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The BEBIG IsoSeeds® Pd-103 are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.

The BEBIG Pd-103 Radionuclide Brachtherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intraabdominal and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.

The BEBIG IsoSeeds® Pd-103 are cylindrical sealead sources containing Pd-103 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium being closed at one end and sealed by a laser weld at the other end in a final step. The metallic palladium-103 is deposited within a porous ceramic tube. A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The radiopaque marker is composed of gold wire.

Palladium seeds have a half live of 16,97 days and are available in a range of activity levels. The BEBIG IsoSeeds® Pd-103 are provided non-sterile and must be sterilized prior to use.

The provided text is a 510(k) summary for the BEBIG IsoSeeds® Pd-103 device, which describes a brachytherapy source. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study of device performance against specific acceptance criteria in the manner typically seen for novel software or diagnostic devices.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as such a study is not typically part of a 510(k) submission for this type of device.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance: The document lists standards and regulations the device complies with (e.g., DIN EN 1441, ISO 9978), but these are not specific performance metrics with acceptance thresholds and measured results in the context of a clinical study.
2. Sample size used for the test set and data provenance: No clinical test set or data provenance is mentioned.
3. Number of experts and their qualifications: No expert ground truth establishment is described.
4. Adjudication method: No adjudication method is mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not relevant to a brachytherapy seed and is not mentioned.
6. Standalone performance study: No standalone performance study against specific clinical metrics is presented.
7. Type of ground truth used: No ground truth in the context of clinical performance is discussed.
8. Sample size for the training set: No training set is mentioned as this is not an AI/ML device.
9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on:

• Device Description: What the device is and how it's constructed.
• Intended Use and Indications: For what purpose the device is used.
• Predicate Devices: Identification of existing, legally marketed devices to which the new device is substantially equivalent.
• Compliance with Standards: A list of international and national standards/regulations that the device manufacturing process and design adhere to (e.g., ISO, DIN EN, FDA QSR). This is the primary "proof" of safety and effectiveness in a 510(k) for this type of medical device – demonstrating that it meets established engineering, quality, and safety standards, and is similar in function and design to already approved devices.

In essence, the "study" proving the device meets criteria in a 510(k) context for a device like this is the demonstration of adherence to these relevant standards and substantial equivalence to predicate devices, rather than a clinical performance study with specific acceptance criteria as you might find for a diagnostic AI product.

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