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The UF Brachytherapy Stand is intended to be used to provide ultrasound probe alignment in planning and performing a prostate brachytherapy implant procedure.

The UF Brachytherapy Stand is a manual, mechanical system that includes an ultrasound probe stabilizing stand and a stepping unit. It is for use clamped to a table top or side-rails.

Here's an analysis of the provided text regarding the UF Brachytherapy Stand.

Important Note: The provided document is a 510(k) summary for a medical device (UF Brachytherapy Stand). 510(k)s primarily focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than detailed performance studies against specific acceptance criteria for a novel device. As such, many of the typical elements of an acceptance criteria and study report for, for example, an AI medical device, are not present in this type of document.

Therefore, the answers below will reflect the information available in the given text, highlighting what is (and isn't) present as per the nature of a 510(k) submission for a mechanical device.

Acceptance Criteria and Device Performance Study Report

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not contain a discrete table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or quantitative measurements typically associated with a new diagnostic or AI device.

For a mechanical device like the UF Brachytherapy Stand, "acceptance criteria" are generally met by demonstrating:

• Substantial Equivalence: The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
• Intended Use Alignment: The device meets its stated intended use.
• Material and Design Properties: The materials, dimensions, and mechanical function are appropriate and, if applicable, comparable to the predicate.
• Compliance with Standards (if applicable): Though not explicitly detailed here, mechanical devices would typically demonstrate compliance with relevant national or international performance and safety standards.

The "reported device performance" is essentially the conclusion of substantial equivalence to the predicate device, K972672, Barzell-Whitmore Maroon Bells, Inc.: Brachystepper Stepping Unit/ Needle Guide Template, Brachystand Support and Manual Adjustment Accessory. The document states:
"This device, with respect to materials, device characteristics and intended use, is substantially equivalent to the predicate device."

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

This document does not describe a "test set" in the context of clinical data, images, or patient cases. This device is a mechanical stand, and its evaluation for a 510(k) typically involves engineering verification, validation, and comparison to the predicate device's design and function, not a clinical study with patient data.

• Sample Size: Not applicable in the context of a clinical test set. The "sample" would be the device itself undergoing engineering testing.
• Data Provenance: Not applicable. There is no patient data described in this 510(k) summary.

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

This information is not applicable and not provided. The "ground truth" for a mechanical device like this would relate to its structural integrity, functionality (e.g., holding an ultrasound probe stable, facilitating stepping), and material compatibility, which are established through engineering principles, bench testing, and comparison to a predicate, not through expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable and not provided. There is no clinical "test set" requiring adjudication.

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 device is a mechanical stand, not an AI or imaging interpretation device. Therefore, no MRMC study or AI assistance assessment would be performed.

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

Not applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device, inferred from a 510(k) submission, relates to its mechanical functionality and safety. This would likely involve:

• Engineering Specifications: Ensuring the device meets its design specifications for stability, adjustability, and material strength.
• Predicate Device Comparison: Demonstrating that its mechanical properties and intended use are similar to the predicate device.
• Relevant Standards: Adherence to any applicable mechanical or medical device safety standards.

There is no mention of "expert consensus, pathology, or outcomes data" in this summary, as these are typically associated with diagnostic or therapeutic devices, not a mechanical accessory.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical stand, not an AI or machine learning model that requires a training set.

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

Not applicable. As noted above, there is no training set for this type of device.

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