(63 days)
The device described here is an accessory to imaging devices previously approved. In general, the intended professional application is described as follows: Breast displacement for imaging purposes with the intention of decreasing radiation dose to the breasts and/or improving image quality. The Chrysalis device is reusable and used external to hospital garb; it does not touch the patient's body.
Chrysalis is composed of vinyl-coated polyester, 1/4 inch polyurethane foam headliner, poly-pro webbing, Buckles: 2" side-release plastic buckles
The provided text indicates that the device "Chrysalis" is an accessory to stationary X-ray systems, intended for breast displacement to decrease radiation dose and/or improve image quality. It is a reusable device used externally and does not touch the patient's body.
Based on the provided information, the device is not a software or AI-driven device, and therefore, the typical performance acceptance criteria related to AI or algorithm performance (such as sensitivity, specificity, accuracy, etc.) and the associated studies are not applicable.
The document explicitly states:
- "Assessment of Performance Standards: Not Applicable"
- "Non-Clinical Testing: Biocompatibility testing and safety evaluations were deemed to be unnecessary due to a lack of patient exposure to the device."
This implies that the device is a simple mechanical accessory and its approval is based on its intended use as an accessory to already approved medical imaging devices, rather than on its own diagnostic or AI-driven performance.
Therefore, most of the requested information regarding acceptance criteria and performance studies (like sample size, ground truth, expert opinions, MRMC studies, standalone performance) is not available or relevant for this specific device based on the provided 510(k) summary.
However, I can extract the information relevant to its regulatory approval:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied by Regulatory Review) | Reported Device Performance (Implied by Regulatory Review) |
|---|---|
| Safe for its intended use as an accessory to stationary X-ray systems. | Biocompatibility and safety evaluations deemed unnecessary due to lack of patient exposure. |
| Functions as an accessory for breast displacement to decrease radiation dose and/or improve image quality. | Device is reusable and used external to hospital garb; it does not touch the patient's body. No explicit performance metrics for dose reduction or image quality improvement are provided in this summary, but its intended function is to facilitate this. |
| Substantially equivalent to legally marketed predicate devices. | Found substantially equivalent to legally marketed predicate devices by the FDA. |
2. Sample size used for the test set and the data provenance: Not applicable, as there were no performance studies of the type described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.