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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:

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The BNLE Access Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not intended for use in the coronary or cerebral vasculature.

The BNLE Access Guidewires are available in 40 cm to 80 cm lengths and in the 0.018" – 0.021" diameter range. The BNLE Access Guidewires are available with Nitinol or Stainless Steel (SS) shafts and in configurations with SS coils or radiopaque Tungsten coils.

The BNLE Access Guidewires consist of a solid core shaft with a ground tapered section at the distal end of the guidewire. A micro-coil is wound with a lumen that is then placed over the tapered distal section. The distal end is secured to the shaft via a weld and the proximal end is bonded to the shaft using adhesive. The micro-coil will provide tip radiopacity in designated models. The finished guidewire is placed in a protective polymer dispenser hoop for either sterile packaging in a labeled Tyvek pouch or shipped in bulk non-sterile condition to use with in a procedure tray by a customer.

The provided text is a 510(k) summary for the BNLE Access Guidewire, a medical device classified as a catheter guide wire (Product Code: DQX, Regulation Number: 21 CFR 870.1330). This document focuses on demonstrating substantial equivalence to a predicate device, the VSI Guidewire (K112631), rather than outlining a study to prove acceptance criteria for a new AI/ML-driven device.

Therefore, the following information, typically requested for AI/ML device studies, is not available in the provided text:

• Acceptance Criteria and Reported Device Performance Table: The document explicitly states "BNLE Access Guidewire raised no new concerns regarding safety or efficacy" and aims to prove "substantially equivalent" rather than meeting specific performance metrics against a predefined acceptance criterion.
• Sample size used for the test set and data provenance: No information on a test set (clinical or otherwise for performance evaluation) is provided. The testing described is primarily mechanical and material-based.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there is no mention of a test set requiring expert ground truth.
• Adjudication method for the test set: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable. This is a conventional medical device, not an AI-assisted one.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, the document does list the performance testing conducted to support the substantial equivalence claim for the BNLE Access Guidewire:

Performance Testing Items:

• Simulated Use/Device Compatibility
• Corrosion
• Kink Resistance
• Tip Flexibility
• Radiopacity
• Tensile
• Dimensional
• Visual Inspection
• Reverse Bend / Flex
• Fracture Resistance
• Torqueability
• Torque Strength
• Shelf Life

**Biocompatibility Testing (per ISO 10993-1 for an external communicating device, limited (

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The Vesta RF Cannula, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.

The Vesta RF Cannula consists of an insulated cannula with an active tip for use in radiofrequency heat lesion procedures for the relief of pain. It is designed to be used with compatible pain management generators and probes that have a maximum voltage rating less than or equal to 280 V. The Vesta RF Cannula is sterilized and intended for single use only.

The information provided is about the Biomerics Vesta RF Cannula, cleared under K190259, which is a medical device and not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) are not applicable.

However, I can provide the acceptance criteria and study information that was conducted for this device. The regulatory submission primarily relies on bench testing and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance (Not applicable for AI/ML device studies)

The device, the Vesta RF Cannula, is a non-AI medical device. Its performance is demonstrated through meeting various industry standards for physical characteristics, sterilization, and biocompatibility, rather than metrics like sensitivity, specificity, or AUC as would be seen in an AI study.

Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-AI/ML device, the following points are largely inapplicable or have no information provided in the given document.

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

   • Test Set Sample Size: Not applicable for an AI/ML test set. For bench and biocompatibility testing, the sample sizes are determined by the respective ISO or test standards. These typically involve a small number of samples for physical and chemical tests (e.g., a few units per test).
   • Data Provenance: Not applicable. The tests are bench and lab-based studies performed to evaluate device characteristics, not clinical data.

2. 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):

   • Not applicable as this is a non-AI/ML device. Ground truth is established by objective measurements against engineering specifications and industry standards for physical and chemical properties.

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

   • Not applicable as this is a non-AI/ML device. Performance is determined by objective measurements and standard compliance.

