Search Results
Found 1 results
510(k) Data Aggregation
(50 days)
CAPRI APPLICATOR
The CAPRI™ Applicator is intended for use during brachytherapy procedures. The multiple lumens of the CAPRI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
The CAPRI Applicator is a specialized applicator that is temporarily inserted into the vagina or rectum to facilitate the application of radiation to the target site in the treatment of carcinoma. The CAPRI Applicator is provided sterile for single use and is disposable.
The provided text describes a 510(k) summary for the CAPRI™ Applicator, a brachytherapy applicator. This type of regulatory submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a standalone study with defined acceptance criteria and statistical analysis.
Based on the provided document, the following observations can be made regarding acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria and reported device performance in the manner typically seen for algorithmic or diagnostic devices. Instead, it states:
| Criterion | Reported Performance |
|---|---|
| Substantial Equivalence | "All necessary verification and validation testing has been performed for the CAPRI Applicator to assure substantial equivalence to the predicate devices." (Predicate devices: BioLucent's Applicator (K061241) and Nucletron's Miami Applicator (K953946)) |
| Intended Use | "Substantially equivalent in intended use... to the BioLucent Applicator (K061241) and the Nucletron Miami Applicator (K953946)." |
| Principle of Operation | "Substantially equivalent in... principle of operation... to the BioLucent Applicator (K061241) and the Nucletron Miami Applicator (K953946)." |
| Technological Characteristics | "Substantially equivalent in... technological characteristics... to the BioLucent Applicator (K061241) and the Nucletron Miami Applicator (K953946)." Also states: "The CAPRI Applicator has similar physical and technical characteristics to the predicate devices." |
| Safety and Efficacy | "Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the CAPRI Applicator is determined by VivaRay, to be substantially equivalent to existing legally marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention a "test set" in the context of an AI/algorithmic device evaluation. The CAPRI™ Applicator is a physical medical device (brachytherapy applicator). Therefore, concepts like retrospective/prospective data, country of origin of data, and sample sizes for test sets are not applicable to the evidence presented for this device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to the CAPRI™ Applicator as it is a physical device, not an AI or diagnostic algorithm requiring expert-established ground truth from images or other data.
4. Adjudication Method:
This information is not applicable for the same reasons mentioned in point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is relevant for evaluating the impact of AI on human reader performance (e.g., radiologists interpreting images). Since the CAPRI™ Applicator is a physical brachytherapy applicator and not an AI-powered diagnostic tool, an MRMC study was not conducted and is not relevant to its submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This type of study is relevant for AI algorithms. As the CAPRI™ Applicator is a physical device, a standalone algorithm performance study was not conducted and is not relevant.
7. Type of Ground Truth Used:
Ground truth, in the context of AI/diagnostic algorithms, refers to the definitive correct answer for a given case. For the CAPRI™ Applicator, the "ground truth" equivalent would be its manufacturing specifications, material properties, and functional performance, which are evaluated through verification and validation testing (e.g., mechanical, biocompatibility, sterilization, dimensional accuracy). The document states: "All necessary verification and validation testing has been performed for the CAPRI Applicator to assure substantial equivalence to the predicate devices."
8. Sample Size for the Training Set:
This information is not applicable as the CAPRI™ Applicator is a physical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons mentioned in point 8.
In summary:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the CAPRI™ Applicator to existing legally marketed predicate devices, rather than presenting a performance study with defined acceptance criteria and statistical results for an AI or diagnostic algorithm. The evidence presented relates to the physical and technical characteristics, intended use, and principle of operation being similar to the predicates, supported by "necessary verification and validation testing." The structure of the information requested (points 1-9) is primarily geared towards AI/algorithmic devices, which the CAPRI™ Applicator is not.
Ask a specific question about this device
Page 1 of 1