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Planmed Verity is intended to be used for X-ray computed cone beam tomography imaging of anatomies within upper and lower extremities, head and neck.

The Planmed Verity is a cone beam computed tomography x-ray system for generating 3D imaging scans of extremity, head and neck anatomies. The Planmed Verity utilizes an amorphous silicon based digital image receptor to capture digital images. The toroidal shaped gantry includes a rotating x-ray source combined with a flat panel image receptor. The scan rotation angle is less than a full circle and during the scan 300 to 400 projection images are being acquired. The receptor directly converts the incoming X-ray photons to digital image data. Projection image data is used to generate a 3D image volume of the anatomy through a reconstruction software algorithm.

The provided text is a 510(k) summary for the Planmed Verity CBCT system. It focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data related to new software features.

Based on the provided document, here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as might be found for an AI diagnostic algorithm. Instead, the acceptance is demonstrated qualitatively and through the clinical evaluation of specific new software features.

The key reported performance is:

• Overall image quality was acceptable for all cases and image types.
• The clinical image quality of the eFoV feature outside the primary field of view is of lower image quality and offers visualization aid, not diagnostic value. (This is a self-acknowledged limitation rather than a "performance metric" per se but is crucial for labeling).
• The new software features have acceptable image quality.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document states "a number of sample scans and diagnostic images." The exact number is not specified.
• Data Provenance: Not explicitly stated, but given the manufacturer (Planmed Oy, Finland) and the context of a 510(k) submission, it's highly likely the data originated from a clinical setting, potentially in Finland or Europe. There is no information on whether it was retrospective or prospective.

3. Number of Experts and Qualifications

• Number of Experts: Two
• Qualifications: "Two experienced radiologists"

4. Adjudication Method for the Test Set

• The radiologists "studied independently" the images and "scored different essential image quality related items."
• "The results have been summarized in a clinical study report."
• There is no explicit mention of an adjudication method (e.g., 2+1, 3+1 consensus). The phrasing "studied independently" suggests individual scoring, followed by a summary, but not necessarily a formal consensus process for discrepancies.

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

• No, an MRMC comparative effectiveness study was not done in the sense of evaluating human readers' improvement with AI vs. without AI assistance.
• The clinical evaluation focused on the image quality produced by the new software features themselves, as assessed by radiologists, not on how these features assisted radiologists in a diagnostic task. The AI here is integrated into the reconstruction and image enhancement, not necessarily a separate diagnostic aid.

6. Standalone (Algorithm Only) Performance

• Implicitly, yes, to the extent that the radiologists were evaluating the image output of the algorithms directly. The "new software features eFoV, improved CALM motion blur reduction, MAR improved metal artefact removal and stitching algorithm performance have been clinically evaluated." This involved the output of the algorithms being presented to experts for assessment of "image quality related items." This is not a quantitative standalone diagnostic performance (e.g., classifying disease), but rather an assessment of the quality of the images produced by the algorithms.

7. Type of Ground Truth Used

• Expert Consensus/Opinion on Image Quality: The "ground truth" here is the qualitative assessment of image quality by two experienced radiologists. This is not pathology, outcomes data, or consensus on disease presence/absence, but rather expert subjective evaluation of the technical and diagnostic quality of the images generated by the new algorithms.

8. Sample Size for the Training Set

• Not specified. The document focuses on the evaluation of the software features, not on the training of any underlying machine learning models. It's possible that these "new software features" (eFoV, CALM, MAR, stitching) are based on traditional image processing algorithms rather than deep learning, in which case a "training set" in the common AI sense might not apply, or was part of internal development.

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

• Since the training set size is not specified, and the nature of the "new software features" is not detailed (e.g., if they are AI/ML based), the method for establishing ground truth for a training set is not provided in this document.

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Planmed Verity is intended to be used for X-ray computed cone beam tomography imaging of anatomies within upper and lower extremities, head and neck.

The Planmed Verity is a cone beam computed tomography x-ray system for generating 3D imaging scans of extremity, head and neck anatomies. The Planmed Verity 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 Verity is controlled from the integrated acquisition workstation and Planmed Verity Manager image acquisition and communications software. The patient information is entered manually or received from the hospital. radiology, or x-ray modality 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 operator, the images are either printed or transferred for soft-copy review.

