Search Results

Traxcess™ 7 Mini Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic catheters. This device is not indicated for use in coronary arteries.

Traxcess™ 7 Mini Guidewire consists of a proximal coated 0.014" stainless steel core wire, and a distal coated 0.007" nitinol core wire. The distal core wire is tapered at the distal tip and is contained within platinum/nickel coil. The platinum/nickel coil is 6 cm in length. The distal 1.4 cm of the guidewire is shapeable by the physician. Traxcess™ 7 Mini Guidewire distal and proximal sections are coated with hydrophilic coating. There is no PTFE coating. The purpose of the hydrophilic coating is to provide lubricity when the MicroVention guidewire is passed through microcatheters. Shaping mandrels, insertion tool, and torque device are also included with the device.

The provided text describes a 510(k) premarket notification for the "Traxcess™ 7 Mini Guidewire." This is a medical device submission seeking substantial equivalence to a previously cleared device, not an AI/ML powered device. As such, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in terms of traditional medical device performance testing, rather than clinical studies involving AI performance metrics like sensitivity, specificity, or reader studies.

Here's a breakdown of the requested information based on the provided text, adapted for a non-AI medical device:

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

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

The document does not explicitly state the sample sizes used for each specific bench test (e.g., number of guidewires tested for tensile strength). The data provenance is described as "Bench Testing," meaning these are laboratory-generated results on physical samples of the device, not patient data. Therefore, concepts like "country of origin of the data," "retrospective or prospective" do not apply in the context of this submission.

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)

This question is not applicable to this type of device submission. The "ground truth" for these physical performance tests are objective engineering specifications and measurements, not expert interpretations of clinical data. For example, a guidewire's diameter is measured with instruments, not subject to expert consensus.

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

This question is not applicable as the tests are objective physical measurements and not subject to human adjudication of clinical findings.

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 question is not applicable. The device is a physical guidewire, not an AI-powered diagnostic or assistive tool that would involve human readers or affect their performance.

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

This question is not applicable, as the device is a physical guidewire, not an algorithm.

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

For the bench testing, the "ground truth" is defined by established engineering and device specifications (e.g., dimensional requirements, material properties, mechanical performance criteria). For the biocompatibility aspect, the ground truth for the reference device (Traxcess™ 14 SELECT Guidewire) would have been established through a series of biocompatibility tests according to ISO standards, which evaluate the biological response to the device material.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a training set.

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

This question is not applicable as there is no training set for this physical device.

Ask a specific question about this device

The SOFIA® EX Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. The SOFIA® EX Catheter can be used to facilitate introduction of diagnostic agents or therapeutic devices. The SOFIA® EX Catheter is not intended for use in coronary arteries.

The SOFIA® EX Catheter is a single-lumen, flexible catheter equipped with the coil and the braid reinforcement. The distal segment is designed to facilitate vessel selection with 55-65cm of distal shaft hydrophilic coating for navigation through the vasculatures. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. The device is provided sterile and for single use. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (polyethylene) that is provided in a sterile barrier tyvek pouch and placed in a carton box.

The provided document is a 510(k) premarket notification for the SOFIA® EX Intracranial Support Catheter. It describes the device, its intended use, comparison to predicate devices, and performance data used to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and the study proving the device meets them, as extracted from the document:

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

The document presents the performance data in a table format under section "VII. Performance Data" (pages 7-8). Each "Test" listed implicitly defines an acceptance criterion (e.g., "Device met acceptance criteria"). Because the document is a 510(k) summary, the specific quantitative acceptance criteria values are not explicitly stated, but the results confirm that the "Device met acceptance criteria" for each test.

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

• Bench Studies: The document does not specify the exact sample sizes for each bench test (e.g., number of catheters tested for tensile strength). However, it implies that sufficient samples were tested to declare that the "Device met acceptance criteria" in each case. These are prospective tests conducted for the purpose of this submission. The origin is implicitly the manufacturing site (Tustin, CA, USA) or associated testing facilities.
• Biocompatibility Studies: Again, the exact sample sizes for these in-vitro and in-vivo tests are generally not detailed in this summary, but the materials and test systems are provided (e.g., L929 Mouse Fibroblast Cell Line, Hartley Guinea Pigs, Rabit Blood, Human Plasma, Albino Swiss Mice, New Zealand White Rabbits). These are prospective studies.
• Animal Study:
  • Sample Size: Three female Yorkshire pigs were used.
  • Data Provenance: The study was conducted in a porcine model, which is an animal study (not human data). It was an acute study performed specifically for this submission, making it prospective. The country of origin is not explicitly stated, but it was conducted in accordance with FDA GLP Regulation (21 CFR Part 58), suggesting it was designed to meet US regulatory standards.

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

• Bench and Biocompatibility Tests: The ground truth for these tests is established by objective measurements and laboratory standards (e.g., ISO standards, ASTM standards, USP guidelines). It is not dependent on expert consensus or human interpretation in the same way clinical image analysis would be. Therefore, there's no mention of a number of experts or their qualifications in this context.
• Animal Study: The document states that the testing was intended to "demonstrate clinical efficacy for catheter tip stability and safety" and notes that "histologic findings were consistent with routine catheterization procedures." While implicit that veterinarians, pathologists, and interventionalists (or researchers with similar expertise) observed and assessed the animal study outcomes, the number and specific qualifications of experts involved in the evaluation of the animal model are not explicitly stated in this 510(k) summary. The ground truth here is derived from direct observation, histological analysis, and physiological assessments in the live animal model.

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

• For the bench and biocompatibility tests, adjudication methods (like 2+1 or 3+1) are not applicable as the results are based on objective measurements and established scientific protocols rather than subjective human interpretation needing consensus.
• For the animal study, no formal subjective adjudication method is described. The results mention "No dissection/perforation, thrombus formation or distal emboli were noted" and "All vessels appeared intact with no visible wall disruptions," implying direct observation and assessment by the research team conducting the animal study. Histological findings would be adjudicated by a veterinary pathologist.

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 device is an intracranial support catheter, a physical medical device, not an AI software. The studies conducted are related to its physical performance, safety, and biocompatibility, not its impact on human reader performance with or without AI assistance.

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

• Not applicable. This submission is for a physical medical device, an intracranial support catheter, not an algorithm or AI software that would have a "standalone performance."

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

• Bench Studies: Ground truth is based on engineering and physical performance measurements against established standards (e.g., ISO, ASTM, USP).
• Biocompatibility Studies: Ground truth is based on biological and toxicological responses measured through standard in-vitro and in-vivo tests, assessed against established biological safety evaluation criteria.
• Animal Study: Ground truth is established through direct observation of clinical efficacy and safety endpoints (e.g., catheter tip stability, absence of dissection/perforation, thrombus formation, distal emboli, vasospasm, luminal narrowing) and histological examination of vessel samples in a live animal model. This combines direct observation with pathological assessment.

8. The sample size for the training set:

• Not applicable. This document describes the testing and approval of a physical medical device. It does not involve machine learning or AI models that require a "training set."

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

• Not applicable. As a physical medical device, there is no training set for an AI model.

Ask a specific question about this device