(90 days)
Vertex Ultra is intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
Vertex Ultra is a gantry (ring type) device designed for single- or dual-detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, two detectors, a collimator storage cabinet with acquisition computer unit, a patient imaging table, and a remote hand controller. The Vertex Ultra gantry is an "open" frame permitting easier access for imaging of standing, seated, and supine patients. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies; or the pallet may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys.
Vertex Ultra 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 relative 90° or relative 180° positions (as study appropriate), static, dynamic, gated, total body and ECT studies (circular orbit), non-circular orbital ECT, coincidence imaging, and gated SPECT (circular and non-circular orbit) imaging studies can be performed with or without a previously cleared ADAC attenuation correction option. In addition, Vertex Ultra acquisition software can be programmed to complete multiple imaging studies called protocol strings, which involve a combination of several imaging studies collected for use in customized clinical procedures.
The provided text describes the Vertex Ultra Gamma Camera System (K982911), which is a device intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices rather than proving specific performance against clinical acceptance criteria with detailed studies and ground truth. Therefore, the information typically found in acceptance criteria tables and detailed study descriptions that you requested is not explicitly present in the provided document.
However, based on the Testing section, we can infer the types of tests performed and the general nature of what would constitute "acceptance."
Here's an attempt to structure the information based on the provided text, while acknowledging its limitations for filling out all requested fields:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Acceptable field uniformity (visual inspection). | Flood phantom images were produced to demonstrate acceptable field uniformity. |
| Proper alignment (e.g., within established tolerances). | Center of rotation (COR) testing was performed to verify proper alignment. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document only mentions "Flood phantom images" and "center of rotation (COR) testing," implying the use of phantom data, not patient data for acceptance.
- Data Provenance: The 'data' (flood phantom images, COR test results) would be generated internally during the device's manufacturing and testing phases by ADAC Laboratories. It is not patient data from a specific country or collected retrospectively/prospectively in a clinical trial sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in the context of the provided document. The "ground truth" for technical performance tests like field uniformity and COR alignment is determined by the physical properties of the phantom and the known geometric parameters of the system, not by clinical experts.
4. Adjudication method for the test set
Not applicable. Technical tests like field uniformity and COR alignment do not typically involve adjudication by multiple experts. The assessment is based on measured values and visual inspection against predetermined specifications.
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
No MRMC comparative effectiveness study was done. The device described is a gamma camera system, not an AI-powered diagnostic algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is a hardware system for image acquisition, not an algorithm.
7. The type of ground truth used
For the described tests:
- Flood phantom images: The ground truth for field uniformity is the expected uniform distribution of radioactivity across the detector field, which is a physical characteristic of the phantom.
- Center of rotation (COR) testing: The ground truth for alignment is the known mechanical axis of rotation of the gantry and detector, used to verify the imaging system's accuracy in identifying this center.
8. The sample size for the training set
Not applicable. This device is a gamma camera hardware system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable (as above).
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Vertex Ultra ADAC Laboratories 510(k) Premarket Notification
Appendix VIII, 510(k) Summary of Safety and Effectiveness Data Page 1 of 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA
I. General Information
| A. | Submitted By: | ADAC Laboratories540 Alder DriveMilpitas, CA 95035Tel: (408) 321-9100Fax: (408) 321-9629 |
|---|---|---|
| Contact Person: | Dennis Henkelman at address above | |
| B. | Device Trade Name:Common Name:Classification Name: | Vertex UltraGamma Camera SystemSystem, Emission Computed Tomography |
| C. | Predicate Device: | Siemens E.CAM Profile ACMillennium MT & MG |
D. Device Description:
Vertex Ultra is a gantry (ring type) device designed for single- or dual-detector nuclear imaging accommodating a broad range of emission computed tomography (ECT) studies. The device includes the gantry frame, two detectors, a collimator storage cabinet with acquisition computer unit, a patient imaging table, and a remote hand controller. The Vertex Ultra gantry is an "open" frame permitting easier access for imaging of standing, seated, and supine patients. The patient imaging table (pallet) is mechanized for patient loading access and for movement during imaging studies; or the pallet may be removed by the operator for imaging of patients in wheelchairs, beds, or gurneys.
Vertex Ultra 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 relative 90° or relative 180° positions (as study appropriate),
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static, dynamic, gated, total body and ECT studies (circular orbit), non-circular orbital ECT, coincidence imaging, and gated SPECT (circular and non-circular orbit) imaging studies can be performed with or without a previously cleared ADAC attenuation correction option. In addition, Vertex Ultra acquisition software can be programmed to complete multiple imaging studies called protocol strings, which involve a combination of several imaging studies collected for use in customized clinical procedures.
-
Indications for Use: E.
Vertex Ultra is intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel. -
F. Technological Comparison:
Vertex Ultra, Siemens E. CAM, and GE Millennium have similar indications for use as well as open and/or ring type gantries and pre-programmed detector motions, and perform the same type of study acquisitions.
II. Testing
Flood phantom images were produced to demonstrate acceptable field uniformity. In addition, center of rotation (COR) testing was performed to verify proper alignment.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dennis W. Henkelman Director, Regulatory Affairs and Quality Assurance ADAC Laboratories 540 Alder Drive Milpitas, CA 95035
Re: K982911
Gamma Camera System Dated: August 17, 1998 Received: August 18, 1998 Regulatory class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Henkelman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrividsmadsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/2/Picture/14 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and is composed of three curved lines that form the head, body, and tail feathers.
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 《9829 //
Device Name: Vertex Ultra
Sponsor Name: ADAC Laboratories
Indications for Use
Vertex Ultra is intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the human body for interpretation by medical personnel.
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use
David h. Symon
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Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
§ 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.