(34 days)
The Confirma Breast MRI Interventional Components are intended to be used in conjunction with a magnetic resonance scanner and the Confirma Access Breast Coil designs to permit MRI-guided interventional procedures, such as breast biopsy and localization of lesions that can be performed and interpreted by a trained physician.
The Confirma Breast MRI Interventional Components provide a grid system to immobilize the breast in an Access Breast Coil device. The grid system allows the physician to perform a biopsy through a needle block inserted in the grid plate. The system supports a standard medial-lateral approach using the Access Breast Coil. The design of the interventional components focuses on ease of patient positioning and set-up by the clinician, and patient ergonomics for enhanced comfort during interventional procedures. The design allows for unilateral or bilateral access, and offers maximum access to aid the physician in MRguided interventional procedures such as breast biopsy and localization of lesions, providing lateral and medial access to the breast. The components are provided non-sterile and are non-disposable. The components must be sterilized at the beginning of each procedure. The components are manufactured from Ultem 1000 polyetherimide which can be autoclaved or sterilized with formaldehyde. The compression plate and grid plate system incorporate locking mechanisms that secure the components once positioned. These locks provide stability during the interventional procedure. The compression and grid plates are bidirectional, allowing them to be placed in either a medial-facing or lateral-facing position. This allows the clinician to perform the interventional procedure from the medial or lateral side. For unilateral breast intervention, the system uses one grid plate and one compression plate. For bilateral breast intervention, the system uses 2 grid plates and 2 compression plates. The components are made of medical grade plastic materials, which are fire rated and have high impact and tensile strength.
The provided text describes the Confirma Breast MRI Interventional Components, a device intended for MRI-guided interventional procedures such as breast biopsy and lesion localization. However, it does not contain any information regarding acceptance criteria, reported device performance, or any studies conducted to prove the device meets specific criteria.
The document is a 510(k) summary for a premarket notification to the FDA, focusing on demonstrating substantial equivalence to legally marketed predicate devices. It discusses:
- Device Description: How the device functions as a grid system for breast immobilization and allows for biopsy.
- Comparison with Legally Marketed Devices: Lists several predicate devices and states that the Confirma device is substantially equivalent to them in terms of functionality and access for interventional procedures.
- Conclusions: Reiterates substantial equivalence and mentions that potential hazards were studied and controlled during product development, including risk analysis, test, and design considerations, and planned verification and validation testing processes. However, no results of these planned tests are provided.
- Indications for Use: Specifies the intended use of the device in conjunction with MRI scanners and specific breast coils for MRI-guided procedures.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about specific studies, as this data is not present in the given text.
To directly answer your specific points based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided in the text. The document focuses on substantial equivalence rather than performance metrics.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the text. No specific test sets or study data are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided in the text. No ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the text.
- 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 performed/not relevant. This device is an interventional component, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not performed/not relevant. This device is a physical component for interventional procedures, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the text.
- The sample size for the training set: Not applicable/Not provided in the text. This is not an AI/algorithm-focused device requiring a training set.
- How the ground truth for the training set was established: Not applicable/Not provided in the text.
§ 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.