(53 days)
The Best Medical International, Inc Best Strand component device is indicated for use as an accessory in brachytherapy procedures. It is supplied sterile, as a single-use device. The Best Strand is indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.
The Best Medical International, Inc., "Best Spacer" device is intended to be used to maintain a predetermined space between radionuclide seeds during the introduction of the seeds into the body during Brachytherapy procedures. Absorbable spacers are indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.
The Best Medical International, Inc, Best Strand consists of synthetic absorbable polymer or copolymer matcrial, braided and non-braided, which is used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures.
The provided text is related to a 510(k) premarket notification for the "Best Strand" device by Best Medical International, Inc. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a performance study with detailed statistical analysis.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.
The document primarily states:
- Device Name: Best Strand (and Best Spacer)
- Intended Use: Accessory in brachytherapy procedures, used to orient, hold, carry, and maintain spacing of radionuclide seeds and spacer components. Indicated for use in soft tissue or organ tissue (not cardiovascular or neurological).
- Predicate Device: CP Medical CARRJER SLEEVE (K034062) and I-125 Rapid Strand's accessory Sleeve (K940632 and K010821).
- Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices for the stated indications.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes used for a test set, data provenance.
- Information on the number or qualifications of experts or adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- The type of ground truth used (as it's not an AI/diagnostic device).
- Sample size for a training set.
- How ground truth for a training set was established.
This type of 510(k) submission generally relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through comparison of technological characteristics and intended use, rather than conducting new clinical performance studies with specific acceptance criteria as one might see for novel AI/diagnostic devices.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.