(89 days)
The SMV TAC-2 accessory to the SMV dual head emission tomographic systems produces images of a patient's anatomy when performing cardiac or wholebody imaging in single photon mode, or in coincidence mode (using the VCR option) . The system is intended to provide an enhancement to the emission images by compensating for the attenuation effects of the human body.
The TAC-2 hardware consists of two sliding line source emitter block/collimator assemblies. Each assembly extends transaxially across the face of each detector of a DST series gamma camera oriented 180°. When in use each emitter block exposes the collimator in the opposing assembly. The assemblies travel in synchrony along the axial direction.
The provided text primarily focuses on the 510(k) summary for the TAC-2 device, its intended use, and substantial equivalence to predicate devices. It lacks the detailed information required to comprehensively answer the request regarding acceptance criteria and a study proving device performance against those criteria.
However, based on the limited information, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria in a quantitative manner. The closest statement regarding performance is:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated | "Images produced were of the same quality as those provided by the manufacturers of the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text only mentions "Clinical and non-clinical studies were conducted."
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. Given the device's nature (attenuation correction for gamma cameras), it's unlikely to be an AI-driven device in the modern sense that would involve human reader improvement with AI assistance. The focus is on image quality enhancement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an accessory that produces images to enhance emission images by correcting for photon attenuation. Its performance would be evaluated on the quality of these corrected images, which is a form of standalone performance in terms of image processing. The statement "Images produced were of the same quality as those provided by the manufacturers of the predicate devices" implies a standalone evaluation against a benchmark. However, details of this evaluation are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document mentions "images that depict the anatomy of a patient" and "correcting for photon attenuation effects of the patient's anatomy." The implied ground truth would be the actual patient anatomy and the actual amount of attenuation, likely assessed through comparison with established imaging techniques or potentially physical phantoms for quantifiable metrics. However, the specific method for establishing ground truth is not provided.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of Study Information Provided:
- Study Purpose: Clinical and non-clinical studies were conducted to evaluate the TAC-2 attenuation correction device.
- Device Under Test: TAC-2 attenuation correction device with a DST-XL with the VCAR option.
- Outcome: "Images produced were of the same quality as those provided by the manufacturers of the predicate devices."
- Comparison: Implied comparison to images from predicate devices (90KPS TAC SMV and 90 KPS MCD-AC ADAC Laboratories).
Key Missing Information for a Comprehensive Answer:
The document is a 510(k) summary, which often provides high-level information for substantial equivalence. It lacks the detailed methodology, specific quantitative acceptance criteria, statistical analysis, and comprehensive results typically found in full study reports required to answer all sections of your request comprehensively.
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Page D-1
Section D. 510 (k) Summary of Safety and Effectiveness
The following information is in conformance with 21 CFR 807.92.
| Date Prepared: | March 11, 1999 |
|---|---|
| Manufacturer: | SMV America8380 Darrow RoadTwinsburg, Ohio 44087(330) 425-1340(330) 405-7682 |
| Contact: | Philip Vernon (extension 6018) |
| Proprietary name: | TAC-2, Transmission Attenuation Correction and DST,DST-XL Gamma Cameras and VISION Power Stationcomputer (K921008, K942837, K912573), for use in singlephoton mode and in conjunction with VCAR (Coincidence)option (K972686). |
| Common names: | Attenuation correction |
| Classification name: | System, Emission Computed Tomography |
| Predicate device: | (K952190) 90KPSTACSMV(K971980) 90 KPSMCD-ACADAC Laboratories |
| Device Description: | The TAC-2 hardware consists of two sliding line sourceemitter block/collimator assemblies. Each assembly extendstransaxially across the face of each detector of a DST seriesgamma camera oriented 180°. When in use each emitterblock exposes the collimator in the opposing assembly. Theassemblies travel in synchrony along the axial direction. |
| Intended Use: | The TAC-2 accessory to the DST and DST-XL GammaCameras and VISION Power Station produces images thatdepict the anatomy of a patient. The accessory is intended toprovide an enhancement to emission images acquired usingthe in SPECT mode or using the VCAR option to the DSTand DST-XL Gamma Cameras by correcting for photonattenuation effects of the patient's anatomy. |
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Page D-2
| TechnologicalComparison: | TAC-2 is similar to the TAC and MCD-AC in that alldevices measure attenuation using external transmissionradionuclide sources. In each device, the transmission dataacquired is used to form attenuation maps to correct emissiondata for attenuation. The transmission radionuclide of TAC-2 ( $^{153}Gd$ ) is the same as in TAC, but is different fromMCD/AC ( $^{137}Cs$ ). The lower energy emissions from $^{153}Gd$ )provide transmission images with increased contrast of bone,soft tissue and lung. The source geometry is also different inthat MCD-AC uses point sources while TAC and TAC-2 useline sources | ||
|---|---|---|---|
| Testing: | Clinical and non-clinical studies were conducted using theTAC-2 attenuation correction device with a DST-XL withthe VCAR option. Images produced were of the samequality as those provided by the manufacturers of thepredicate devices. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird with three horizontal lines extending from its body, creating a sense of movement or flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 2 1999
Philip Vernon SMV America A Nuclear Medicine Company 8380 Darrow Road Twinsburg, Ohio 44087
Re:
K991565 TAC-2 option for use with DST, DST-XL Gamma Cameras Dated: April 21, 1999 Received: May 5, 1999 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS
Dear Mr. Vernon:
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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified 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 (QS) 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page E-1
Section E. Indications for Use Form
Section E. Indications for Use Form
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: TAC-2
Indications For Use:
The SMV TAC-2 accessory to the SMV dual head emission tomographic systems produces images of a patient's anatomy when performing cardiac or wholebody imaging in single photon mode, or in coincidence mode (using the VCR option) . The system is intended to provide an enhancement to the emission images by compensating for the attenuation effects of the human body.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K991565 |
| Prescription Use(Per 21 CFR 801.109) | ✓ |
| (Optional Format 3-10-98) |
Final
§ 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.