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For In Vitro Diagnostic Use

Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.

Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module (3.3).

Sectra Digital Pathology Module (3.3) is intended for use with Leica's Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.

The Sectra Digital Pathology Module (3.3) [henceforth referred to DPAT (3.3)] is a digital slide viewing system. The DPAT (3.3) is intended for use together with FDA-cleared whole-slide image scanner GT 450 DX and Dell U3223QE display.

The DPAT (3.3) can only be used as an add-on module to Sectra PACS. Sectra PACS consists of Sectra Workstation IDS7 (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000). Sectra PACS is not part of the subject device. Sectra Workstation is the viewing workstation in which the Pathology Image Window is run. Pathology Image Window is the client component of the subject device.

The system capabilities include:

• retrieving and displaying digital slides,
• support for remote intranet access over computer networks,
• tools for annotating digital slides and entering and editing metadata associated with digital slides, and
• displaying the scanned slide images for primary diagnosis by pathologists.

The subject device is designed to accurately display colors. The monitor is not part of the subject device.

Digital pathology images originating from WSI scanners other than those listed in the Indications for Use will be marked with the disclaimer "For Non-clinical Use Only" in the Pathology Image Window.

Image acquisition will be managed by the scanner which is not part of the subject device:

• The scanner delivers images with a tag in the file header that identifies the originating scanner.
• The scanner includes applications for controlling the scanning process and performing related quality control (e.g., ensuring that images are sharp and cover all tissue on the slide).

The DPAT (3.3) supports reading digital slides on a Dell U32230E display monitor, enabling pathologists to make clinically relevant decisions analogous to those they make using a conventional microscope. Specifically, the system supports the pathologist in performing a primary diagnosis based on viewing the digital slide on a computer monitor. These capabilities are provided by the Pathology Image Window.

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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For In Vitro Diagnostic Use

Sectra Digital Pathology Module device is a software intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.

Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module.

Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.

Sectra Digital Pathology Module is a software-only device running under the Microsoft Windows operating system for displaying and manipulating digital pathology images (scanned slides) obtained from the Aperio AT2 DX scanner.

Sectra Digital Pathology Module may only be used in combination with Sectra PACS which consists of Sectra Workstation (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000).

The Sectra Pathology Import Server (SPIS) is used for importing digital pathology images (scanned slides) from the scanner. These images are viewed and manipulated by end users in the Pathology Image Window which is displayed on the Sectra Workstation IDS7 (using the Dell MR2416 monitor).

Here's an analysis of the acceptance criteria and the study conducted for the Sectra Digital Pathology Module, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample size for any specific test set regarding color reproducibility, turnaround time, or measurements. It mentions a "test image containing objects with known sizes" for measurements, and "multiple tiles" for color reproducibility.

The data provenance is not specified (e.g., country of origin). The testing seems to be internal development and verification testing rather than involving external patient data.

3. Number of Experts for Ground Truth and Qualifications:

The document does not mention the use of experts to establish ground truth for the technical performance tests described (color reproducibility, turnaround time, measurements, human factors). These appear to be objective, quantifiable tests directly comparing the device's output to a known standard or the predicate device's output.

For "Human factors testing," it states "Task-based usability tests showed the Sectra Digital Pathology Module user interface to be intuitive, safe, and effective for the range of intended users." While suggesting involvement of intended users (pathologists likely), the number and specific qualifications of these users are not detailed.

4. Adjudication Method for Test Set:

No adjudication method is mentioned. The tests described are primarily objective comparisons or measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The document explicitly states: "Substantial equivalence determination is not based upon clinical study results."

6. Standalone (Algorithm Only) Performance Study:

Yes, standalone (algorithm only, meaning the software itself without human interaction for diagnostic purposes) performance was done. The studies listed under "Non-clinical test results" (Color Reproducibility, Turnaround times, Measurements) evaluate the technical performance of the software. The device itself is described as a "software-only device."

