Search Results

The Planmed Clarity 2D and S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D and S systems are intended to be used for screening and diagnosis of breast cancer. The Planmed Clarity 2D and S systems may also be used for additional diagnostic workup of the breast. Additionally, the Planmed Clarity 2D and S systems can be used to provide digital x-ray images of breast biopsy specimens.

The Planmed Clarity 2D and Clarity S are Full Field Digital Mammography (FFDM) systems for generating mammographic x-ray images that can be used for screening and diagnosis of breast cancer. Planmed Clarity 2D and Clarity S utilize an amorphous silicon based digital image receptor to capture images. The receptor directly converts the incoming X-ray photons to digital image data.

The workflow with Clarity 2D is controlled by the side displays/touch panels and the workflow of Clarity S is controlled from the acquisition workstation and Clarity Manager acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality worklist. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.

Acceptance Criteria and Study for Planmed Clarity 2D and S

This response synthesizes the information provided about the Planmed Clarity 2D and S mammography systems, focusing on the acceptance criteria and the studies conducted to demonstrate compliance.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily details performance testing rather than explicitly stated acceptance criteria with numerical targets. However, based on the descriptions, we can infer the acceptance criteria. The device's performance is deemed acceptable if it meets these inferred criteria and demonstrates clinical image quality comparable to the predicate device.

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

• Test Set Sample Size: 6 patients particpated in routine breast cancer screening. The clinical evaluation used images from these 6 patients, with some cases also including diagnostic mammograms (spot and/or magnification images).
• Data Provenance: The data was obtained from two sites: one in Belgium and one in Bulgaria. The study appears to be prospective in nature, as images were "taken at one site in Belgium and one site in Bulgaria where altogether 6 patients participated to routine breast cancer screening."

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

• Number of Experts: Three
• Qualifications: "MQSA qualified experienced US interpreting physicians independently."

4. Adjudication Method for the Test Set

The document states, "The images were then reviewed by three MQSA qualified experienced US interpreting physicians independently." This indicates that there was no formal adjudication method (e.g., 2+1 or 3+1 consensus) described. Each expert provided an independent assessment, and the aggregate finding (all images rated good or excellent) was reported.

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

No, a formal MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not described in the provided text. The study primarily focused on the standalone performance of the image processing algorithm and its impact on image quality for human interpretation. The clinical image evaluation assessed if the image quality produced by the new software was acceptable for human readers, not whether AI assistance improved human performance.

6. Standalone Performance Study

Yes, a standalone performance evaluation of the new image processing algorithm (CORE) was implicitly performed. While not in the context of a "standalone algorithm" in isolation from the hardware, the "Clinical image evaluation" aimed to determine if the images processed with the new Planmed CORE software algorithm were of "sufficiently acceptable quality for mammographic usage when reviewed by MQSA qualified experienced interpreting physicians." This assesses the algorithm's output quality as a standalone component contributing to the overall system's diagnostic utility. The physical laboratory testing also evaluates the image chain, including the processing, in a standalone manner from actual diagnostic human interpretation.

7. Type of Ground Truth Used

For the clinical image evaluation, the "ground truth" used for assessing image quality was expert consensus on image quality acceptability. The experts rated images as "good" or "excellent," and the overall judgment ("acceptable for all cases and image types") served as the ground truth criterion. The selection of cases with BI-RADS score 1 or 2 suggests that the intent was to evaluate images from non-cancerous breasts (or breasts with benign findings) to assess general image clarity, rather than a diagnostic accuracy study where pathology or outcomes data would be directly compared.

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for a training set for the CORE image processing algorithm. The algorithm is described as "developed by Planmed in-house," but details on its development data (training, validation, testing) are not included in this summary.

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

As no information is provided about a training set, the method for establishing its ground truth is not described in the document.

Ask a specific question about this device

The Planmed Clarity 2D and Planmed Clarity S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D/S systems are intended to be used for screening and diagnosis of breast cancer. The Clarity 2D/S systems may also be used for additional diagnostic workup of the breast.

The Planmed Clarity 2D and Clarity S are Full Field Digital Mammography (FFDM) systems for generating mammographic x-ray images that can be used for screening and diagnosis of breast cancer. Planmed Clarity 2D and Clarity S utilize an amorphous silicon based digital image receptor to capture images. The receptor directly converts the incoming X-ray photons to digital image data.

