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The Sectra MicroDose Mammography L30 is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Sectra MicroDose Mammography L30 is intended to be used in the same clinical applications as traditional film/screen systems.

The Sectra MicroDose Mammography L30 is a type of full-field digital mammography system comprised of an image acquisition system, a gantry and an acquisition workstation computer equipped with a keyboard, a keypad, a mouse, and a monitor. The image acquisition system includes a digital detector of photon counting technology, x-ray tube (with tungsten target and aluminum filtration), high voltage generator, compression paddle(s), and multi-slit collimator. The acquisition workstation is the user interface for preparing and initiating image acquisition, image processing, and image transfer to the desired destination (e.g. PACS) for diagnosis and archiving.

The Sectra MicroDose Mammography 130 detector is based on photon counting technology and consists of a large number of crystalline silicon strip detectors. The technology enables high detection efficiency of photons and efficient rejection of electronic noise. The Sectra MicroDose Mammography L30 uses a multi-slit scanning technique that prevents image degradation caused by scattered radiation by removing photons scattered in the breast and not directed towards the detector. These factors combine into a dose efficient system.

The Sectra MicroDose Mammography L30 provides three exposure modes; manual, automatic (parameters predefined based on compressed breast thickness), and SmartAEC. SmartAEC continuously adjusts the exposure based on measured transmission from the leading detector edge.

This 510(k) premarket notification describes the Sectra MicroDose Mammography L30, a full-field digital mammography system. The submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristic comparisons and non-clinical performance data, rather than specific acceptance criteria from a clinical study for an AI-powered device. Therefore, a direct table of acceptance criteria and reported device performance related to AI is not available in the provided text.

Based on the provided information, I can extract the following relevant details that loosely align with your request regarding how the device meets acceptance criteria, though it's important to note this is not an AI device and the evaluation process differs significantly from what you might expect for AI-driven systems:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from Non-Clinical Testing and Predicate Comparison):

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

• Test Set Sample Size: Not explicitly stated as a number of images or patients for clinical testing using a test set. The document refers to "Performance data from non-clinical testing," which typically involves phantoms and laboratory measurements, not patient images in a "test set" in the context of AI evaluation.
• Data Provenance: The non-clinical testing was performed in line with generally accepted test methods (e.g., IEC standards). No specific country of origin for a clinical test set is mentioned because a clinical test set for performance comparison was not detailed. This was a 510(k) submission based on technical equivalence and non-clinical data.

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

• Not applicable in the context of this 510(k) submission. The evaluation was based on non-clinical performance data compared to predicate devices, and an "image attribute evaluation" was conducted, but the number and qualifications of experts establishing a "ground truth" for a test set (as would be done for an AI model) are not provided. The image attribute evaluation "concluded that the images were of sufficiently acceptable quality for clinical mammographic usage," implying expert review, but details are absent.

4. Adjudication Method for the Test Set:

• Not applicable. No formal adjudication method for a clinical "test set" is described for this submission.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or described. This device is a mammography system (hardware and basic processing), not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a mammography imaging system, not a standalone AI algorithm. Its performance is inherent in the image acquisition and primary processing, not as an independent diagnostic algorithm.

7. Type of Ground Truth Used:

• For the non-clinical performance evaluation, the "ground truth" was established by comparison against established standards and predicate device performance. For the "image attribute evaluation," the ground truth was expert consensus on the acceptability of image quality for clinical mammographic usage, as per the FDA Guidance for Industry and FDA Staff. No pathology or outcomes data are mentioned for this particular evaluation of the system's image quality.

8. Sample Size for the Training Set:

• Not applicable. This device is a hardware system with integrated image acquisition and processing. There is no concept of a "training set" in the context of how this device was evaluated for its 510(k) submission.

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

• Not applicable, as there is no training set for this type of device.

Summary of the Study:

The study described is primarily a technical comparison and non-clinical performance evaluation to demonstrate substantial equivalence of the Sectra MicroDose Mammography L30 system to two legally marketed predicate devices (FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE and SENOGRAPHE 2000D).

• Study Design: The manufacturer performed non-clinical testing covering various image quality and dose parameters (sensitometric response, spatial resolution, noise analysis, DQE, dynamic range, AEC performance, phantom testing, patient radiation dose, image stability). The results of these tests were then compared to the data available from the PMA Summaries of Safety and Effectiveness of the predicate devices.
• Evaluation Standard: The testing was done "in accordance with generally accepted test methods, e.g. using IEC standards, published factors for dose calculations etc." An "image attribute evaluation" was also conducted as per the "Class II Special Controls Guidance Document: Full-Field Digital Mammography System," concluding the images were of "sufficiently acceptable quality for clinical mammographic usage."
• Conclusion of the Study: The study concluded that the Sectra MicroDose Mammography L30 device performed "as well as or better than the predicate devices in all relevant areas" and that the technical differences did not raise new questions of safety and effectiveness, thus demonstrating substantial equivalence.

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The Sectra Workstation is intended for the manipulation and displaying of medical images, including mammograms. 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 mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.

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

The Sectra Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The Sectra Workstation is used as a client together with a Sectra provided server (Sectra PACS Core, Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.

