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

The Apollo Gamma Camera System offers all the features of the Forte™ Gamma Camera System (K033254) while adding the following new features: Caudal/Cephalic Imaging, a second LEHR collimator with improved sensitivity, new CHR collimator, larger Field of View (FOV) with square cornered detectors, < 3-inch brain reach, 3/4' detector crystal (in lieu of 5/8"), Automatic Body Contouring (ABC) with BodyGuard™, MegaBody Mode Imaging, 9-axis ring gantry, extra large patient bore (38" diameter), cart-based semi-automatic exchanger, optional chamfered pallet for low edge attenuation, DICOM MPPS, additional Data Management features (Audit Trail & Patient Privacy), support for new detector, and port server applications from Solaris to LINUX.

Caudal/Cephalic Imaging will allow rotational "tilt" motion of at least one of the detectors about an axis of the detector (parallel to the face of the ring) of at least ±15 degrees. MegaBody mode imaging provides independent variable height positioning of the detectors which includes caudal/cephalic angulations. The detector FOV reach for brain imaging will be less than 3 inches while the detector FOV will be larger (15.5" x 21" instead of 15" x 20") due to the use of the square cornered detectors. In all these cases, the basic functionality of the detector will remain the same (as the detector in the Forte™), while adding detector flexibility to provide a better view of the heart and brain and improve image quality.

The use of ¾" crystal in lieu of the 5/8" crystal for applications that require higher energy isotopes is now a common trend in the medical device industry. The ¾" crystal has higher system sensitivity (per NEMA NU-1, Section 3.8) than the 5/8" crystal. Another improvement to the system sensitivity is the use of a second type of LEHR collimator in the Apollo System. Higher system sensitivity will improve image quality and may reduce acquisition time and/or applied radiopharmaceutical dosage to the patient. A new collimator will also be used, CHR (aka Rembrandt™ Collimators) which is long-bore collimation that eliminates dead-space in the 90° corner and preserving resolution at depth. This collimator is a variation of the VXGP collimator used in the Forte™ System.

The ABC mode with BodyGuard™ is an addition to the current manual mapping feature available in the Forte System. It is a refinement of the non-circular SPECT and learn-mode TB currently used in Forte™. Also, the BodyGuard™ is the sensing mechanism providing the same functionality as the Collision Avoidance feature in Forte™.

The 9-axis gantry frame provides additional gantry motions designed to improve image quality. Also, the larger bore diameter provides openness for even the largest patients. The cart-based collimator exchanger uses a semi-automatic approach to simultaneously change both collimators. The chamfered pallet option is the same material and basic design as the standard pallet used for the Apollo System. It may be used in lieu of the standard pallet for certain studies that require low edge attenuation.

DICOM MPPS completes the DICOM suite and is a computerized notification stating the type of study being done and when it has been completed. Audit Trail and Patient Privacy are Data Management programs to comply with HIPAA requirements. The remote desktop feature is used in the Forte™ system by remote service personnel. To enhance this feature, remote monitoring will be added to the Apollo System.

The Apollo System is designed to provide extended imaging functionality relative to a ring style gantry. It is designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, display panel, two detectors, a collimator storage unit, an acquisition computer unit (with an optional customer desk), a patient imaging table (includes pallet catcher), and a hand controller. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies. The table may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys. The pallet includes removable arm, leg/knee, shoulder and headrest supports for patient positioning during studies that require support.

The Apollo 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). Apollo can be used to perform static, dynamic, gated, total body, circular-orbit and noncircular orbit SPECT studies, coincidence studies, gated SPECT (circular and noncircular) studies, computer-programmed 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 document is a 510(k) Summary for the Apollo Gamma Camera System, comparing it to a predicate device, the Forte™ Gamma Camera System. The focus of the submission is on establishing substantial equivalence rather than performing a clinical study with detailed acceptance criteria and performance metrics for a new diagnostic device.

Therefore, the requested information regarding acceptance criteria, study details, and performance evaluations cannot be fully extracted as such a study is not part of this 510(k) submission.

Here's a breakdown of why the specific questions cannot be answered based on the provided text, and what can be inferred:

1. A table of acceptance criteria and the reported device performance

• Cannot be provided directly. The document does not specify quantitative acceptance criteria or detailed performance metrics from a formal clinical study. It describes features and improvements over a predicate device.
• Inferred Acceptance Criteria: Substantial equivalence to the predicate device in terms of intended use, indications for use, technological comparison, and overall system performance.
• Reported Device Performance: Instead of specific performance metrics, the document highlights improvements and new features that contribute to better image quality, flexibility, and potentially reduced acquisition time/radiopharmaceutical dosage.

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

• Not applicable / Not provided. This 510(k) summary does not describe a clinical study with a test set of patient data being evaluated for device performance. It focuses on engineering and design comparisons with a predicate device.

3. 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)

• Not applicable / Not provided. Since there's no clinical study involving interpretation of images by experts to establish ground truth, this information is not present.

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

• Not applicable / Not provided. See explanation for #3.

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. The device is a gamma camera system, a hardware imaging device, not an AI-powered diagnostic software. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not applicable. This is a hardware system, not a standalone algorithm.

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

• Not applicable / Not provided. As no specific clinical performance study for image interpretation is described, ground truth establishment is not discussed. The "ground truth" for this submission is implicitly the performance and safety established for the predicate device.

8. The sample size for the training set

• Not applicable / Not provided. This document describes a new hardware system (gamma camera) and its features, not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established

• Not applicable / Not provided. See explanation for #8.

Summary of what the document does provide in relation to "acceptance criteria" and "proof":

• Acceptance Criteria (Implicit): Substantial equivalence to the predicate device (Forte™ Gamma Camera System) in intended use, indications for use, technological characteristics, and overall system performance.
• Proof (Argument for Substantial Equivalence):
  • Identical Intended Use and Indications For Use.
  • Technological Comparison: Stating that Apollo and Forte™ are "technologically equivalent" with the same main mechanical and electrical components.
  • New Features: Detailing enhancements in Apollo (e.g., Caudal/Cephalic Imaging, larger FOV, 3/4" detector crystal, ABC with BodyGuard™, 9-axis gantry, DICOM MPPS) that are presented as improvements that maintain or enhance safety and effectiveness, rather than fundamentally altering the device's mechanism or intended use. These improvements aim to "improve image quality," "reduce acquisition time and/or applied radiopharmaceutical dosage."
  • NEMA NU-1 Standard: Mentioning that the 3/4" crystal has higher system sensitivity "per NEMA NU-1, Section 3.8," indicating adherence to recognized performance standards for imaging devices.

In conclusion, this 510(k) summary is a regulatory filing for substantial equivalence based on design and feature comparison, not a clinical trial report with explicit acceptance criteria and corresponding performance data from a patient study.

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