Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The Onset Medical Access Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

The Onset Access Catheter System is a two-catheter system comprised of a Sheath and a Dilator. The Sheath has a distal region which expands when the Dilator is advanced. The Onset Access Catheter System can be used with hydrophilic guidewires up to.038 inches in diameter to access the desired anatomy. The proximal ends of the Sheath and the Dilator have a luer fitting to allow attachment of accessories and infusion of liquids through the catheter. The catheter is offered in various sizes to accommodate physician preferences and patient anatomy. A split sheath is provided in the package to provide support and facilitate the introduction of the Sheath's distal expandable region into the catheter introducer sheath. The Catheter System is provided sterile, non-pyrogenic, and is intended for single use only.

The provided document describes the "Onset Access Catheter System," a medical device. However, it does not contain the specific information required to answer the questions about acceptance criteria for an AI/ML powered device, as this is a traditional medical device (a catheter). The document focuses on demonstrating substantial equivalence to a predicate device through biocompatibility, sterilization, and bench-top testing.

The questions you've asked are typically related to the validation of AI/ML-powered medical devices, which involve performance metrics like accuracy, sensitivity, and specificity, and studies to establish ground truth. This document describes a physical medical device and its general performance and safety.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance (for AI/ML metrics)
2. Sample size used for the test set and the data provenance (for AI/ML models)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (for AI/ML models)
4. Adjudication method (for AI/ML models)
5. 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 (for AI/ML models)
6. If a standalone study was done (for AI/ML models)
7. The type of ground truth used (for AI/ML models)
8. The sample size for the training set (for AI/ML models)
9. How the ground truth for the training set was established (for AI/ML models)

What the document does provide in relation to "acceptance criteria" and "study":

The document details a series of bench-top (design verification) tests and biocompatibility tests to show that the Onset Access Catheter System meets established criteria for substantial equivalence to a predicate device.

Acceptance Criteria and Reported Device Performance (Bench Tests):

Biocompatibility Testing:

Study Information (for this traditional device):

• Sample sizes: Not explicitly detailed for each test (e.g., number of catheters tested for torque response), but the document states "All testing was performed on units which were twice sterilized."
• Data provenance: Not applicable in the context of clinical AI/ML data; these are laboratory and animal (in vivo) tests.
• Experts/Ground Truth/Adjudication: Not applicable in the context of clinical AI/ML data. The "ground truth" for these tests is defined by established engineering and biological standards.
• MRMC / Standalone / Training Set: Not applicable as this is not an AI/ML device.

In summary, the provided text describes the performance validation of a physical medical device through standard engineering and biocompatibility testing, not the performance validation of an AI/ML algorithm.

Ask a specific question about this device

The SoloPath™ Balloon Expandable TransFemoral Introducer 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 iliac arteries.

The SoloPath™ Balloon Expandable TransFemoral Introducer is an intravascular catheter introducer and is Intended for travel over a 0.038″ or smaller guidewire. The device includes a flexible Sheath composed of reinforced polymer that is compressed, folded and wrapped around a central, removable balloon dilatation catheter (the Expander). One radiopaque marker is located on the Sheath to indicate the end of the expandable portion of the Sheath.

The Expander balloon is non-compliant and size limited. The Expander has both an inflation lumen and a guidewire lumen. The Expander is configured to be used with standard inflation devices having an appropriate pressure rating, a male Luer lock coupler, and a capacity of 25-CC.

The Sheath is terminated, at its proximal end, by a hub having a straight through hemostasis port capable of accepting catheters equal to the full sheath inner diameter. An aspiration and infusion port, terminated with a 3-way stopcock, permits infusion of heparinized saline into the central port of the Sheath hub, prior to and during the procedure. The Expander incorporates a T connector, the through lumen port being terminated with a hemostasis valve for guidewire introduction, while the right angle port is for inflation of the Expander balloon. A separate aspiration and infusion side port, terminated with a 3-way stopcock, is also provided which permits fluid transfer into or from the guidewire lumen of the Expander.

This document describes a 510(k) premarket notification for a medical device, not a study involving AI or human readers for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria, study design for AI evaluation, and ground truth establishment is not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The device described is the SoloPath™ Balloon Expandable TransFemoral Introducer, intended for use in the femoral artery. The acceptance criteria are based on demonstrating substantial equivalence to a predicate device (SoloPath™ Balloon Expandable TransFemoral Introducer, K092014) and satisfying product design specifications for its intended use through in vitro bench testing.

