(29 days)
The Best Radiopaque Strand (Marker Strand) is made of radiopaque xxx markers (i.e, seeds) and absorbable spacers, inside an absorbable strand, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures.
The Best Radiopaque Marker (Marker) is made of a radiopaque xxx solid seed, is indicated for use in brachytherapy, soft tissues, or organ tissue, but should not be used during cardiovascular or neurological procedures.
The Best Radiopaque Strand (marker strand) is composed of two radiopaque markers, separated by absorbable spacers, and enclosed in an absorbable strand. It is supplied sterile.
The Best Radiopaque Marker (marker) is composed of a radiopaque nonradioactive seed (gold, platinum, stainless steel, titanium, or tungsten) which is supplied non-sterile.
The placement of the markers and marker strand in soft tissue, prior to therapeutic procedures, allows better dosimety coverage of the targeted site due to clearer identification of the anatomic regions.
The provided text is a 510(k) summary for the Best Radiopaque Strand and Best Radiopaque Marker. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to legally marketed predicate devices.
However, this document does not contain explicit acceptance criteria or a study demonstrating that the device meets specific performance criteria. The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies with acceptance criteria in the same way a clinical trial for a new drug or a more complex medical device might.
Therefore, many of the requested details about acceptance criteria and study design are not present in this document.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices, which implies that the performance is at least similar to the predicate, but specific quantitative acceptance criteria are not given.
- Reported Device Performance: The document describes the characteristics and intended use of the device, primarily that it is a radiopaque marker or strand for brachytherapy and soft tissue/organ localization. It does not provide quantitative performance metrics (e.g., visibility in specific imaging modalities, migration rates, etc.) that would typically be associated with a "reported device performance" in the context of 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)
- Not provided. The document does not describe any specific test set or clinical study with patient data.
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)
- Not applicable/Not provided. Since no specific test set or ground truth establishment process is described, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No test set or adjudication process is mentioned.
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 physical radiopaque marker, not an AI or software device. Therefore, an MRMC study comparing human readers with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical radiopaque marker, not an algorithm or software.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No specific ground truth for performance evaluation is mentioned, as the submission focuses on substantial equivalence to predicate devices rather than a detailed performance study with a defined ground truth.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/machine learning device, so there is no training set in that context. If "training set" refers to any pre-clinical testing or validation work on the materials or design, that information is not detailed in this summary.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
In summary:
This 510(k) summary focuses on the administrative process of demonstrating substantial equivalence of the Best Radiopaque Strand and Best Radiopaque Marker to existing predicate devices. It provides device descriptions, intended use, and classification information. It does not include detailed studies with specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods typically found in a performance study report for a novel or more complex device, especially those involving AI or diagnostic interpretation. The FDA's letter confirms that substantial equivalence was found based on the provided information, allowing the device to be marketed.
§ 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.