The provided text describes the Planmed Verity, a Cone Beam Computed Tomography (CBCT) system, and its comparison to a predicate device for FDA 510(k) clearance. The focus of the changes in the subject device is the inclusion of new image enhancement software (ULD and CALM) and a slightly updated flat panel detector.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a clear, tabulated format. Instead, it relies on demonstrating equivalence to the predicate device and showing improvements in specific aspects. The primary acceptance criterion seems to be "substantial equivalence" to the predicate device in terms of safety and effectiveness for the stated indications for use, with additional improvements.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Image Evaluation):

  • Sample Size: The document mentions "representative sample scans and diagnostic images" for the clinical image evaluation. It does not provide a specific numerical sample size.
  • Data Provenance: The text does not explicitly state the country of origin or whether the clinical data was retrospective or prospective for the main clinical image evaluation. However, the ULD protocol verification was performed "at a clinic in Helsinki, Finland." The clinical image evaluation was performed with a system not in final form (using 'D' detector instead of 'DX'), suggesting it might have been an early prospective study or an evaluation based on existing data.

• Phantom Study (CALM):

  • Sample Size: Not specified (likely a single phantom with various simulated motion scenarios).
  • Data Provenance: Not specified, likely an in-house laboratory study.

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

• Clinical Image Evaluation: "an experienced radiologist" - One expert. Qualifications: "experienced radiologist." No further detail regarding years of experience or subspecialty is provided.
• ULD Protocol Verification: "The radiologists evaluated the clinical image quality..." - Multiple experts (plural "radiologists"). Qualifications: "radiologists." No further details on their experience or subspecialty.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method like 2+1 or 3+1. For the clinical image evaluation, it states "an experienced radiologist scored representative sample scans." For the ULD protocol, "The radiologists evaluated the clinical image quality." This suggests individual evaluation without a formal multi-reader adjudication process described in the text.

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

• No explicit MRMC comparative effectiveness study is mentioned comparing human readers with AI vs. without AI assistance.
  • The CALM feature study compares imaging quality with CALM vs. without CALM, implying an algorithm performance comparison, not necessarily a human reader performance study with and without that algorithm. It improves image quality, which could indirectly improve human reader performance, but this is not directly assessed in an MRMC setting.
  • The ULD protocol evaluation focused on whether the image quality was "clinically suitable," not on a direct comparison of human diagnostic accuracy with and without ULD-processed images.

6. Standalone (Algorithm Only) Performance Study

• Yes, standalone performance (algorithm only) was implicitly evaluated for the new software features:
  • CALM: The statement "The effectiveness of the CALM feature was additionally verified with imaging a scull phantom with suitable test inserts. Simulated small and large amplitude motion blur as well as step-like distortion was added to the projection images and the effectiveness of the CALM feature to correct the motion blur was verified. Results show that the CALM algorithm clearly reduces motion blur." This is a standalone assessment of the algorithm's ability to correct motion blur using a phantom.
  • ULD: While radiologists evaluated the clinical suitability, the ULD feature itself is an image processing algorithm designed to maintain image quality at lower doses. Its effectiveness in lowering dose while producing acceptable images is a standalone characteristic.

7. Type of Ground Truth Used

• Expert Consensus/Opinion: For the clinical image evaluation, the "experienced radiologist" provided the 'ground truth' by scoring image quality. Similarly, "the radiologists" for the ULD protocol provided their clinical suitability judgment. This relies on expert opinion.
• Phantom Data: For the CALM feature evaluation, the 'ground truth' was derived from the known simulated motion blur introduced into the phantom images. This is a controlled experimental ground truth.
• Non-clinical Physics Data: For the detector comparison, the ground truth was based on objective physical metrics (MTF, DQE, noise performance) provided by the manufacturer (Varex).

8. Sample Size for the Training Set

• The document does not provide information on the sample size used for training the algorithms (ULD noise filtration, CALM motion blur reduction). This is a common omission in 510(k) summaries, which often focus on verification and validation of the final product.

9. How Ground Truth for the Training Set Was Established

• The document does not provide information on how ground truth was established for the training data used for the ULD and CALM algorithms.

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Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomies within upper and lower extremities and maxillofacial area.

The device is to be operated and used by legally qualified health care professionals.

Planmed Verity utilizes the CBCT (Cone Beam Computed Tomography) technology with a flat panel detector to provide high resolution volumetric images. During image acquisition the detector and X-ray tube perform a single rotation around the target of imaging, during which an amount of snapshot X-ray images are acquired. The X-ray radiation is pulsed so that it is active only when data is collected for the projection images. Before reconstruction, calibration corrections are applied to the image data. The reconstruction is then performed using a dedicated reconstruction engine and algorithm.

