Search Results

The 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)
Adult Cephalic

Acclarix AX4/ Acclarix LX4 is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

The provided text is a 510(k) summary for the Acclarix AX4 and Acclarix LX4 Diagnostic Ultrasound Systems. It details the device's intended use and compares it to predicate devices to demonstrate substantial equivalence. However, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, specifically for an AI/ML component.

The document discusses non-clinical tests for electrical safety, electromagnetic compatibility, and acoustic output, as well as biocompatibility. These are standard tests for ultrasound systems and are about the hardware and general safety, not specifically about the performance of an AI/ML algorithm within the device.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance from this document, nor can I provide details on sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size for an AI/ML component, as this information is not present in the provided text.

The document explicitly states: "Clinical test: Clinical testing is not required." This further indicates that no studies demonstrating specific clinical performance or AI/ML algorithm effectiveness were conducted or reported in this 510(k) summary.

In summary, the provided text describes the regulatory clearance process for an ultrasound system based on substantial equivalence to existing devices, focusing on hardware safety and performance, not AI/ML algorithm performance.

Ask a specific question about this device

The Edan AX4 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)
• · Adult Cephalic

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

The Acclarix AX4 is a portable laptop diagnostic ultrasound system, intended for use by a qualified physician or sonographer for ultrasound evaluation in Point of Care environments such as Emergency Departments, Interventional procedures and mobile imaging centers.

The provided text is a 510(k) Pre-market Notification for the Acclarix AX4 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data to define acceptance criteria for novel device performance. Therefore, the document does not describe acceptance criteria for device performance based on a study, nor does it present results from such a study.

Instead, it asserts substantial equivalence by comparing the Acclarix AX4 to a predicate device (Acclarix AX8 Diagnostic Ultrasound System, K171824) across various parameters, including intended use, indications for use, safety standards, patient contact materials, modes of operation, measurements, principle of operation, acoustic output, transducer types, and features.

The document states that "Clinical testing is not required" for this submission, further indicating that no study was conducted to prove the device meets specific performance acceptance criteria beyond demonstrating equivalence to the predicate.

However, based on the information provided, I can respond to some of your specific questions related to the non-clinical testing performed to support substantial equivalence.

1. A table of acceptance criteria and the reported device performance:

The document does not provide specific performance acceptance criteria in terms of metrics like sensitivity, specificity, accuracy, or effect size. Instead, it relies on demonstrating compliance with recognized safety and performance standards, and sameness in various operational and technical specifications compared to the predicate device.

Note: The document explicitly states "Clinical testing is not required." The basis for clearance is substantial equivalence to a predicate device, supported by non-clinical testing demonstrating compliance with recognized standards and comparable specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no clinical performance study was conducted. The non-clinical testing involved device verification and validation activities against standards and specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical ground truth was established from expert review for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical ground truth was established.

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. This device is an ultrasound system, not an AI-assisted diagnostic tool, and no MRMC comparative effectiveness study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an ultrasound system, not an algorithm, and no standalone performance study was mentioned.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this 510(k) submission, the "ground truth" for the device's acceptability relies on its compliance with international safety and performance standards and its substantial equivalence to a previously cleared predicate device, rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

Not applicable, as no AI/machine learning model was trained for this device.

9. How the ground truth for the training set was established

Not applicable, as no AI/machine learning model was trained for this device.

Ask a specific question about this device