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As a guiding needle in obtaining core biopsy samples from soft tissue such as liver, kidney, spleen, lymph nodes and various soft tissue lesions.

Gangi-SoftGuard Coaxial Needle together with Gangi-HydroGuard Coaxial Needle forms the Gangi Coaxial Needle family. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle are manually operated, sterile, single use coaxial guiding needles with a spring loaded blunt-tip stylet, to be used as a guiding needle for biopsy instruments in procedures in soft tissue. Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle has the same intended use.

Coaxial Needle and Gangi-SoftGuard Gangi-HydroGuard Coaxial Needle are gastroenterological, manually operated, sterile, single use coaxial introducer needles. Both Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle consists of three parts: a needle (cannula) provided with a trocar stylet, and a spring-loaded blunt tip stylet. The difference from Gangi-SoftGuard Coaxial Needle is that Gangi-HydroGuard Coaxial Needle has a Luer hub located on the blunt stylet housing and the blunt stylet is hollow and has a distal tip hole. This enables injection of fluid without the need to remove the blunt stylet.

The provided text describes a medical device submission (K181756) for the Gangi-SoftGuard Coaxial Needle and Gangi-HydroGuard Coaxial Needle. This submission is for a traditional medical device (biopsy needle) and does not involve an Artificial Intelligence/Machine Learning (AI/ML) powered device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth for training set) are not applicable.

However, I can extract information regarding the acceptance criteria and the studies performed for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a non-AI/ML medical device, the "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity for clinical outcomes. Instead, they are related to compliance with recognized standards and design requirements for a biopsy needle. The "reported device performance" refers to the successful verification against these standards and requirements.

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

• Not Applicable (N/A) for an AI/ML device. For this traditional medical device, testing involved bench testing of components and the final device against engineering and biocompatibility standards. The document does not specify exact sample sizes for each test unless it's inherent in the standard (e.g., number of units tested for mechanical performance or biocompatibility). Data provenance is not described as country of origin, but rather as "bench testing." These were likely performed in a controlled laboratory setting by the manufacturer (AprioMed AB, Sweden). The nature of these tests is prospective for the device evaluation.

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):

• Not Applicable (N/A): This is not an AI/ML device or a diagnostic device requiring expert interpretation for ground truth. Ground truth for the tests performed (biocompatibility, mechanical strength, dimensional conformity) is established by adherence to recognized international standards and engineering specifications, verified by testing laboratories or internal qualified personnel.

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

• Not Applicable (N/A): This concept primarily applies to AI/ML or diagnostic studies where human experts disagree on findings. For bench testing, results are typically objective measurements against set specifications.

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 (N/A): This is a traditional medical device (biopsy needle), not an AI/ML system. No MRMC study was performed.

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

• Not Applicable (N/A): This is a traditional medical device, not an algorithm.

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

• For this traditional medical device, the "ground truth" for its performance is:
  • Adherence to recognized international standards: e.g., ISO 10993 (biocompatibility), ISO 9626 (metal tubing), ISO 7864 (hypodermic needles), ISO 594 (conical fittings).
  • Compliance with internal design requirements: for mechanical performance, penetration force, and spring force. These are objective engineering specifications.

8. The sample size for the training set:

• Not Applicable (N/A): This is a traditional medical device, not an AI/ML system, so there is no "training set."

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

• Not Applicable (N/A): As there is no training set for an AI/ML model, this question is irrelevant to the provided document.

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The BiomarC Coaxial Needle allows delivery of fiducial markers into soft tissue.

The BiomarC Coaxial Needle is a sterile, pyrogen free, single patient use, disposable coaxial needle that consists of an outer cannula with an attached female luer lock hub, an inner stylet with an attached male luer lock hub, and a flexible slip ring style depth stop. The BiomarC Coaxial Needle is designed for use with BiomarC Fiducial Markers. The outer cannula is only one gauge size larger than the appropriate BiomarC Fiducial Marker needle, e.g., 18g BiomarC Coaxial Needle for a 19g BiomarC Fiducial Marker needle.

This document is not a study, but rather a 510(k) Premarket Notification for a medical device (BiomarC Coaxial Needle). It doesn't contain information about a clinical study with acceptance criteria and reported device performance in the way a traditional clinical trial report would. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested fields regarding acceptance criteria, study design, sample sizes, experts, and ground truth are not applicable or cannot be extracted from this type of document.

However, I can extract information related to the device's intended performance and how its characteristics are compared to predicate devices, which implicitly serves as the basis for its safety and effectiveness claims for regulatory purposes.

Here's a breakdown of what can and cannot be extracted:

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

This document does not present explicit "acceptance criteria" and "reported device performance" in the context of a clinical study with measured outcomes against predefined thresholds. Instead, it relies on demonstrating that the proposed device has technological characteristics and performance substantially equivalent to legally marketed predicate devices.

The table below summarizes the comparison between the proposed device and its predicates, which serves as the implicit "proof" of meeting performance expectations for substantial equivalence.

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

• Sample Size: Not applicable. This document does not describe a test set or comparative study with specific sample sizes. The submission relies on a comparison of technological characteristics to predicate devices already on the market.
• Data Provenance: Not applicable. The "study" here is a regulatory submission demonstrating substantial equivalence, not a clinical trial.

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

Not applicable. There was no "test set" requiring ground truth established by experts in the context of a performance study.

4. Adjudication method for the test set

Not applicable. There was no "test set" requiring adjudication.

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 not an AI/software device and no MRMC study was performed or described.

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

Not applicable. This is a physical medical device (coaxial needle), not an algorithm or AI.

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

Not applicable. There was no "ground truth" in the clinical study sense. The "ground truth" for the device's acceptability is its substantial equivalence to legally marketed devices, implying that their established safety and effectiveness applies to the new device given its similar characteristics and intended use.

8. The sample size for the training set

Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no concept of a "training set."

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

Not applicable. See point 8.

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The Coaxial Needle is used for endoscopic injection to control bleeding or lift sessile polyps using various media. An irrigation tube or syringe may be attached to the aspiration port of the needle in order to flush the injection site for better visualization.

The Coaxial Needle is used for endoscopic injection to control bleeding or lift sessile polyps using various media. An irrigation tube or syringe may be attached to the aspiration port of the order to flush the injection site for better needle in visualization.

This document is a 510(k) summary for a Coaxial Needle and does not contain the acceptance criteria or a study demonstrating the device meets those criteria.

The provided text focuses on:

• Product Description: How the Coaxial Needle is used (endoscopic injection for bleeding control or polyp lifting) and its components (irrigation tube/syringe attachment).
• Contraindications: Uncooperative patient and severe coagulopathy.
• Manufacturing and Quality Assurance: Mentions U.S.E.'s adherence to performance specifications, Quality Systems Regulations, and MIL-STD-9858.
• Sterilization: EtO sterilization is used.
• Bibliography: Lists general references related to gastroenterologic procedures.
• FDA 510(k) Clearance Letter: Confirms the device's substantial equivalence to predicate devices and clearance to market.
• Indications for Use Statement: Reiterates the intended uses of the device.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them because it is not present in the provided text.

To answer your questions, the document would need to include information such as:

• Specific performance metrics (e.g., needle sharpness measurements, flow rates, durability tests).
• Quantifiable targets for these metrics (the acceptance criteria).
• Details of a study (e.g., experimental design, methodology, results) that evaluated the device against these metrics.

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