(15 days)
The SKYLight Imaging 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 SKYLight Imaging System offers all the features of the existing SKYLight Imaging System (K013496) while expanding the Concurrent Imaging feature for Multi-Energy/Multi-Isotope Imaging and the addition of DICOM to the JETStream™ 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 SKYLight is designed to provide extended imaging functionality relative to a ring style gantry. The SKYLight was designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes a gantry frame, two detector arms (with detectors), a collimator storage structure with an acquisition computer unit, a patient imaging table, and a remote hand controller. The modified SKYLight is capable of accommodating two separate patient tables. 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 tables do not move during imaging since the gantry is flexible enough to perform all required motions for non-circular orbits. The imaging pallet includes removable arm, leg, breast, and headrest supports for patient positioning during studies that require support.
SKYLight® is an 'open frame' imaging system, the 'open frame' consisting of an overhead rectangular structure that is supported by 4 (or more) columns that are bolted to the imaging room floor. A detector arm support structure is mounted onto the open frame, which allows for the detector arm support structure (and both detector arms) to move in the longitudinal motion (X-axis). Arms that can telescope up and down (Z-axis) support the detectors. These detector arms are supported by a structure that allows for each detector arm to move toward or away from each other (Y-axis). Each detector has the ability to rotate and acquire images independently
The combination of these four motions (Z, Y, X, and detector rotate), permit the detectors to perform all standard non-circular and circular ECT studies in both the 90-degree and 180-degree relative position. The detectors use two standard collimators, or MCD shields, which may be exchanged using an automatic exchange unit.
The modified JETStream SKYLight acquisition computer uses the same acquisition software (subsystem) as existing SKYLight to acquire ECT imaging studies and interfaces with a Pegasys computer system (workstation). The acquisition CPU is used to install the camera software and to archive and restore acquisition parameters and correction tables. The acquisition software is used to complete pre-programmed gantry motions for setup of imaging studies and exchange of collimators; to perform quality assurance tests on the SK YLight system; and to program image parameters and gantry for clinical studies.
When using either a single detector or dual detectors placed in a relative 90-degree or relative 180-degree positions (as study appropriate), SKYLight 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 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 acquisition sub-system interfaces with a Pegasys computer system for entry into the database. The Pegasys workstation also includes software used for image processing, database utilities, and archiving utilities.
Acceptance Criteria and Study for SKYLight Imaging System (K031705)
The provided document describes the 510(k) summary for the SKYLight Imaging System (K031705), which is a modification of a previously cleared device (K013496). The key focus of this submission is on the substantial equivalence of the modified device to its predicate, rather than establishing de novo performance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define specific quantitative acceptance criteria or numerical performance metrics for the modified SKYLight Imaging System. Instead, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria (Implicit: Substantial Equivalence to Predicate K013496) | Reported Device Performance |
|---|---|
| 1. Identical Intended Use: The modified device has the same medical purpose as the predicate. | The modified SKYLight Imaging System has an "identical intended use and indications for use" as the existing SKYLight Imaging System (K013496). |
| Intended Use: "The SKYLight Imaging 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." | |
| 2. Identical Indications for Use: The conditions for which the device is used remain unchanged. | As above, "identical intended use and indications for use." |
| 3. Technological Identicality (Mechanical & Electrical): No changes to fundamental hardware components that could impact safety or effectiveness. | The modified and existing SKYLight are "technologically identical." "They share the identical mechanical and electrical components. No changes or modifications have been made to the mechanical or electrical components." |
| 4. Maintenance of Existing Features: All functionalities of the predicate device are retained. | "All the features provided on the existing SKYLight are provided on the modified SKYLight." |
| 5. Changes (Software) Do Not Raise New Questions of Safety/Effectiveness: The modifications introduced (software-only) are assessed to ensure they do not alter the risk profile or reduce performance. | "The only change has been to the JETStream acquisition software, which provides the modified SKYLight Imaging System with the expanded feature of Concurrent Multi-Energy/Multi-Isotope Imaging and DICOM Export/Worklist." |
| These changes are presented as enhancements to functionality and workflow, rather than alterations to fundamental image acquisition or processing algorithms, which "remain the same." The implication is that these software additions do not negatively impact the established safety and effectiveness of the existing device. | |
| 6. Overall System Performance Equivalence: The modified system performs as well as the predicate device. | The conclusion explicitly states: "The modified SKYLight® Imaging System is substantially equivalent to the predicate device SKYLight based upon identical indications for use, technological comparison and overall system performance." This statement asserts that the overall performance remains equivalent, despite the lack of specific quantitative data provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information regarding a specific "test set" in the traditional sense of evaluating a new algorithm's performance on a distinct set of cases. This is because the submission is for a modification of an existing device (software updates), not a novel algorithm requiring a comprehensive clinical performance study. The evaluation relies on demonstrating the equivalence of the modified software features to the predicate, primarily through technical comparison and the assertion that core algorithms for imaging remain unchanged.
Therefore, there is no mention of:
- Sample size used for a test set.
- Data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
As no specific test set requiring ground truth establishment is described for a performance study, there is no information on the number or qualifications of experts for this purpose.
4. Adjudication Method for the Test Set
Since no specific test set requiring ground truth establishment is described, there is no information on any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. The submission focuses on demonstrating substantial equivalence through technical comparison and the nature of the software modifications, not a clinical trial evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
No, a standalone performance study was not described or performed for the modified functionalities. The document emphasizes that the "basic underlying algorithms for concurrent imaging remain the same." The software modifications primarily extend data acquisition capabilities and workflow (DICOM export/worklist), which are not typically assessed through standalone algorithmic performance studies aimed at diagnostic accuracy.
7. The Type of Ground Truth Used
Given the nature of the submission (software update for an existing imaging system), there are no specific types of ground truth mentioned as being used for a performance evaluation in this summary. The "ground truth" for the device itself would implicitly be the established clinical utility of gamma camera systems in depicting radioisotope distributions for medical interpretation, which is already accepted for the predicate device.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This is consistent with the nature of the submission, which is not about a new AI/ML algorithm requiring a distinct training phase.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth might have been established.
§ 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.