Search Results
Found 2 results
510(k) Data Aggregation
(127 days)
BEEKLEY CORP.
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. |
Ask a specific question about this device
(198 days)
BEEKLEY CORP.
Breast Bolster was specifically designed to enable stereotactic breast biopsy procedures to be performed on thin-breasted patients.
Not Found
Analysis of Acceptance Criteria and Study for the Breast Bolster Device
Based on the provided document, the "Breast Bolster" (K020624) is a Class II medical device, and the FDA's decision is a Substantial Equivalence (SE) determination to a legally marketed predicate device. This means the device met acceptance criteria not through a standalone performance study with defined metrics, but by demonstrating that it is as safe and effective as a device already on the market.
Therefore, the requested information categories about direct performance metrics, sample sizes, expert involvement, and ground truth for a diagnostic AI/ML device do not directly apply to this 510(k) submission for the Breast Bolster. The 510(k) process for this type of device focuses on comparison to a predicate, not on a primary clinical performance trial with novel acceptance criteria.
However, I can extract information relevant to the 510(k) process as it relates to acceptance for marketing.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence, the "acceptance criteria" is primarily demonstrating similarity to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. There are no specific performance metrics like sensitivity or specificity reported in this document.
| Acceptance Criteria (Implied for 510(k) SE) | Reported Device Performance (as per 510(k) process) |
|---|---|
| Intended Use Equivalence: Device's intended use is the same as the predicate. | "Breast Bolster was specifically designed to enable stereotactic breast biopsy procedures to be performed on thin-breasted patients." (This intent would be compared to a predicate device's intended use). |
| Technological Characteristics Equivalence: Device has similar technological characteristics, or any differences do not raise new questions of safety or effectiveness. | Not explicitly detailed in this letter, but would have been part of the full 510(k) submission. This would involve comparing materials, design, mechanism of action, etc. with the predicate. |
| Safety and Effectiveness Equivalence: Device is as safe and effective as the predicate. | Not explicitly detailed in this letter. This would be demonstrated through comparison of non-clinical and/or clinical data with the predicate, or justification that new aspects do not impact safety/effectiveness. |
| Regulatory Compliance: Adherence to general controls and relevant specific controls. | The FDA letter confirms the device can be marketed "subject to the general controls provisions of the Act," and notes that it may be subject to additional controls if classified as Class II. |
Regarding the Study that Proves the Device Meets Acceptance Criteria:
The "study" that proves the device meets acceptance criteria in a 510(k) substantially equivalent submission is the comparison to a legally marketed predicate device.
- The document explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified..."
The information requested below for a performance study is generally not applicable to this type of 510(k) submission where direct clinical performance metrics are not the primary basis for market clearance.
2. Sample size used for the test set and the data provenance: Not applicable. The 510(k) focused on comparison to a predicate, not an independent test set for performance metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance metrics was not established as part of this 510(k) for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a "Breast Bolster," a physical accessory for mammography, not an AI/ML diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed performance metrics and ground truth are not the basis for this type of 510(k) clearance. The "ground truth" for a 510(k) SE is the established safety and effectiveness of the predicate device.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
Page 1 of 1