(29 days)
GENETRA ™ with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized tumors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent turnors. GENETRA may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.
GENETRA ™ utilizes Pd-103 as the radionuclide for brachytherapy. GENETRA™ exists in the form of a coiled rhodium wire. The rhodium matrix also provides the radiopacity of the device. GENETRA™ is a naturally sealed source in the form of a wire. GENETRA™ is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave. GENETRA™ will be manufactured, labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to specifications. The devices will be tested in accordance with Standard Operating Procedures. The sources are delivered using a 19 gauge needle and stylet.
The provided document describes the GENETRA™ brachytherapy radionuclide source and its submission for 510(k) clearance. However, it does not contain a detailed study report with specific acceptance criteria and performance data for a device in the context of diagnostic AI or image analysis.
The document focuses on comparing GENETRA™ to its predicate device (RadioMed™ Source K001070) based on shared technological characteristics and compliance with manufacturing and safety standards. The "Performance Testing" section lists categories of tests but provides no numerical acceptance criteria or performance results.
Therefore, I cannot directly answer most of your detailed questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or comparative effectiveness with AI. The device described is a medical implant (radioactive source), not a diagnostic AI or imaging device that would typically involve such studies.
Here's a breakdown of what can be extracted or inferred from the provided text, addressing your points where possible, and noting where information is missing:
Acceptance Criteria and Device Performance for GENETRA™
The document does not explicitly state numerical acceptance criteria or specific performance results for the GENETRA™ device in the format typically used for diagnostic or AI-based devices. Instead, performance is framed in terms of meeting established industry standards for radioactive sources and being identical in fundamental design and characteristics to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Inferred from standards and predicate comparison) | Reported Device Performance (Inferred from "Summary of standards achieved" and "identical to predicate") |
|---|---|---|
| Material Composition | Identical to predicate RadioMed™ Source (rhodium matrix). Radionuclide: Palladium - 103, identical to predicate. Packaging: modified from original stainless steel cartridge to utilize a glass barrel, but fundamentally similar. | GENETRA™ uses rhodium as did the predicate RadioMed™ Source. Radionuclide for GENETRA™ is Palladium - 103, which is the same as the predicate. |
| Energy Emission | Identical to predicate RadioMed™ Source (20-23 keV x-rays). | Energy emitted for GENETRA™ and the RadioMed™ Source is identical: 20-23 keV x-rays. |
| Physical Design | Identical to predicate RadioMed™ Source. "Sealed source in the form of a wire from which to deliver a therapeutic dosage of radioactive energy." | The design of the predicate RadioMed™ Source is identical to GENETRA™. |
| Sterilization | To be sterilized by the end-user in accordance with a validated sterilization process (exposure to steam autoclave). Complies with AAMI Standard 11134-1994 (Recommended practice for Steam Autoclave). | Device is packaged non-sterile, single use, and is to be sterilized by the end user via steam autoclave. Compliance with AAMI 11134-1994 is listed. |
| Manufacturing Quality | Compliance with FDA QSR 21 CFR Part 820 Good Manufacturing Practices. Devices inspected to assure compliance to specifications and tested in accordance with Standard Operating Procedures. | Manufactured, labeled, and packaged under GMP controls. Inspected to assure compliance to specifications. Tested in accordance with Standard Operating Procedures. |
| Biological Evaluation | Compliance with ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices. | Compliance with ISO 10993-1 1992 (E) listed. |
| Sealed Source Testing | Compliance with ANSI N43.6-1997 (Classification of sealed radioactive sources), ANSI N44.1-1973 (Integrity and Test Specifications for selected Brachytherapy Sources), ANSI N44.2-1973 (Leak testing radioactive brachytherapy sources), and ISO 9978: 1992(E) ("Radiation protection - Sealed radioactive sources - Leakage test methods"). | Compliance with ANSI N43.6-1997, ANSI N44.1-1973, ANSI N44.2-1973, and ISO 9978: 1992(E) listed under "Summary of standards achieved." "Sealed Source Testing" is one of the four performance categories. |
| Needle Gauge | Delivery through a 19 gauge needle and stylet. (Predicate uses 17 or 18 gauge). | GENETRA™ sources are delivered using a 19 gauge needle and stylet. (This is a design modification from the predicate, but is a stated characteristic of GENETRA™). |
| Activity Range | 0.1 to 5.0 mCi per centimeter length. | GENETRA™ produced with activities from 0.1 to 5.0 mCi per centimeter length. |
| Radiation Energy | No specific numerical acceptance criteria provided in the text beyond "identical to predicate". | "Radiation Energy" is listed as a performance category. The energy emitted is 20-23 keV x-rays, identical to the predicate. |
| Source Strength Measurement: Calibration and Calibration Accuracy | No specific numerical acceptance criteria provided in the text. | "Source Strength Measurement: Calibration and Calibration Accuracy" is listed as a performance category. No specific results are reported. |
| Dose Comparison | No specific numerical acceptance criteria provided in the text. | "Dose Comparison" is listed as a performance category. No specific results are reported, but given the identical radionuclide and energy, the dose characteristics are implied to be clinically comparable to the predicate. |
Missing Information (Not applicable or not typically included for this type of device)
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set of clinical cases or patient data is mentioned as this is a device clearance for a radiation source based on substantial equivalence and engineering standards, not a clinical trial of its efficacy with patient outcomes in a diagnostic context.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical diagnosis or image interpretation is not relevant for this type of device submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI or diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a device quality and safety submission based on substantial equivalence. The "ground truth" here is compliance with engineering, manufacturing, and safety standards for radioactive sources.
- The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.