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510(k) Data Aggregation
(28 days)
The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.
The Bandit guidewire is a 0.014" diameter stainless steel core guidewire with a 0.008" diameter tapered distal tip. It is available in 200 cm and 300 cm lengths. The 200 cm length is compatible with a guidewire extension. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating.
The provided text is a 510(k) summary for the Bandit guidewire, which is a medical device. This document describes the device, its intended use, and how it was determined to be substantially equivalent to a predicate device.
Crucially, this document describes a medical device (a guidewire), not a software or AI-powered medical device. Therefore, many of the requested categories in your prompt (such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of device and study. The "acceptance criteria" here refer to standard engineering and biocompatibility tests for a physical device, not performance metrics of a diagnostic or AI algorithm.
Here's a breakdown of the information that is available, and why other parts are not:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Performance Testing | Met specified acceptance criteria | Results met specified acceptance criteria and did not raise different questions of safety and effectiveness. |
| Tensile Strength | Specific engineering standards (not fully detailed in this document) | Passed |
| Torque Strength | Specific engineering standards (not fully detailed in this document) | Passed |
| Torqueability | Specific engineering standards (not fully detailed in this document) | Passed |
| Tip Flexibility | Specific engineering standards (not fully detailed in this document) | Passed |
| Coating Adherence/Integrity | Specific engineering standards (not fully detailed in this document) | Passed |
| Catheter Compatibility | Specific engineering standards (not fully detailed in this document) | Passed |
| Dimensional Analysis | Specific engineering standards (not fully detailed in this document) | Passed |
| Radiopacity | Specific engineering standards (not fully detailed in this document) | Passed |
| Corrosion | Specific engineering standards (not fully detailed in this document) | Passed |
| Biocompatibility Testing (ISO 10993-1) | Various biological safety standards (e.g., non-cytotoxic, non-sensitizing) | Passing results |
| Cytotoxicity | (Acceptance criteria for non-toxicity) | Non-cytotoxic |
| Sensitization | (Acceptance criteria for non-sensitization) | Non-sensitizing |
| Irritation | (Acceptance criteria for non-irritation) | Non-irritating |
| Acute Systemic Toxicity | (Acceptance criteria for non-toxicity) | Non-systemically toxic |
| Material Mediated Pyrogenicity | (Acceptance criteria for non-pyrogenicity) | Non-pyrogenic |
| Hemolysis | (Acceptance criteria for non-hemolytic) | Non-hemolytic |
| Complement Activation | (Acceptance criteria for non-activation) | Not an activator of the complement system |
| Thrombogenicity | (Acceptance criteria for non-thrombogenicity) | Thromboresistant |
The study that proves the device meets the acceptance criteria:
The study refers to a series of bench performance tests and biocompatibility tests. This is a pre-clinical study (laboratory-based testing), not a clinical trial involving human subjects for performance evaluation in the context of AI.
The document states: "The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence that the Bandit guidewire is substantially equivalent to the predicate device. The device design was verified through the following tests: [list of bench tests]. The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety and effectiveness."
For biocompatibility, it states: "The biocompatibility evaluation for the Bandit guidewire was conducted in accordance with the International Standard ISO 10993-1... The battery of tests included the following: [list of biocompatibility tests]. Passing results from biomaterial tests demonstrate that the Bandit guidewire is non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant."
Information Not Applicable or Not Provided for this Device Type:
- 2. Sample sized used for the test set and the data provenance: Not applicable. These were laboratory bench and biocompatibility tests on physical device samples, not studies on "test sets" of data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical guidewire is established through engineering and biological testing standards and measurements, not expert consensus on medical images or patient data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 a physical medical device, not an AI or diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device, in the spirit of your question, is established by engineering specifications and international standards (e.g., ISO 10993-1) for physical performance and biological safety.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
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