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510(k) Data Aggregation
(165 days)
Clarity Viewer is software that retrieves digital images and data from various sources (e-g. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
Images (including mammography) and data can be retrieved and displayed within the system and or across computer networks at distributed locations.
Clarity's archiving engine utilizes lossless algorithms for compression services (JLSL, J2KR, and JPLL). Lossless compressed mammographic images can be reviewed for primary image interpretation. Lossy compressed mammographic images received from outside sources and digitized film screen images must not be reviewed for primary image interpretation.
Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
Clarity Viewer is software that retrieves digital images and data from various sources (e-g. CT scanners, MR scanners, ultrasound systems, RIF Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
Images (including mammography) and data can be retrieved and displayed within the system and or across computer networks at distributed locations.
Clarity's archiving engine utilizes lossless algorithms for compression services (JLSL, J2KR, and JPLL). Lossless compressed mammographic images can be reviewed for primary image interpretation. Lossy compressed mammographic images received from outside sources and digitized film screen images must not be reviewed for primary image interpretation.
Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
The provided document is an FDA 510(k) clearance letter for the iCRco Clarity Viewer, which is a Picture Archiving and Communications System (PACS). This document does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a 510(k) submission's performance section.
The letter confirms substantial equivalence but does not provide the specifics of the studies conducted to demonstrate that equivalence. The information requested regarding acceptance criteria, sample sizes, expert qualifications, ground truth, and specific study designs (MRMC, standalone) is not present in this document.
The document only states the "Indications For Use" and general device function:
- Device Name: Clarity Viewer
- Indications For Use: Software that retrieves digital images and data from various sources (e.g., CT, MR, ultrasound, R/F, computed & direct radiographic devices, secondary capture, scanners, imaging gateways, or other imaging sources). Images (including mammography) and data can be retrieved and displayed within the system and/or across computer networks at distributed locations.
- Compression: Utilizes lossless algorithms for compression services (JLS, J2KR, and JPLL). Lossless compressed mammographic images can be reviewed for primary image interpretation. Lossy compressed mammographic images from outside sources and digitized film screen images must not be reviewed for primary image interpretation.
- Mammography Interpretation Requirement: Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
To answer the questions posed, the actual 510(k) submission document (K132499) would need to be consulted, specifically the sections detailing the performance studies and bench testing. This clearance letter is merely the FDA's decision based on that submission.
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(252 days)
The iCR3600M CR Mammography Feature together with iCR3600M CR Mammography Cassette comprise a device which, when used in conjunction with an iCRco 3600 CR System and a mammographic x-ray machine, generates digital mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by an MQSA qualified physician using either hardcopy film or softcopy display at a workstation.
The iCR3600M CR Mammography Feature together with iCR3600M CR Mammography Cassette comprise a device which, when used in conjunction with an iCRco 3600 CR System and a mammographic x-ray machine, generates digital mammographic images.
The provided text does not contain detailed information about acceptance criteria and the study that proves the device meets the acceptance criteria. It is a 510(k) premarket notification letter from the FDA regarding the iCRco 3600M full-field digital mammography system, stating that the device is substantially equivalent to legally marketed predicate devices.
The letter mentions that the device generates digital mammographic images and is intended for screening and diagnosis of breast cancer, for use in the same clinical applications as traditional screen-film based mammographic systems, and that images can be interpreted by an MQSA qualified physician. However, it does not provide the specific performance metrics (like sensitivity, specificity, or accuracy) that would serve as acceptance criteria, nor does it detail a study that proves the device meets such criteria.
Therefore, I cannot extract the requested information from the provided text for the following points:
- A table of acceptance criteria and the reported device performance: Not available.
- Sample sized used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not available.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document is primarily a regulatory approval notice, not a clinical study report.
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(135 days)
The Claris CBCT Computed Tomography X-Ray System is a dedicated Xray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.
The Claris CBCT accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both twodimensional images and three-dimensional renderings ...
The Claris CBCT Computed Tomography X-Ray System is a dedicated Xray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.
The Claris CBCT accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both twodimensional images and three-dimensional renderings ...
This document is a 510(k) clearance letter for the Claris CBCT device. It indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, it does not contain the acceptance criteria or the study data that proves the device meets those criteria.
Therefore, I cannot provide the requested information based on the provided text. The document is primarily an administrative letter from the FDA, confirming clearance, and does not delve into the technical validation of the device's performance against specific acceptance criteria.
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(206 days)
The iCRco Fusion Flat Panel DR System is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding, fluoroscopy, angiography and mammography. Fusion Flat Panel DR allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called "Fusion Flat Panel." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily states that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.
Therefore, the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text.
The document states:
- Device Name: Fusion Flat Panel
- Indications For Use: The iCRco Fusion Flat Panel DR System is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding, fluoroscopy, angiography and mammography. Fusion Flat Panel DR allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
- Regulation Number: 21 CFR 892.1650
- Regulation Name: Image-intensified fluoroscopic x-ray system (though the indications for use explicitly exclude fluoroscopy, this is likely a broader regulatory classification that applies)
- Product Code: MOB
To answer your request, you would need a different document, such as a summary of safety and effectiveness, a clinical study report, or internal validation data for the device.
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(309 days)
The iDR is indicated for use in generating diagnostic medical x-rays images of human anatomy. It is intended to replace radiographic film/ screen systems in all general - purpose diagnostic radiographic procedures. It is not intended for mammography applications.
Not Found
This document is a 510(k) clearance letter from the FDA for the iDR device, an x-ray system. It does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter primarily:
- Acknowledges the submission and the substantial equivalence to a predicate device.
- Outlines regulatory requirements for the device.
- Specifies the "Indications for Use" for the iDR, which is "generating diagnostic medical x-rays images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic radiographic procedures." It also explicitly states, "It is not intended for mammography applications."
Therefore, I cannot provide the requested information based on the provided text.
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