(64 days)
The Cedars-Sinai Motion Correction (MoCo) software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.
The MoCo program is an independent, standalone software application developed by Cedars-Sinai Medical Center for the automatic and manual correction of SPECT acquisition motion artifacts from gated and ungated projection datasets. MoCo is the most popular motion correction application in the field of nuclear myocardial perfusion SPECT imaging. The software has the same indication for use and function as the Motion Correction function module of Mirage software (Segami Corporation, K972886), which is currently being used on Digirad 2020tc SPECT Imaging systems.
The provided document describes the Cedars-Sinai Motion Correction (MoCo) Software, a standalone application for correcting patient motion artifacts in SPECT data. However, it does not contain information regarding detailed acceptance criteria, a specific study proving it meets these criteria, or a table comparing acceptance criteria to device performance metrics beyond a general statement of "Functionality tests were conducted to demonstrate that the MoCo software application functioned as per its specifications. All tests passed with the actual results substantially matching the expected results."
Here's an analysis of the available information, noting what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document. The submission states that functionality tests were conducted and passed, but it does not specify the quantitative acceptance criteria or the reported performance metrics (e.g., specific accuracy, sensitivity, or specificity values) from these tests.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided document. The document mentions "functionality tests" but does not detail the number of cases or datasets used in these tests. Information on the country of origin of the data or whether it was retrospective or prospective is also not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not available in the provided document. The method and number of experts for establishing ground truth for any test set are not mentioned.
4. Adjudication Method for the Test Set
Not available in the provided document. No information is provided regarding any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available in the provided document. There is no mention of an MRMC study being conducted, nor any effect size regarding human reader improvement with or without AI assistance.
6. Standalone Algorithm Performance
The document states that the MoCo program is an "independent, standalone software application." The functionality tests described imply a standalone evaluation, where the software's performance against its specifications was assessed. However, specific performance metrics are not given.
7. Type of Ground Truth Used
Not available in the provided document. The document does not specify how the "expected results" for the functionality tests were determined or what type of ground truth (e.g., expert consensus, pathology, outcomes data) was used.
8. Sample Size for the Training Set
Not available in the provided document. The document does not provide any information about a training set or its sample size.
9. How Ground Truth for the Training Set Was Established
Not available in the provided document. Since no training set is mentioned, there is no information on how its ground truth was established.
Summary of available information related to testing:
The document mentions "Functionality tests were conducted to demonstrate that the MoCo software application functioned as per its specifications. All tests passed with the actual results substantially matching the expected results." This indicates that some form of internal validation was performed to ensure the software performed as designed, but the details of this validation (specific criteria, data used, and quantitative outcomes) are not present in this submission. The submission primarily focuses on the device's classification, intended use, and substantial equivalence to predicate devices, rather than a detailed performance study with quantifiable acceptance criteria.
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)023110
Identification:
Date of Application:
September 18 , 2002
NOV 22 2002
Applicant's and Name and Address:
Corey Stewart Quality Assurance Manager Digirad Corporation 9350 Trade Place San Diego, CA 92126
Telephone and Fax Numbers of the Applicant
Telephone: (858) 537 – 2118 Fax: (858) 549 - 9789 Email: cstewart@digirad.com
Signature
Cory Stuart
Date 9/18/02
Device name and classification
Classification Code:
90 KPS
Panel Identification:
Radiology
Proprietary Name:
Cedars-Sinai Motion Correction (MoCo) Software
Common Name:
Gamma Camera System
Classification Name: System, Emission Computed Tomography
Classification Class:
Class II Product
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Substantial Equivalence
Predicate devices
| GE/SMV | ELGEMS Ltd. | |
|---|---|---|
| Cedars- | QPS/BPGS/MoCo | |
| Sinai BPGS | Processing | |
| and MoCo | Applications | |
| Product Code | 90 KPS | 90 KPS |
| 510(k) Number | K010509 | K003264 |
Device Description
The MoCo program is an independent, standalone software application developed by Cedars-Sinai Medical Center for the automatic and manual correction of SPECT acquisition motion artifacts from gated and ungated projection datasets. MoCo is the most popular motion correction application in the field of nuclear myocardial perfusion SPECT imaging. The software has the same indication for use and function as the Motion Correction function module of Mirage software (Segami Corporation, K972886), which is currently being used on Digirad 2020tc SPECT Imaging systems.
Intended Use
The Cedars-Sinai Motion Correction (MoCo) software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.
Testing
Functionality tests were conducted to demonstrate that the MoCo software application functioned as per its specifications. All tests passed with the actual results substantially matching the expected results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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NOV. 22. 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Corey Stewart Quality Assurance Manager DIGIRAD CORPORATION 3950 Trade Place SAN DIEGO CA 92126
Re: K023110
Trade/Device Name: Cedars-Sinai Motion Correction (MoCo) Software, Model 111005 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system
Regulatory Class: II Product Code: 90 KPS Dated: September 18, 2002 Received: September 19, 2002
Dear Mr. Stewart:
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. Iisting 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 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.
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.
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Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Vernie C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Digirad Corporation, Traditional 510(k) Submission Cedars-Sinai Motion Correction (MoCo) Software Program
APPENDIX I. INDICATIONS FOR USE STATEMEN
02311 510(k) Number (if known): K_
Device Name:
Cedars-Sinai Motion Correction (MoCo) Software Program on computer systems with a PC architecture, the Windows operating system and a PC X windows server software.
Indications For Use:
The Cedars-Sinai Motion Correction (MoCo) 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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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use $\underline{\checkmark}$
Daniel A. Deegan
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
09/18/2002
§ 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.