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:

   • Not applicable. This device is an RF cannula, not an AI-powered diagnostic or assistive tool. No MRMC study was performed.

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

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

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

   • For this device, the "ground truth" for its safety and effectiveness is established by compliance with recognized international standards (ISO, IEC, ASTM) for material properties, sterilization, physical dimensions, and biocompatibility. This involves objective measurements and qualitative assessments (e.g., "non-irritant," "non-cytotoxic") based on established laboratory protocols.

7. The sample size for the training set:

   • Not applicable. This is a non-AI/ML device, so there is no "training set."

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

   • Not applicable. This is a non-AI/ML device.

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The Nimbus Electrosurgical Radiofrequency Multitined Expandable Electrode, in combination with an RF generator and probe, are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain.

The NIMBUS Electrosurgical Radiofrequency Mutitined Expandable Electrode consists of an insulated cannula with an active tip that directs RF energy into target tissues, and a pair of deployable tines which expand the volume of the ablation. It is intended, in combination with an RF generator and probe, for use in radiofrequency (RF) heat lesion procedures for relief of pain.

The provided 510(k) summary for the NIMBUS Electrosurgical Radiofrequency Multitined Expandable Electrode describes a regulatory submission establishing substantial equivalence to a predicate device, rather than a clinical study with detailed acceptance criteria and performance metrics for an AI device. Therefore, a direct response to your request, which presumes a study showing an AI device meeting specific acceptance criteria, cannot be fully provided from the given document.

However, I can extract the information that is present and indicate what is not available based on the nature of this submission.

The document discusses performance tests conducted to demonstrate substantial equivalence to a predicate device (BMC RF Cannula, K972846). The objective of these tests was to show that the Nimbus device performs similarly and is as safe and effective as the predicate, not to meet pre-defined acceptance criteria in the context of an AI device's performance.

Here's the information synthesized from the document, acknowledging its limitations regarding typical AI device study data:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a medical device and not an AI algorithm, there are no specific "acceptance criteria" presented in the form of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for an AI device. Instead, the document lists performance tests (implicitly with internal pass/fail criteria) performed to demonstrate substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for any of the performance tests. The testing appears to be bench testing and not a clinical study involving human subjects or data sets in the way an AI study would.
• Data Provenance: Not applicable in the context of an AI study. The tests were likely conducted in a controlled laboratory environment by the manufacturer (Biomerics, LLC) in Salt Lake City, Utah, USA.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This is not an AI device, and the ground truth for its performance tests (e.g., electrical measurements, physical dimensions, lesion formation) is based on engineering specifications and measurement standards, not expert interpretations of medical images or patient outcomes.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no expert interpretations or consensus required for typical engineering and performance bench tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study is specifically for evaluating the effectiveness of a diagnostic aid (like AI) on human reader performance. This device is a surgical tool, not a diagnostic aid.

6. Standalone (Algorithm Only) Performance

• Not Applicable. The device itself is the "algorithm" in a sense (its design and function), and its performance is evaluated directly through physical and electrical tests, not as a standalone software algorithm separate from human interaction for diagnostic purposes.

7. Type of Ground Truth Used

• Engineering Specifications and Standardized Test Methods: The "ground truth" for the performance tests would be established by validated measurement equipment and adherence to relevant industry standards (e.g., for electrical safety, material properties, biocompatibility) and the device's own design specifications. For example, a dielectric strength test has a pass/fail threshold defined by an electrical standard. Lesion formation is likely compared to a predefined expectation or to the predicate device's measured lesion formation under identical conditions.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI device trained on data. There is no concept of a "training set" for the NIMBUS Electrosurgical Radiofrequency Multitined Expandable Electrode.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. (See point 8).

Summary Regarding AI-Specific Information:

The provided document is a 510(k) summary for a physical medical device (an electrosurgical electrode), not an Artificial Intelligence (AI) enabled device. Therefore, the questions related to AI acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance are not applicable to the content of this document. The document describes traditional device verification and validation activities aimed at demonstrating substantial equivalence to a predicate device.

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