(90 days)
The Artoscan S is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spinspin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
The Artoscan S is a magnetic resonance diagnostic device. It is a "C" shaped Neodymium alloy permanent magnet system with a static field strength of 0.18 T. It has solenoidal and DPA receiver coils designed for specific anatomical sites. The system includes a central processing unit, control processor, acquisition and reconstruction processor, hard disk unit, rewritable optical disk unit, and a display monitor. It supports various data acquisition modes and pulse sequences, allowing for different slice thicknesses, orientations, and acquisition matrices. The device also includes automatic and non-automatic image filtering capabilities and networking functions for printing and sending images in DICOM3 protocol form. It is designed for fixed area installation.
Here's a summary of the acceptance criteria and the study information for the Artoscan S device, based on the provided text.
This document describes the Artoscan S MRI system and its substantial equivalence to previously marketed devices (predicates ARTOSCAN M, AIRIS, and PRIMA 1TG). The submission focuses on comparing the technical characteristics of the Artoscan S to these predicates rather than presenting a performance study with specific acceptance criteria that the device had to meet through a clinical trial.
It's crucial to understand that this submission is a 510(k) for substantial equivalence, not a premarket approval (PMA) application. Therefore, it does not contain a typical clinical study designed to "prove" the device meets detailed performance acceptance criteria in terms of diagnostic accuracy or efficacy. Instead, it demonstrates that the device is as safe and effective as existing legally marketed devices.
The "acceptance criteria" in this context are interpreted as the technical specifications and clinical uses that the Artoscan S demonstrates to be substantially equivalent to the predicate devices. The "reported device performance" is the Artoscan S's claimed capabilities based on its design and comparison to the predicates.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate devices. The reported performance of the Artoscan S matches or improves upon the predicate devices in various technical and clinical use categories.
| Characteristic | Acceptance Criterion (from Predicates) | Reported Artoscan S Performance | Device Meets Criteria? |
|---|---|---|---|
| Clinical Use | Orthopedic regions, including knee, leg, ankle, foot, hand, wrist, forearm, elbow | Knee, leg, ankle, foot, hand, wrist, forearm, elbow, shoulder, hip | Yes (Expanded) |
| Field of View (FOV) | 50 to 350 mm diameter (AIRIS) | 100 to 300 mm, step 10 mm (140 mm displayed) | Yes (Specific to limbs) |
| Type of Magnet | "C" shaped Neodymium alloy permanent magnet | "C" shaped Neodymium alloy permanent magnet | Yes |
| Static Field Strength | 0.3 T (AIRIS); unspecified (ARTOSCAN M) | 0.18 T | Yes (Within range of similar low-field systems) |
| Fringe Field | 5 G line at 2.5 m max (AIRIS) | 5 G line at 1.4 m maximum | Yes (Improved/Less) |
| Gantry Opening | 1000 x 380 mm (AIRIS) | 620 mm x 240 mm (w x h) | Yes (Specific to limb MRI) |
| Radiographic System Coils | Solenoidal and DPA coils for joints | Solenoidal (Shoulder/Knee, Hip) and DPA (Knee, Ankle, Hand/Wrist) coils with different shapes | Yes (New shapes for gantry/limbs) |
| RF Power | up to 5000 W peak pulse (AIRIS) | up to 600 W peak pulse | Yes (Lower, suitable for low-field) |
| Patient Comfort | Large magnet opening to reduce claustrophobia | Large magnet opening, patient mostly out of magnet | Yes (Enhances comfort) |
| Patient Positioning | Adjustable table/couch for limb positioning | Adjustable couch, manual push into gantry | Yes (Similar philosophy) |
| Installation Area | 4m x 5m (scanner) + 4m x 2.5m (console) (AIRIS) | ||
| Fixed or mobile (ARTOSCAN M) | 3.7 m x 3.7 m (Fixed area only) | Yes (Smaller footprint, fixed installation) | |
| RF Shielding | External shielding to 60 dB (AIRIS) | ||
| Self-contained or external shielding (ARTOSCAN M) | Self-contained (up to 30 dBμV/m), External (up to 100 dBμV/m) | Yes | |
