Search Results

This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO® GT 018 G12 and G30 Peripheral Guide Wires in this submission are a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) in available lengths of 190cm and 300cm. The devices have a solid core with a hydrophilic coated coil-type distal end. The entire coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2 cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the guide wire with a length of less than 300 cm. A Torque device is included in the same package.

The provided document is a 510(k) summary for the VASSALLO® GT 018 G12 and G30 Peripheral Guide Wires. This type of submission is for medical devices that claim substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information typically requested regarding AI/human reader studies, ground truth establishment for training, and detailed performance metrics as one might find for an AI-powered diagnostic device, is largely not applicable here.

The document describes non-clinical testing performed to demonstrate that the device meets acceptance criteria and performs similarly to its predicate device.

Here's the information extracted from the document:

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

The document states that the VASSALLO GT 018 G12 and G30 met all acceptance criteria for the non-clinical tests performed. Specific acceptance values are not provided in this summary, but the types of tests and the conclusion that the device met the criteria are listed.

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

The document does not specify sample sizes for each non-clinical test. This is typically found in the detailed test reports, not the summary. The tests are non-clinical laboratory tests, meaning they were performed in a controlled lab environment and are not based on human or animal data provenance (e.g., country of origin, retrospective/prospective).

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 as the tests are non-clinical, mechanical, and material property evaluations. There is no "ground truth" to be established by human experts in the context of diagnostic interpretation.

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

This information is not applicable as there is no diagnostic image or data interpretation by experts that would require an adjudication method. The tests are objective measurements of physical properties.

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 device is a physical medical device (peripheral guide wire), not an AI diagnostic or assistance tool. Therefore, MRMC studies are not relevant.

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

This information is not applicable. This device is a physical medical device, not an algorithm.

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

This information is not applicable for the non-clinical tests described. The "ground truth" for these tests would be the established engineering specifications, material properties, and performance benchmarks that the device is designed to meet.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this physical medical device.

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

This information is not applicable.

Ask a specific question about this device

This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The VASSALLO GT 018 Hybrid consists of a hybrid NiTi alloy and stainlesssteel core wire and a coil assembly on the distal end of the device. The coil assembly is soldered to the NiTi alloy portion of the core. The coil is radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy. Coatings are applied on the surface of the VASSALLO GT 018 Hybrid. The proximal portion is coated with PTFE. The distal section is coated with a hydrophilic coating and polyurethane coating. When wet, the hydrophilic coating increases the lubricity of the quidewire surface. The middle portion of the device is coated with PFA and silicone coatings. The VASSALLO GT 018 Hybrid has an outer diameter of 0.018 inches (0.45 mm) and is available in 190cm and 300cm lengths. About 2cm of the distal end can be shaped. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300 cm. A Torque device is included in the same package.

This document describes the VASSALLO® GT 018 Hybrid, a peripheral guide wire. It focuses on non-clinical and biocompatibility testing to establish substantial equivalence to predicate devices, rather than a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested fields are not applicable (N/A) in this context.

Here's an analysis of the provided text:

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

The document states, "The in vitro bench tests demonstrated that the VASSALLO GT 018 Hybrid met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not explicitly list the quantitative acceptance criteria for each test or detailed performance metrics. It only lists the tests performed.

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: Not specified. The document only mentions "Non-clinical laboratory testing" and "in vitro bench tests."
• Data provenance: The applicant is FILMECC CO., LTD. located in Japan. The tests are non-clinical, so "retrospective or prospective" as generally understood in clinical trials is not applicable. The tests are likely performed in a laboratory setting.

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 is a non-clinical device submission based on bench testing and biocompatibility. There is no mention of human-expert-established ground truth in the context of radiology or similar fields. The "ground truth" would be the objective results of the engineering and biological tests conducted.

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

N/A. This concept is not applicable for non-clinical bench testing.

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

N/A. This document is for a medical device (guide wire), not an AI-powered diagnostic or assistive tool, so an MRMC study is not relevant.

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

N/A. This document is for a medical device (guide wire), not an AI algorithm.

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

The "ground truth" for this submission would be defined by the pre-established engineering specifications and industry standards for guide wire performance and safety (e.g., ISO standards for medical devices, ASTM standards for material properties). The tests measure if the device meets these objective standards.

8. The sample size for the training set

N/A. This is not an AI/machine learning device; therefore, there is no "training set."

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

N/A. Not an AI/machine learning device.

Ask a specific question about this device