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I3RAD 1351 Seeds 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 of residual disease after excision of the primary tumor or recurring turnors. They may also be used at completion of external beam radiation therapy. Tumors of the head, neck, lung, pancreas, breast, prostate (early stages), and other accessible tumors are commonly treated.

The I3RAD. 1251 Seeds use 1251 beads encapsulated in a titanium tube.

The provided text describes a 510(k) premarket notification for the International Isotopes Inc. I3RAD 125I Seed, a radionuclide brachytherapy source.

This submission does NOT contain the details of a study that establishes acceptance criteria or reports device performance based on objective metrics.

Instead, the documentation focuses on demonstrating substantial equivalence to previously marketed devices. The core of the argument is that the I3RAD 125I Seed is technologically similar to its predicates (EndoSeed, Amersham Model 6711, Mentor IoGOLD) and thus, is expected to be equally safe and effective.

Here's what can be extracted and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics in the provided document. The acceptance criteria seem to be implicit in demonstrating "safety and efficacy" and "substantial equivalence" to predicate devices, which implies meeting the performance standards already established for those devices.
• Reported Device Performance: No specific quantitative performance data (e.g., radiation output accuracy, seed integrity under specific conditions) derived from a study of the I3RAD 125I Seed are reported in this summary. The summary states: "The I3RAD 125 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." This is a qualitative statement of compliance, not a report of specific performance values against defined acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document refers to "standard tests," but no sample sizes for these tests are provided.
• Data Provenance: Not specified. It's unclear if the testing was performed internally by International Isotopes, Inc. or by an external laboratory, or where it occurred. The nature of "standard tests" for radionuclide devices would typically involve physical and radiological measurements rather than clinical data in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable and not provided. The "ground truth" concept relating to expert consensus or clinical outcomes is typically relevant for diagnostic AI/software devices. For a physical medical device like a brachytherapy seed, the "ground truth" would be established through physical and radiological measurements and engineering specifications, often against international or national standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable and not provided. Adjudication methods are typically relevant for human-interpretable data (e.g., images) where multiple experts might disagree on findings.

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 AI software or a device that involves human readers interpreting data.

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

• Not applicable. This device is a brachytherapy seed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• As discussed in point 3, the concept of "ground truth" in the cognitive sense (like expert consensus on an image or pathology for a diagnosis) doesn't directly apply here. For this type of physical device, the "ground truth" is established by physical and radiological measurement standards (e.g., measurements of activity, dose rate, physical dimensions, material composition, biocompatibility testing standards). The review process by the FDA, including their determination of "substantial equivalence," implies that these standards were met.

8. The sample size for the training set

• Not applicable. This device is a physical brachytherapy seed, not an AI model requiring a training set.

9. How the ground truth for the training set was established

• Not applicable.

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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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