(37 days)
The Versana Active is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Active clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage.
The Versana Active is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The Versana Active is a compact, portable system, the device includes operator control panel, display monitor and transducers. The system provides digital acquisition, processing and display capability. The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time use. The operator control panel includes function keys, trackball and an alfa-numeric keyboard as input sources of the device. The Versana Active design enables the system to be attached to an optional mobile cart. The variety of transducers include convex, linear and sector. The access types include trans- body surface, transrectal, transvaginal and transcranial. Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning. The system has a HDMI port connection. The system has an option for an external Printer USB Isolator for printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the Bluetooth USB adapter is connected to the system.
This document is a 510(k) Summary for the GE Versana Active ultrasound system. It is a premarket notification to the FDA, asserting substantial equivalence to previously cleared devices rather than providing a study demonstrating the device meets specific acceptance criteria through a clinical trial.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test/training sets, expert qualifications, and adjudication methods is not present in the provided text.
The document explicitly states: "The subject of this premarket submission, Versana Active, did not require clinical studies to support substantial equivalence."
Instead, the document details:
- Device Trade Name: Versana Active
- Regulation Number/Name/Class/Product Code: 21 CFR 892.1550, Ultrasonic pulsed doppler imaging system, Class II, Product Code IYN, IYO, ITX
- Indications for Use: General purpose diagnostic ultrasound for various clinical applications (Fetal/Obstetrics, Abdominal, Pediatric, Small Organ, etc.) and modes of operation (B-mode, M-mode, Doppler modes, etc.).
- Predicate Devices: Versana Premier (K182277) as the primary predicate, with LOGIQ e (K151028), LOGIQ P9 (K181783), Vivid iq (K181727), and Venue Go (K183362) used for specific changes to transducer applications or features.
- Comparison to Predicate Devices: It highlights similarities and differences, noting new applications or modes added that were previously cleared on other GE ultrasound systems (the predicates). This comparison forms the basis of the "substantial equivalence" claim.
- Summary of Non-Clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning/disinfection, and thermal, electrical, electromagnetic, and mechanical safety, complying with relevant medical device safety standards (e.g., AAMI/ANSI ES60601-1, IEC60601-1-2, ISO10993-1).
- Quality Assurance Measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit/Module/Integration/Performance/Safety Testing.
To directly answer your questions based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document focuses on showing substantial equivalence to predicate devices, not on meeting specific, quantifiable acceptance criteria from a pre-defined study.
- Sample sizes used for the test set and the data provenance: Not applicable, as no clinical study with a test set was required or conducted. Non-clinical tests are mentioned but no specifics on data or sample sizes for those tests are detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study with a test set was conducted.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 an ultrasound system, not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate human reader performance with AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study was performed. The "ground truth" for this submission is based on previously cleared predicate devices and compliance with non-clinical safety and performance standards.
- The sample size for the training set: Not applicable, as no algorithm training (e.g., AI/ML) is mentioned, and no clinical study was conducted.
- How the ground truth for the training set was established: Not applicable.
§ 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.