(127 days)
The intended use of the product is to remove the cold from the bucky by placing this sheet between the patient's breast and the imaging receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.
Indications for Use: To be applied to the mammography receptor plate, one per patient
Bella is to be used on the bucky or the imaging receptor plate of mammography imaging equipment where the breast is placed for mammograms. The purpose of the product is to remove the cold from the bucky by placing this sheet between the patient's breast and the imaging receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.
Bella is designed to include a non-woven fabric type material that will feel like fabric on the skin. The material is non-compressable and the sizes are to include all leading mammography equipment for small and large buckies. Bella includes printed graphics to aid in the mental comforting of the patient. There is adhesive backing to Bella which allows easy application and removal from the bucky. The material and adhesive do not affect imaging.
Here's a breakdown of the acceptance criteria and study information for the Bella device, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The core acceptance criteria for Bella revolve around its intended use and comparison to the predicate device (MammoPad). Both devices aim to increase patient comfort during mammography without compromising image quality.
| Acceptance Criteria Category | Specific Criteria | Bella Reported Performance |
|---|---|---|
| Patient Comfort | Removes cold from the bucky/imaging receptor plate and makes the patient feel more comfortable and less cold. | "The product proved to fulfill its design intentions of removing the cold from the mammography receptor plate with its fabric type material, making the patient more at ease with its floral pattern..." (Implied via patient feedback and design intention, though no quantitative comfort scores are presented). |
| Image Quality | Does not interfere with image quality. Images produced with the device should be comparable to images produced without the device (or without the predicate device). "Radiolucent" and "does not interfere with imaging." | Non-clinical (prototype testing): "This test proved there were no differences in the image with Bella as compared to without." |
| Clinical (patient testing): "...again no differences between the image with Bella as compared to the image without." | ||
| "The product... did not interfere with imaging quality." | ||
| "Substantial equivalence based on assessment of clinical performance-Both products are considered radiolucent and do not interfere with imaging." | ||
| Physical Properties | - Remains where placed (adherence to bucky). |
- Non-compressible.
- Compatible with mammography equipment.
- Disposable.
- Biocompatible. | - "Remain where placed" (listed in table).
- "The material is non-compressable" (from description).
- "The product is applied directly to the bucky." (description)
- "Disposable" (listed in table).
- "Fabric and FDA approved varnish on ink" (listed in table). |
| Safety | No adverse effects (radiation, chemical, mechanical, electrical, thermal safety, biocompatibility, etc.). | - "Does not image" (radiation safety, listed in table). - No specific safety tests mentioned beyond biocompatibility (fabric and FDA approved varnish on ink). Implied safety through "does not interfere with imaging" and comparison to predicate. |
Study Information
This 510(k) summary describes a series of non-clinical and clinical tests for Bella, primarily focused on proving substantial equivalence to the MammoPad predicate device by demonstrating no interference with image quality.
| Information Category | Detail |
|---|---|
| 1. Sample size (Test Set) | Non-clinical: Not explicitly stated, described as "a prototype to be tested on the mammography equipment receptor plate under the phantom." |
| Clinical: 200 tests (implying 200 patients/cases, each having one breast imaged with Bella and one without). | |
| 2. Data Provenance (Test Set) | Country of origin: Not explicitly stated, but "6 locations" are mentioned for the clinical tests. No geographical specifics are provided. |
| Retrospective/Prospective: Prospective (tests were conducted for the purpose of this submission). | |
| 3. Number of Experts (Ground Truth) | Not explicitly stated. The text mentions "no differences in the image" and "did not interfere with imaging quality," implying expert assessment of image quality, but the number and qualifications are not provided. For the predicate device, Dr. Laszlo Tabar is mentioned as performing "intense clinical trials" and concluding no adverse effects. |
| 4. Adjudication Method (Test Set) | Not explicitly stated. The nature of the assessment ("no differences in the image") suggests a direct comparison, likely by radiologists, but no formal adjudication process like 2+1 or 3+1 is described. |
| 5. MRMC Comparative Effectiveness Study | No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not performed. The study focused on demonstrating non-inferiority in image quality (i.e., no interference) rather than an improvement in human reader performance with AI assistance (as this is not an AI device). |
| 6. Standalone Performance Study | Yes, the study essentially describes standalone performance regarding image quality. It evaluated whether the device itself, when placed on the bucky, interfered with the resulting mammogram image. The conclusion was that it did not. |
| 7. Type of Ground Truth Used | Expert assessment of image quality. The determination of "no differences in the image" implies a qualitative assessment by qualified personnel (likely radiologists or radiographers) of the mammograms taken with and without Bella. It is not pathology, outcomes data, or a formalized consensus panel. |
| 8. Sample Size (Training Set) | Not applicable. Bella is a physical accessory, not a machine learning algorithm, so there is no "training set" in the conventional sense. |
| 9. How Ground Truth for Training Set Established | Not applicable. As above, there is no training set for this type of device. |
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.