(190 days)
The Edan Acclarix LX8 Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:
- Abdominal
- Gynecology (including endovaginal)
- Obstetric
- Cardiac
- Small parts (Breast, Testes, Thyroid, etc.)
- Urology
- Musculoskeletal
- Peripheral vascular
- Intra-operative
- Pediatric
- Neonatal (including abdominal and cephalic).
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
The Edan Acclarix LX8 Diagnostic Ultrasound system consists of a main system along with associated transducers. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The waves are then reflected within the body and detected by the transducer, which then converts back to an electrical signal. The Acclarix LX8 Diagnostic Ultrasound system then analyzes the returned signal to generate an image or conduct Doppler processing. The Acclarix LX8 Diagnostic Ultrasound system gives the operator the ability to measure anatomical structures, and offers analysis packages that provide information used by competent health care professionals to make a diagnosis. The system provides both touch screen and hard buttons for the User Interface.
This document is a 510(k) Premarket Notification for the Acclarix LX8 Diagnostic Ultrasound System. It aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices. The document does not describe acceptance criteria or a study that proves the device meets specific performance acceptance criteria beyond regulatory safety and performance standards. It primarily focuses on comparing the new device's features and safety compliance with predicate devices to establish substantial equivalence.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy for a diagnostic task) or clinical performance metrics. Instead, it outlines regulatory compliance and feature equivalence as the basis for substantial equivalence.
The "reported device performance" is essentially that the device complies with various safety and performance standards and offers similar or expanded features compared to its predicates.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Must be the same or similar to predicate devices. | Same as predicate devices (Diagnostic ultrasound imaging or fluid flow analysis of the human body). |
| Indications for Use | Must be the same or similar to predicate devices. The document notes "Difference" but implies the differences are acceptable and don't raise new questions of safety/effectiveness, as they are mostly additions of previously cleared applications marked "N" (new indication) or already "P" (previously cleared by FDA) on specific transducers. | Similar, with additions for certain transducers (e.g., new "N" indications cleared). |
| Product Design | Similar to predicate devices. | Similar to predicate devices. |
| Performance Effectiveness | Similar to predicate devices, demonstrated through technical specifications and compliance with standards. | Same as predicate devices (in terms of modes of operation, acoustic output, transducer frequency, display). |
| Performance Safety | Similar to predicate devices, demonstrated through compliance with recognized consensus standards. | Same as predicate devices. Complies with IEC 60601-1, -1-2, -2-37, ISO 10993 series, NEMA UD 2, UD3. |
| Features | Similar or enhanced compared to predicate devices, without raising new questions for safety/effectiveness. Some features (e.g., Auto IMT) are noted as having "Difference" but are considered not to affect basic design principles, usage, effectiveness, or safety. | Similar, with some feature differences and additions. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document explicitly states: "Clinical test: Clinical testing is not required."
Therefore, there is no test set of patient data, nor is there information on data provenance (country of origin, retrospective/prospective). The assessment for substantial equivalence relies on non-clinical tests and comparisons to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts:
Since no clinical testing was performed, there was no test set requiring ground truth established by experts.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The document states "Clinical test: Clinical testing is not required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. The device is a diagnostic ultrasound system, not an AI algorithm for standalone performance evaluation in the context of this submission. The "algorithm" here refers to the internal signal processing of the ultrasound system itself, which is evaluated through technical performance standards rather than clinical algorithm performance studies.
7. The Type of Ground Truth Used:
For the demonstration of substantial equivalence, the "ground truth" primarily refers to:
- Compliance with recognized consensus standards (e.g., IEC 60601 series for electrical safety and electromagnetic compatibility, ISO 10993 series for biocompatibility, NEMA UD for acoustic output). These standards define technical performance requirements.
- Equivalence to predicate devices based on their previously cleared performance and safety profiles.
8. The Sample Size for the Training Set:
Not applicable. This document describes a traditional medical device (ultrasound system) submission, not an AI/Machine Learning device that undergoes a training phase with a specific dataset.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned.
§ 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.