Search Results

These devices are intended to be used to mark an open or These devices are incended to be assabically mark the location of the biopsy site.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a Biopsy Site Tissue Marker Device. It does not contain information about acceptance criteria, study details, or performance metrics for the device. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

Therefore, I cannot extract the requested information regarding acceptance criteria, study design, or performance from this document.

Ask a specific question about this device

This device is intended to be used for percutaneous transjugular li access during diagnostic and interventional procedures.

Co-Axial Introducer Needle; Co-Axial Introducer Set/Transjugular Liver Access Set

This document is a 510(k) clearance letter from the FDA for a medical device called a "Co-Axial Introducer Needle" or "Co-Axial Introducer Set/Transjugular Liver Access Set" manufactured by Promex, Inc.

The letter grants clearance for the device to be marketed based on its substantial equivalence to a legally marketed predicate device. This type of regulatory document does not contain information about specific acceptance criteria or detailed study results proving a device meets those criteria, particularly not in the context of an AI/ML device where performance metrics like sensitivity, specificity, or AUC would be relevant.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on regulatory approval, not on detailed performance study outcomes typically associated with AI/ML device evaluations.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

To obtain percutaneous core biopsy samples from soft tissue 10 obtain perculations core bropsy surves, kidney, prostate, and culturs of sach organs as awnen used for breast blopsy, the product is for diagnosis only.

Automated Core Biopsy Device

The provided text is an FDA 510(k) clearance letter for the "Automated Core Biopsy Device" and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily states that the device has been found substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory matters such as general controls, manufacturing practices, and labeling, but does not include technical details about the device's validation or performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided input.

Ask a specific question about this device

These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow.

A. Intended Use: These devices are intended to be used to obtain percutaneous biopsy samples of Bone Marrow. B. Materials: 304 Stainless Steel and polycarbonate or similar material. For more detail about materials refer to Section I - Attachments A. C. Additional Features: Currently, Manan (Northbrook, IL) provides features such as: Luer fittings on Cannula and adjustable depth stop (Illinois style). Promex's products will incorporate these features as well. A listing of available needle dimensions is included in Section I - Attachment B.

Here's an analysis of the provided text regarding acceptance criteria and study details:

The provided documents do not contain information about acceptance criteria or a study that proves the device meets those criteria.

The documents are a 510(k) summary and an FDA clearance letter for a "Bone Marrow Aspiration Needle." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific performance acceptance criteria through a dedicated study with the details you've requested.

Here's a breakdown of why each point you asked for cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) summary describes the device's intended use and materials, but no performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned.
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): No experts, ground truth establishment, or test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is mentioned as there's no test set described.
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: This is completely irrelevant to a bone marrow aspiration needle. MRMC studies are typically for imaging devices or AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned.
8. The sample size for the training set: No training set is mentioned.
9. How the ground truth for the training set was established: No training set or ground truth establishment is mentioned.

In summary: The provided 510(k) documents focus on demonstrating that the "Bone Marrow Aspiration Needle" is substantially equivalent to existing devices based on its intended use, materials, and design, rather than presenting a performance study against specific acceptance criteria. For devices like this, substantial equivalence is often established through comparison of design features, materials, and intended use, sometimes supported by basic engineering tests (e.g., strength, sterility), but not typically detailed clinical performance studies in the way you're asking for.

Ask a specific question about this device

For the manual application of a radionuclide source into the body for radiation therapy.

Prostate Seeding Needle

This document is a 510(k) premarket notification letter from the FDA for a Prostate Seeding Needle. It's a regulatory approval document and does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot answer your request based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.

Ask a specific question about this device

For the removal of soft tissue and bone in the ear, nose & throat.

Promex ENT Tissue Removal System

The provided text is a 510(k) premarket notification letter from the FDA for the Promex ENT Tissue Removal System, dated September 29, 1997. This document approves the device for marketing and confirms its substantial equivalence to previously marketed devices.

This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details requested in your prompt.

The letter explicitly states that the device is approved "for the indications for use stated in the enclosure," which on the second page is "For the removal of soft tissue and bone in the ear, nose & throat."

Since the document is a regulatory approval letter and not a study report, it does not provide the requested information regarding the performance study that would typically establish acceptance criteria and demonstrate device effectiveness.

Ask a specific question about this device

Ask a specific question about this device