The Sectra Workstation is a family of devices, including several workstations or types of workstations (see Table 1).

The provided text is a 510(k) summary for the Sectra Workstation and the FDA's clearance letter. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, a study proving device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document states that the device is "developed according to ISQ 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0" and concludes that it is "safe, effective, and substantially equivalent to the predicate device." This indicates that the regulatory pathway relied on demonstrating adherence to existing standards and equivalence to an already approved device, rather than a new performance study with specific acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input.

The information requested, such as acceptance criteria, sample sizes for test and training sets, details of ground truth establishment, and MRMC studies, is typically found in clinical validation studies or performance bench-marking reports, which are not part of this 510(k) summary.

Ask a specific question about this device

The Sectra Workstation is intended for the manipulation and displaying of medical images, including mammograms. 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 mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

For primary diagnosis, post process DICOM "for presentation" images must be used.

The Sectra Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The Sectra Workstation is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.

The Sectra Workstation is a family of devices, including several workstations or types of workstations.

To handle specific user needs it is also possible to activate Sectra developed add-ons for the Sectra Workstation. An add-on is thus an additional feature set that can be used on the Sectra Workstation. There are add-ons on Sectra Workstation IDS5 but are included as ordinary features for IDS7. Examples:

The provided 510(k) summary for K063093, "Sectra Workstation," does not contain detailed information regarding acceptance criteria or a specific study proving device performance in the way described in your request.

This submission focuses primarily on demonstrating substantial equivalence to a predicate device (K051315, Sectra IDS5 Workstation) rather than presenting a detailed performance study with quantitative acceptance criteria. The document states that the device is "similar to the predicate device" and that "the device and the predicate device share the same certification or conformance to performance standards and both function as Image Processing System (LLZ)."

Therefore, most of the specific information requested cannot be extracted from this 510(k) document. Here's what can be inferred or explicitly stated:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics like sensitivity, specificity, accuracy, etc. for the software's image processing or display capabilities. It assumes equivalence based on its technological characteristics and intended use.

However, the general "acceptance criteria" can be inferred as meeting regulatory and technical standards, which are mentioned:

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

Not applicable. No specific test set or performance data related to clinical or diagnostic accuracy is presented. This 510(k) does not describe a clinical study.

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 applicable. No ground truth establishment is described as there is no clinical performance study presented. The device is a Picture Archiving and Communications System (PACS) workstation, primarily a display and manipulation tool for medical images, rather than an AI-driven diagnostic aid with its own independent diagnostic performance to be evaluated against ground truth.

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

Not applicable. No adjudication method is described as there is no clinical performance study presented.

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 applicable. This document describes a PACS workstation, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.

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

Not applicable. This is a workstation for human users, not a standalone diagnostic algorithm.

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

Not applicable. No ground truth is discussed as no clinical performance study is presented. The device serves to display images, and its "performance" is primarily defined by its ability to correctly handle and render these images according to DICOM and other technical standards, which are typically verified through engineering and software testing rather than clinical ground truth comparisons.

8. The sample size for the training set

Not applicable. Given this is a PACS workstation and not an AI/machine learning device, there is no concept of a "training set" in the context of this 510(k) submission.

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

Not applicable. As there's no training set, there's no ground truth for a training set to be established.

Ask a specific question about this device

The Sectra IDS5 device is intended for the manipulation and displaying of medical images, including mammograms. 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 mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

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

The Sectra IDS5 Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The IDS5 is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.

The Sectra IDS5 Workstation is in fact a family of devices, including several workstations or types of workstations, e.g. the following:

• Primary diagnostics workstation and the most powerful version of IDS5 -. IDS5/dx.net. It contains tools for assisting advanced users, e.g. the radiologists, in making a diagnosis.
• Dedicated workstation for mammography IDS5/mx.net. It has all functionality as an . IDS5/dx.net but with an additional mammography package. Reading of mammographic images shall only be conducted with IDS5/mx.net.
• Quality assurance workstation, mainly used by the technologists to prepare the images . for the reviewing radiologist.
• Clinicians workstation used by the clinicians within the hospital to view the medical . images and to read the report.
• . "Web" workstation that can be used by remote clinics to view images and reports.
• "At-home" workstation that can be used by users, e.g. radiologists, over a low . bandwidth connection.

The provided document (K051315) is a Special 510(k) submission for the Sectra IDS5 Workstation, which is primarily a software product for visualizing and processing digital medical images. However, the document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria with quantitative performance metrics.

Instead, it's a "Substantial Equivalence" submission, which means the manufacturer is asserting that their new device is as safe and effective as a legally marketed predicate device (in this case, another version of the Sectra IDS5 Workstation, K050196). This type of submission often relies on demonstrating that the new device has "technological characteristics" and "performance data" that are similar to the predicate, rather than conducting new, large-scale clinical studies with specific performance targets.

