(15 days)
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,
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.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.