(52 days)
The LineUP is intended to be used for 3-D imaging of the foot, knee, hand, and elbow regions to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures.
It is also intended to capture 2-D images (standard plain x-ray projections) of the foot, knee, hand, and elbow regions.
This modality is anticipated to be applicable to pediatric* cases as well as adults, when appropriate diagnosis of a given condition is considered necessary. Patient parameters: 50 lbs to 400 lbs
*2D Imaging not intended for pediatric use
The LineUP is a Cone Beam Computed Tomography Imaging Device that acquires 360-degree rotational projection sequences which are reconstructed into 3D volumetric images of the examined anatomical region. It can also capture 2D plain X-Ray projections. The device uses a gantry assembly, which is comprised of an X- ray source, image detector, and a motorized gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software. For hand and elbow scans, a patient transporter accessory allows the patient to sit and then recline into a position where he/she can comfortably place his/her anatomy into the imaging bore. The transporter can also be configured to permit a seated non-weight bearing scan of the feet.
The gantry assembly is mounted on vertical actuators and can travel vertically to capture weight-bearing anatomy at various heights ranging from the feet to knee regions. The LineUP provides total vertical travel of 17 inches to accommodate patients of various sizes. Images produced by the LineUP can be sent electronically to a DICOM complaint image viewing software.
The provided text is a 510(k) Summary for a medical device called "LineUP," a Computed Tomography X-ray system. Here's a breakdown of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantified, pass/fail manner. Instead, it describes performance in terms of diagnostic quality and equivalence to predicate/reference devices.
| Feature / Criterion (Implicit) | Reported Device Performance (LineUP) |
|---|---|
| 3D Imaging Diagnostic Quality (Foot, Knee, Hand, Elbow) | Datasets of foot, knee, hand, and elbow regions were reviewed by a board-certified radiologist and found to be of diagnostic quality. Anatomic hand, foot, elbow, and knee phantom scans were also reviewed by a radiologist and found to be of diagnostic quality. Performance testing by a medical physicist with an image quality phantom also confirmed diagnostic quality. |
| 2D Imaging Diagnostic Quality (Foot, Knee, Hand, Elbow) | The LineUP was tested to IEC 60601-2-54 and met all performance requirements. A medical physicist did performance and image quality tests on X-Ray Images and found them to meet industry standards. A radiologist reviewed 2D images of the foot, knee, hand and elbow and found them to be of diagnostic quality. |
| Equivalence of Image Quality (vs. PedCAT for CT) | Performance testing demonstrated that the image quality of the CMOS detector (LineUP) is statistically equivalent or superior to that of the amorphous silicon flat panel detector of the predicate device (PedCAT). New reconstruction method's performance has been evaluated in bench testing and found to be equivalent to predicate method. Performance testing by a medical physicist with an image quality phantom confirmed equivalence. |
| 2D Imaging Performance (vs. X-Cel X-Ray System for 2D) | Bench testing was done and the LineUP was found to perform to industry standards. The LineUP was also tested to IEC 60601-2-54 and was found to meet all safety and performance requirements. |
| Safety and Effectiveness | Complies with applicable FDA and international standards pertaining to electrical, mechanical, software, EMC, and radiation safety of medical devices (AAMI ES60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 62366, IEC 62304, IEC 60601-2-44, IEC 60601-2-54, IEC 60601-1-2, IEC 61223-3-5, NEMA PS 3.1-3.20). |
| Patient Parameter Range | 50 lbs to 400 lbs (same as predicate for adult weight range, with extension down to 50 lbs for pediatric cases in 3D). |
| Support Structures Safety | New support structures (for knee, hand, elbow) tested to applicable safety standards. |
| Geometric Differences (Source to Imager/Axis Distance) | Performance testing demonstrated that new geometry does not harm image quality. |
2. Sample Sizes used for the test set and data provenance:
- Sample Size for Test Set: The document does not provide specific numerical sample sizes for the "datasets of foot, knee, hand, and elbow regions" or "anatomic hand, foot, elbow, and knee phantom scans" that were reviewed by radiologists. It refers to these as "datasets" and "anatomic phantom scans" without quantification. For 2D X-ray images, it states "X-Ray images of the foot, knee, hand, and elbow regions" were reviewed, again without a specific number.
- Data Provenance: Not explicitly stated. The context implies that the data would be internal to CurveBeam's testing, likely from phantom studies and potentially some clinical volunteers for the specific anatomies scanned. It does not mention country of origin or whether it's retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Multiple instances refer to "a board-certified radiologist" (singular) reviewing images for diagnostic quality. It also mentions "a medical physicist" for technical image quality assessments.
- Qualifications of Experts: For clinical image review, the expert is identified as "a board-certified radiologist." For technical performance, the expert is "a medical physicist." No specific years of experience are provided.
4. Adjudication method for the test set:
- The document describes a sole expert review (a single board-certified radiologist and a single medical physicist). There is no mention of an adjudication process (such as 2+1, 3+1) because only one expert appears to have been involved in each specific type of review.
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, an MRMC comparative effectiveness study was not conducted or described. The LineUP device is an imaging system, not an AI-assisted diagnostic tool for interpretation. The study focused on assessing the diagnostic quality of images produced by the device itself and its equivalence to predicate devices, not on comparing human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance evaluations described are essentially "standalone" in the context of the device itself.
- For 3D CT imaging, the device's image quality was assessed by a medical physicist using phantoms and by a radiologist reviewing datasets and anatomical phantom scans for diagnostic quality.
- For 2D X-ray imaging, technical performance was bench-tested against industry standards and reviewed by a medical physicist and a radiologist.
- The focus is on the device's ability to produce diagnostic-quality images, not on its ability to interpret those images or interact with a human reader's workflow.
7. The type of ground truth used:
- The ground truth for image quality and diagnostic utility appears to be primarily expert consensus/opinion by a board-certified radiologist for clinical aspects and a medical physicist for technical aspects.
- For technical performance (e.g., meeting IEC standards, detector performance, reconstruction algorithm performance), the ground truth is established through bench testing against established industry standards and internal performance requirements.
8. The sample size for the training set:
- The document does not provide information regarding a specific "training set" or its sample size. This is typical for a 510(k) submission for an imaging device, which primarily demonstrates image quality and safety, rather than an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established:
- Since no specific training set is mentioned in the document, there is no information on how ground truth for such a set was established.
§ 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.