7. Type of Ground Truth Used:

• Color Reproducibility: Ground truth was implicitly the visual output and pixel data of the predicate device (Aperio ImageScopeDX).
• Turnaround Time: Ground truth was the pre-defined maximum acceptable time limits (7 seconds for case load, 0.5 seconds for panning).
• Measurements: Ground truth was a "test image containing objects with known sizes."
• Human Factors: Ground truth was established by assessing usability (intuitiveness, safety, effectiveness) through "task-based usability tests" likely with intended users.

8. Sample Size for the Training Set:

The document does not mention a training set. The Sectra Digital Pathology Module is described as a "software intended for viewing and management of digital images," rather than an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established:

Since no training set is mentioned for an AI/ML algorithm, this question is not applicable based on the provided text. The device is a viewer and management tool, not an AI diagnostic algorithm.

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The Sectra Angiography and Cardiology Package provides quantitative and reproducible information regarding the calculated dimensions of arterial segments, and quantitative information regarding the calculated dimensions and calculated performance characteristics of the left vertical of the heart, imaged during angiographic x-ray procedures typically performed in cath labs.

This information is suitable for use in the following applications:

1. Scientific and research studies, assessing the angiographic condition of patients and the result of device and drug therapeutics,
2. Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.

Sectra Angiography and Cardiology Package is intended to support radiologists and cardiologists in the diagnostic process to quantify findings. The device has functionality for quantitative analysis of the arteriograms (QCA and QVA) and quantitative analysis of the left ventricular angiographic images (LVA). Measurements can be applied on angiographic images.

The provided text does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document is a 510(k) summary for the Sectra Angiography and Cardiology Package, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies or specific acceptance criteria.

The "Performance Data" section merely states: "The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0." This indicates compliance with quality management systems and communication standards, not a clinical performance study with acceptance criteria.

Therefore, I cannot populate the requested table or answer most of the questions, as the information is not present in the provided text.

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The Sectra IDS device is intended for the manipulation and displaying of x-ray images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.

Device options make possible telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.

Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

The IDS5 10.1 Radiology Workstation is mainly a software product. It is used for visualization and processing of digital radiology images. The system runs under the Window 2000 and Windows XP operating system. The requirements on hardware are quite ordinary for a system used for displaying images. Most notably up to four monitors can be used.

This document describes a 510(k) submission for the Sectra IDS5 Radiology Workstation - Version 10.1, a Picture Archiving and Communications System (PACS).

Here's an analysis of the acceptance criteria and study information provided in the input, specifically focusing on what is present and absent from the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Absent. The document does not describe a clinical study or a test set of images with a defined sample size. The performance data section refers to compliance with standards rather than a specific study involving image data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Absent. Since there is no described clinical study or test set for evaluation of image interpretation performance, there is no mention of experts establishing ground truth for such a set. The document states that images and information are "interpreted by a physician or trained medical personnel," implying human oversight during clinical use, but not in the context of device validation.

4. Adjudication method for the test set

• Absent. No test set or corresponding adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Absent. The device described is a PACS workstation, an image processing and display system. It does not appear to incorporate AI or CAD (Computer-Aided Detection/Diagnosis) directly for interpretation assistance. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

• Absent. As noted above, this device is a workstation for displaying and manipulating images, not a standalone AI algorithm for diagnostic interpretation. Its performance is related to its ability to correctly process and present images according to standards, leaving interpretation to human users.

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

• Absent. This information is not relevant in the context of the provided performance data, which focuses on compliance with technical standards (ISO, DICOM) and substantial equivalence to a predicate device for its intended function as an image display and processing system. The core function is presenting images, not independently deriving diagnostic conclusions that would require a ground truth comparison.

8. The sample size for the training set

• Absent. This device is a software product for viewing and manipulating images; it does not explicitly use a "training set" in the context of machine learning for diagnostic tasks. Its development followed ISO 9001:2000, which is a quality management system standard.

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

• Absent. As there is no described training set for a machine learning model, the establishment of ground truth for such a set is not applicable.

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