(89 days)
The device is a general purpose ultrasound system. Specific clinical applications include: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal
The Voluson i/e consists of a portable, notebook type console with integrated keyboard controls and color LCD display. It supports a variety of. It utilizes a variety of linear, curved linear transducers including mechanical scanning transducers supporting all standard acquisition modes (B, M. PWD, Color Color M and Amplitude Doppler modes, Harmonic Imaging and Coded Pulse). The Voluson i/e also utilizes motor driven transducers and image processing software that are specialized for 3D/4D volume imaging. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.
The provided document is a 510(k) Premarket Notification Submission by GE Healthcare for the Voluson i/e Diagnostic Ultrasound System. This submission focuses on modifications to an existing device, primarily the addition of new transducers and migration of existing software features from predicate devices. As such, the document does not contain acceptance criteria or a study proving the device meets said criteria in the typical sense of a novel device seeking clearance for a specific clinical task.
Instead, the submission demonstrates substantial equivalence to previously cleared predicate devices by showing that the modified device, including new transducers and software features, falls within the same intended use and performance characteristics as the predicates. The FDA's review and clearance (K131937) confirm this substantial equivalence.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, and expert involvement are not applicable to this type of submission.
Here's an breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or detailed performance metrics in the way a study for a new clinical indication would. The "acceptance criteria" in this context are implied by demonstrating substantial equivalence to predicate devices, meaning the device must perform similarly and safely for the same clinical applications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance with safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, EMC, mechanical safety). | "[The device] has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards." "The Voluson i/e and its applications comply with voluntary standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set." "Transducer materials and other patient contact materials are biocompatible." |
| Performance of software features migrated from predicate devices (SRI, XTD View, VCI, 4D-biopsy, STIC, HD-Flow, HD-Zoom, Volume Cine, Sono VCAD, Sono AVC, SonoNT, SonoRenderStart). | These software features were "migrated from predicate K122327" (Voluson E6/E8 E8 Expert/E10). The implication is that their performance remains consistent with their cleared state on the predicate device. No specific performance metrics for these features are provided in this summary. |
| Performance of new transducers (IC50-9W-RS, RAB2-6-RS, 8C-RS, 9L-RS, RAB4-8-RS, RNA5-9-RS, RIC5-9W-RS, AB2-7-RS, SP10-16-RS) for specified clinical applications and modes of operation. | The new transducers are indicated for various clinical applications and modes of operation, marked as "P" (previously cleared), "P*" (previously cleared on another GE Ultrasound System), "E" (added under Appendix E of FDA Ultrasound Guidance), or "N" (new indication for this specific transducer on this device). The performance is not quantified but is deemed substantially equivalent to predicates. |
| Maintenance of general purpose ultrasound system functionality and existing specific intended clinical uses. | "The device is a general purpose ultrasound system. Specific Intended Use: clinical applications remain the same as previously cleared." The 510(k) clearance confirms this. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable (N/A). The document explicitly states: "The subject of this premarket submission. Voluson i/e, did not require clinical studies to support substantial equivalence." Therefore, no test set of patient data was used for a clinical study within this submission. The evaluation was based on engineering verification, validation, and comparison to predicate devices, not on a new clinical performance study.
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)
- Not applicable (N/A). As no new clinical studies were conducted, there was no "ground truth" to be established by experts for a test set in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable (N/A). No new clinical studies were conducted, so no adjudication method was used for a test set.
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 (N/A). This submission is for modifications to a diagnostic ultrasound system and does not describe any AI-assisted features or MRMC studies evaluating human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable (N/A). This device is a diagnostic ultrasound system, not a standalone algorithm. Its performance is intrinsically linked to human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable (N/A) for clinical performance in this submission. The "ground truth" for the engineering evaluation was adherence to recognized standards and previous performance of predicate devices.
8. The sample size for the training set
- Not applicable (N/A). This submission does not describe the development of new algorithms or machine learning models that would require a 'training set.'
9. How the ground truth for the training set was established
- Not applicable (N/A). As there was no training set, there was no ground truth for it.
In summary, this 510(k) submission for the GE Healthcare Voluson i/e Diagnostic Ultrasound System is a submission for device modifications (new transducers and migrated software features). It leverages the concept of substantial equivalence to predicate devices and adherence to recognized safety and performance standards rather than presenting new clinical study data with specific acceptance criteria, sample sizes, or ground truth evaluations.
§ 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.