(18 days)
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:
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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.
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
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The sample size for the training set: Not applicable. This is a physical medical device, not an AI model requiring a training set.
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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.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.