(107 days)
RIC Conformal Source Model 100 Brachytherapy Source, containing 32Phosphorus with activity up to 200 mCi is indicated for treatment on the surface of tumors. It can be used either as primary surface application to treat intact tumors or as treatment after excision of primary or recurrent tumors. It can be used concurrently with or following treatment with other interventions, such as external beam therapy. Chordomas, chondrosarcomas, soft tissue sarcomas, skin cancers and other treatable tumors could be commonly treated by the RIC Conformal Source, containing 32Phosphorus.
RIC Conformal Source Model 100 Brachytherapy Source is designed for use in medical Brachytherapy applications. The capacity of each source is up to 200 millicuries of 32Phosphorus. The physician could prescribe a physical size up to 50mm by 100mm. This RIC Conformal Source is a flat flexible planar radioactive 32Phosphorus polymeric film that could be made conformal to different surface geometries such as flat, concave or convex semi-cvlindrical shapes through the use of an appropriately shaped shield / holder or by placement on an area to be treated and made conformal by the weight of a flexible compliant media. At the option of the prescribing physician, the RIC Conformal Source could be attached to a manual radionuclide applicator (available from RI Consultants, Class I device, 892.5650) to facilitate handling and to provide shielding to the clinician. The RIC Conformal Source consists of 32Phosphorus chemically bound to the biocompatible polymeric film. The polymeric film thickness is 0.3mm (0.012 inch) to 0.7 mm (0.028 inch). The 32Phosphorus polymeric film is then coated with a flexible biocompatible silicone coating which is about 0.01 mm (0.0005 inch) thick. The 32Phosphorus is chemically bonded to the polymer molecule and is an integral part of the film.
The provided text is a 510(k) summary for the RIC Conformal Source Model 100 Brachytherapy Source, a medical device. It describes the device, its intended use, and its similarities to legally marketed predicate devices.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The 510(k) summary is primarily focused on demonstrating substantial equivalence to a predicate device, as required for FDA clearance, rather than presenting detailed performance study data.
Therefore, I cannot provide the requested table and study details from the given text.
To address your request, I would need a document specifically detailing the performance studies conducted for the RIC Conformal Source Model 100 Brachytherapy Source, including information such as:
- Clinical trial reports or validation studies: These would contain the acceptance criteria and performance metrics.
- Study protocols: These would outline the methodology, sample sizes, and ground truth establishment.
- Statistical analysis plans: These often detail how performance metrics are calculated and compared.
Without such information, any attempt to provide the requested details would be speculative and not based on the provided document.
§ 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.