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The BrachySciences Radioactive Seed Localization Needle with AnchorSeed is intended for the localization of suspicious tissues (non-palpable lesions) for excision in the use of radioactive seeds.

BrachySciences Radioactive Seed Localization Needle with AnchorSeed.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "BrachySciences Radioactive Seed Localization Needle with AnchorSeed," along with its "Indications For Use" statement.

This document does not describe:

• Acceptance criteria for a device's performance (beyond the general regulatory requirement of substantial equivalence).
• Any specific study that proves the device meets particular performance criteria.
• Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.

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The WorldWide Medical Technologies Synthetic Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Rrachstherapy procedures.

The devices are sterile, single patient use product.

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "WorldWide Medical Technologies Synthetic Spacer." It confirms the device's substantial equivalence to a legally marketed predicate device.

However, this document does not contain information about the acceptance criteria, study details, or performance data of the device itself. It is a regulatory approval letter, not a scientific study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document explicitly states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
• "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act..."

This indicates that the approval is based on substantial equivalence to an existing device, which is a regulatory pathway, and not necessarily on a new study demonstrating performance against specific acceptance criteria presented in this letter.

To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) from the 510(k) submission, or a separate clinical study report for the device.

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The World Wide Medical Technologies Anchor Marker and Marker Strand intended use is to, provide radiopaque markers for clearer identification of anatomic regions by providing reference positions around a proposed treatment site. They are indicated for use in brachytherapy, soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures

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The provided document is a 510(k) clearance letter from the FDA for a device called "Worldwide Medical Technologies, Anchor Marker, Marker and MarkerStrand." This type of document does not typically contain the detailed study information required to answer your questions about acceptance criteria and study design.

The 510(k) process primarily evaluates substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to establish safety and effectiveness for every submission. As such, the letter confirms clearance based on regulatory equivalency, not on a detailed analysis of performance against specific acceptance criteria from a new clinical study.

Therefore, I cannot extract the requested information regarding acceptance criteria and detailed study data from this document. This information would typically be found in the 510(k) submission itself, which is not publicly available in this format, or in associated scientific publications if such studies were performed and published.

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