(50 days)
The In Reach is intended to be used for 3-D imaging of the hand, wrist, elbow, knee, foot, and ankle regions, to visualize and assess the osseous and certain soft tissue structures, bone angles and fractures. This modality is anticipated to be applicable to pediatric* cases as well as adults*, when appropriate diagnosis of a given hand, wrist, elbow, knee, foot or ankle condition is considered necessary.
- Patient parameters: 50 lbs to 400 lbs
The In Reach is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray projection sequence and reconstructs a three-dimensional volume of the examined anatomical region, comprised of a stack of slices of specified thickness. The device uses a gantry assembly, which is comprised of an Xray source, image detector, and motorized gantry. The gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software.
The gantry assembly is mounted on vertical rails and can travel up and down those rails depending on the anatomical region of interest and patient scanning position. The vertical travel allows placement of the field-of-view opening (bore) at the desired height depending on the extremity to be scanned. The In Reach provides total vertical travel of 23.5 inches to facilitate placement of the leg or arm extremity into the bore, one limb at a time. The In Reach provides software tools to measure distances and angles on slices and 3D renderings. Images produced by the In Reach can be printed or optical media, or sent electronically. The In Reach software also displays the selected set of reconstructed slices and 3D renderings on the workstation monitor for viewing.
The provided document is a 510(k) summary for a medical device called "In Reach," a Computed Tomography X-Ray System. It does not contain information about acceptance criteria or a study that directly proves the device meets those criteria in terms of clinical performance or specific diagnostic accuracy metrics, as would be expected for an AI/ML-based device.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (CurveBeam PedCat) by comparing technological characteristics, intended use similarities, and performance through phantom testing to ensure image quality and safety.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. The "performance" described is largely comparative to the predicate device and related to image quality and safety assessments using phantoms.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Image Quality (Spatial Resolution) | Authentic and accurate representations of imaged objects within expected CBCT tolerance; very similar to the predicate device. Specific evaluation included "visible line pairs". |
| Image Quality (Uniformity of Hounsfield Units - HU's) | Uniformity of HU's in water equivalent material evaluated and found similar to predicate device. |
| Image Quality (HU values of various density materials) | HU values of various density materials in the resolution and density phantom evaluated and found similar to predicate device. |
| Anatomical Visualization (Osseous details & Joint spaces) | Hand, elbow, foot, and knee phantom scans showed osseous details and joint spaces very similar to the predicate device. |
| Scatter Radiation | Measured and found to be in a very low range and comparable to the predicate device. |
| Compliance with Applicable Standards (Safety, EMC, Electrical, etc.) | Complies with listed IEC, ANSI/AAMI, ISO, UL, NEMA standards. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The test set appears to consist of various phantoms: a resolution and density phantom, a water equivalent material phantom, and anatomic hand, foot, and knee phantoms (skeleton enclosed in soft tissue equivalent material). The exact "sample size" in terms of number of phantoms or scans is not specified, but it implies a single instance of each type of phantom being scanned and evaluated.
- Data Provenance: Not applicable in the context of phantom testing. These are controlled, manufactured phantoms, not patient data from specific geographical regions. The testing was performed by CurveBeam, LLC.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Number of Experts: One board-certified radiologist.
- Qualifications: Board-certified radiologist. No specific experience length is provided.
4. Adjudication Method for the Test Set
N/A. For the phantom testing, a single board-certified radiologist evaluated the anatomical phantom scans. There is no mention of multiple readers or an adjudication process for these technical performance evaluations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. The document describes technical phantom testing and comparison to a predicate device, not a human reader study with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device itself is the imaging system, not an AI algorithm. The performance evaluation focuses on the image quality and physical characteristics of the CT scanner. Therefore, a "standalone algorithm performance" is not applicable in the typical AI/ML sense. The device's performance stands alone as the output of the CT scan.
7. The Type of Ground Truth Used
For the phantom testing:
- For spatial resolution, HU uniformity, and HU values, the ground truth is the known physical properties and characteristics of the manufactured phantoms (e.g., the specified line pairs, the known density of water, the calibrated densities of materials in the phantom).
- For anatomical phantom scans, the "ground truth" for evaluating osseous details and joint spaces was based on the expert opinion of a board-certified radiologist.
8. The Sample Size for the Training Set
N/A. This document pertains to a medical imaging device (CT scanner), not an AI/ML algorithm that would involve a training set. The device's software components use standard FDK back-projection algorithms for reconstruction, not machine learning that requires a "training set" in the common sense.
9. How the Ground Truth for the Training Set Was Established
N/A (as per point 8).
§ 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.