The workflow with Clarity 2D is controlled by the side displays/touch panels and the workflow of Clarity S is controlled from the acquisition workstation and Clarity Manager acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS. respectively), as a format of modality worklist. Subsequently, the images are acquired. processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.

Here's a breakdown of the acceptance criteria and study information for the Planmed Clarity 2D and Clarity S device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

2. Sample Size and Data Provenance for Test Set:

• Sample Size: 6 patients
• Data Provenance: One site in Bulgaria. The cases selected also included diagnostic mammograms (spot and/or magnification images) in addition to routine screening images (BI-RADS score 1 or 2).
• Retrospective/Prospective: The text does not explicitly state if the study was retrospective or prospective. Given that "6 patients participated to routine breast cancer screening" and images were then selected for evaluation, it suggests a prospective acquisition for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Number of Experts: Two
• Qualifications: MQSA qualified experienced US radiologists.

4. Adjudication Method for Test Set:

• Method: The two MQSA qualified experienced US radiologists reviewed the images independently. There is no mention of a formal adjudication process (like 2+1 or 3+1) if their independent ratings differed. The statement "All images were rated good or excellent" suggests they either agreed or the individual assessments were sufficient.

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

• Was it done?: No, a formal MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not performed as described in the provided text. The study focused on physician perception of image quality from the new device rather than reader performance with AI.

6. Standalone (Algorithm Only) Performance Study:

• Was it done?: No, a standalone algorithm-only performance study was not described. The evaluation focused on the overall system's image quality as reviewed by human experts.

7. Type of Ground Truth Used (Test Set):

• Type: The ground truth for the clinical image evaluation was based on expert consensus/review by two MQSA qualified experienced US radiologists, who rated the images as "good or excellent" for mammographic usage. The images themselves were selected based on BI-RADS scores 1 or 2 (indicating negative or benign findings), and some diagnostic mammograms.

8. Sample Size for Training Set:

• The provided text does not mention a training set or any machine learning/AI components requiring a training set. The descriptions relate to the hardware and software of a digital mammography system and its image quality validation.

9. How Ground Truth for Training Set was Established:

• Not applicable, as no training set for a machine learning model is mentioned.

Ask a specific question about this device

The Planmed Clarity 2D mammography unit acquires digital 2D mammographic images. The Planned Clarity 2D system is intended to be used for screening and diagnosis of breast cancer. The Planmed Clarity system may also be used for additional diagnostic workup of the breast.

The Planmed Clarity is a Full Field Digital Mammography (FFDM) system for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Planmed Clarity utilizes an amorphous silicon based digital image receptor to capture digital images. The receptor directly converts the incoming X-ray photons to digital image data. The workflow with Planmed Clarity is controlled from the acquisition workstation and Planmed Clarity Manager image acquisition and communications software. The patient information is entered manually or received from the hospital. radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality worklist. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.

The provided text describes the 510(k) submission for the Planmed Clarity Full Field Digital Mammography (FFDM) system. However, it does not contain information about acceptance criteria or a study proving the device meets those acceptance criteria for an AI/algorithm-based diagnostic device.

The document outlines the testing and performance data for the mammography imaging system itself, focusing on its physical and technical capabilities compared to a predicate device. This includes:

• Biocompatibility testing
• Electrical safety and electromagnetic compatibility (EMC)
• Software Verification and Validation Testing (for the system's software, not an AI algorithm)
• Physical laboratory testing (sensitometric response, spatial resolution, noise analysis, dynamic range, repeated exposures, AEC performance, phantom tests, patient radiation dose, breast compression system)
• Clinical image evaluation by an MQSA certified radiologist to assess overall image quality.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance specifically for an AI/algorithm.
2. Sample size used for the test set and data provenance for an AI/algorithm study.
3. Number of experts and their qualifications for AI ground truth establishment.
4. Adjudication method for AI test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance for an AI algorithm.
7. Type of ground truth for AI.
8. Sample size for AI training set.
9. Ground truth establishment method for AI training set.

The document confirms the Planmed Clarity is a mammography imaging system, not an AI diagnostic device. The "Software Verification and Validation Testing" refers to the operational software of the mammography unit, not a separate AI diagnostic algorithm subject to specific diagnostic performance acceptance criteria. The clinical image evaluation mentioned is for the image quality of the output of the imaging system and not for the diagnostic performance of an AI model using those images.

Ask a specific question about this device