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CP Medical's absorbable seeding spacers are intended to be used to maintain a predetermined space between radionuclide seeds for the introduction of the seeds into the body during brachytherapy procedures. Seeding spacers are indicated for use in soft tissues or organ tissue but should not be used during cardiovascular or neurological procedures.

The CP Medical Accu-Space and BioSpacer consists of absorbable spacer material and is a small cvlindrical component device utilized to provide space between the radionuclide seeds as they are implanted into the body.

This document (K013964) is a 510(k) premarket notification for an absorbable seeding spacer product. It's a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving device performance against acceptance criteria. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this type of document.

The document primarily focuses on:

• Manufacturer and Device Information: Name, contact, device name (Absorbable Seeding Spacers), classification, and date.
• Predicate Device: K010621 (Accu-Space absorbable seeding spacers).
• Device Description: Small cylindrical absorbable component used to maintain space between radionuclide seeds during brachytherapy.
• Indications for Use: To maintain predetermined space between radionuclide seeds for introduction into the body during brachytherapy procedures in soft or organ tissue, but not in cardiovascular or neurological procedures.
• FDA Determination: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details based on the provided text. This 510(k) submission does not contain the information typically found in a clinical study report that would address those points.

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