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The Aarhus Applicator Set is indicated for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy within a hospital CT or MRI environment.

The Aarhus Applicator Set is an applicator for intracavitary/interstitial brachytherapy. The Applicator is inserted into the patient and connected to an afterloader. The applicator acts to guide the radioactive source from the afterloader to the correct location or locations for treatment. This combination places the remote-controlled radioisotope treatment source (brachytherapy source) nearby the target tissue.

Device Acceptance Criteria and Performance Study Analysis for Aarhus Applicator Set (K222775)

Based on the provided FDA 510(k) summary for the Aarhus Applicator Set (K222775), this device is a medical accessory for brachytherapy treatment and not an AI/ML-enabled software device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI/ML software (e.g., performance metrics like sensitivity, specificity, AUC) is not directly applicable in the same manner.

This 510(k) submission focuses on demonstrating substantial equivalence to a predicate device (K150839 - 3D Interstitial Ring Applicator Set). Substantial equivalence means the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The "acceptance criteria" in this context are primarily related to safety, performance, and technological similarity to the predicate, verified through non-clinical testing.

Here's a breakdown of the information requested, interpreted in the context of this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a physical medical device (an applicator set) for brachytherapy, the acceptance criteria are not typically presented as quantitative diagnostic performance metrics like those for AI/ML software. Instead, they relate to:

• Functionality: Does the device perform its intended physical role (guiding radioactive sources)?
• Safety: Does the device pose undue risks to patients or users? This includes material biocompatibility, sterility, mechanical integrity, and compatibility with other medical equipment.
• Performance: Does it meet design inputs for its specified use (e.g., accurate source positioning, durability)?
• Compatibility: Is it compatible with relevant afterloaders (VariSource iX, 200, BRAVOS models) and imaging environments (CT, MRI)?

Table: Acceptance Criteria (Implied) and Reported Device Performance (as per 510(k))

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

This is not applicable in the typical sense of an AI/ML test set with patient data. The "tests" performed are non-clinical verification and validation activities on the device itself.

• Sample Size: Not specified as a number of "cases" or "patients." These would be engineering tests, potentially involving multiple units of the applicator set to ensure reproducibility and reliability. The document states "Validation testing was performed on production equivalent devices."
• Data Provenance: Not applicable. This is not clinical data but rather data generated from engineering and performance testing.

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

This is not applicable. "Ground truth" in the context of an AI/ML study refers to a definitive diagnosis or outcome. For a physical device like this, "ground truth" is adherence to engineering specifications, safety standards, and functional requirements. These are established through:

• Design Input Requirements: Defined by Varian's internal design control processes.
• Industry Standards: Conformance to relevant ISO and AAMI standards (e.g., ISO 14971, IEC 62366-1, ISO 10993 series, ANSI AAMI ST79, IEC 60601-2-17, etc.).
• Qualified Personnel: The document states "Validation testing was performed... by qualified personnel," but specific numbers or qualifications (e.g., "radiologist with 10 years experience") are not required or provided for this type of device submission as there are no "diagnoses" being made.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements in expert annotations of clinical data for AI/ML ground truth. For this device, verification and validation are systematic engineering processes against predefined specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is a clinical study comparing the diagnostic performance of multiple readers on multiple cases, typically used for AI/ML in imaging. The 510(k) explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." This confirms that no MRMC study was performed or required for this type of device.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is irrelevant as the device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

As discussed, "ground truth" for this physical device is defined by:

• Engineering Specifications: The device's design inputs and performance requirements.
• International and National Standards: Compliance with a comprehensive list of standards related to medical devices, quality management, risk management, usability, biocompatibility, sterilization, and electrical safety (e.g., ISO 14971, IEC 62366-1, ISO 10993 series, ANSI AAMI ST79, IEC 60601-2-17, ISO 13485).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML system, so there is no "training set."

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

Not applicable, as there is no training set for this physical device.

Summary Conclusion from the 510(k):

The FDA's review and Varian's submission conclude that the Aarhus Applicator Set is substantially equivalent to its predicate device based on:

• Similar intended use and indications for use.
• Similar basic operation and technological characteristics.
• Non-clinical verification and validation testing demonstrating that the device meets design input requirements and performs as intended.
• Conformance to a comprehensive set of recognized and non-recognized standards (e.g., ISO 14971, IEC 62366-1, ISO 10993 series) addressing risk management, usability, biocompatibility, sterilization, and electrical safety.

The key differences (CT/MRI environment compatibility, expanded afterloader compatibility, PEEK-only material) were assessed through these non-clinical tests to ensure they did not raise new questions of safety or effectiveness.

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