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The Mick HDR Interstitial Implant Accessories (consisting of needles, catheters, and fixation buttons) presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader sealed sources in the interstitial treatment of cancer of the oral cavity, oropharyngeal tumors, head and neck and soft tissue sarcomas.

The Mick HDR Interstitial Implant Accessories (consisting of needles, catheters, and fixation buttons) presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader sealed sources in the interstitial treatment of cancer of the oral cavity, oropharyngeal tumors, head and neck and soft tissue sarcomas. The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy requires the ability to guide and position the radioactive source under remote control so that the sealed source is contained within the treatment volume providing precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick HDR Interstitial Implant Accessories are designed to act as such.

This 510(k) submission (K051423) for the Mick HDR Interstitial Implant Accessories does not contain a detailed study with acceptance criteria and device performance results.

Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as devices already legally marketed, primarily because it shares similar design, construction, materials, intended use, and performance characteristics.

Therefore, many of the requested elements for a detailed study report are not present in this document. Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

Study Information (Not Applicable or Not Provided in this Document)

The 510(k) submission for the Mick HDR Interstitial Implant Accessories details a substantial equivalence (SE) determination, not a standalone clinical or performance study with the specific elements requested. The FDA determined the device was substantially equivalent to predicate devices (K890341, K811279 for Mick Radio-Nuclear Instruments, Inc., and K933400 for Best Medical Industries).

Here's a breakdown of the requested information based on the provided document:

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

   • N/A. No specific "test set" or clinical study data is presented in this 510(k) summary. The demonstration of substantial equivalence relies on similarity to predicate devices rather than new performance data.

2. 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):

   • N/A. No de novo ground truth establishment for a specific test set is described.

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

   • N/A. No adjudication method is described as there is no specific test set or clinical study.

4. 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:

   • N/A. This device is an accessory for brachytherapy, not an AI-driven diagnostic or imaging device. Therefore, an MRMC study related to AI assistance is irrelevant and not performed.

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

   • N/A. This device is not an algorithm; it is a physical medical accessory. Standalone algorithm performance is not applicable.

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

   • N/A. The "ground truth" here is essentially the established safety and effectiveness of the predicate devices, which are already legally marketed. The submission argues that the new device is fundamentally the same and therefore shares that "ground truth."

7. The sample size for the training set:

   • N/A. No training set for an algorithm is applicable or described.

8. How the ground truth for the training set was established:

   • N/A. Not applicable, as there is no training set for an algorithm.

In summary: This 510(k) document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed report of a performance study for a novel device with specific acceptance criteria that require extensive new testing and data collection. The "proof" that the device meets acceptance criteria stems from its demonstrated similarity to already approved devices.

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