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The CT Compatible / MR Unsafe HDR Kobold Ring and Tandem Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines.

The Kobold Ring and Tandem Applicator Set is intended for continuous use of up to 24 hours of contact with patient.

The CT Compatible / MR Unsafe HDR Kobold Ring and Tandem Applicator Set™ design is based on the modified conventional Ring/Tandem applicator with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation boost to the cervix and parametrical tissues in conjunction with external beam radiation therapy. The applicator consists of precision manufactured intrauterine rings, ring caps, and tandems, interlocking via a ring bracket. All components are designed for a defined geometry. The rings are provided in three different angles (30 degrees, 45 degrees, and 60 degrees) with three different tandem lengths (20 mm, and 60 mm from the ring axis) provided for each ring angle. Two ring caps are provided (5.0 mm and 7.0 mm).

The provided text is a 510(k) summary for the Kobold Ring and Tandem Applicator Set, which is a medical device used in high dose rate (HDR) radiation treatment. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting acceptance criteria and a study proving the device meets those criteria from an AI/algorithm performance perspective.

Therefore, many of the requested items related to AI system evaluation (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance) are not applicable to this type of device clearance document.

However, I can extract information regarding the device's characteristics and the basis for its clearance, framed in terms of substantial equivalence.

Here's the breakdown of the information that can be extracted or deduced from the document:

1. A table of (implied) acceptance criteria and the reported device performance from the provided text:

Since this is a substantial equivalence submission for a physical medical device, the "acceptance criteria" are not standard performance metrics for an AI algorithm. Instead, they are characteristics that demonstrate the new device is as safe and effective as a legally marketed predicate device. The "reported device performance" is the comparison made to establish this equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. This document describes a physical medical device, not an AI algorithm evaluated on a dataset. The "testing" involved bench testing, not evaluation on patient data.
• Data Provenance: Not applicable for the reasons above.

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. Ground truth as typically understood for AI evaluation is not relevant to this type of device clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

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 device.

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

• Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. For this physical device, the "ground truth" for demonstrating substantial equivalence relied on comparing its design, materials, intended use, and performance characteristics (through bench testing and documentation) to a predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" presented is a 510(k) Premarket Notification which aims to demonstrate substantial equivalence to a predicate device already on the market (Kobold Fletcher Type Applicator Set; Kobold Henschke Type Applicator Set, K123912).

The core of the "proof" relies on:

• Comparison Table: A detailed comparison of the new device (K142330) with the predicate device (K123912) across various characteristics, including indications for use, afterloader compatibility, design geometry, materials, packing, sterility, sterilization methods, biocompatibility, anatomical sites, and environmental compatibility.
• Bench Testing: The document states, "Extensive testing in accordance with known standards is documented by the manufacturer for predicate device K123912" and that the predicate device's acceptance procedures are provided. This implies that the new device either underwent similar bench testing or leverages the established safety and performance of the predicate through design similarity and material equivalence. The key statement is, "The FDA has not established special controls or performance standards for this device," suggesting that meeting the requirements for substantial equivalence to a device with a known safety profile is sufficient.
• Conclusion: The submission concludes that the Kobold Ring and Tandem Applicator Set is "similar in intended use and technological characteristics to predicate device reviewed" and "similar with respect to indications for use and physical characteristics to predicate device in terms of section 510(k) substantial equivalency."

In essence, the device is deemed to meet "acceptance criteria" because it is shown to be as safe and effective as a device already legally marketed, based on direct comparison of features and relevant non-clinical (bench) testing.

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