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The Brachytherapy Source Device, with apparent activities between 0.19mCi and 1.01mCi, is indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intra-abdominal, and intra-thoracic tumors. Tumors of the head, neck, lung, pancreas and prostate (early stages) are commonly treated.

The Brachytherapy Source Device, with total apparent activities greater than 1.01mCi, is indicated for interstitial treatment of tumors which have the following characteristics; unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation applications as temporary implants.

The Brachytherapy Source Device is indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with seeds.

The Brachytherapy Source Device, Model 9011, is a welded titanium capsule containing Iodine-125 adsorbed onto a silver rod.

Here's an analysis of the provided text regarding the Brachytherapy Source Device, Model 9011.

It's important to note that this document is a 510(k) summary for a medical device, specifically a brachytherapy source. Brachytherapy sources are physical objects that emit radiation for cancer treatment, not a diagnostic AI/ML algorithm. Therefore, many of the requested categories related to AI/ML software performance (like effect size of AI assistance, MRMC studies, ground truth establishment for training, etc.) are not applicable to this type of device. The acceptance criteria and "studies" are focused on the physical characteristics and safety of the radiation source itself, not its diagnostic accuracy or AI performance.

Acceptance Criteria and Device Performance (Brachytherapy Source Device, Model 9011)

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: For a 510(k) submission, "acceptance criteria" are largely based on demonstrating substantial equivalence to a predicate device. This means the new device should be as safe and effective as the predicate, often by meeting the same or equivalent engineering specifications and performance standards. In this case, the predicate's characteristics serve as the de facto acceptance criteria that the new device aims to match or justify deviations from. The substantial equivalence is based on the argument that the modified characteristics (smaller diameter) do not raise new questions of safety or effectiveness, especially since other critical parameters (like capsule material, isotope, length ranges) remained the same.

2. Sample Size for Test Set and Data Provenance

The document does not specify a "test set" in the context of an AI/ML algorithm or a study involving patient data. This is a physical medical device. The "testing" involved:

• Physical Prototypes: "Prototype sources have been manufactured and assessed against predetermined criteria for Design Verification and Design Validation." The exact number of prototypes is not specified.
• Sealed Source Testing: The device was tested according to ISO 2919, which is a standard for sealed radioactive sources. This likely involves a series of physical tests (e.g., temperature cycling, external pressure, impact, vibration, puncture) on a sample of devices to ensure their integrity. The sample size for these specific tests is not explicitly stated in the 510(k) summary, but ISO standards typically define sample requirements.
• Activity Measurements: "Activity measurements have been obtained from NIST Report (Report of Air-Kerma rate measurements)." This refers to calibration and measurement standards from the U.S. National Institute of Standards and Technology.

Data Provenance: Not applicable in the context of patient data as this is a physical device safety and performance evaluation. The provenance of the testing (e.g., "NIST Report") is mentioned, indicating U.S. national standards.

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

Not applicable. This is a physical device, not a diagnostic imaging or AI algorithm that relies on expert interpretation of data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of patient cases requiring expert adjudication.

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

No. This type of study is relevant to diagnostic imaging devices or AI algorithms where human readers interpret medical images. It is not applicable to a radioactive implantable seed.

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

Not applicable. This device is a physical brachytherapy source, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, international standards (ISO 2919), and national metrology standards (NIST).

• Device Specifications: The stated dimensions, materials, and isotope are the design "ground truth."
• Performance Standards: Compliance with ISO 2919 for sealed source integrity ensures the physical safety and containment of the radioactive material.
• Radioactivity Calibration: NIST reports provide the "ground truth" for the accurate measurement of the device's radioactive output (Air-Kerma rate), which is critical for safe and effective dosimetry in patient treatment.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this physical medical device.

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

Not applicable. There is no "training set" for this physical medical device.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets acceptance criteria consists of non-clinical testing focused on the physical and radiological properties of the brachytherapy source.

1. ISO 2919 Testing: The device underwent testing "according to ISO 2919 for sealed sources." This standard specifies the classification of sealed radioactive sources based on their safety requirements and defines a series of environmental and mechanical tests (e.g., temperature, external pressure, impact, vibration, puncture) designed to demonstrate that the source will maintain its integrity and containment of radioactive material under normal and accident conditions. Meeting this standard indicates the physical robustness and safety of the sealed source.
2. NIST Report for Activity Measurements: "Activity measurements have been obtained from NIST Report (Report of Air-Kerma rate measurements)." This confirms that the radioactive output of the device (Iodine-125) has been accurately measured and calibrated to national standards as verified by the National Institute of Standards and Technology. Accurate activity measurement is fundamental for physicians to calculate appropriate treatment dosages for patients.
3. Design Verification and Design Validation: "Prototype sources have been manufactured and assessed against predetermined criteria for Design Verification and Design Validation." This process ensures that the manufactured device meets its design specifications (verification) and fulfills its intended use requirements (validation). This typically involves comparing actual prototype performance against the established design requirements and user needs.

These non-clinical tests demonstrate that the Brachytherapy Source Device, Model 9011, is physically safe, robust, and accurately characterized in terms of its radioactive output, thereby establishing its substantial equivalence to the predicate device despite minor dimensional changes.

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Imagyn 125I Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can to 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 Imagyn 125I Seeds use 125I beads encapsulated in a titanium tube.

The provided document does not contain information about acceptance criteria or a study proving the device meets them in the way typically expected for a diagnostic or AI device.

This document is a 510(k) summary for a medical device called the "Imagyn 1251 Seed," which is a brachytherapy seed used for treating localized tumors. The submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than performing a performance study to meet specific acceptance criteria for a new type of device or an AI algorithm.

Here's a breakdown of why the requested information isn't present and what is discussed:

1. Table of acceptance criteria and the reported device performance: Not applicable. The document states, "There are no biocompatibility or other safety and effectiveness differences between this device and other predicate devices." The substantiation is based on similarity to already approved devices.

2. Sample size used for the test set and the data provenance: Not applicable. There was no specific "test set" in the context of typical device performance evaluation (e.g., for diagnostic accuracy). The comparison is foundational, asserting that the new device's design (encapsulation method, activity range) is similar to approved devices.

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" was established in the context of evaluating a diagnostic or AI device's performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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. This device is a brachytherapy seed, not an imaging or diagnostic AI-powered device that a human reader would use.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.

8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding "acceptance criteria" and "proof":

Instead of performance criteria and studies, the document describes the following:

• Acceptance Criteria/Proof: The device's "acceptance" is based on demonstrating substantial equivalence to predicate devices already approved by the FDA. The crucial statement is: "The Imagyn 1251 Seed has been tested for safety and biocompatibility by standard tests used for radionuclide devices and found to safe and effective and substantially equivalent to other predicate devices."
• Study/Evidence: The "study" isn't a performance trial but rather a comparison of technological characteristics and safety/biocompatibility testing against existing standards and predicate devices.
  • Technological Characteristics: The device "uses the same type of encapsulation of I251 as predicate devices. The range of activity is similar to other devices."
  • Safety and Biocompatibility: It "has been tested for safety and biocompatibility by standard tests used for radionuclide devices." While the specific details of these standard tests are not included in this summary, the FDA's acceptance of the 510(k) implies these tests were deemed sufficient for demonstrating equivalence.

In essence, the device meets "acceptance criteria" by being proven to be "substantially equivalent" to legally marketed predicate devices in terms of its intended use, technological characteristics, safety, and effectiveness. This is a common pathway for medical device approval, particularly for devices that are variations of existing technologies.

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