(30 days)
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric: Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.
The medical device in question, the GE Voluson P6, Voluson P8 Ultrasound System, is a general-purpose ultrasound system. The provided information does not detail a study that defines specific acceptance criteria for a new AI feature or algorithm. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K132913 Voluson E Series and K122387 Voluson P6/P8).
The "acceptance criteria" presented here are inferred from the declaration of substantial equivalence, which implies that the device must perform equivalently to its predicates across various clinical applications and imaging modes. The "reported device performance" is the statement that the device IS substantially equivalent.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| General System Performance: | |
| - Safety: Conformance to applicable medical device safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set). | - 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 to applicable medical device safety standards. Voluson P6/P8 and its applications comply with listed voluntary standards. |
| - Effectiveness: Equivalent imaging capabilities, technological characteristics, and safety as predicate devices. | - The Voluson P6/P8 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness. |
| - Intended Use: Support diagnostic ultrasound imaging and fluid flow analysis for specified clinical applications (Fetal/Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional and Superficial, Transrectal, Transvaginal). | - The Voluson P6/P8 and predicate Voluson P6/P8 systems have the same clinical intended use. |
- The device supports the intended uses and modes of operation as detailed in the Indications for Use forms (Pages 7-14), with 'P' indicating applications previously cleared by FDA for the predicate devices. |
| - Acoustic Power Levels: Below applicable FDA limits. | - The systems have acoustic power levels which are below the applicable FDA limits. |
| - Transducers: Identical to predicate Voluson P6/P8 systems. | - The Voluson P6/P8 and predicate Voluson P6/P8 systems transducers are identical. The submission lists the following transducers: RAB2-6-RS, 4C-RS, E8C-RS, 12L-RS, RICS-9W-RS, RAB2-5-RS, 3S-RS. |
| - Digital Imaging & Reporting: Similar capability in performing measurements, capturing digital images, reviewing and reporting studies as predicate devices. | - The Voluson P6/P8 and predicate Voluson P6/P8 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. |
| - New Software Features (HDLive, Sono IT, SonoBiometry, Sono L&D): Same features cleared on predicate Voluson E Series (K132913). | - New software features added to Voluson P6/P8: HDLive, Sono IT, SonoBiometry and Sono L&D are the same features cleared on predicate Voluson E Series (K132913). |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document indicates that no clinical studies were required to support the substantial equivalence claim for the Voluson P6, Voluson P8. Therefore, there is no specific test set sample size and no data provenance (country of origin, retrospective/prospective) related to clinical performance testing for this submission. The evaluation was based on non-clinical tests and comparison to predicate device specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical studies were performed, there was no ground truth established by experts for a test set in the context of this 510(k) submission.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
As no clinical studies were performed, there was no adjudication method used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study was performed as indicated by the statement: "The subject of this premarket submission, Voluson P6, Voluson P8, did not require clinical studies to support substantial equivalence." Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The submission does not describe a standalone algorithm performance study. The "new software features" (HDLive, Sono IT, SonoBiometry, Sono L&D) are stated as being "the same features cleared on predicate Voluson E Series (K132913)," implying their performance was already established, likely as part of the predicate device's clearance.
7. The Type of Ground Truth Used
For this 510(k) submission, the "ground truth" used for demonstrating substantial equivalence was effectively the established safety and performance of the predicate devices. The device's compliance was evaluated against established medical device safety standards and the known characteristics of the predicate systems. There was no de novo clinical ground truth establishment in this submission.
8. The Sample Size for the Training Set
Since no new AI algorithms requiring a training set are explicitly detailed as being newly developed and tested for this submission (rather, the new features are already cleared on a predicate), no training set sample size is mentioned.
9. How the Ground Truth for the Training Set Was Established
As no new training set is described, no information on how ground truth was established for a training set is provided. The substantial equivalence argument relies on the prior clearance of features on predicate devices.
§ 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.