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The BNLE Hydrophilic Jacketed Peripheral Guidewires are intended to direct a catheter to a desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The BNLE Hydrophilic Jacketed Peripheral Guidewire is available in 150 cm - 260 cm lengths and in 0.018" - 0.035" diameter ranges. The hydrophilic coated guidewire consists of a nickel-titanium alloy core wire and tungsten infused polyurethane jacket in configurations of wire stiffness and tip shape. The finished guidewire is placed in a dispenser hoop and Tyvek pouch. Five (5) Tyvek pouches are placed into a shelf box with an IFU, and 26 shelf cartons are placed into a shipper box. Labels are placed on the Tyvek pouch and shelf box. The finished product is EO sterilized.

The provided text is a 510(k) summary for a medical device (BNLE Hydrophilic Jacketed Peripheral Guidewire). It does not describe a study involving an AI/Machine Learning device or a diagnostic device that would have acceptance criteria related to accuracy metrics like sensitivity, specificity, or AUC, nor does it involve expert readers establishing ground truth.

Instead, this document details the substantial equivalence of a physical medical device (a guidewire) to a predicate device. The "performance testing" described is for the physical and biological characteristics of the guidewire itself, not for an algorithm's performance.

Therefore, most of the requested information (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone algorithm performance, AI-related ground truth types) is not applicable to this document.

However, I can extract the acceptance criteria and performance as described for this physical device.

Acceptance Criteria and Device Performance (for a physical medical device - Guidewire)

Since this document pertains to a physical medical device (a guidewire) and not an AI/diagnostic algorithm, the "acceptance criteria" discussed are related to the device's physical and biocompatibility characteristics. The document doesn't provide specific numerical acceptance criteria or performance metrics for each test, but it states the overarching conclusion that the device "met all predetermined acceptance criteria."

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation for "Pass": The document states: "BNLE Hydrophilic Peripheral Jacketed Guidewire met all predetermined acceptance criteria and raised no new concerns regarding safety or efficacy." This implies that for each listed test, the device's performance fell within the acceptable range defined by the manufacturer for demonstrating substantial equivalence. Specific numerical ranges or results for each test are not provided in this summary.

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

• This information is not applicable as this is a physical device, not an AI/diagnostic algorithm using a "test set" of patient data.
• The tests are performed on samples of the manufactured guidewire itself. The sample size for each specific physical or biocompatibility test is not detailed in this 510(k) summary.
• Data provenance for a physical device refers to the conditions under which the tests were conducted (e.g., lab conditions, animal models for biocompatibility). These specifics are not detailed in this public summary.

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

• This is not applicable for a physical medical device. "Ground truth" in this context would be established by validated test methods and standards (e.g., ISO, ASTM standards), not by human experts interpreting images or data.

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

• Not applicable. This concept is for resolving discrepancies in expert interpretations of data, which is not relevant to the testing of a physical guidewire.

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 framework for evaluating diagnostic AI algorithms involving human readers, which is not the subject of this 510(k) summary.

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

• Not applicable. This refers to the evaluation of an AI algorithm's performance on its own, which is not relevant to a physical guidewire.

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

• For physical devices, "ground truth" is typically established by:
  • Standardized Test Methods: Adherence to recognized industry standards (e.g., ISO, ASTM) and internal design specifications.
  • Physical Measurements: Direct measurements of device dimensions, strength, flexibility, etc., against predefined specifications.
  • Chemical Analysis: Verification of material composition.
  • Biological Response in vitro/in vivo: Assessment of biocompatibility based on established biological assays (e.g., cytotoxicity, sensitization, hemolysis) and animal studies (e.g., thrombogenicity in canine).

8. The sample size for the training set:

• Not applicable. This refers to the data used to train machine learning models, which is not relevant to this physical device.

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

• Not applicable for the same reason as above.

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