Table of Acceptance Criteria and Reported Device Performance:

Study Information (as applicable to this type of device submission):

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

   • Sample Size: The document does not specify the exact number of units or samples used for each in vitro bench test (e.g., how many devices were bent, inflated, or tested for tensile strength).
   • Data Provenance: The tests are in vitro bench tests, meaning they were conducted in a laboratory setting, not on patient data. There is no information regarding country of origin or whether it's retrospective or prospective, as these terms are typically associated with clinical studies involving human subjects.

2. 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 this type of device submission. The "ground truth" for in vitro bench testing typically involves predefined engineering specifications, regulatory standards (like ISO 10993-1), and performance thresholds. There's no mention of experts establishing a "ground truth" in the diagnostic sense.

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

   • This is not applicable. Adjudication methods are relevant in studies where multiple human readers or algorithms interpret data and discrepancies need to be resolved. For in vitro engineering tests, the results are typically quantitative measurements against known standards.

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:

   • This is not applicable. This submission is for a physical medical device (catheter introducer), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed.

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

   • This is not applicable. As stated above, this is not an AI algorithm.

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

   • The "ground truth" for this device's performance testing is based on pre-defined engineering specifications, international standards (like ISO 10993-1), and successful comparison to the performance characteristics of the legally marketed predicate device. There is no "expert consensus" or "pathology" relevant to the performance evaluation described.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is not a machine learning or AI device.

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

   • This is not applicable. No training set was used.

Ask a specific question about this device

The SoloPath™ Balloon Expandable TransFemoral Introducer 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 iliac arteries.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "SoloPath™ Balloon Expandable TransFemoral Introducer." It states that the device is substantially equivalent to legally marketed predicate devices.

This type of document (a 510(k) clearance letter) does not include the detailed study information, acceptance criteria, or performance data that would be used to prove the device meets acceptance criteria. The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials to establish new efficacy or safety claims as would be required for a Premarket Approval (PMA).

Therefore, based solely on the provided text, I cannot extract the information required to populate the requested table and answer the questions about acceptance criteria and the study that proves the device meets them.

The document only provides:

• Device Name: SoloPath™ Balloon Expandable TransFemoral Introducer
• Intended Use: "The SoloPath™ Balloon Expandable TransFemoral Introducer 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 iliac arteries."
• Regulatory Class: Class II (Product Code: DYB)
• FDA Clearance Date: October 8, 2009
• 510(k) Number: K092014

To provide the requested information, you would need to consult the original 510(k) submission (K092014) which would contain the test reports and performance data submitted by Onset Medical Corporation to the FDA.

Ask a specific question about this device

The Onset Balloon Expandable Transseptal Introducer (BETI) is intended to establish a conduit, into the left side of the heart, through the inter-atrial septum, for the introduction of various cardiovascular catheters.

Onset Expandable Transseptal Introducer (BETI)

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for the Onset Medical Corporation's Onset Expandable Transseptal Introducer (BETI), confirming its substantial equivalence to a predicate device. It defines the device’s indications for use but does not detail any studies or performance metrics the manufacturer may have submitted as part of their 510(k) application.

Ask a specific question about this device

The Onset Medical Pathway™ Balloon Expandable Ureteral Access Sheath is intended to establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device called the "Pathway™ Balloon Expandable Ureteral Access Sheath." This type of document does not contain the detailed information requested regarding acceptance criteria and the specifics of a study proving device performance.

510(k) clearance signifies that a device is "substantially equivalent" to a legally marketed predicate device, meaning it has similar indications for use and technological characteristics, and that it is as safe and effective as the predicate. The FDA review for a 510(k) does not typically involve a new, comprehensive clinical trial for efficacy against specific acceptance criteria in the way a PMA approval might. Instead, it relies on demonstrating equivalence through comparison to existing devices, often including performance testing that is not detailed in the public clearance letter.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily states:

• Device Name: Pathway™ Balloon Expandable Ureteral Access Sheath
• 510(k) Number: K061009
• Indication for Use: To establish a conduit, during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the ureter by way of the urethra and bladder.
• Regulatory Class: II
• Product Code: EZN
• Regulation Name: Ureteral dilator
• Predicate Device: The letter states the device is substantially equivalent to legally marketed predicate devices, but does not explicitly name them.

To obtain the detailed study information you're asking for, you would typically need to refer to the 510(k) summary document or the full 510(k) submission to the FDA, which are sometimes publicly available through different FDA databases, but are not part of this clearance letter.

Ask a specific question about this device

The Onset Medical Pathway™ Expandable Ureteral Sheath (the Expandable Sheath) is intended to establish a working channel, admitting access to the ureter by way of the urethra and bladder, during endoscopic urological procedures.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Pathway™ Expandable Ureteral Sheath." This document is a regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving device performance based on the provided input. This type of information would typically be found in the 510(k) submission itself, which is a much larger document than this clearance letter.

Ask a specific question about this device