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To detect and image the distribution of high-energy photons from an administered positron-emitting radioactive agent (radionuclides) in the human body, specifically cardiac imaging. The Ultra-High Energy General Purpose Collimator (UHGP) will be used on the dual detector Forte Gamma Camera (K982911) and on the dual detector Vertex Gamma Camera (K922080).

The Ultra-High Energy General Purpose Collimator (UHGP) is an optional device for the Forte™ and Vertex™ gamma camera systems, similar to conventional low energy collimators. It was developed to collimate the gamma rays emitted perpendicularly from a patient to a gamma ray detector, so that a proper image can be formed. This design concept is essentially the same as other conventional lower energy collimators used in Nuclear Medicine clinics, except that the current device is intended for ultra-high energy (511 keV) radiopharmaceuticals. Hence, the focus of the design elements are 1) proper hole size and thickness to provide proper spatial resolution and sensitivity for clinical use and 2) a proper mechanical mechanism to ensure safety. The UHGP collimator consists of three major components: the collimation core, collimator frame, and collimator cover. The weight of this collimator is 300 pounds. The collimator core is made of lead. The hole size, the septal length, and septal thickness are 2.7, 60 and 2.3 mm, respectively. The collimator frame is used to support the core and connect to the detector buckets. For the Forte and Vertex systems, the frame and core size are the same as shown by the specification for the imaging Field of View (FOV). The collimator cover is used to prevent direct patient contact with the lead core. More importantly, it has a collision sensor to prevent any unexpected detector motion resulting in collimator contact with patient, including un-intended detector radius move-in by operators.

The provided text describes the acceptance criteria and the study for the Ultra-High Energy General Purpose Collimator (UHGP).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the UHGP collimator are primarily its performance characteristics in comparison to a predicate device (Picker UHE collimator) and NEMA NU1 standards. The critical performance metrics are resolution and sensitivity.

Note on Sensitivity: While the reported sensitivity of the UHGP (<174 cpm/μCi) is lower than the predicate (435 cpm/μCi), the document states that this is due to better resolution and is "very comparable to the low energy collimators," thus deemed adequate. This suggests that while numerically lower, it met an internal adequacy criterion for clinical use.

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

The document does not explicitly state a numerical sample size for a "test set" in terms of patient data or a specific number of imaging cases. The performance evaluation was primarily based on:

• Physical measurements of the device's characteristics (resolution, sensitivity, septal penetration, mechanical properties).
• Clinical images which "were also examined." (No further details on number or nature of these images).

The data provenance is not specified beyond "clinical images were also examined." It is implied to be laboratory testing and potentially some internal clinical evaluations, but no specific country of origin or whether the clinical images were retrospective or prospective is mentioned.

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

This information is not provided in the document. The ground truth for the performance metrics (resolution, sensitivity) was established through objective physical measurements according to NEMA NU1 standards. For the "clinical images," no details on expert interpretation or ground truth establishment are given.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the context of expert review of images. The primary evaluation involved physical measurements based on NEMA NU1 standards. Mechanical safety features were also tested (collision sensor, latching).

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

No, an MRMC comparative effectiveness study was not done. This document describes a collimator, which is a physical component of a gamma camera system, not an AI-based diagnostic algorithm. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical collimator and does not involve an independent algorithm. Its performance is measured as part of the overall imaging system.

7. The Type of Ground Truth Used

The ground truth for the device's performance was established through objective physical measurements and engineering specifications.

• NEMA NU1: Performance Measurements of Scintillation Cameras (1994) standards were used for measuring resolution and sensitivity.
• Engineering specifications and tests were conducted for mechanical safety (e.g., collision sensor activation pressure, latching mechanism).
• For the "clinical images," the type of ground truth used is not specified.

8. The Sample Size for the Training Set

Not applicable. This device is a physical component (collimator), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As indicated above, this device is a physical component, and the concept of a training set and its ground truth establishment does not apply.

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