(157 days)
The Nfick Radio-Nuclear Instruments, Inc. Vienna System is intended to be used as an accessory to the Nfick CT HDR Tandem / Ring Applicator and is indicated for High Dose Rate irradiation of the vierus and cervix.
The Vienna System consists of perforated Build-Up Caps and complementary Needle Collectors which connect to the Nfick CT HDR Tandem / Ring Applicator. The Vienna System is comprised of two sizes of Build-Up Caps, both 5.0mm & 7.5mm, to replicate the original Build-Up Caps in the applicator set and complementary Needle Collectors. The system is designed to utilize implanted rigid interstitial needles that are commercially available and must be purchased separately. The Vienna System is not designed to be used in conjunction with any type of Rectal Retractor. The Vienna Build-Up Caps have nine pre-drilled holes in the circumference of the Build-Up ring to accept separate interstitial needles for a wider dose distribution during treatment. One size Vienna Build- Up Cap can accommodate all three angles of Rings and Tandems. Needle Collectors are offered as part of the system and are used to "collect", stabilize and protect interstitial needles inserted through the Vienna Build-Up Cap. The Needle Collector is offered in three different angles (30°, 45° & 60°) and all have nine channels oriented to the pre-drilled hole positions in the Vienna Build-Up Cap.
The information provided is for a 510(k) premarket notification for the Vienna System, an accessory to a remote controlled radionuclide applicator system used in brachytherapy. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria in the context of diagnostic accuracy.
Therefore, many of the requested points regarding acceptance criteria, study design, and performance metrics for an AI/device algorithm are not applicable to this type of regulatory submission. The document emphasizes mechanical design, material equivalence, and intended use as the basis for clearance.
Here's a breakdown of the relevant information from the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantitative performance metrics for a diagnostic or AI device. The acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices in terms of design, construction, materials, intended use, and performance characteristics (which are mechanical/functional in nature, not diagnostic accuracy). The core "acceptance" is that "No new issues of safety or effectiveness are introduced by using this device."
- Reported Device Performance: No quantitative performance metrics (ee.g., sensitivity, specificity, accuracy) are reported because the device is an accessory for brachytherapy application, not a diagnostic or AI-driven decision support system. The performance is inferred by its equivalence to predicate devices and its ability to function as intended without altering the indication of use of the main applicator.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission does not involve a "test set" in the context of evaluating a diagnostic algorithm's performance on patient data. It's a review of a medical device accessory's design and materials.
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. There is no "ground truth" establishment in the context of diagnostic assessment for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication for diagnostic outcomes.
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 is not an AI-assisted diagnostic device, so no MRMC study or AI improvement metrics are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth for diagnostic purposes is used. The "ground truth" in this context is the established safety and effectiveness of the existing predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI algorithm.
Summary of Relevant Information from the Document:
- Device Name: Vienna System
- Regulatory Class: II (21 CFR 892.5700)
- Product Code: JAQ
- Intended Use: As an accessory to the Mick CT HDR Tandem/Ring Applicator for High Dose Rate irradiation of the uterus and cervix. It enhances the standard HDR treatment by enabling the introduction of up to nine interstitial needles.
- Key Argument for Clearance: Substantial Equivalence to predicate devices (K030110, K122840, K080934).
- Basis for Substantial Equivalence:
- Similar in design and construction.
- Utilizes the same materials (Acetal for Build-Up Cap, Titanium for Colpostat/Tandem material).
- Has the same intended use and performance characteristics (mechanical/functional).
- Crucially, "No new issues of safety or effectiveness are introduced by using this device."
- Manufacturing: According to Good Manufacturing Practices (GMPs) as defined in 21 CFR part 820.
- Biocompatibility: No new issues raised regarding materials.
- Performance Testing: "Performance Test Results or In vitro Testing / In vivo Testing are not applicable to the Vienna System" because no new issues of safety or effectiveness are raised and the fundamental scientific technology is unchanged from the predicate devices.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.