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The Hologic SecurView DX is intended for selection, display, manipulation, filming and media interchange of multi-modality images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.

The SecurView DX is typically used by trained professionals, including, but not limited to physicians, radiologists, nurses, medical technicians and assistants.

The Hologic SecurView DX is mainly a software product. It is used for visualization and manipulation of digital radiology images. The SecurView DX is a multi-modality review workstation software focused on mammographic applications. The software can drive high-resolution displays (FDA cleared for Mammography), a PC mouse, a keyboard, optional lower resolution monitors and dedicated workflow keypad.

The software accepts standard or multi-frame mammography images that have been created according to the "FOR PRESENTATION" specification of the DICOM Standard with no compression or using lossless compression. Image processing is external to the SecurView DX software.

The software accepts standard or multi-frame multimodality images of US, MR, DR, CR, SC, CT, PET, and other DICOM formats for display and manipulation on high resolution displays (FDA cleared for mammography) or on other lower resolution color displays in 2-D or 3-D view.

The SecurView DX software can be used in a single or in a multi-workstation configuration.

The provided 510(k) summary for SecurView DX (K103385) describes a software product that is substantially equivalent to its predicate device (K062107). This means the primary "study" proving its acceptance involves demonstrating that the modified device behaves essentially the same as the previously cleared device, with minor changes that do not raise new questions of safety or effectiveness.

Therefore, the documentation does not contain information about a traditional clinical study with acceptance criteria and reported device performance metrics in the way one might expect for a novel device or AI algorithm with specific performance claims. Instead, the acceptance is based on demonstrating substantial equivalence through a comparison of features and by verifying that the modified software continues to function as intended.

Below is an attempt to structure the requested information based on the provided document, highlighting what is present and what is absent due to the nature of a substantial equivalence submission for a software update.

Acceptance Criteria and Device Performance for SecurView DX (K103385)

Given that this is a 510(k) submission for substantial equivalence of a software update (SecurView DX, K103385) to a predicate device (SecurView DX, K062107), the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate device and verification that the modified software performs its intended functions without introducing new safety or effectiveness concerns. There isn't a separate, quantifiable performance outcome defined with specific thresholds for sensitivity, specificity, etc., as would be the case for a device with a quantifiable diagnostic claim.

The primary acceptance criteria for this submission are that the modified device is substantially equivalent to the predicate device in terms of intended use, indications for use, and conformance to relevant standards, and that the modifications do not introduce new safety or effectiveness issues.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable or not specified in the document. This submission relies on demonstrating substantial equivalence through comparison to the predicate and internal verification/validation activities of the software changes. There is no mention of a "test set" in the context of clinical images or patient data for performance evaluation. The "bench testing designed to simulate clinical factors" implies internal testing, not a formal clinical trial with a defined patient sample size.
• Data Provenance: Not applicable or not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. This type of information is not typically part of a substantial equivalence submission for a software update of this nature, as there isn't a "ground truth" establishment in the context of a diagnostic performance study.

4. Adjudication Method for the Test Set

• Not applicable. There is no mention of a formal test set requiring adjudication in the context of a clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance

• No, an MRMC comparative effectiveness study was not done. The SecurView DX is a viewing workstation and does not incorporate AI in the sense of a diagnostic algorithm to which human readers would be compared or assisted by for specific diagnostic tasks with an effect size measurement. The mention of "AIE Region of Interest Image Enhancement for Digital Mammography software, cleared as K062059" refers to an external, separate medical device whose output SecurView DX can display, not an AI component integrated into SecurView DX itself for diagnostic assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. The SecurView DX is a display and manipulation software, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

• Not applicable. Ground truth, in the context of diagnostic performance, is not discussed as there is no diagnostic performance study described for this submission. The "ground truth" for the software's functionality is its adherence to specifications and its ability to correctly display and manipulate medical images, similar to the predicate device.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI algorithm that requires a training set of images.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no training set for an AI algorithm.

