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The Tracer Implantation Kit is indicated for use to radiographically and radioactively mark soft tissue for future therapeutic procedures.
The Tracer is indicated for permanent implantation in the prostate.
The Tracer is intended to be used in conjunction with the RealEye system as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator.
The IndeX Implantation Kit is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
The IndeX is intended to be used as a radiographic fiducial marker for visualization using x-ray, CT, or Cone Beam CT.

The Tracer is a Platinum/Iridium radioactive soft tissue fiducial for implantation in the prostate, in or near the treatment target for radiotherapy treatments. The Tracer emits photons that enable its localization by the Navotek RealEye system that is designed to track localized gamma-emitting radioactive sources.
The implantation of the Tracer is performed using an Implantation Device, which is supplied with the Tracer pre-loaded within it. Therefore, the Tracer is supplied as a 'Tracer Implantation Kit' which includes the Tracer and the Implantation Device. The Tracer lmplantation Kit is provided in a single package, sterile (by gamma radiation) and ready for use. It is intended for single use only.
The IndeX is identical to the Tracer in all respects except that it is not radioactive. It is intended for use to radiographically mark soft tissue and to be visible in x-ray, CT, and Cone Beam CT images.

{"1. A table of acceptance criteria and the reported device performance": "The document describes performance testing that demonstrated the Tracer Implantation Device performs "according to specifications and function as intended." It also states that "differences in technology compared to the predicate device do not impact safety or effectiveness." However, specific quantifiable acceptance criteria (e.g., minimum accuracy rates, success rates, or ranges of performance metrics) are not explicitly provided in the document. Therefore, a table comparing acceptance criteria to reported performance cannot be fully constructed.", "2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)": "The document mentions "clinical testing" but does not specify the sample size used for this testing. It also does not provide information on the country of origin of the data or whether the study was retrospective or prospective.", "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)": "The document does not provide information regarding the number of experts used to establish ground truth or their qualifications.", "4. Adjudication method (e.g., 2+1, 3+1, none) for the test set": "The document does not specify any adjudication method for the test set.", "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned. The device is a fiducial marker, not an AI-assisted diagnostic tool for human readers.", "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "This is a physical medical device (fiducial marker and implantation kit), not a software algorithm. Therefore, a standalone algorithm performance study is not applicable.", "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The document mentions "bench, animal, and clinical testing" as part of the performance evaluation. For a fiducial marker, ground truth would likely involve direct physical measurements (for bench testing), imaging verification (for animal and clinical testing), and potentially long-term follow-up for outcomes related to marker stability and efficacy in therapy. However, the document does not explicitly state the type of "ground truth" used for each test.", "8. The sample size for the training set": "This is a physical medical device. The concept of a "training set" as used in AI/ML is not applicable here.", "9. How the ground truth for the training set was established": "This question is not applicable as the device is not an AI/ML algorithm that requires a training set."}

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