Search Results

The Forte Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.

The modified Forte Gamma Camera System offers all the features of the existing Forte Gamma Camera System (K982911) while expanding the Concurrent Imaging feature for Multi-Energy/Multi-Isotope Imaging and the addition of DICOM to the acquisition system. The basic underlying algorithms for concurrent imaging remain the same. Software modifications to the Multi-Energy/Multi-Isotope application extend the current functionality to include acquisition of more image events simultaneously. Acquisition data can be exported to the Pegasys or any other processing station via DICOM by translating image data from the native XML format to a DICOM 3.0 complaint format. The addition of DICOM to the acquisition software will enhance workflow by providing DICOM Worklist and the capability to import patient information for scheduling purposes. The DOS-based user interface in Atlas acquisition system (predicate) is replaced by a Java based graphical user interface JETStream™. The Java graphical user interface provides a modern graphics presentation as opposed to the DOS text based interface of the predicate. In addition, P-scope (patient positioning/count rate) and gantry display information are now available on a touch screen for easy accessibility.

The Forte is designed to provide extended imaging functionality relative to a ring style gantry. The Forte is designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes a gantry frame, display panel, two detectors, a collimator storage structure with an acquisition computer unit, a patient imaging table, and a remote hand controller. The gantry is "open" so that a high degree of imaging flexibility is available to image patients sitting, standing or lying down, with or without the included patient imaging table. The patient imaging tables are mechanized to allow for patient loading access and then raised to an imaging height. The imaging pallet includes removable arm, leg, breast, and headrest supports for patient positioning during studies that require support.

The Forte is designed to allow acquisition of a broad range of imaging studies using single or dual detectors. When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), Forte can be used to perform static, dynamic, gated, total body, circular-orbit and non-circular orbit SPECT studies, coincidence studies, gated SPECT (circular and non-circular) studies, computerprogrammed protocol strings, and reference scans (dual detectors only). SPECT and total body acquisitions are routinely acquired with two detectors. There are some planar procedures such as bone statics and lung scan that also use two detectors. There are many additional nuclear medicine procedures that only use one detector at a time. These single detector procedures are typically renal, gastric emptying, hepatobiliary, flow studies, GI bleed, thyroid, and delayed static views.

This 510(k) submission (K033254) from ADAC Laboratories for the Forte™ Gamma Camera System focuses on modifications to an existing device (K982911), primarily in software, rather than presenting a de novo device with new acceptance criteria. Therefore, the traditional elements of acceptance criteria and a study proving a device meets them, particularly for performance metrics like sensitivity, specificity, accuracy, or reader improvement in AI contexts, are not present.

The submission claims substantial equivalence based on identical indications for use, technological comparison, and overall system performance. This implies that the device is expected to perform at least as well as the predicate device.

Here's an analysis based on the provided text, addressing the points where information is available or implicitly understood due to the nature of a 510(k) for a modified device:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for device modifications, specific quantitative acceptance criteria (e.g., minimum sensitivity/specificity thresholds) and detailed performance data (e.g., clinical study results with these metrics) are not provided nor typically required in this format for substantial equivalence of software updates to an existing gamma camera. The focus is on demonstrating that the modifications do not adversely affect safety and effectiveness and that the overall system performance remains equivalent to the predicate.

The "performance" demonstrated for this type of submission is typically through:

• Verification and Validation Activities: (Implied) Ensuring the new software features function as intended and do not introduce new risks. These would likely include functional testing, performance testing (e.g., speed, data integrity, DICOM compliance), and possibly phantom studies to confirm image quality is maintained.
• Technological Comparison: The submission explicitly states: "The modified Forte™ Gamma Camera System and existing Forte Gamma Camera System have identical intended use and indications for use. The modified Forte and the existing Forte are technologically equivalent. They have the same main mechanical and electrical components. All the features provided on the existing Forte are provided on the modified Forte."

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

• Sample Size: Not applicable/not provided in this document as it's not a clinical trial for diagnostic performance. The "test set" would refer to testing environments for software and system functionality.
• Data Provenance: Not applicable.

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

• Not applicable/not provided. Ground truth in the context of a 510(k) for software updates to an imaging system usually relates to functional correctness and image quality, often verified by engineers and potentially nuclear medicine physicians during internal testing, rather than complex diagnostic ground truth.

4. Adjudication Method for the Test Set

• Not applicable/not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. This is not an AI-assisted diagnostic device where human reader improvement would be measured. It's a gamma camera system with software updates.

6. Standalone Performance Study (Algorithm Only)

• No standalone performance study of an algorithm was done in the context of comparing diagnostic accuracy. The "algorithms for concurrent imaging remain the same." The software modifications are largely about extending functionality (e.g., more simultaneous image events) and user interface (Java GUI, DICOM). The performance metrics would be related to the proper functioning of these software features and maintenance of image acquisition quality, not diagnostic accuracy of an AI algorithm.

7. Type of Ground Truth Used

• Functional correctness and image acquisition quality. For a gamma camera, ground truth would relate to the physical properties of the acquired images (e.g., spatial resolution, energy resolution, uniformity) using phantoms, and the correct operation of the software interface and data export. It's not typically "expert consensus" on disease diagnosis, pathology, or outcomes data for this type of submission.

8. Sample Size for the Training Set

• Not applicable/not provided. This is not a machine learning or AI device that requires a training set.

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

• Not applicable. As above, no training set for an AI algorithm is mentioned or implied.

Summary of Acceptance Criteria and Reported Performance (Based on Implied Substantial Equivalence):

In conclusion, the K033254 submission is a demonstration of substantial equivalence for software and user interface modifications to an existing gamma camera system. It does not contain the typical "acceptance criteria" and detailed study results found in submissions for novel AI/CAD devices or devices with novel diagnostic claims. Instead, the "study" is the comparison against the predicate device to ensure that the modifications do not negatively impact the established safety and effectiveness of the device.

Ask a specific question about this device

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.

Ask a specific question about this device