(17 days)
The Orison Embrace is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patients breast when used with an automatic scanning linear array transducer.
The Embrace™ 3D Ultrasound Tomography System is an easy to use diagnostic ultrasound system to be used as an adjunct to mammography for imaging a patient's breast. Ultrasound images are acquired using a general purpose ultrasound system capable of B-mode imaging in conjunction with an automatic scanning concave transducer. The acquired images are reconstructed using 3-D visualization software at a separate clinical review workstation.
The Orison Embrace System is an ultrasound tomography system intended for use as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Identification of cystic masses in a phantom breast. | All 12 masses were successfully identified. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 1 phantom breast with 12 cystic masses.
- Data Provenance: The 'test set' was a phantom breast, not human data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable, as a phantom breast was used. The 'known number of cystic masses' and their positions serve as the ground truth.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth (number and location of cystic masses) was inherently known due to the nature of the phantom.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. The study described is a technical verification using a phantom, not a clinical study involving human readers.
6. Standalone Performance Study (Algorithm Only)
- Standalone Study Done? Yes. The System Verification and Validation Testing seems to be a standalone performance study where the device (Orison Embrace System) was tested on its own to identify known masses in a phantom.
7. Type of Ground Truth Used
- Type of Ground Truth: Known physical characteristics in a phantom model (known number and positions of cystic masses).
8. Sample Size for the Training Set
- Training Set Sample Size: Not explicitly stated or detailed in the provided summary. The submission focuses on verification testing rather than algorithm training.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not explicitly stated in the provided summary. As this is a 510(k) submission for an ultrasound system, rather than an AI/CADe device, the concept of a separate "training set" with established ground truth in the context of machine learning isn't a primary focus of the non-clinical testing described. The primary "test set" was a phantom.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. 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 biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging 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.