(78 days)
The STASYS Motion Correction software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.
STASYS™ is a software application developed by Digirad for the correction of SPECT acquisition motion artifacts from gated and non-gated projection datasets. When the program is activated, STASYS uses algorithms developed by Digirad to minimize motion error metrics over the set of acquired projections. The resulting STASYS corrected projections are presented to the operator for acceptance or rejection of the correction. With STASYS software, cardiac SPECT studies acquired with both parallel hole and non-parallel hole collimators, can be motion corrected. The STASYS software has the same indications for use and function as the Cedars-Sinai designed MoCo software, currently being used on Digirad SPECT imaging systems and processing workstations.
The provided document describes the STASYS™ Motion Correction Software, intended for correcting patient motion artifacts in SPECT data. The submission is a 510(k) summary, aiming to demonstrate substantial equivalence to previously cleared devices.
Based on the provided text, the following information can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software functions correctly and meets specifications | All tests passed with actual results matching expected results. |
| Performance is substantially equivalent to predicate devices | Software performs as well as predicate devices. |
| Safe and effective | Deemed as safe, effective, and performs as well as predicate devices. |
| Intended use aligns with predicate devices | The indications for use are the same as the predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document mentions "Verification and Validation tests," but does not provide details on the number of SPECT studies or datasets used in these tests.
- Data Provenance: Not explicitly stated. The document does not specify the country of origin of the data or whether it was retrospective or prospective.
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 explicitly stated. The document does not mention the use of experts to establish a ground truth for testing. The testing focuses on comparing the software's performance to its specifications and predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not explicitly stated. There is no mention of an adjudication method in the testing description. The evaluation appears to be based on whether test results matched expected results and if the software performed equivalently to predicate devices.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The document describes the software's ability to correct motion artifacts and its equivalence to predicate devices, but it does not evaluate the improvement in human reader performance with or without the AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the testing described appears to be a standalone evaluation of the algorithm. The software is designed to "minimize motion error metrics" and produce "corrected projections," which are then "presented to the operator for acceptance or rejection." The verification and validation tests assess the software's performance against specifications and predicate devices, suggesting an evaluation of the algorithm's output independently, even if human review is the final step in clinical use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly define a "ground truth" in the traditional sense for diagnostic accuracy. Instead, the testing framework seems to rely on:
- Specifications: Whether the software's output aligned with pre-defined expected results for motion correction.
- Predicate Device Performance: Comparison of the STASYS software's performance to the established performance of the cleared Cedars-Sinai MoCo software. This implies that the predicate devices' outputs or their established effectiveness served as a benchmark for "ground truth" regarding desired motion correction.
8. The sample size for the training set
Not applicable/Not explicitly stated. The document refers to "algorithms developed by Digirad" and "internally developed proprietary algorithms," but it does not mention a "training set" or a machine learning model that would require one in the context of typical AI/ML development. This appears to be a rule-based or traditional signal processing algorithm rather than a data-driven machine learning model requiring a distinct training phase with labeled data.
9. How the ground truth for the training set was established
Not applicable/Not explicitly stated. As mentioned above, the document does not indicate the use of a training set for a machine learning model.
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Appendix 2: 510(k) Summary
Sponsor A.
DEC 1 7 2008
Digirad Corporation 13950 Stowe Drive Poway, California 92064 Contact Person: Joel Tuckey Tel: (858) 726-1527 Fax: (858) 726-1700
Date Prepared: September 26, 2008 B.
Device Name C.
Trade Name: STASYSTM Motion Correction Software Common Name: Gamma Camera System Classification Name: System, Emission Tomography Product Code: KPS
Cleared/Predicate Devices D.
The STASYS™ Motion Correction Software is substantially equivalent to the following cleared devices:
Cedars-Sinai Motion Correction (MoCo) Software cleared November 22, 2002 under (1) K023110 for Digirad Corporation.
Cedars-Sinai BPGS and MoCo software cleared April 27, 2001 under K010509 for (2) GE/SMV America.
E. Device Description
STASYS™ is a software application developed by Digirad for the correction of SPECT acquisition motion artifacts from gated and non-gated projection datasets. When the program is activated, STASYS uses algorithms developed by Digirad to minimize motion error metrics over the set of acquired projections. The resulting STASYS corrected projections are presented to the operator for acceptance or rejection of the correction. With STASYS software, cardiac SPECT studies acquired with both parallel hole and non-parallel hole collimators, can be motion corrected. The STASYS software has the same indications for use and function as the Cedars-Sinai designed MoCo software, currently being used on Digirad SPECT imaging systems and processing workstations.
F. Intended Use
The indications for use are the same as the predicate devices. The STASYS Motion Correction Software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.
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G. Technology
In STASYS, Digirad internally developed proprietary algorithms are implemented using in DTAB Pro, Digital Interesternally developed algorithms used in the predicate devices are also implemented using software technology.
H. Testing
Verification and Validation tests were conducted to demonstrate the STASYS software worldedion and with specifications. All tests passed with the actual results module raneitoned as per expected results. Testing included an evaluation of the software Substitually matering are sompared to the predicate devices, with results showing it performs as well.
I. Conclusion
Testing results demonstrate that the STASYS software meets the specifications and is as safe, as effective, and performs as well as the predicate devices.
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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joel Tuckey Vice President. Quality Digirad Corporation 13950 Stowe Drive POWAY CA 92064-8803
Re: K082904
Trade/Device Name: STASYSTM Motion Correction Software Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: September 26, 2008 Received: September 30, 2008
Dear Mr. Tuckey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Vogue M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use 510(k) Number (if known): IBS K 082904 Device Name: STASYSTM Motion Correction Software
Indications for Use:
The STASYS Motion Correction software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.
Prescription Use 1 (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helut Remen
(Division Sign-Off) Division of Reproductive, Abdominal, 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.