| Gradient Strength | 21 mT/m (PRIMA 1TG whole-body set) | 20 mT/m | Yes (Comparable, with noted spatial resolution improvement potential) |
| Rise Time (Gradients) | 0.5 msec to full amplitude (PRIMA 1TG) | 0.5 msec from 0 to 20 mT | Yes |
| Data Acquisition Modes | Spin warp 2D/3D, Half Scan, Half Echo (ARTOSCAN M) | Spin warp 2D/3D, Half Scan, Half Echo | Yes (Unchanged) |
| Pulse Sequences | Comprehensive list (ARTOSCAN M) | Identical comprehensive list (ARTOSCAN M) | Yes (Unchanged) |
| Slice Thickness | 2D FT: 2-10 mm; 3D FT: 0.6-10 mm (ARTOSCAN M) | 2D FT: 2-10 mm; 3D FT: 0.6-10 mm | Yes (Unchanged) |
| Interslice Spacing | Contiguous slicing available (ARTOSCAN M) | Contiguous slicing available | Yes (Unchanged) |
| Slice Orientation | Transverse, Sagittal, Coronal, Oblique, Multislice (ARTOSCAN M) | Transverse, Sagittal, Coronal, Oblique, Multislice | Yes (Unchanged) |
| Acquisition Matrix | 2D FT: 192x128 to 256x256; 3D FT: 192x128 to 256x256 (ARTOSCAN M) | Identical | Yes (Unchanged) |
| Spatial Resolution | Up to 0.4 mm (ARTOSCAN M) | Up to 0.4 mm | Yes (Unchanged) |
| Multi-slice / Multi-echo | 128 slices max/2 echoes max (ARTOSCAN M) | 128 slices max/2 echoes max | Yes (Unchanged) |
| Scan Parameters (TR, TE, TI, FA) | Various range limits (ARTOSCAN M) | Largely identical, some shorter TEs due to higher gradient strength | Yes (Substantially unchanged, improved for some sequences) |
| Image Reconstruction Time | 2D: 1 sec/img; 3D: ≈ 35 sec (ARTOSCAN M) | Identical | Yes (Unchanged) |
| Display Matrix | Format1: 510x478; Format4: 254x238 (ARTOSCAN M) | Identical | Yes (Unchanged) |
| Grey Scale | 2D: 4096; 3D: 256 (ARTOSCAN M) | Identical | Yes (Unchanged) |
| Image Filtering | Automatic and non-automatic adaptive/non-adaptive filters (ARTOSCAN M) | Identical | Yes (Unchanged) |
| Networking Functions | DICOM3 printing/sending, TCP/IP, PPP (ARTOSCAN M) | Identical | Yes (Unchanged) |
Study Information (Based on a 510(k) Submission)
This document is a 510(k) Premarket Notification for substantial equivalence. It does not describe a clinical study in the typical sense of prospectively gathering patient data to prove diagnostic accuracy against a gold standard. Instead, it relies on demonstrating that the Artoscan S is as safe and effective as its predicate devices by comparing their technical features and intended uses.
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Sample size used for the test set and the data provenance: Not applicable. The submission is a technical comparison, not a clinical trial with a "test set" of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "test set" with ground truth established by experts is described for this 510(k) submission. The safety and effectiveness are established by the substantial equivalence to predicate devices, which would have undergone their own regulatory evaluations (potentially including clinical data for their initial clearance).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical "test set" and thus no adjudication method is mentioned.
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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: Not applicable. This is an MRI device itself, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical imaging system, not an algorithm being evaluated independently.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness relies on the technical performance of the device meeting established MRI principles and being comparable to legally marketed predicate devices.
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The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document demonstrates substantial equivalence by thoroughly comparing the technical specifications and intended uses of the Artoscan S with three cleared predicate MRI devices (ARTOSCAN M, AIRIS, and PRIMA 1TG). The "proof" is in demonstrating that the Artoscan S has similar indications for use and addresses any differences in technology in a manner that does not raise new questions of safety or effectiveness. The FDA's letter explicitly states that the device is "substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976...or to devices that have been reclassified."
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.