(26 days)
The WBR Xact.cardiac & Xpress.cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.
The Xact.cardiac & Xpress.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac data is reconstructed by the Xact.cardiac. . Gamma camera cardiac, fast acquired, data is reconstructed by the Xpress.cardiac. The Xact.cardiac & Xpress.cardiac utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Xact.cardiac & Xpress.cardiac device:
Based on the provided 510(k) summary and FDA clearance letter, specific acceptance criteria and detailed study data (like sample sizes for test and training sets, exact ground truth establishment, or MRMC studies) are not explicitly provided. The document is a regulatory submission summary rather than a detailed scientific publication of a study.
The submission focuses on declaring substantial equivalence to a predicate device, and the "Safety & Effectiveness" section primarily states that the device was designed, verified, and validated according to 21 CFR 820.30 regulations. It generally claims that "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back-projection. No adverse affects have been detected."
Given the limitations of the provided text, I will address each point based on what can be inferred or is directly stated, and explicitly state when information is not available in the document.
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image Resolution Equivalent or Better than Filter Back-Projection | Reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back-projection. |
| No Adverse Effects | No adverse affects have been detected. |
| Compliance with 21 CFR 820.30 | Device has been designed, verified and validated complying to 21CFR 820.30 regulations. |
| Substantial Equivalence to Predicate Devices (Mirage Workstation K972886, WBR - fHR and WBR -fWB K040370) | UltraSPECT opinion that the Xact.cardiac & Xpress.cardiac are substantially equivalent in terms of safety and effectiveness to the above predicate device. |
Study Details:
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Sample size 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 "bench and clinical data" but does not quantify the sample size of the clinical data used for validation.
- Data Provenance: Not explicitly stated. Given UltraSPECT Ltd. is based in Haifa, Israel, it's possible some data originated there, but this is not confirmed. It's also not stated if the data was retrospective or prospective.
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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 provide details on ground truth establishment or the involvement of experts in the validation process.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not explicitly stated. There is no information provided about any adjudication methods used for the test set.
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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
- Not explicitly stated. The document does not mention a multi-reader, multi-case study nor does it discuss human reader improvement with or without AI assistance. The device is an image processing system for reconstruction, not explicitly an AI-assisted diagnostic tool in the sense of a standalone AI system for interpretation.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied: The device is an "image processing system" that "reconstructs" images. The claim is about the quality of the reconstructed images being equivalent or better. This suggests the primary "study" (clinical data) would assess the output images themselves, likely in a standalone manner comparing them to images generated by the predicate or traditional methods. However, a formal "standalone performance" study with specific metrics (e.g., sensitivity, specificity for a diagnostic task) is not detailed. The focus is on image quality.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. Given the claim is about "resolution," the "ground truth" for image quality assessment would likely involve objective measures of resolution (e.g., phantom studies, edge sharpness, contrast-to-noise ratio) and/or subjective assessments by experts comparing images, rather than a diagnostic ground truth like pathology for identifying disease. The document states "reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back-projection," suggesting a comparison of image characteristics.
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The sample size for the training set
- Not explicitly stated. The document does not provide details about a training set. As an image reconstruction algorithm, it might involve algorithm development and tuning without a distinct "training set" in the machine learning sense, or if it did, the size is not disclosed.
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How the ground truth for the training set was established
- Not explicitly stated. Since information on a training set itself is absent, the method for establishing its ground truth is also not mentioned.
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510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name
Proprietary Device Name: Xact.cardiac & Xpress.cardiac.
Establishment Name and Registration Number of Submitter
Name: UltraSPECT Ltd. Corresponding Official: Dan Laor
Building 30, MATAM Haifa, 31905 Israel
Device Classification
Device Code: CFR section: Panel Identification: Device Description: Classification:
90 KPS 892.1200 Radiology Emission computed tomography system Class II Product
Reason for 510(k) Submission
Special 510(k) Submission
Identification of Legally Marketed Equivalent Devices
Mirage Workstation (K972886) WBR - fHR and WBR -fWB (K 040370)
Device Description
The Xact.cardiac & Xpress.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac data is reconstructed by the Xact.cardiac. . Gamma camera cardiac, fast acquired, data is reconstructed by the Xpress.cardiac. The Xact.cardiac & Xpress.cardiac utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.
Intended Use of Device
The Xact.cardiac & Xpress.cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs
Safety & Effectiveness
The device has been designed, verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back - projection. No adverse affects have been detected.
Substantial Equivalency
It is UltraSPECT opinion that the Xact.cardiac & Xpress.cardiac are substantially equivalent in terms of safety and effectiveness to the above predicate device.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized representation of a human figure with three overlapping profiles, suggesting a sense of community and interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and its national scope.
Public Health Service
APR 2 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan Laor QA Manager UltraSPECT Ltd. 30 MATAM, Haifa, 31905 ISRAEL
Re: K050815 Trade/Device Name: WBR Xact.cardiac & Xpress.cardiac Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving communications system Regulatory Class: II Product Code: KPS and LLZ Dated: March 28, 2005 Received: April 6, 2005
Dear Mr. Laor:
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 (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 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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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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy 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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Indications for Use
510(k) Number (if known):
K05Df/5
Device Name: WBR Xact.cardiac & Xpress.cardiac
Indications For Use: The WBR Xact.cardiac & Xpress.cardiac is indicated for the are Indications For Ose. The VPBK Adol.sarantigraphy camera output data. They are acquisition, formating and storage of tointigraphy camment in traditional formats, as
capable of processing and displaying the acquired information in tradition of animated capable of processing and displaying the stigated.
well as in pseudo three dimensional renderings, and in various forms of animated well as in polusion kinetic attributes of the image organs.
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Ylancyi Burgion
(Division Sign Off) Division of Reproductive, Abdominal, and Redictionical Devices 5 It (x) 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.