(99 days)
The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil, used for obtaining MR images of the breast and auxiliary tissue. The biopsy plate allows access to the breast anatomy during biopsy procedures. No biopsy needles are included with, or packaged with the Open Breast Coil with Biopsy Plates. The indications for use are the same as for standard MR Imaging. The Open Breast Coil with Biopsy Plates is designed for use with the 0.3T Airis-Elite MRI scanner manufactured by Hitachi Medical System.
The Open Breast Coil with Biopsy Plates is designed to provide Magnetic Resonance Images of the breast anatomy and aid in guidance during biopsy procedures. The Open Breast Coil with Biopsy Plates is designed for use with the Hitachi Airis Elite .3T scanner.
The Airis Elite .3T system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil. The coil consists of three sections: a supporting base and two insulating coil chambers, one for each breast. Each of the hollow coil chambers houses two coil elements that are insulated from the patient by a ridged plastic housing. The coil housing is made of plastic materials, which are fire rated and have high impact and tensile strength. The Open Breast coil with Biopsy plates is designed to offer optimized imaging capabilities and maximum lateral access to each breast for biopsy procedures.
The provided text describes a 510(k) premarket notification for a medical device called the "Open Breast Coil with Biopsy Plates." This document is a summary of safety and effectiveness, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study with detailed acceptance criteria and performance metrics typically found in clinical trials for new technologies.
Therefore, the requested information for acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be fully provided from the given document. The document states that the device is similar to a previously cleared device (Liberty 5000 Breast Coil with Disposable Biopsy Plate manufactured by USA Instruments, Inc. - K022007) and its indications for use are the same as for standard MR imaging. This implies that the device is expected to perform comparably to established MRI technology and its predicate.
Here's an attempt to address the points based on the available information, noting where information is missing:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided document, K050128-21, is a Summary of Safety and Effectiveness for a 510(k) submission. For this type of submission, the primary aim is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than to independently prove its performance against a set of specific, quantifiable acceptance criteria through novel studies. The "acceptance criteria" here are implicitly tied to the performance characteristics of the predicate device.
The study described is a comparison of the modified device's features to those of the predicate device, emphasizing their similarities to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence claim, explicit "acceptance criteria" against specific performance metrics (e.g., sensitivity, specificity, image quality scores) are not detailed in this document. Instead, the "acceptance criteria" are implied to be the established safety and effectiveness profile of the predicate device and standard MRI imaging. The "reported device performance" is essentially that the new device shares similar characteristics and intended use with the predicate, thereby being safe and effective for its intended purpose.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate K022007 and Standard MRI) | Reported Device Performance (as described in the document) |
|---|---|
| Safety: | |
| * No RF burns | - "Does not transmit RF power; decoupling isolates the coil elements from RF fields during RF transmission; coil elements and circuitry are enclosed in a non-conductive housing." - Similar to predicate. |
| * Limited Radio Frequency Absorption (SAR) | - "Coil is a receive-only coil and does not transmit RF power: power deposition during imaging is limited by SAR algorithm." - Similar to predicate. |
| * Prevention of resonant loop formation | - "Decoupling isolates coil elements from RF fields during RF transmission; length of cable and stiffness does not permit looping." - Similar to predicate. |
| * Biocompatibility of materials | - Coil Enclosure Material: Polyurethane Plastic, ABS Plastic, Polycarbonate and Delrin. (Implied to be safe and similar to predicate materials). |
| Effectiveness (Imaging Capability): | |
| * Ability to produce MR images of breast and auxiliary tissue | - "The Open Breast Coil with Biopsy Plates is a phased array, receive-only MRI coil, used for obtaining MR images of the breast and auxiliary tissue." - "Designed to offer optimized imaging capabilities." - Intended use and Indications identical to predicate and routine MRI. |
| * Compatibility with specified MRI scanner | - "Designed for use with the 0.3T Airis-Elite MRI scanner manufactured by Hitachi Medical System." (This is a specific compatibility criterion that must be met.) |
| * Allows access for biopsy procedures | - "The biopsy plate allows access to the breast anatomy during biopsy procedures." - "Designed to offer... maximum lateral access to each breast for biopsy procedures." - This feature is a direct part of the device design and intended use, similar to the predicate's "Disposable Biopsy Plate." |
| * Maintains comparable image quality to predicate and standard MRI. | - The document does not explicitly present image quality metrics but by stating "Similar to Liberty 5000 Breast Coil with Disposable Biopsy Plate manufactured by USA Instruments, Inc. (K022007)" across multiple design features, it implies comparable performance given the same underlying MRI physics and receiver coil technology. The indication for use being "the same as for standard MR Imaging" also implies meeting established imaging effectiveness standards. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable/not reported in this document. Substantial equivalence claims often rely on engineering analysis, component comparisons, and adherence to design specifications rather than clinical test sets with patient data. If any testing involved physical measurements or bench tests, the "sample size" would relate to the number of units tested, but this is not specified.
- Data Provenance: Not applicable/not reported. No patient data, country of origin, or retrospective/prospective nature of a study is mentioned. The comparison is against the design and performance characteristics of a previously cleared device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts/Qualifications: Not applicable/not reported. As there is no clinical test set with patient images requiring expert interpretation for ground truth, this information is not relevant to this document.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable/not reported. No test set for clinical performance is described.
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:
- MRMC Study/Effect Size: No. This device is a passive MRI coil accessory, not an AI-powered diagnostic tool. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a hardware component (MRI coil), not an algorithm or software. It does not have "standalone" algorithmic performance.
7. The type of ground truth used:
- Type of Ground Truth: The "ground truth" for this type of submission is the established safety and effectiveness of the predicate device (K022007) and the principles of standard MRI imaging. The manufacturer is asserting that the new device, due to its similar design and intended use, will perform equivalently without introducing new risks.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/not reported. No machine learning or AI component is described there that would require a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set Establishment: Not applicable/not reported, as there is no training set for an algorithm.
In summary, the document fulfills the requirements for a 510(k) submission by demonstrating substantial equivalence through a detailed comparison of the new device's features and intended use to those of a predicate device. It does not contain information about clinical studies with specific performance metrics, patient sample sizes, or expert adjudication, as would be expected for a novel diagnostic algorithm or a device requiring new clinical evidence of effectiveness.
§ 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.