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510(k) Data Aggregation
(21 days)
The Intended use of the device is to produce attenuation- corrected NM Images. The attenuation maps are also displayed with the NM images to facilitation of the NM activity in the patient anatomy.
The "Hawkeye 4 Option" is a modification of the "Hawkeye" option (K991841). "Hawkeye 4 Option" is a Functional Anatomical Mapping and Attenuation Correction option, designed to be used on SPECT system "GE Quasar Nuclear Medicine System" (K022960 trade name "Infinia"). The X-Ray system consists of an X-ray source, High voltage power supply, collimation assembly, X-ray detection unit for 4- detectors, and data collection and processing SW. The X-ray unit is completely integrated with the Infinia (K022960) gamma camera, using the same acquisition station, patient table, and slip-ring gantry. The "Hawkeye 4 Option" provides additional features to optimize radiation dose to the patient up to 700W. The "Hawkeye 4 Option" features a multi-slice X-Ray detector, with four 5mm slices and total axial coverage of 20mm. The "Hawkeye 4 Option" also utilizes helical CT scanning to further improve the image quality, shorten the acquisition time, and enhance dose efficiency. The "Hawkeye 4 Option" provides additional features to optimize radiation dose to the patient using a range of X-ray generator power from 350W to 700W.
The provided document, K052434, is a 510(k) summary for the "Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera". This submission asserts substantial equivalence to a predicate device, the "Hawkeye Option for Dual-Head Variable Angle Gamma Camera" (K991841), rather than demonstrating a novel performance claim requiring extensive new clinical studies and detailed acceptance criteria.
Therefore, the document does not contain the detailed information requested in the prompt, such as specific acceptance criteria for a device's performance, a study proving it meets them, sample sizes for test and training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC study results, or standalone algorithm performance.
Based on the provided text, here's what can be extracted regarding the device's evaluation:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria and reported device performance in the manner typically seen for new performance claims for an AI/ML device. Instead, it states that the device was evaluated for safety and conformance to standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Electrical, mechanical, and radiation safety | Conforms to applicable medical device safety and performance standards. |
| Conformance to regulatory standards (21 CFR 820, ISO 9001 and ISO 13485) | Conforms to quality systems and applicable standards. |
| Substantial equivalence to predicate device (K991841) | Determined to be substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify any sample size used for a test set (e.g., number of images, patients, etc.) for evaluating the "Hawkeye 4 Option" beyond general safety testing. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention using experts to establish ground truth as would be relevant for an AI/ML diagnostic or prognostic device's performance claim. The evaluation seems to focus on engineering and safety standards.
4. Adjudication Method for the Test Set:
Not applicable, as no test set requiring expert adjudication for ground truth is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned. The submission is a 510(k) for substantial equivalence based on technical modification and safety testing, not a new comparative effectiveness claim.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable, as this is a medical imaging system (hardware and software), not an AI algorithm being evaluated for standalone performance. The "Hawkeye 4 Option" is an integral part of a SPECT system.
7. The Type of Ground Truth Used:
The ground truth or evaluation metrics described are related to electrical, mechanical, and radiation safety standards, and conformance to quality systems (21 CFR 820, ISO 9001, ISO 13485), rather than clinical ground truth (e.g., pathology, outcomes data, or expert consensus) for a diagnostic performance claim.
8. The Sample Size for the Training Set:
The document does not refer to a "training set" as would be used in machine learning or AI development.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set is mentioned in the context of an AI/ML development pipeline.
Summary of the Document's Focus:
The K052434 submission is a Special 510(k) for device modification. Its primary purpose is to demonstrate "substantial equivalence" of the "Hawkeye 4 Option" to its predicate device (K991841). The evaluation described is centered on:
- Device Description: Highlighting modifications like multi-slice X-Ray detection, helical CT scanning, and optimized radiation dose (350W to 700W vs. 700W initially).
- Safety and Performance Standards Conformance: Stating that the device has been evaluated for electrical, mechanical, and radiation safety and conforms to applicable medical device safety and performance standards (e.g., 21 CFR 1020.30, 21 CFR 1020.33, 21 CFR 820, ISO 9001, ISO 13485).
- Intended Use: The intended use remains the same: "to produce attenuation-corrected NM Images" and "to facilitate the localization of the NM activity in the patient anatomy."
- Conclusion of Substantial Equivalence: Based on similar technological characteristics, safety and effectiveness features, basic design, construction, materials, and intended use as the predicate device.
Therefore, this document does not contain the detailed, quantitative performance studies and acceptance criteria typically associated with new AI/ML device submissions, but rather focuses on demonstrating safety and equivalence for a modified imaging system component.
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(13 days)
The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncolgy, Cardiology, Neurology and other clinical diagnostic imaging applications.
The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT . Gated SPECT . Whole body SPECT , Camera based PET - also known as Coincidence Detection). Acquisition types include single and multiisotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation corrcction and functional anatomic mapping.
Not Found
The provided text is a 510(k) summary for the GE Quasar System, a nuclear medicine imaging system. It details the device's name, submitter, classification, and intended use. However, it does not contain any information regarding acceptance criteria, device performance studies, or details about ground truth establishment, sample sizes, or expert qualifications.
Therefore, I cannot provide the requested information based on the given document.
The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices for the purpose of FDA clearance. It does not include the detailed performance study results that would typically contain acceptance criteria and performance metrics.
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