(52 days)
The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, 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 highly accurate real-time three-dimensional provide imaging supporting all standard acquisition modes.
Based on the provided document, the device (GE Voluson E6, Voluson E8, Voluson E10 ultrasound systems) did not require clinical studies to support substantial equivalence. This means that the device meets acceptance criteria primarily through demonstrating substantial equivalence to predicate devices and adherence to non-clinical safety and performance standards, rather than through a study proving device performance against specific clinical acceptance criteria.
Therefore, many of the requested details about acceptance criteria and a study proving their fulfillment are not applicable or cannot be extracted from this document. The document primarily focuses on demonstrating that the new device shares the same intended use, technological characteristics, and safety and effectiveness as already cleared predicate devices.
Here's what can be inferred from the provided text:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study was conducted as part of this 510(k) submission to demonstrate specific performance metrics against clinical acceptance criteria, such a table cannot be created from the provided text. The "acceptance criteria" for this submission are primarily focused on equivalence to predicate devices and adherence to recognized standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary of Non-Clinical Tests & Equivalence Claims) |
|---|---|
| Intended Use Equivalence: Same clinical applications as predicate. | "The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared." (Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Musculo-skeletal, Peripheral Vascular, Transvaginal, Transrectal). |
| Technological Equivalence: Same fundamental scientific technology. | "The Voluson E Series... employs the same fundamental scientific technology as its predicate devices." |
| Imaging Capabilities Equivalence: Same imaging modes. | "The proposed Voluson E Series and predicate Voluson E Series systems have the same imaging modes." |
| Transducer Equivalence/New Transducer Performance: New transducers are within predicate system's indications for use. | "The proposed Voluson E Series adds three new transducers IC4-10-D, C1-6-D and C2-9-D to the system. Applications for these probes are within the indications for use of the predicate system." |
| System Indications for Use Match: No change to system indications. | "There is no change to the system indications for use." |
| Material Biocompatibility: Materials safe for intended use. | "The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device." "Transducer materials and other patient contact materials are biocompatible." |
| Acoustic Output Safety: Levels below FDA limits. | "The systems have acoustic power levels which are below the applicable FDA limits." |
| Functional Equivalence: Similar capability for measurements, image capture, review, reporting. | "The proposed Voluson E Series and predicate systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies." |
| Electrical & Physical Safety: Compliance with approved standards. | "The proposed Voluson E Series and predicate systems have been designed in compliance with approved electrical and physical safety standards." Conforms to AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37. |
| Acoustic Output Measurement Standards: Compliance with NEMA UD 3, NEMA UD 2. | Conforms to NEMA UD 3, NEMA UD 2. |
| Risk Management: Application of risk management to medical devices. | Conforms to ISO14971. |
| Digital Imaging and Communications: DICOM compliance. | Conforms to NEMA PS 3.1 - 3.20 (2011) DICOM Set. |
| Software Feature Equivalence/Enhancement: Improved semi-automation for SonoVCAD Heart, Fetal Cardio preset on new transducers. | "The proposed Voluson E Series adds improved semi-automation to the existing software feature SonoVCAD Heart." "The proposed Voluson E Series is adding a Fetal Cardio preset to two new C1-6-D and C2-9-D transducer. Fetal Cardio setting is already implemented and cleared with probes eM6C, eM6CG2, RM6C, C1-5-D and C4-8-D (K152567)." |
2. Sample size used for the test set and the data provenance:
- Not Applicable. No clinical test set data is described due to the nature of the 510(k) submission relying on substantial equivalence, not de novo clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for a test set is described.
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. Such a study was not performed as per the statement: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." The document mentions "improved semi-automation to the existing software feature SonoVCAD Heart" and a "Fetal Cardio preset," which suggests some level of AI/automation, but no MRMC study or effectiveness data is provided.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. No standalone algorithm performance study is described. The device is an ultrasound system with integrated features, not a standalone AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable. No ground truth for specific clinical performance is described as clinical studies were not required. The "ground truth" for this submission revolves around documented adherence to engineering standards and comparison to predicate devices.
8. The sample size for the training set:
- Not Applicable. No training set for an AI/algorithm is described, as no clinical study or specific AI performance evaluation was submitted in this document. While the device does have "improved semi-automation" for SonoVCAD Heart, details about its development (including training sets) are not within this summary.
9. How the ground truth for the training set was established:
- Not Applicable. No training set or its associated ground truth establishment is described.
§ 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.