The system is designed as a compact, stand-alone unit from which the whole imaging procedure from patient information management to image acquisition, processing and archiving can be performed.

The unit provides a motorized gantry with adjustable height and tilt for the best possible extremity and maxillofacial area positioning. The construction also enables a weight-bearing option, in which the patient stands inside the gantry during image acquisition. Weight-bearing imaging of the extremity shows the anatomy under natural load.

The provided document is a 510(k) summary for the Planmed Verity, a Computed Tomography X-ray System. It describes the device, its intended use, and comparisons to a predicate device, but it does not contain a table of acceptance criteria and reported device performance as requested. Therefore, I cannot generate the table or directly answer some of the specific questions about acceptance criteria in numerical detail.

However, I can extract information related to the studies performed and general conclusions:

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

The document does not provide a table of acceptance criteria with specific thresholds or reported numerical device performance against those criteria. It states: "All results were equivalent or slightly better in Planmed Verity than in the predicate device." and "the imaging performance of Planmed Verity was found both substantially equivalent to the predicate device and sufficient for clinical use." Without specific metrics defined in the document, a table cannot be constructed.

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

• Test Set Description: "A clinical study was completed to evaluate the image quality of Planmed Verity's maxillofacial area. The images for this clinical study were selected from patients imaged as part of normal clinical routine in a university hospital in Finland."
• Sample Size: The sample size for this clinical study is not specified in the provided text.
• Data Provenance:
  • Country of Origin: Finland (university hospital).
  • Retrospective/Prospective: The phrasing "selected from patients imaged as part of normal clinical routine" suggests a retrospective collection of images.

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

This information is not provided in the document.

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

This information is not provided in the document.

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

The document describes a clinical study to evaluate "image quality" and compares the new device to a predicate device, focusing on "imaging performance." It does not mention an AI component or evaluate human reader performance with or without AI assistance. Therefore, an MRMC study comparing human readers with AI assistance was not done based on the provided text.

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

The device is a CT X-ray system, not an AI algorithm. The performance evaluation would be for the imaging system itself, not a standalone algorithm. The clinical study assessed the "image quality" of the system.

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

The document states the clinical study was to evaluate "image quality." It does not explicitly define the "ground truth" method used for this evaluation beyond stating that the "results show that the imaging position... gives a clinically sufficient image quality." This usually implies expert assessment/consensus of the images for diagnostic quality, but the specifics are not detailed.

8. The sample size for the training set

This information is not applicable as the document describes a CT imaging device evaluation, not a machine learning model's training set.

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

This information is not applicable for the same reason as point 8.

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Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomies within upper and lower extremities.

The use of Planmed Verity X-ray unit is allowed only under supervision of a health care professional.

Planmed Verity utilizes the CBCT (Cone Beam Computed Tomography) technology with a flat panel detector to provide high resolution volumetric images. During image acquisition the detector and X-ray tube perform a single rotation around the target of imaging, during which an amount of snapshot X-ray images are acquired. The X-ray radiation is pulsed so that it is active only when data is collected for the projection images. Before reconstruction, calibration corrections are applied to the image data. The reconstruction is then performed using a dedicated reconstruction engine and algorithm.

The system is designed as a compact, stand-alone unit from which the whole imaging procedure from patient information management to image acquisition, processing and archiving can be performed.

The unit provides a motorized gantry with adjustable height and tilt for the best possible extremity positioning. The construction also enables a weight-bearing option, in which the patient stands inside the gantry during image acquisition. Weight-bearing imaging of the extremity shows the anatomy under natural load.

The provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for the Planmed Verity device, seeking clearance based on substantial equivalence to a predicate device (Xoran xCATTM). It describes the device's intended use, technology, and comparison to the predicate device.

Here's a breakdown of why the requested information cannot be extracted from the given text:

• No specific acceptance criteria are listed. The document states that "non-clinical studies were completed to compare the imaging performance... The non-clinical comparison included common image quality measures such as high contrast resolution, image noise and Hounsfield Unit (HU) accuracy." However, it does not provide specific thresholds or targets for these measures.
• The "study" is a comparison to a predicate device, not a study demonstrating achievement of specific performance criteria against predefined benchmarks. The conclusion states that the device was found "both substantially equivalent to the predicate device and sufficient for clinical use," implying the predicate device's performance serves as the de facto "acceptance criteria."

Therefore, I cannot provide the requested table or detailed study information. The current document primarily focuses on establishing substantial equivalence rather than detailing an independent study against predefined acceptance criteria for the Planmed Verity.

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