravascular catheter. The 510(k) is for the addition of a secondary indication for use. Therefore, the information provided focuses on non-clinical performance and substantial equivalence to a predicate device, rather than a traditional study with strict acceptance criteria for AI model performance.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a medical device and not an AI/ML product, the "acceptance criteria" are tied to demonstrating substantial equivalence to a predicate device and adherence to relevant ISO standards, rather than metrics like sensitivity or specificity. The "reported device performance" refers to the successful completion of specified tests.

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

• Sample Size: The document does not specify a "sample size" in terms of number of patients or cases for "testing." Instead, it refers to a series of non-clinical performance tests on the physical device. The number of devices or components tested for each specific bench test (e.g., RBP, fatigue) is not explicitly stated, but it's implied that sufficient numbers were tested to meet the requirements of the ISO standard.
• Data Provenance: The data provenance is from non-clinical bench testing of the SoloPath Re-Collapsible Access System itself. It is not human subject data, so concepts of country of origin or retrospective/prospective do not apply.

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

• This is not applicable as the "ground truth" for non-clinical bench testing is defined by the physical properties of the device and adherence to engineering standards. No human experts were used to establish a "ground truth" for a test set in the way one would for diagnostic imaging.

4. Adjudication Method for the Test Set

• Not applicable for non-clinical bench testing. Performance is evaluated against objective engineering specifications and standard test methods.

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

• No. This is a 510(k) for a physical medical device (catheter introducer) and not an AI/ML product. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or included in this document.

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

• No. This is for a physical medical device. There is no algorithm or AI component involved.

7. The Type of Ground Truth Used

• The "ground truth" used for this device's performance testing is based on objective engineering and material specifications, and compliance with recognized industry standards (ISO 10555-4:2013). For example, for "Balloon rated burst pressure," the ground truth is the specified pressure that the balloon must withstand. For "Biocompatibility," the ground truth is compliance with ISO 10993.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" for a physical medical device like this in the context of AI/ML. The device itself is manufactured based on design specifications; it does not "learn" from data.

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

• Not applicable. There is no training set or ground truth established for a training set.

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The SoloPath® Re-Collapsible Access System is intended to be inserted percutaneously into the femoral artery, over a guidewire and once expanded, to provide a guide for catheters and/or devices introduced into the femoral artery.

The SoloPath® Re-Collapsible Access System is a cardiovascular device designed to be used as a guide for catheters and/or devices introduced into the femoral artery. The device is provided sterile for single use. Onset Medical Corporation's SoloPath® Re-Collapsible Access System is a sterile, single use device. It consists of a flexible, reinforced polymer sheath with an external collapsible outer jacket and specially folded, radially-collapsed distal end (the Sheath) pre-mounted over a central balloon dilatation catheter (the Expander), and equipped with a proximal hub assembly incorporating a hemostasis valve. The folded distal region of the Sheath is small in diameter, thus facilitating passage through the vessel. The SoloPath Assembly is inserted percutaneously into the femoral artery, over a guidewire, with the deflated Expander in place. Once positioned into the artery, the Expander balloon, when inflated with liquid, exerts controlled radial force, enlarging the folded distal region of the Sheath and surrounding anatomy. The Expander balloon is deflated and the Expander is removed leaving a large central lumen extending from the proximal end to the distal end of the Sheath, which maintains its expanded size by means of malleable distal reinforcement. The Sheath is designed as a guide for catheters and/or devices introduced into the femoral artery. Prior to removal, the outer jacket is activated with liquid unde pressure, collapsing the outer sheath diameter for ease of removal. The sheath is capable of expanding and actively collapsing.

The SoloPath® Re-Collapsible Access System is a cardiovascular device designed to be used as a guide for catheters and/or devices introduced into the femoral artery. The device is provided sterile for single use.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document mentions that "both the 19Fx35 cm and 24Fx35cm the SoloPath® Re-Collapsible Access System" were tested. This implies testing was conducted on at least two distinct configurations of the device. However, the exact number of units tested for each specific test (e.g., how many sheaths for a burst test) is not provided.
• Data Provenance: The study was conducted as in vitro bench studies. There is no mention of human or animal studies, or clinical data. Therefore, there is no country of origin for patient data, and it is entirely retrospective in the sense of being laboratory-based testing, not involving ongoing patient recruitment.

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

• This information is not applicable as the studies conducted were in vitro bench studies and biocompatibility testing. There was no "ground truth" derived from expert interpretation of medical images or patient outcomes. The ground truth was based on pre-defined engineering and biological standards and criteria.

4. Adjudication Method for the Test Set:

• This information is not applicable for the same reasons as above. No adjudication method was necessary as these were objective measurements against pre-defined engineering and biological acceptance 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:

• No, an MRMC comparative effectiveness study was NOT done. This type of study is relevant for AI-powered diagnostic or assistive devices where human interpretation is involved. The SoloPath® Re-Collapsible Access System is a physical medical device, and its performance is evaluated through bench testing and biocompatibility.

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

• No, this is not applicable. The SoloPath® Re-Collapsible Access System is a physical medical device, not an algorithm or software-only device. Its performance is inherent to its physical properties and design, not an algorithm.

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

• The ground truth for the bench studies and biocompatibility testing was based on pre-defined engineering specifications, performance standards, and established international biocompatibility standards (ISO 10993-1). It was not derived from expert consensus, pathology, or patient outcomes data.

8. The sample size for the training set:

• Not applicable. There was no "training set" for this device. This concept is relevant for machine learning or AI algorithms, which are not involved in the SoloPath® Re-Collapsible Access System's evaluation as described.

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

• Not applicable. As there was no training set, there was no ground truth for a training set to be established.

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