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The Hologic SecurView DX device is intended for selection, display, manipulation, filming and media interchange of multi-modality images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards.

The device used with FDA cleared monitors may be used by a trained physician for display, manipulation and interpretation of lossless compressed or non-compressed mammographic images for screening and diagnostic mammography, as well as any other DICOM multi-modality image.

The Hologic Secur View DX is mainly a software product. It is used for visualization and manipulation of digital radiology images. The SecurView DX is a multi-modality review workstation software focused on mammographic applications. The software can drive at least two high-resolution gray scale displays (FDA cleared for Mammography), a PC mouse, a keyboard and an optional dedicated workflow keypad.

The software accepts standard or multi-frame mammography images that have been created according to the "FOR PRESENTATION" specification of the DICOM Standard with no compression or using lossless compression. Image processing is external to the SecurView DX software.

The software accepts multimodality images of US, MR, DR, CR, SC, CT, PET, and other DICOM formats for display and manipulation on the high resolution 5 MP gray scale displays or on a color 2 MP display in 2-D or 3-D view.

The SecurView DX software can be used in a single or in a multi-workstation configuration.

The minimum computer requirements to run the Secur View DX software are: Windows XP® Operating System Intel CPU with a clock rate of 2.0 GHz or greater 2.0 GB RAM or greater 140 GB Hard drive or greater, operating at 160 Mbs or greater CD-ROM/R 10/100 Base TX Network Interface

The provided document is a 510(k) summary for the Hologic SecurView DX, a software product for viewing and manipulating digital radiology images, primarily mammograms. The submission is a "Special 510(k)," meaning it's a modification to an already cleared device (K041555). Therefore, the study presented focuses on demonstrating substantial equivalence to the predicate device rather than establishing de novo performance criteria through a new clinical effectiveness study.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in the typical sense of a de novo device submission (e.g., specific sensitivity or specificity targets). Instead, the acceptance criterion for this Special 510(k) is substantial equivalence to its predicate device (SecurView DX K041555).

The reported device performance is demonstrated through its functional similarity and compliance with relevant standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific test set or clinical study with patient data to evaluate diagnostic performance. As a Special 510(k) for a software modification, the focus is on verification and validation (V&V) of the software and hardware changes, demonstrating that the modified device performs as intended and is equivalent to the predicate. The "study" here is primarily an engineering and quality systems V&V process rather than a clinical trial.

Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided because such a study was not deemed necessary for this type of submission.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Since no clinical study with a test set of patient cases is described, there is no information provided on experts establishing ground truth for such a dataset. The "experts" involved would have been the Hologic engineering and quality assurance teams validating the software modifications.

4. Adjudication Method for the Test Set

As there is no described test set of patient cases, there is no adjudication method mentioned.

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

The document does not report on a multi-reader multi-case (MRMC) comparative effectiveness study. The submission is a Special 510(k) focused on demonstrating substantial equivalence through software and hardware modifications, not on measuring the comparative effectiveness of human readers with or without AI assistance. The device itself is a viewing workstation, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The SecurView DX is a "Picture archiving and communication system" and a "multi-modality review workstation software." It is designed for "display, manipulation and interpretation of lossless compressed or non-compressed mammographic images using FDA cleared displays for screening and diagnostic mammography." This explicitly describes a human-in-the-loop device. Therefore, no standalone (algorithm-only) performance study was conducted or is relevant for this device's intended use.

7. Type of Ground Truth Used

Given that no clinical study with patient data is described, formal "ground truth" in the clinical sense (e.g., pathology, outcomes data) was not used for this submission to establish diagnostic accuracy. The ground truth for this submission relates to the functional correctness and compliance of the software and hardware modifications, established through internal testing, validation against DICOM standards, and verification against the predicate device's specifications.

8. Sample Size for the Training Set

No training set is mentioned because the SecurView DX is a software workstation for displaying and manipulating images, not a machine learning or AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML algorithm mentioned, this information is not applicable.

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