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The GM Implant Tubes is indicated for use for irradiation treatments which require a flexible source guiding lumen including treatments of the head, neck, tongue, bladder, gynecology and prostate using HDR or PDR brachytherapy.

The Length Cutting Gauge in its variable length is indicated for use to cut implant tube or breast applicator treatment channels to the correct treatment length.

The GM Implant Tubes, listed in many of the submission document titles, is the family name covering the Flexible Interstitial Implant Tube Set and its required and optional components and the Length Cutting Gauge is an accessory component used with the Flexible Interstitial Implant Tube Set.

The Flexible Interstitial Implant Tube Set (GM11004680) from the GM Implant Tubes includes a variety of flexible implant tube lengths that create the optimal distance between the source and the layers of tissue to be treated. The implant tubes need to be cut down using the length cutting gauge to the required length. The set also includes a number of associated accessories for sterilization (K152018: Leak Stop Button, and Leak Stop Channel Marker Sets).

The provided document is a 510(k) Premarket Notification from Varian Medical Systems, Inc. for "GM Implant Tubes" and "Length Cutting Gauge." It describes the devices, their indications for use, comparison to a predicate device, and a summary of performance data.

However, the document does NOT contain information regarding:

• Specific acceptance criteria (numerical thresholds for performance metrics).
• Reported device performance against such criteria.
• The sample size used for a test set (as no studies evaluating algorithm performance are mentioned).
• Data provenance, number of experts, adjudication methods, or ground truth details for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Training set details (sample size, ground truth establishment) as the device does not employ machine learning or AI.

The document states, "GM Implant Tubes and Length Cutting Gauge do not contain or consist of software/firmware. The devices do not contain any biologics or drug components." Therefore, there is no AI algorithm to evaluate.

The performance data listed pertains to physical device attributes and safety, not algorithm performance. These include:

• Biocompatibility Testing (cytotoxicity, implantation, sensitization, toxicity)
• Sterilization Testing (suitability of design and material for use life and reprocessing cycles, validation/efficacy of cleaning, disinfection, sterilization cycles)
• CT Compatibility Test and Analysis
• Rationale MR Properties

Conclusion:

Based on the provided document, the devices ("GM Implant Tubes" and "Length Cutting Gauge") are purely mechanical/physical medical devices. They do not involve software, firmware, or artificial intelligence. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/algorithm performance (e.g., sensitivity, specificity, F1-score with associated sample sizes, ground truth, experts, MRMC studies, standalone studies) are not applicable to this submission.

The "studies" conducted and mentioned in the document are non-clinical hardware tests to ensure physical safety, efficacy, and compatibility, such as biocompatibility, sterilization efficacy, and imaging compatibility.

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