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The RadioMed"10 Source with activities from 0.1 to 5.0mCi per centimeter is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The Pd-103 sources may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

The RadioMed™ source utilizes Pd-103 as the radionuclide for brachytherapy. The RadioMed The Source exists in the form of a coiled rhodium wire. The rhodium matrix also provides the radiopacity of the device. The RadioMed™ Source is a naturally sealed source in the form of a wire.

The RadioMed The Source is packaged non-sterile, single use, and is intended to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave.

The RadioMed" Source will be manufactured. labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to specifications. The devices will be tested in accordance with Standard Operating Procedures.

The sources are delivered in the same manner as brachytherapy seeds currently on the market, i.e. a 17 or 18-gauge needle and stylet.

The provided text describes a 510(k) premarket notification for the "RadioMed™ Source," a brachytherapy radionuclide source. It primarily focuses on demonstrating substantial equivalence to existing predicate devices. Consequently, the document does not detail specific acceptance criteria for performance metrics or present a study proving the device meets those criteria in the way one might expect for a diagnostic or AI-driven device.

Instead, the "Performance Testing" section outlines the standards achieved for different aspects of the device, implying that compliance with these standards serves as the "acceptance criteria" and the "study" is the demonstration of adherence to these standards.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text for certain categories:

Acceptance Criteria and Device Performance Study for RadioMed™ Source

The RadioMed™ Source is a brachytherapy radionuclide source. Its "performance" is subdivided into four categories, and the device's acceptance is based on its compliance with established standards and specifications for these categories and general regulatory requirements.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of a typical clinical trial or performance study for a diagnostic device. The performance testing appears to refer to engineering and quality assurance tests conducted on manufactured units.

• No specific sample size for a "test set" is mentioned.
• Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as the testing relates to manufacturing and product specifications rather than clinical data.

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

Not applicable. The ground truth for this device is based on objective measurements against engineering standards, physical properties of the radionuclide, and established regulatory benchmarks, rather than subjective expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective data (e.g., image interpretation). For this device, compliance is determined by objective measurements and adherence to technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a brachytherapy source, not a diagnostic imaging or AI-driven device intended to assist human readers. Therefore, an MRMC study is irrelevant to its evaluation.

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

Not applicable. The RadioMed™ Source is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the RadioMed™ Source's performance and safety is:

• Engineering Specifications: Compliance with design blueprints and material properties.
• Physical Standards: Adherence to established physical properties of the radionuclide (Pd-103 energy emission).
• Regulatory Standards: Compliance with national and international standards for medical devices, manufacturing (GMP, QSR), radiation safety (ANSI, ISO), and biocompatibility (ISO).
• Predicate Device Equivalence: The comparison to legally marketed predicate devices serves as a "ground truth" for demonstrating substantial equivalence in function and safety.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

Not applicable, as there is no training set.

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