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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.

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.

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The SAVI Applicator Kit 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.

This submission for the SAVI Applicator Kit (K080565) from Cianna Medical, Inc. is a 510(k) premarket notification. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on comparability rather than extensive new clinical trial data with specific acceptance criteria and detailed performance metrics as one might find for a novel, high-risk device.

Based on the provided text, a detailed table of acceptance criteria and reported device performance, as well as an effect size from an MRMC study, sample size for training/test sets, or information about expert ground truth adjudication, are not explicitly stated or applicable in the context of this 510(k) submission.

Here's a breakdown of the available information according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided as a quantifiable table with specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity). The submission's "Performance Data Summary" states: "Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device."

The conclusion further states: "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."

This implies that the performance demonstration was to show that the SAVI Applicator performs at least as well (or equivalently) to its predicate devices for its intended use, rather than meeting specific numerical performance targets.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/Not provided. This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, often supported by bench testing and sometimes small clinical studies for specific aspects if there are significant technological differences. The document does not describe a traditional clinical study with a "test set" in the context of AI or diagnostic device performance evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable/Not provided. As there's no described "test set" and ground truth establishment in the context of AI or diagnostic performance, this information is not present.

4. Adjudication Method for the Test Set

Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

No information provided. This is unlikely for a device of this nature and type of submission (510(k) for substantial equivalence of an accessory device).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable/Not provided. The SAVI Applicator is a physical medical device (an accessory to brachytherapy equipment), not an algorithm or AI.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable/Not provided in the context of a "test set" evaluation. The "ground truth" for this device's approval is its substantial equivalence to predicate devices, meaning it meets the same functional and safety requirements that previous similar devices have already established.

8. The Sample Size for the Training Set

Not applicable/Not provided. This is not an AI or machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided.

Summary of Device and Approval Context:

The SAVI Applicator is an "accessory to commercially available remote afterloading equipment used during brachytherapy procedures." Its function is to "provide pathways from which a prescribed radiation dose is delivered to the treatment area."

The approval (K080565) is based on a 510(k) submission, which aims to demonstrate substantial equivalence to predicate devices (Biolucent Applicator K062830, K061241, K070659).

The "Performance Data Summary" indicates that "Performance testing was conducted on the SAVI Applicator to demonstrate the integrity, suitability and substantial equivalence of the device." This typically involves bench testing, material compatibility, and engineering analyses to ensure the device performs as intended and is as safe and effective as the predicate devices.

Key FDA Limitation: The FDA, in its approval letter (K080565), imposed a specific warning: "The safety and effectiveness of the SAVI Applicator Kit for breast brachytherapy as a replacement for whole breast irradiation in the treatment of breast cancer has not been established." This highlights that while the device was found substantially equivalent for its intended accessory use, its potential broader implication as a replacement therapy had not been proven and required a specific disclaimer.

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