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The ATI Medical, Inc. IsoRod Pd-103 Radionuclide Brachytherapy Source is intended for permanent interstitial implantation for the treatment of selected localized tumors with low to moderate radiosensitivity. They are used either as primary treatment for tumors such as those of the head, neck, lung, intra-abdominal, pancreas, prostate, and unresectable tumors, or for residual disease after excision of primary or secondary tumors. IsoRod Pd-103 implants may be used concurrently with or following treatment with other interventions, such as external beam therapy or chemotherapy.

The IsoRod implant is a permanently implanted, radioactive device, designed for the treatment of deep- seated tumors. IsoRod implants are comprised of base metallic rods that are coated with radioactive palladium. The radioactive palladium is then encapsulated with a metallic coating.

The base rod is composed of a palladium/cobalt alloy. The rod is 1 millimeter and 10 millimeters in length. The thin layer (0.2 micron) that comprises the radioactive layer is a combination of radioactive and non-radioactive palladium (Pd-103 and Pd-102 respectively). The encapsulation layer of 6-8 microns is pure palladium, a metal that is utilized in permanent implants based on its favorable biocompatibility characteristics.

The activity of each IsoRod implant is between 0.5 mCi and 3.0 mCi. The source is exceptionally isotropic based on the fact that the radioactive material is evenly deposited on the source and is shielded in every direction only by the thin layer of non-radioactive palladium.

The provided text, K020683, is a 510(k) summary for the IsoRod Pd-103 Implant Brachytherapy Source. This document describes a medical device rather than an AI/ML device, and thus the requested information regarding acceptance criteria, study details, and AI/ML-specific metrics (like human reader improvement with AI, standalone algorithm performance, training set details) is not applicable.

The 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through:

• Intended Use: Showing the same indications for use as predicate devices.
• Technological Characteristics: Highlighting similar isotope, apparent activity, and device description.
• Biocompatibility Testing: Confirming the device is biocompatible for its intended use.
• Dosimetry: Mentioning Monte Carlo analysis for dosimetry, with physical dose measurements to be completed.

Therefore, many of the specific questions asked are not relevant to this type of device submission.

However, I can extract the information that is present:

1. A table of acceptance criteria and the reported device performance:

• Activity: 0.5 mCi to 3.0 mCi per implant
• Design: Base metallic rods coated with radioactive palladium and encapsulated with pure palladium. Rod is 1mm x 10mm. |
  | Biocompatibility: Safe for permanent implantation | Biocompatibility tests (summarized in Appendix 7) indicate the device is biocompatible under conditions of intended use. (Specific criteria and results not detailed in the summary). |
  | Dosimetry: Appropriate for brachytherapy | Dosimetry determined by Monte Carlo analysis at UCLA using MCNP4C code. Physical dose measurements in a phantom to be completed prior to marketing. (Specific values or ranges not detailed in the summary). |

2. Sample size used for the test set and the data provenance:

• Not applicable. This submission performs no "test set" evaluation in the context of an AI/ML study. The evaluation focuses on comparison to predicate devices and engineering/biocompatibility testing, not clinical performance data from a patient cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No test set or adjudication method described.

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:

• Not applicable. The device is a brachytherapy source, not an AI-assisted diagnostic or prognostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. The device is a physical radioactive implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For biocompatibility: Ground truth would be established through standardized biocompatibility testing protocols defined by relevant ISO standards (e.g., ISO 10993) which determine material safety for implantation. The summary states these tests were performed, but not the specific "ground truth" method.
• For dosimetry: Ground truth would be established through physical measurements and validated Monte Carlo simulations demonstrating accurate radiation dose distribution.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI/ML device.

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