(91 days)
The Versana Premier are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac, Muscular, Musculoskeletal Conventional, Musculos-keletal Superficial, Transcranial, Transvaginal, Tissue Biopsy/Fluid Drainage.
The Versana Premier is a general purpose, diagnostic ultrasound system for use by qualified healthcare professionals. The system consists of a mobile console, operator control panel, display monitor and some transducers. The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. The operator control panel includes an ultrasound keyboard, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device. The variety of transducers include convex, linear, sector and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial.
The provided text describes a 510(k) premarket notification for the GE Versana Premier ultrasound system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove safety and effectiveness from scratch. Therefore, the information typically found in a study demonstrating device performance against acceptance criteria for a novel device is not fully present.
However, based on the provided text, I can extract information related to the comparison with predicate devices, which serves as the basis for the FDA's substantial equivalence determination.
Here's an analysis of the provided text in the context of your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed reported device performance in a table for most features. Instead, it asserts "similar" or "same" characteristics when compared to predicate devices for many aspects. The main "performance" demonstrated is the similarity to the predicate devices.
| Feature/Criterion | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (Versana Premier) |
|---|---|---|
| Intended Use | Same as predicate devices | Same clinical indications for use as LOGIQ F8 (K160277) |
| Imaging Modes | Similar to predicate devices | Similar imaging modes to LOGIQ F8 (K160277) |
| Transducers | Similar to predicate devices | Similar to LOGIQ F8 (K160277) transducers. Specific new additions: |
- Coded Pulse mode (8C-RS, E8C-RS, RAB2-6-RS, E8Cs-RS)
- Non-vascular access (4C-RS)
- Vascular access and Non-vascular access (L6-12-RS)
- RIC5-9A-RS transducer (newly added; applications from LOGIQ P9 K163596 for Transrectal, Tissue Biopsy/Fluid Drainage)
- 12L-RS transducer (newly added; from LOGIQ P9 K163596, with added Coded Pulse mode and Non-vascular access)
- LK760-RS transducer (newly added; from LOGIQ e K151028, with added Coded Pulse mode)
- 12S-RS transducer (newly added; from LOGIQ P9 K163596, with added Power Doppler Imaging mode, Cardiac application from Vivid T8 K160078, and Transcranial application from Vivid iq K161706) |
| Features | Equivalent or improved compared to predicate devices | Added Vocal, Breast Productivity, Thyroid productivity, TVM (from LOGIQ P9 K163596)
Added Needle recognition and Follow-Up tool (from LOGIQ e K151028)
Added Auto Bladder Volume and Tricefy Uplink (from Vscan Extend K180995)
Added new features: Breast Care 2.0 and Whizz |
| Hardware | Similar to predicate devices (with some additions) | Some new hardware added |
| Measurements, Digital Imaging, Reviewing, Reporting | Similar capability to predicate devices | Similar capability to LOGIQ F8 (K160277) |
| Materials | Safe for intended use | Manufactured with materials evaluated and found safe |
| Acoustic Output | Below applicable FDA limits | Below applicable FDA limits |
| Safety Standards | Designed in compliance with approved standards | Designed in compliance with approved electrical and physical safety standards; Complies with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2, ISO14971, NEMA PS 3.1-3.20 (DICOM) |
| Biocompatibility | Biocompatible | Transducer material and other patient contact materials are biocompatible |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "The subject of this premarket submission, Versana Premier, did not require clinical studies to support substantial equivalence." This means no dedicated clinical test set (sample size, data provenance) was used for this submission to prove performance against specific acceptance criteria. The equivalence is based on the technical and functional similarity to already cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical studies were performed for this submission, there was no "test set" requiring ground truth established by experts. The determination of substantial equivalence is an administrative and technical review process by the FDA, relying on a comparison to predicate devices, not on new clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used for this submission.
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. The Versana Premier is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation for improved human reader performance. Its purpose is imaging itself. No MRMC study was conducted or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Versana Premier is a physical ultrasound imaging system that requires a human operator, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical studies were conducted for this premarket submission. The "ground truth" for the FDA's decision is the established safety and effectiveness of the identified predicate devices, based on previous clearances.
8. The sample size for the training set
Not applicable. This submission is for a medical imaging device, not a machine learning algorithm that requires a training set. The device's design and functionality are based on proven engineering principles and features from existing cleared devices.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.