(127 days)
The AU6 (Technos/TechnosMP) ultrasound imaging system is intended to be used by a physician for diagnostic imaging in pediatric, small organ, neonatal cephalic, transrectal, transvaginal, intraoperative abdominal, intraoperative peripheral vascular, laparoscopic, adult cephalic and musculoskeletal applications.
Not Found
This is a 510(k) premarket notification for an ultrasound imaging system. Such notifications typically focus on establishing substantial equivalence to a legally marketed predicate device rather than presenting detailed standalone performance studies with specific acceptance criteria and outcome metrics like accuracy, sensitivity, or specificity.
Based on the provided document, here's what can be extracted and what cannot be determined:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for image quality or diagnostic accuracy/performance. The "reported device performance" is essentially that it is substantially equivalent to the predicate devices and supports the specified imaging modes and clinical applications.
The tables within the document (e.g., "Comparison Chart for Substantial Equivalence", and tables for individual transducers) indicate capabilities and modes of operation for various clinical applications, rather than quantifiable performance metrics against acceptance criteria.
| Feature/Criterion (Implied) | Acceptance Criteria (Not explicitly stated as quantitative performance, but implied functionality) | Reported Device Performance (as presented in the 510(k) comparison) |
|---|---|---|
| General Characteristics | ||
| Transducer Type (Linear) | Must support Linear Array | YES (for AU6 Digital and This Submission) |
| Transducer Type (Convex) | Must support Convex Array | YES (for AU6 Digital and This Submission) |
| Transducer Type (Phased) | Must support Phased Array (for specified predicate) | YES (for AU6 Digital and This Submission) |
| Transducer Type (Pencil) | Must support Pencil (for specified predicate) | YES (for AU6 Digital and This Submission) |
| Imaging Modes | ||
| B Mode | Must support B Mode | YES (for AU6 Digital and This Submission) |
| M Mode | Must support M Mode | YES (for AU6 Digital and This Submission) |
| PWD (PW) | Must support PWD (PW) | YES (for AU6 Digital and This Submission) |
| CWD | Must support CWD (for specified predicate) | YES (for AU6 Digital and This Submission) |
| Color Doppler (CFM) | Must support CFM | YES (for AU6 Digital and This Submission) |
| Amplitude Doppler (PD) | Must support PD | YES (for AU6 Digital and This Submission) |
| Combined Modes | Must support Combined Modes | YES (for AU6 Digital and This Submission) |
| Duplex | Must support Duplex | YES (for AU6 Digital and This Submission) |
| Triplex | Must support Triplex | YES (for AU6 Digital and This Submission) |
| TEI/CTEI | Must support TEI/CTEI | YES (for AU6 Digital and This Submission) |
| 3D (Module) | Must support 3D imaging (for AU5 3D and This Submission) | YES (for AU5 3D and This Submission) |
| Clinical Applications (New/Added) | Functionality for Musculoskeletal Conventional and Superficial | N (New) - the device specifically adds these applications to the AU6 model. Performance is implied to be equivalent to safely and effectively enable these applications. |
| Functionality for 3D Imaging | Functionality for 3D imaging across various clinical applications. | N (New) or P (Previously Cleared) / E (Added under Appendix) depending on the specific transducer and application, for 3D-DSM2/DSM3 mode. |
| Safety and Standards | Compliance with IEC 60601-1 and Track 3 for Ultrasound safety | IEC 60601-1, Track 3 (Reported as compliant to the same standards as predicate devices) |
2. Sample Size for the Test Set and Data Provenance:
The document does not provide any information about a specific "test set" in the context of an accuracy study. This submission is a 510(k) for an ultrasound imaging system, which primarily demonstrates substantial equivalence through technical comparison and compliance with performance standards (e.g., electrical safety, acoustic output), rather than clinical performance studies against a gold standard for specific diagnostic tasks. The "data provenance" for a clinical test set is therefore unstated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided as there is no mention of a clinical performance study with a test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not provided as there is no mention of a clinical performance study with a test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not report on an MRMC comparative effectiveness study, nor does it mention any effect size of human readers improving with AI vs. without AI assistance. This device is an ultrasound imaging system, not an AI-powered diagnostic aide in the context of this submission.
6. Standalone (Algorithm Only) Performance Study:
The document does not report on a standalone performance study. The device is an ultrasound imaging system, where its "performance" for 510(k) purposes is largely demonstrated through technical specifications and adherence to safety and performance standards.
7. Type of Ground Truth Used:
As no clinical performance study with a "test set" is described, there is no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set:
The document does not provide any information about a training set. This is not an AI/machine learning device in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided as no training set is mentioned.
Summary of the Study (Based on the 510(k) provided):
The "study" presented in this 510(k) is a substantial equivalence comparison. The manufacturer, Biosound Esaote, sought clearance for the AU6 (Technos/Technos MP) Ultrasound Imaging System with the addition of 3D Imaging Mode and Musculoskeletal Indication.
The study primarily involves a technical comparison of the proposed device (AU6 Technos/Technos MP with 3D/Musculoskeletal additions) against predicate devices: the Esaote AU5 3D (K000931) for 3D capabilities and the Esaote AU6 Digital (Technos K990360) for general ultrasound capabilities.
The "acceptance criteria" are implicitly met if the new device demonstrates similar technological characteristics and performance specifications for the modes and applications it claims, and meets relevant electrical and ultrasound safety standards (IEC 60601-1 and Track 3 for Ultrasound safety). The performance is "reported" by affirming the device's capabilities match or are comparable to the predicates for the cleared indications and modes, while explicitly highlighting the new applications (Musculoskeletal Conventional, Musculoskeletal Superficial, and 3D imaging in certain contexts) as additions with these capabilities. The FDA's letter of clearance confirms that the device is "substantially equivalent" for the stated indications for use.
§ 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.