(90 days)
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obsternes); Abdominal (including renal and GYN/pelvic); Pediatic; Small Organ (breast, testes, thyroid, salivary gland, Jymph nodes, pediatic and neonatal patients); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-sketal Conventional and Superficial; Transrectal (Including Urology and Prostate) (TR); Transvaginal (TV).
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal / Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal, Transvaginal.
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD display, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate realtime three dimensional imaging supporting all standard acquisition modes.
The provided document is a 510(k) Premarket Notification for the GE Healthcare Voluson P6 / Voluson P8 Ultrasound Systems. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with acceptance criteria in the same way an AI-powered diagnostic device might.
Based on the document, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a typical acceptance criteria table with corresponding device performance metrics for a diagnostic accuracy study. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices, and conformity to various electrical, safety, and performance standards.
The document discusses various operating modes and clinical applications for which the device and its transducers are indicated. The "performance" is implicitly tied to being equivalent to previously cleared devices which are presumed safe and effective for these applications.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Same fundamental scientific technology as predicate devices | Voluson P6 / Voluson P8 employs the same fundamental scientific technology as its predicate devices. |
| Substantially equivalent intended use as predicate devices | The Voluson P6 / Voluson P8 and predicate Voluson P Series systems have the same clinical intended use. |
| Substantially equivalent imaging capabilities as predicate devices | The Voluson P6 / Voluson P8 and predicate Voluson P Series systems have the same imaging modes. |
| Substantially equivalent technological characteristics as predicate devices | Transducers are identical or similar, with additions and removals noted for specific models; beam former changed to STB MLA4 (previously cleared). |
| Safety and effectiveness equivalent to predicate devices | Systems are manufactured with materials evaluated and found safe; acoustic power levels are below FDA limits; complies with approved electrical and physical safety standards and voluntary standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA PS 3.1 - 3.20). |
| Biocompatibility of patient contact materials | Transducer materials and other patient contact materials are biocompatible. |
| Similar capability in performing measurements, capturing digital images, reviewing and reporting studies | The Voluson P6 / Voluson P8 and predicate Voluson P Series systems have similar capability. |
| Added features (SIM card, GYN measurement tool) are previously cleared | SIM card (K142472) and IOTA LR2 model (K142472) were previously cleared. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, Voluson P6 / Voluson P8, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set sample size and no data provenance as defined for clinical performance evaluation. The evaluation was primarily based on non-clinical testing and comparison to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical studies were required or performed for this specific submission, no experts were used to establish ground truth for a test set.
4. Adjudication Method for the Test Set
As no clinical study was performed, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No MRMC comparative effectiveness study was done. The submission did not involve evaluating human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
No standalone algorithm performance study was done. This device is a general-purpose ultrasound system, not an AI-powered diagnostic algorithm.
7. The Type of Ground Truth Used
No ground truth was established in the context of a diagnostic performance study. The "truth" for this submission is based on demonstration of compliance with safety standards and equivalence to predicate devices.
8. The Sample Size for the Training Set
This device is not an AI/ML algorithm that is trained on a dataset. Therefore, there is no training set sample size.
9. How the Ground Truth for the Training Set was Established
As this is not an AI/ML device, no ground truth was established for a training set.
In summary, the provided document describes a 510(k) submission for an ultrasound system focusing on demonstrating substantial equivalence to predicate devices and adherence to safety and performance standards, rather than presenting a performance study with acceptance criteria and ground truth for an AI/ML powered device.
§ 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.