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BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed Implants are indicated to treat residual tumors following a course of external radiation therapy and for recurrent tumors.

BrachySource® Seed Implants consist of a welded titanium capsule containing lodine-125 absorbed onto a nickel/copper coated, gold cored aluminum wire. The implants are nominally 4.5mm long by 0.8mm in diameter. lodine-125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and a 35.5 keV gamma. The titanium wall of the BrachySource® Seed Implant absorbs the electrons.

The provided text is a 510(k) summary for the BrachySource® Brachytherapy Seed Implants. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance studies in the way a clinical trial for a new drug or a novel medical device would.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct comparison of the device's performance against such criteria. The core of the 510(k) submission is to demonstrate "substantial equivalence" to a predicate device, which implies that the new device is as safe and effective as the existing one.

Instead of a table, the document makes the following statement regarding performance:

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

The document does not provide information about a "test set" in the context of typical device performance evaluation (e.g., a set of patient data or samples used to validate performance metrics like sensitivity/specificity). The testing mentioned is for a "modification" of the device, which is typically engineering or laboratory testing to ensure the modification does not alter the fundamental characteristics or safety.

Therefore, this section cannot be filled out from the provided text.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of submission. The 510(k) is about device design and manufacturing, not diagnostic performance requiring expert interpretation of results.

4. Adjudication Method

This information is not applicable to this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. Brachytherapy seeds are medical devices for treatment, not diagnostic tools that involve human readers interpreting images.

6. Standalone (Algorithm Only) Performance Study

This information is not applicable. This device is a physical brachytherapy seed implant, not an algorithm.

7. Type of Ground Truth Used

This information is not explicitly stated as "ground truth" in the diagnostic sense. The "ground truth" for this device would be its physical and radiological properties (e.g., half-life, energy emission, dimensions, material composition) and its clinical effectiveness in treating tumors. The document implies that these fundamental properties are consistent with the predicate device. For "indications for use," the ground truth would be established by medical consensus and historical clinical outcomes for brachytherapy.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product, not a machine learning algorithm that requires a "training set."

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

This information is not applicable for the reasons stated above.

Summary and Caveats:

The provided text is a 510(k) summary for a brachytherapy seed implant. A 510(k) submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device. This process typically involves:

• Comparison of Intended Use: Showing the new device has the same intended use as the predicate.
• Comparison of Technological Characteristics: Demonstrating that differences in technological characteristics do not raise new questions of safety or effectiveness.
• Performance Data: This usually refers to bench testing, engineering tests, biocompatibility, sterilization validation, software validation (if applicable), and sometimes limited human factors testing, all aimed at confirming the device meets design specifications and is as safe and effective as the predicate. It generally does not involve large-scale clinical trials or diagnostic performance studies with specific sensitivity/specificity acceptance criteria unless a significant functional change or a new indication is being sought.

Therefore, the detailed metrics requested in your prompt (sample sizes for test/training sets, expert consensus, adjudication, MRMC studies, standalone algorithm performance) are typically associated with the development and validation of diagnostic AI tools or novel, high-risk medical devices, not usually with a 510(k) for a brachytherapy seed implant. The "acceptance criteria" here are fundamentally about meeting the requirements for substantial equivalence.

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