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Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment for residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, prostate (early stages), and other accessible tumors are commonly treated.

The Imagen isoSTARTM I-125 Interstitial Seed, Model IS-12501 uses 131 spheres encapsulated in a titanium tube.

Here's an analysis of the provided text regarding the Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, focusing on acceptance criteria and study details.

Based on the provided 510(k) summary (K991526), this device is a medical implant (brachytherapy seed) and not an AI or software-as-a-medical-device (SaMD). Therefore, most of the requested information regarding AI device acceptance criteria, study design, and ground truth is not applicable. The regulatory pathway for this device is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices, rather than proving performance against specific acceptance criteria through clinical studies in the way an AI/SaMD would.

However, I can extract the relevant information from the provided document as it pertains to medical device approval, even without a direct AI component.

1. Table of Acceptance Criteria and Reported Device Performance

For non-AI medical devices like brachytherapy seeds, "acceptance criteria" are generally related to demonstrating substantial equivalence to existing predicate devices in terms of safety and effectiveness, and meeting relevant performance standards. The provided document doesn't list explicit, quantifiable acceptance criteria in the way a diagnostic AI algorithm might (e.g., "sensitivity > 90%"). Instead, the acceptance is based on demonstrating comparable characteristics and safety/biocompatibility.

2. Sample Size Used for the Test Set and Data Provenance

• Not Applicable in the context of an "AI test set."
• For this type of device, the "testing" refers to bench testing for safety (e.g., radiation leakage, physical integrity) and biocompatibility, not performance on a dataset of patient cases. The document states "has been tested for safety and biocompatibility by standard tests used for radionuclide devices." It does not specify sample sizes or data provenance for these engineering/material tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. As this is a physical medical device (radioactive seed), there is no 'ground truth' in the context of expert diagnosis or interpretation of an AI output. The ground truth for such a device would be its physical properties, radiation output, and biological safety/biocompatibility, confirmed through laboratory and engineering tests, not expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

• Not Applicable. There is no "test set" in the sense of medical images or patient data requiring expert adjudication for this device.

5. If a Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This type of study is relevant for diagnostic devices (especially imaging-based AI) where human readers interpret cases. It is not applicable to a radioactive implantable seed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

• For the purpose of substantial equivalence for this brachytherapy seed, the "ground truth" (or basis for comparison) is primarily:
  • Predicate Device Characteristics: The established safety, effectiveness, and technological characteristics of legally marketed I-125 brachytherapy seeds (e.g., Imagyn isoSTAR™ I-125 Interstitial Seed Model IS-12500, EndoSeed, Amersham Model 6711, Mentor IoGOLD).
  • Standard Test Outcomes: Results from "standard tests used for radionuclide devices" confirming physical integrity, radiation safety, and biocompatibility.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. No training set exists for this device.

Summary regarding the device:

The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, gained 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. The key elements for this determination were:

• Similar technological characteristics (encapsulation method, range of activity).
• No differences in biocompatibility or other safety and effectiveness aspects.
• Confirmation of safety and biocompatibility through "standard tests used for radionuclide devices."
• Identical intended use as predicate devices.

The regulatory process for this device did not involve clinical trials or performance assessments against diagnostic accuracy metrics, as it is a physical therapeutic implant rather than a diagnostic AI/software.

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