(121 days)
emBRACE is intended to provide padding for patient comfort and aid in positioning during radiologic visualization of the breast using x-ray technology.
emBRACE is a radiolucent foam cushion used during radiologic visualization of the breast. emBRACE is non-sterile and is a single use device.
emBRACE will be offered in the following configurations for ease of use dependent o the radiological system used:
- Product Number 00283-001 for use on an 18x24cm bucky. .
- Product Number 00283-100 for use on a 25x29cm bucky. .
- Product Number 00283-200 for use on a 29x30cm bucky. .
The provided text describes the regulatory clearance for the "emBRACE" device, a radiolucent foam cushion used for patient comfort and positioning during mammography. However, it does not include the details typically found in a study proving a device meets acceptance criteria related to AI/ML or diagnostic performance.
The document is a 510(k) summary for a Class II medical device (IZH) and Class I (IYX) that received clearance based on substantial equivalence to a predicate device (MammoPad® Radiolucent Cushion). This type of submission generally focuses on demonstrating that the new device has the same intended use, principles of operation, and overall technological characteristics, and raises no new questions of safety and effectiveness compared to the predicate device. It typically does not involve clinical performance studies with specific acceptance criteria as would be expected for a diagnostic or AI-based device's accuracy or efficacy.
Therefore, many of the requested fields cannot be filled from the provided text as the information is not present.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified directly in terms of performance metrics. The general "acceptance criteria" for a 510(k) in this context is demonstrating substantial equivalence to a predicate device in terms of intended use, principles of operation, and technological characteristics, and not raising new questions of safety or effectiveness. | The device was determined to be "substantially equivalent" to the predicate device (MammoPad® Radiolucent Cushion). |
| Intended Use: provide padding for patient comfort and aid in positioning during radiologic visualization of the breast. | The emBRACE device has the same intended use. |
| Principles of Operation: Radiolucent foam cushion. | The emBRACE device is a radiolucent foam cushion. |
| Technological Characteristics: Non-sterile, single use, available in configurations for 18x24cm, 25x29cm, and 29x30cm buckies. | The emBRACE device shares these characteristics. |
2. Sample size used for the test set and the data provenance
- Not applicable/Not provided. This type of information would be relevant for a clinical performance study, which is not described as being conducted for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No clinical performance study requiring expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No clinical performance study requiring adjudication 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
- No, this was not done. The device is a physical cushion, not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this was not done. The device is a physical cushion, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided. No ground truth establishment was necessary for this type of device and submission. The "ground truth" for a 510(k) of this nature is typically the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not applicable/Not provided. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. This is not an AI/ML device requiring a training set.
§ 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.