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This device is a disposable biopsy needle and can be used in , CT, Mammographic Radiographic and Echographic procedures to obtain biopsies of various tissues including those from Prostate, Kidney, Breast and Liver using an automatic device.

This device is a disposable biopsy needle

This submission (K021525) is a Premarket Notification (510(k)) for the TOPCUT™ Cutting Biopsy Needle, indicating the device's substantial equivalence to a predicate device. However, the provided document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria.

The document primarily focuses on the administrative aspects of the 510(k) submission, including:

• Applicant and contact information.
• Device trade name, common name, and classification.
• Identification of a predicate device (MANAN Medical Products, Automatic Cutting Needle), implying that the new device is being compared to this existing, legally marketed device.
• The indication for use statement for the TOPCUT™ Biopsy Needle.
• FDA's determination of substantial equivalence and subsequent approval to market the device.

To provide the requested information about acceptance criteria and a study demonstrating compliance, the original 510(k) submission document or a more detailed technical file for K021525 would be needed. This type of information is typically found in the performance data section of a 510(k) submission, which is not present in the provided excerpt.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies based on the provided text.

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This biopsy instrument is used for drawing of osteomedullary substance and or for Explantation of bone marrow

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets the acceptance criteria. The document is a 510(k) summary for a "BMN 'I' Type Marrow Biopsy Needle," which is a premarket notification to the FDA. It includes:

• Applicant and contact information.
• Device name, common name, and classification.
• Indication for use.
• FDA's determination of substantial equivalence to a predicate device.
• Regulatory information regarding marketing, general controls, and compliance.

There is no mention of performance metrics, acceptance criteria, study design, results, or ground truth establishment. Therefore, I cannot extract the requested information to fill in the table or answer the specific questions about a study.

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This biopsy instrument is used for drawing of osteomedullary substance and or for explantation of bone marrow.

A disposable single use Biopsy Needle. The product consist of a 304 stainless steel cannula and 302 stainless steel stylet. The cannula is inserted molded into an ABS hub that provide a grip for manipulation of the Needle. Inside of the cannula is a stylet made by 302 stainless steel, inserted molded into an ABS hub. An additional patented stylet is provided to be used for trapping the sample in the cannula. An extracting 302 stainless steel wire with safety grip. The protective cover of cannula is made of polypropilene.

The provided document is a 510(k) summary for a medical device (TrapSystem® Set Bone Marrow Biopsy Needle) and does not contain information on acceptance criteria, device performance studies, or details relevant to artificial intelligence/machine learning (AI/ML) device performance.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set and data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is for a conventional medical device (a biopsy needle) seeking substantial equivalence and does not involve AI/ML components or associated performance studies as typically found in submissions for AI/ML-powered devices.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device