Search Results

The Oasis system is indicated for the processing and review of scintigraphy data and other related diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. Oasis is capable of processing and displaying the medical image data in traditional formats, as well as in pseudo three-dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs. The Oasis system displays the processed images using an integrated computer. Oasis provides manual and automatic report creation plus the ability to view these reports remotely. Oasis also provides patient scheduling tools. This device is not used in the primary diagnosis of Mammography images.

Not Found

This document is a 510(k) clearance letter for the Oasis, Release 1.0 device, which is a Picture Archiving and Communication System (PACS). This type of document typically provides regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against specific acceptance criteria.

The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is typically found in the 510(k) submission summary or in the actual performance studies conducted by the manufacturer, which are not directly part of this FDA clearance letter.

Therefore, based solely on the provided text, I cannot extract the detailed information requested regarding acceptance criteria and the study that proves the device meets them. The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered acceptable relative to those devices, but it does not specify performance metrics or the studies used to establish this equivalence in detail.

Ask a specific question about this device

The DGSCOPE system is indicated for the review of diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. The DGSCOPE system displays the processed images using an integrated computer. The DGSCOPE's PC's surfaces can be disinfected using an FDA approved liquid disinfectant indicating that the use of the DGSCOPE system is appropriate in an operating room environment. The display of CT, MR, X-Ray, NM, US, and other diagnostic data is in the standard planar and pseudo-three dimensional formats in both static and dynamic review modes. This device is not used in the primary diagnosis of Mammography images.

Not Found

The provided text is a 510(k) premarket notification approval letter for the DGSCOPE, Release 1.0 device. This document primarily focuses on the regulatory approval and indications for use, rather than detailed performance studies or statistical metrics. As such, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.

Here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Not available in the provided text. This document is an approval letter, not a performance report.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available. The document does not describe any specific test sets or data provenance.

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 available.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not available.

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

Not available. The DGSCOPE is described as a device for "review of diagnostic medical images" and "displays the processed images." There is no mention of AI assistance or a comparative effectiveness study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not available. The DGSCOPE is described as a display system, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not available.

8. The sample size for the training set

Not available.

9. How the ground truth for the training set was established

Not available.

Summary of available information from the document:

• Device Name: DGSCOPE, Release 1.0
• Regulation Number: 21 CFR 892.2050
• Regulation Name: Picture archiving and communications system
• Regulatory Class: II
• Product Code: LLZ
• Indications for Use: The DGSCOPE system is indicated for the review of diagnostic medical images produced by DICOM-based multimodality sources. These sources may include, but are not limited to, radiological diagnostic systems, picture archival computers (PACS), and processing workstations. The DGSCOPE system displays the processed images using an integrated computer. The DGSCOPE's PC's surfaces can be disinfected using an FDA approved liquid disinfectant indicating that the use of the DGSCOPE system is appropriate in an operating room environment. The display of CT, MR, X-Ray, NM, US, and other diagnostic data is in the standard planar and pseudo-three dimensional formats in both static and dynamic review modes. This device is not used in the primary diagnosis of Mammography images.
• FDA Determination: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

To obtain the requested information, one would need to refer to the actual 510(k) submission document or supporting technical files, which are not included in the provided regulatory approval letter.

Ask a specific question about this device

The Mirage system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is 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 imaged organs.

Not Found

The provided document is a 510(k) clearance letter for the "Mirage Cedars Option" device, which is a Picture Archiving and Communications System (PACS) for scintigraphy camera output data. It does not contain a detailed study report or specific acceptance criteria with reported device performance. Therefore, I cannot provide the requested information based solely on the text provided.

However, based on the nature of a 510(k) submission for a PACS device, I can infer some general aspects and typical requirements. For a complete answer, one would need to access the full 510(k) summary or the original study data submitted to the FDA.

From the given document, I can only extract these pieces of information:

• Trade/Device Name: Mirage Cedars Option
• Regulation Number: 21 CFR 892.2050
• Regulation Name: Picture archiving and communications system
• Regulatory Class: II
• Product Code: LLZ
• Indications for Use: The Mirage system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is 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 imaged organs.
• 510(k) Number: K070683 (also K07106 is mentioned, but K070683 is the primary one in the letter header).

Regarding the specific questions you asked, here's an explanation of why the information is not present in this document and what would typically be expected for a PACS system:

1. A table of acceptance criteria and the reported device performance:

   • Information in document: Not present.
   • Typical for PACS: For a PACS system, acceptance criteria usually relate to image display accuracy (e.g., adherence to DICOM Part 14 grayscale display function standard), image retrieval speed, data integrity, security, and functionality as described in the indications for use. Performance would be assessed against these functional and technical specifications rather than diagnostic accuracy (as it's a display/archiving tool, not a diagnostic AI algorithm).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Information in document: Not present.
   • Typical for PACS: A "test set" in the context of an algorithm's diagnostic performance isn't directly applicable here because the device is a PACS, not an AI diagnostic algorithm. Testing would involve system validation and verification with various types of scintigraphy images (DICOM compliance, correct display, retrieval) rather than a diagnostic evaluation.

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):

   • Information in document: Not present.
   • Typical for PACS: Ground truth in the diagnostic sense is not relevant for a PACS. Instead, validation would involve technical experts (e.g., medical physicists, IT professionals) to verify system functionality and adherence to standards, and potentially clinical users (e.g., nuclear medicine physicians) to confirm aesthetic and functional usability.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Information in document: Not present.
   • Typical for PACS: Adjudication is not typically used for PACS validation.

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:

   • Information in document: Not present.
   • Typical for PACS: An MRMC study is not relevant for a PACS, as it's not a diagnostic AI tool intended to assist readers with interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Information in document: Not present.
   • Typical for PACS: Not applicable. A PACS is a system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Information in document: Not present.
   • Typical for PACS: Not applicable in the diagnostic sense. The "ground truth" would be technical specifications and clinical expectations for image display and archiving.

8. The sample size for the training set:

   • Information in document: Not present.
   • Typical for PACS: Not applicable. PACS systems are not typically "trained" in the machine learning sense. They are engineered software systems.

9. How the ground truth for the training set was established:

   • Information in document: Not present.
   • Typical for PACS: Not applicable.

In summary, the provided document is a regulatory clearance letter and does not contain the detailed technical and clinical study results that would typically be found in a 510(k) summary or the full submission. For a PACS device like the "Mirage Cedars Option," the focus of testing and acceptance criteria would be on system functionality, compliance with standards (e.g., DICOM), data integrity, and display accuracy, rather than diagnostic performance metrics of an AI algorithm.

Ask a specific question about this device

The Mirage Release 5.5 system is indicated for the acquisition, processing, review and archiving of scintigraphy camera output data and related diagnostic images. It is 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 imaged organs.

Not Found

The provided text describes a 510(k) premarket notification for the "Mirage Release 5.5" device. However, this document is a regulatory approval letter and an Indications for Use statement. It does not contain details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information from the given text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its regulatory clearance, but it does not elaborate on the specific performance studies that would typically be conducted to prove this equivalence.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification that includes the device validation and verification data.

Ask a specific question about this device