Search Results

Geotek Disposable Core Biopsy Needles (Three Models: Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, and Maxicore-M Automatic Biopsy Needle and Instrument) are intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not Intended for use in bone.

Not Found

The provided text is related to an FDA 510(k) clearance letter for "Geotek Disposable Core Biopsy Needles." This document does not contain information regarding acceptance criteria or the study that proves the device meets those criteria.

The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices. This determination of substantial equivalence is based on a comparison of the new device to an existing predicate device, considering aspects like indications for use, technological characteristics, and safety and effectiveness information.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and the reported device performance: This document only states the device's intended use and FDA clearance.
• Sample size used for the test set and the data provenance: No performance study details are included.
• Number of experts used to establish the ground truth and their qualifications: No ground truth establishment details are included.
• Adjudication method for the test set: No adjudication method details are included.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• If a standalone performance was done: No standalone performance study is mentioned.
• The type of ground truth used: Not specified.
• The sample size for the training set: Not applicable as no AI/machine learning device is described.
• How the ground truth for the training set was established: Not applicable.

To obtain such details, one would typically need to refer to the full 510(k) submission, which is not provided here, or other regulatory documents detailing the specific performance studies conducted for the device.

Ask a specific question about this device

GTK Disposable Needle Guides when used in conjunction with ultasound system transducer where configuration is suitable (e.g. Aloka, Alpinion, BK, Esaote, GE, Hitachi, Mindray, Philips, Toshiba, Siemens, and Shimadzu ultrasound systems) and attached to the ultrasound system's transducers, is to facilitate proper needle placement to access anatomical structures.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a device called "GTK Disposable Needle Guides." It outlines the FDA's determination of substantial equivalence to a predicate device and details regulatory requirements.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The letter primarily focuses on:

• The FDA's decision on market clearance based on substantial equivalence.
• Regulatory requirements for the manufacturer (registration, labeling, adverse event reporting, quality systems, etc.).
• Contact information for various FDA divisions.
• The Indications for Use statement for the device.

Therefore, I cannot provide the requested information based on the content of this document.

Ask a specific question about this device