(89 days)
The Aurora® MR-Guided Interventional System (the System) is an optional accessory to the Aurora Imaging Technology, Inc., Magnetic Resonance Diagnostic Device. The System is intended to aid in the performance of minimally invasive diagnostic procedures of the lateral or medial side of either breast and adjacent anatomies, which may be facilitated by MR guidance. Such procedures must be performed with MR-compatible devices as selected and evaluated by the clinical user.
The use and operation of the Aurora® MR-Guided Interventional System and other MR-guided biopsy systems is based on the well-known method of target planning to determine the desired placement of an interventional device in three dimensions from an MR image. The basic targeting technique uses a three-dimensional MR-visible crosshair mounted near the needle guide in a fixed and known location. The stage is moved so that the needle guide and, consequently, the marker are moved to the general vicinity of the lesion to be targeted. The Aurora® MR-Guided Interventional System consists of four major subsystems: (1) Base plate system and components, (2) Needle guidance stage and components, (3) Position display unit (PDU), and (4) Target Planning Application (software).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aurora® MR-Guided Interventional System:
Based on the provided 510(k) summary, the information regarding robust clinical studies with specific acceptance criteria, sample sizes, and expert adjudication is not present. This document focuses primarily on establishing substantial equivalence to predicate devices through design and performance specifications, quality control, and general verification/validation.
Here's a breakdown of the requested information, noting what can (and cannot) be found in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly detailed in the provided summary. The document states: "The Aurora® MR-Guided Interventional System was tested to and demonstrated in compliance with design and performance specifications and included biocompatibility testing, reprocessing validation, and verification/validation testing." This implies that internal acceptance criteria were met for these tests, but the specific metrics are not publicly disclosed in this document.
For a medical device of this nature, typical performance criteria would include:
- Targeting Accuracy: The precision with which the system guides an interventional device to a lesion.
- Reproducibility: Consistency of targeting accuracy across multiple uses.
- Ease of Use/Workflow: How efficiently and intuitively the system can be operated by a clinician.
- System Latency: The time delay between user input and system response.
- Biocompatibility: Assessment of materials in contact with the patient.
- Reprocessing Validation: Confirmation that the device can be effectively sterilized or disinfected.
| Acceptance Criteria (Inferred/Typical) | Reported Device Performance (As stated in document) |
|---|---|
| Compliance with design specifications | Demonstrated in compliance with design specifications |
| Compliance with performance specifications | Demonstrated in compliance with performance specifications |
| Biocompatibility | Biocompatibility testing included |
| Reprocessing Validation | Reprocessing validation included |
| Verification/Validation | Verification/validation testing included |
2. Sample Size Used for the Test Set and Data Provenance
Not specified. The document does not provide details on sample sizes for any specific performance tests. There is no mention of "test sets" in the context of clinical data for performance evaluation in patients. The focus is on technical "design and performance specifications."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable/Not Specified. Since there are no explicit details about a test set with patient data requiring ground truth, there is no information about experts or their qualifications for this purpose.
4. Adjudication Method for the Test Set
Not Applicable/Not Specified. As above, no explicit test set with patient data is described that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not mention any MRMC study or any comparative effectiveness study with human readers, either with or without AI assistance. The device is purely an accessory for MR-guided intervention, not an AI software interpreting images.
6. If a Standalone Study Was Done
No relevant standalone study described in this context. The device itself is an accessory system for MR-guided procedures. Its "standalone" performance would likely refer to its mechanical and software accuracy in guiding a needle, which is covered under general "design and performance specifications" and "verification/validation testing" but not detailed as a distinct 'standalone study' with specific metrics.
7. The Type of Ground Truth Used
Not explicitly specified for performance evaluation. For biocompatibility and reprocessing validation, the ground truth would be established by validated laboratory standards and protocols. For the core functionality of the device (targeting), the ground truth for "design and performance specifications" would likely come from engineering measurements against a known target or phantom, rather than clinical pathology or outcomes data.
8. The Sample Size for the Training Set
Not Applicable/Not Specified. The document describes a mechanical/software system, not an AI or machine learning algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not Applicable/Not Specified. Since there's no mention of a training set, the method for establishing its ground truth is also not applicable.
Summary of Findings:
The provided 510(k) summary for the Aurora® MR-Guided Interventional System focuses on demonstrasting substantial equivalence to predicate devices and adherence to general design and performance specifications, biocompatibility, reprocessing, and verification/validation testing. It does not include detailed specific acceptance criteria, clinical study designs, sample sizes, expert involvement, or adjudication methods typically found in submissions for AI-powered diagnostic devices or those requiring extensive clinical outcome studies to demonstrate efficacy. This is common for accessory devices where performance is primarily assessed through engineering and bench testing rather than large-scale human clinical trials.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.