(42 days)
RAPID Strand™ Rx is a device specifically made in accordance with a medical specialist's written prescription, specified dose and design characteristics. It is intended to be use only for an individual named patient and 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.
RAPID Strand ™ Rx is indicated for permanent interstitial implantation of selected localized tumors, which are low to moderate radio sensitivity. They may be used either as primary tunnors, which are low to moderate racterestable tumors) or for treatment of residual disease after excision of the primary tumor.
RAPID Strand™ Rx may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
RAPID Strand™ Rx is consists of absorbable seeding spacers and radionuclide brachytherapy sources spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method. The apparent activity of the seed ranges from 0.191 to 1.01 mCi that correspond air kerma strength value of 0.243 to 1.285 µGym2/h per seed. RAPID Strand™ RX is sterilized and ready to be use when shipped. RAPID Strand™ Rx should not be re-sterilized.
The provided text is a 510(k) summary for the RAPID Strand™ Rx, a radionuclide brachytherapy source. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a standalone clinical study or multi-reader multi-case (MRMC) study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present in this type of regulatory submission.
Here's an breakdown of the information that can be extracted and a clear indication of what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the 510(k) summary. The document focuses on demonstrating equivalence to a predicate device, not on meeting predefined acceptance criteria for novel performance.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The submission states "Non-clinical test data that includes design validation, process validation, bench test results and sterilization validation have been provided in the Section-H." However, it does not specify sample sizes or data provenance for a clinical test set because a clinical study of this nature appears not to have been conducted for this submission. The "test set" here refers to non-clinical bench testing.
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/provided. There is no mention of a clinical test set requiring expert ground truth establishment. The evaluation is against a predicate device based on technological characteristics and non-clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No clinical test set requiring an adjudication method is described.
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
This information is not applicable/provided. The device is a radionuclide brachytherapy source, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the context of a clinical study. The device's "ground truth" for its safety and effectiveness is largely based on its technological characteristics being equivalent to a predicate device that has already been deemed safe and effective. Non-clinical testing would have relied on established engineering and materials standards.
8. The sample size for the training set
This information is not applicable/provided. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
Summary of available information regarding the device and its assessment from the provided text:
- Device: RAPID Strand™ Rx, a radionuclide brachytherapy source.
- Purpose of Submission: To demonstrate substantial equivalence to a legally marketed predicate device (RAPID Strand™) under 510(k) K030594 and K940632.
- Basis for Equivalence:
- Comparison of similar and different technological characteristics presented in "Section-F".
- All components of the subject device have been previously cleared through the 510(k) process.
- Changes made to the design and manufacturing processes do not raise questions about safety and efficacy, supported by "Non-clinical Test Data" (design validation, process validation, bench test results, sterilization validation) provided in "Section-H".
- The labeling has been revised for clarity, and these changes are non-significant.
- Conclusion of FDA: The FDA determined the device to be substantially equivalent to legally marketed predicate devices.
In essence, this 510(k) submission is a "predicate device" pathway, meaning the manufacturer is asserting their device is so similar to an already approved device that it doesn't require new clinical efficacy and safety studies based on novel acceptance criteria. The "study" mentioned is the comparison to the predicate and the non-clinical bench testing, which is implicitly accepted if it demonstrates the equivalence and safety of the changes.
§ 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.