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The World Wide Medical Technologies StrandPort intended use is to provide a disposable carrier for seed strands containing radionuclide seeds for the introduction by the user of radionuclide seeds into Prostate Seeding Needles for brachytherapy procedures.

disposable carrier for seed strands containing radionuclide seeds

This document is a 510(k) clearance letter from the FDA for a medical device called "Worldwide Medical Technologies StrandPort."

Based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on:

• Device Name: Worldwide Medical Technologies StrandPort
• Regulation Number: 21 CFR 892.5730
• Regulation Name: Radionuclide brachytherapy source
• Regulatory Class: II
• Product Code: KXK
• Indications For Use: To provide a disposable carrier for seed strands containing radionuclide seeds for the introduction by the user of radionuclide seeds into Prostate Seeding Needles for brachytherapy procedures (transperineal approach for radionuclide seed application in and around the prostate). It is a sterile, single-patient-use product.
• FDA Clearance: The letter states that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This allows the company to market the device subject to general controls.

The document does not contain any of the following information requested:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This is a regulatory clearance document, not a detailed technical report of a performance study.

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