(35 days)
The SAVI Applicator is intended for use as an accessory to commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the SAVI Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.
The SAVI Applicator is an expandable cylindrical device with radially positioned catheters, which is inserted into the target volume. The SAVI Applicator is provided sterile and is a single use device.
Let's break down the information provided about the Cianna Medical SAVI Applicator Kit (K081677) to address your questions.
It's important to note that this 510(k) submission is for a medical device (applicator) used in brachytherapy, not an AI or software-as-a-medical-device (SaMD) product. Therefore, many of the questions related to AI performance metrics, ground truth establishment, and training/test sets for algorithms are not directly applicable or discussed in this type of submission. The focus here is on demonstrating substantial equivalence to predicate devices through physical performance testing and intended use.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria in a table format for performance metrics that would be analogous to sensitivity, specificity, or accuracy for an AI system. Instead, the performance testing focuses on demonstrating the integrity, suitability, and substantial equivalence of the device through engineering and biocompatibility tests.
The typical acceptance criteria for a device like this would revolve around its physical properties, sterility, dimensional accuracy, material compatibility, and functionality as an accessory to existing brachytherapy equipment.
| Acceptance Criteria (Implied by context) | Reported Device Performance (Summary from text) |
|---|---|
| Device Integrity | "Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device." (No specific quantitative results are provided in this summary, but the FDA's clearance implies successful completion of such tests.) |
| Suitability for Intended Use | "Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device." (Implied to be suitable as an accessory to remote afterloading equipment for delivering radiation.) |
| Substantial Equivalence to Predicates | "The SAVI Applicator is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics." |
| "Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the SAVI Applicator is determined to be substantially equivalent to existing legally marketed devices." | |
| Sterility | "The SAVI Applicator is provided sterile and is a single use device." (This implies testing to ensure sterility standards are met.) |
| Biocompatibility | (Not explicitly stated in the summary, but required for medical devices. Testing would have been performed to ensure the materials are safe for human contact.) |
| Dimensional Accuracy/Fit | (Not explicitly stated in the summary, but required for proper function and compatibility with remote afterloading equipment. Testing would have been performed.) |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the context of an AI/SaMD study for this device. The "test set" for this physical device would involve a series of engineering tests on a sample of manufactured applicators to verify physical properties, rather than a clinical dataset for an algorithm. The document does not provide details on the number of units tested for physical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable. The "ground truth" for a physical medical device like the SAVI applicator is established through engineering and biological testing against predefined specifications and regulatory standards, not expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of data (e.g., medical images for an AI system). For a physical device, performance is typically assessed against objective test methods and specifications.
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 question is not applicable. The SAVI Applicator is a physical medical device, not an AI system or an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The SAVI Applicator is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance would be:
- Engineering specifications: Compliance with design drawings, material properties, and dimensional tolerances.
- Sterility standards: Confirmation of adherence to established sterilization protocols.
- Biocompatibility standards: Evidence that the materials are safe for human contact per ISO 10993 or equivalent standards.
- Functionality verification: Demonstrating that the device can successfully integrate and function with remote afterloading equipment as intended.
8. The Sample Size for the Training Set
This question is not applicable. The device is not an AI system that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. As there is no AI algorithm, there is no training set or ground truth in that context.
§ 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.