(1086 days)
This device is intended for use with the listed transducers for the transcutaneous, transrectal, and transvaginal imaging of organs or structures as an aid in the detection and assessment of physical and functional abnormalities using established diagnostic criteria; and in obstetric patients for the transcutaneous, or transvaginal imaging of the fetus and uterine structures including the performance of fetal measurements for the purpose of assessing fetal growth and maturity.
This device is intended to obtain and display B-scan and Mmode images as well as Pulsed Wave and Continuous Wave Doppler spectra, or Color Flow images. Additionally, the COMBISON 530 offers the VOLUSON 3D-scan system, which performs a number of B-scans, one adjacent to the other (only with special probes) and gives the user the possibility to visualize planes within the "volume" without the patient.
This document describes the Kretztechnik AG COMBISON® 530 Diagnostic Ultrasound Scanner and its associated transducers. The submission is a 510(k) premarket notification, indicating the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a concise table format for performance. Instead, it refers to general compliance with standards and product specifications, and comparison to predicate devices. The main performance aspects assessed are electrical safety, imaging performance, and acoustic output.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC Standard 601.1 limits for Class 1, Type BF devices regarding electrical leakage currents (ground, housing, patient device, mains voltage at patient device) and guard wire resistance. | "Measured electrical leakage currents... were measured and found to be well within the limits for Class 1, Type BF devices established by IEC Standard 601.1." |
| Imaging Performance | Imaging performance characteristics (image quality, frame rate, image orientation, measurement accuracy, sector angle, noise level) for each operating mode must be within product specifications as determined by the Kretztechnik AG Transducer-Software Check Protocol. | "All performance values were found to be within the limits stated in product specifications." |
| Acoustic Output | Maximum acoustic output for each transducer and operating mode, as measured under worst-case conditions, must be "lower than the officially published maxima for previously approved devices for the same intended uses" and comparable to predicate devices. | Detailed tables of ISPTA and ISPPA values are provided for each transducer and mode. The summary states: "All values obtained for the listed transducers during acoustic output testing were lower than the officially published maxima for previously approved devices for the same intended uses. ... the test data also indicate substantial equivalence with respect to the acoustic output." |
| Overall Equivalence | "Safe and effective" and performs "as well or better" than legally marketed predicate devices. | "results demonstrate that these devices are safe, effective, and perform as well or better than the legally marketed devices with which this scanner and these transducers have been compared." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly states "Formal clinical studies were not conducted". The tests performed were "appropriate nonclinical tests". Therefore, there is no patient-based "test set" in the context of clinical performance evaluation with a specified sample size.
- Data Provenance: The data are from nonclinical tests performed by Kretztechnik AG (the manufacturer). The specific country of origin is Austria (Kretztechnik AG, Zipf, Austria). The data are prospective in the sense that they were generated specifically for this submission through controlled testing, not retrospectively collected clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. As no formal clinical studies with human subjects were conducted and the evaluation focused on nonclinical performance, there was no "ground truth" derived from expert consensus on medical conditions for a test set. Ground truth, where applicable (e.g., for measurement accuracy), would come from the known properties of the phantoms used in the "Kretztechnik AG Transducer-Software Check Protocol". The qualifications of individuals performing these nonclinical tests are not detailed in the provided text.
4. Adjudication Method for the Test Set
N/A. There was no clinical test set requiring adjudication in the context of diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. No MRMC study was performed. The device is an ultrasound scanner, and the evaluation is for substantial equivalence to predicate devices, not improvement of human reader performance with AI assistance. The document explicitly states "Formal clinical studies were not conducted".
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The COMBISON® 530 is a diagnostic ultrasound scanner, a hardware device with software, not an AI algorithm. Its performance is intrinsically tied to a human operator. Therefore, a standalone (algorithm only) performance study, as understood in the context of AI, is not applicable or described. The performance described relates to the device's physical and technical capabilities.
7. Type of Ground Truth Used
For the nonclinical performance tests:
- Electrical Safety: Ground truth is established by the specified limits of IEC Standard 601.1.
- Imaging Performance: Ground truth for characteristics like frame rate, measurement accuracy, sector angle, and noise level would be based on the known properties of the phantoms used and the product specifications defined by the manufacturer (Kretztechnik AG).
- Acoustic Output: Ground truth is derived from direct physical measurements of acoustic output and comparison against "officially published maxima for previously approved devices" and FDA guidelines (TRACK III reporting procedures).
8. Sample Size for the Training Set
N/A. This document describes a new hardware device (ultrasound scanner and transducers) and does not involve an AI algorithm with a distinct "training set" of data.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no AI algorithm training set, this question is not applicable.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.