(235 days)
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.
| Acceptance Criterion (Inferred) | Reported Device Performance | Study Demonstrating Performance |
|---|---|---|
| Biocompatibility | No adverse effect on patient from material contact. | Safety evaluation of acute and repeat toxicity. |
| Electrical Safety & EMC | Complies with IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-54, ISO 10993-1, and IEC 60601-1-2. | Electrical safety and EMC testing. |
| Software V&V | Demonstrated to perform as intended; "Moderate" level of concern. | Software verification and validation testing. |
| Image Quality (General) | Overall image quality acceptable for all cases and image types. | Clinical image evaluation by an experienced radiologist. |
| Image Quality (Detector) | Imaging performance of new detector is essentially equal to predicate, or slightly better (MTF, DQE, noise). | Comparison of manufacturer's (Varex) non-clinical physics data for detector types. |
| Image Quality (CALM) | Improves imaging quality in most cases; reduces risk of re-takes due to patient movement; clearly reduces motion blur. | Clinical test report scoring CALM vs. no CALM; phantom study with simulated motion blur. |
| Image Quality (ULD) | Clinically suitable for imaging head and neck anatomies; lowers patient dose while maintaining/improving diagnostic image quality. | Separate study at a clinic in Helsinki, Finland, where radiologists evaluated clinical image quality. |
| Safety and Effectiveness | As safe and effective as the predicate system for its indicated use. | Overall conclusion based on all testing (biocompatibility, electrical safety, software, physical, clinical). |
2. Sample Sizes and Data Provenance
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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.
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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.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.