Here's a breakdown of the information that is available based on your request, and where the document is lacking for other points:

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

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics. The implicit acceptance criteria appear to be substantial equivalence to the predicate device.
• Reported Device Performance:
  • Developed according to ISO 9001:2000.
  • Complies with ACR/NEMA Digital Imaging Communications in Medicine (DICOM) version 3.0.
  • Functions as an Image Processing System (LLZ).
  • The document implies that the device performs its intended functions (image manipulation and displaying, mammography reading, etc.) reliably and safely, similar to the predicate.

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

• Not provided. The document does not describe a test set or any specific data used for a performance study. This is typical for a 510(k) where substantial equivalence is claimed based on compliance with standards and functional similarity to a predicate.

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 applicable/Not provided. No explicit test set or ground truth establishment process is described in this document. The device is a viewer/processor, and its "performance" is primarily assessed against technical standards and functional equivalence, not diagnostic accuracy requiring ground truth. The primary diagnostics workstation (IDS5/dx.net) "contains tools for assisting advanced users, e.g. the radiologists, in making a diagnosis," but the performance of this assistance is not quantified here.

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

• Not applicable/Not provided. No adjudication method is described as there is no specific test set or diagnostic study outlined.

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

• No. This document predates widespread AI assistance in such systems and does not describe any MRMC study or AI-related performance enhancement. The purpose of this device is image display and processing, not AI-driven diagnostic assistance.

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

• No. The device is an image display and processing workstation that is inherently designed for "human-in-the-loop" operation. The document explicitly states: "Images and information being reviewed, processed, relayed, and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention."

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

• Not applicable/Not provided. No ground truth is described as no diagnostic performance study of the device itself (beyond its functional capabilities and adherence to standards) is detailed.

8. The sample size for the training set

• Not applicable/Not provided. This document does not describe any machine learning component or a "training set" in the context of AI.

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

• Not applicable/Not provided. As there's no described training set, there's no ground truth establishment process for it.

In summary:

This document is a regulatory submission focused on demonstrating "substantial equivalence" of the Sectra IDS5 Workstation to a previously cleared predicate device, based on shared technological characteristics, adherence to quality management systems (ISO 9001:2000), and compliance with industry standards (DICOM). It explicitly states that "Images and information being reviewed, processed, relayed, and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention." Therefore, it does not contain the detailed performance study data, acceptance criteria (in terms of quantitative metrics), or ground truth establishment methods typically associated with AI/CADe devices or diagnostic accuracy studies.

Ask a specific question about this device

The Sectra IDS5 device is intended for the manipulation and displaying of medical images, including mammograms. 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 mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

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

The Sectra IDS5 Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The IDS5 is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.

The Sectra IDS5 Workstation is in fact a family of devices, including several workstations or types of workstations, e.g. the following:

• . Primary diagnostics workstation and the most powerful version of IDS5 -IDS5/dx.net. It contains tools for assisting advanced users, e.g. the radiologists, in making a diagnosis.
• Dedicated workstation for mammography IDS5/mx.net. It has all functionality as an . IDS5/dx.net but with an additional mammography package.
• Quality assurance workstation, mainly used by the technologists to prepare the images . for the reviewing radiologist.
• Clinicians workstation used by the clinicians within the hospital to view the medical ● images and to read the report.
• "Web" workstation that can be used by remote clinics to view images and reports. .
• "At-home" workstation that can be used by users, e.g. radiologists, over a low . bandwidth connection.

The provided document is a 510(k) summary for the Sectra IDS5 Workstation, a Picture Archiving and Communications System (PACS). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting comprehensive performance studies with acceptance criteria and detailed study results typical for novel devices.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The key takeaway from this document regarding performance is that the device is deemed "safe, effective, and substantially equivalent to the predicate device" based on a comparison to its predecessor, K040376, which was also a Sectra IDS5 Workstation.

Here's a breakdown of why the specific information requested is not present in this type of submission:

• Acceptance Criteria and Reported Device Performance: This document describes the device's functions and purpose but does not contain a quantitative performance evaluation with predefined acceptance criteria. This is common for PACS workstations, which are tools for displaying and managing images, rather than diagnostic AI algorithms that generate specific findings.
• Sample Sizes (Test/Training) and Data Provenance: Not applicable as no specific performance study is detailed.
• Number of Experts and Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned, as the focus is on equivalence in functionality for a PACS workstation, not improved diagnostic accuracy with AI assistance.
• Standalone Performance: Not explicitly detailed as an algorithm-only performance study would be. The device's performance is tied to "competent human intervention."
• Type of Ground Truth: Not applicable, as there isn't a diagnostic algorithm being evaluated against a ground truth. The device facilitates viewing and processing images, and the interpretation is by human professionals.
• Training Set Sample Size and Ground Truth Establishment (for training): Not applicable for this type of device.

Conclusion stated in the document:

The conclusion emphasizes that the device:

• Does not contact the patient.
• Does not control any life-sustaining devices.
• Images and information are interpreted by a physician or trained medical personnel, allowing for "competent human intervention."
• Shares the same certification or conformance to performance standards as the predicate device.
• Functions as an Image Processing System (LZ).
• Device failures can be recovered.
• Requires passwords for operation and security.

This re-affirms that the evaluation relies on functional equivalence and human oversight rather than quantitative performance metrics against a medical condition's ground truth.

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