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OptiSource103 implants are indicated for interstitial implantation of select focalized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. OptiSource103 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.

OptiSource103 is a permanent interstitial implant 5.0 mm long by 0.88 mm in diameter with a polymeric shell and containing Pd-103 in two solid polymeric cylinders separated by a gold marker to provide visibility.

This document is a 510(k) premarket notification for the OptiSource™ device, a radionuclide brachytherapy source. As such, it is a submission for regulatory clearance and does not contain the results of a study designed to demonstrate performance against specific acceptance criteria for diagnostic or AI-driven medical devices.

The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, providing general device information, and receiving FDA clearance to market.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, study details, sample sizes, ground truth establishment, or clinical effectiveness studies in the format you provided. This type of information is typically found in clinical trial reports, peer-reviewed publications, or more detailed technical documentation, which are not present in this regulatory submission.

Here's what can be inferred from the provided text, but it falls short of the detailed study information requested:

• Device Type: The device is a "Radionuclide Brachytherapy Source" for interstitial implantation. It is not an AI-driven or diagnostic device that would typically have acceptance criteria related to accuracy, sensitivity, specificity, etc., in the way you've outlined. Its performance is related to its physical characteristics, radiation output, and safety.
• Regulatory Context: This is a 510(k) submission, which aims to demonstrate that a device is "substantially equivalent" to an existing legally marketed device. This process generally does not involve new clinical efficacy studies unless substantial equivalence cannot be established through other means (e.g., performance testing against recognized standards, comparison to predicate device specifications).
• Intended Use: "OptiSource103 implants are indicated for interstitial implantation of select focalized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, and unresectable tumors, or for residual disease after excision of the primary tumor. OptiSource103 implants are indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy."

In summary, the provided document does not contain the information needed to fill out your requested table and study details as it pertains to a regulatory clearance for a physical medical device (brachytherapy source) rather than a performance study for an AI or diagnostic device.

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