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510(k) Data Aggregation
(27 days)
The Acclarix AX8 Series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics.
The Acclarix AX8 Series Diagnostic Ultrasound System clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Peripheral vascular, Musculoskeletal, Pediatric, Neonatal, Adult Cephalic, Thoracic/Pleural and Trans-esophageal Cardiac.
The Modes of Operation for Acclarix AX8 Series include B mode, M mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.
The Acclarix AX9 Series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics.
The Acclarix AX9 Series Diagnostic Ultrasound System clinical applications include Abdominal. Gynecology, Obstetric, Cardiac, Small parts, Urology, Peripheral vascular, Musculoskeletal, Pediatric, Neonatal, Adult Cephalic, Thoracic/Pleural and Trans-esophageal Cardiac.
The Modes of Operation for Acclarix AX9 Series include B mode, M mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.
The Acclarix AX8 Series & Acclarix AX9 Series Diagnostic Ultrasound System 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 in hospitals and clinics. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.
The provided text focuses on the 510(k) summary for the Edan Instruments Inc. Acclarix AX8 and AX9 Series Diagnostic Ultrasound Systems. It primarily addresses the substantial equivalence to a predicate device and outlines non-clinical performance data. It explicitly states "Clinical data: Not applicable," which means that no clinical studies were performed to establish acceptance criteria or demonstrate device performance against clinical metrics.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such a study involving clinical data and performance metrics is explicitly stated as "Not applicable" in the document.
However, I can extract information about the non-clinical testing performed:
1. A table of acceptance criteria and the reported device performance:
Since no clinical acceptance criteria or performance metrics were reported, this table cannot be created as requested in the context of clinical performance. The document only states that the device complies with certain electrical safety, EMC, and performance standards.
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1:2005+A1:2012+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Complies with the standard. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | Complies with the standard. |
| Performance Testing - Bench | IEC 60601-2-37: 2007+A1:2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | Meets relevant guidance and consensus standards. |
| IEC 60601-2-18: 2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment | Meets relevant guidance and consensus standards. | |
| FDA's Guidance "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" | Meets relevant guidance and consensus standards. | |
| Software Verification and Validation | FDA's Guidance "Content of Premarket Submissions for Device Software Functions" | Verification and validation testing conducted, documentation provided as recommended. |
Regarding the other requested information, the document states "Clinical data: Not applicable." Therefore, the following points cannot be addressed from the given text:
- 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 due to lack of clinical data.
- 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 due to lack of clinical data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable due to lack of clinical data.
- 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. The device is a diagnostic ultrasound system, and the document doesn't mention AI assistance or MRMC studies.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an ultrasound system, not an AI algorithm intended for standalone performance.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable due to lack of clinical data.
- 8. The sample size for the training set: Not applicable as no clinical training data is mentioned.
- 9. How the ground truth for the training set was established: Not applicable as no clinical training data is mentioned.
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