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510(k) Data Aggregation
(34 days)
The SonoSite Edge Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
Ophthalmic Fetal - OB/GYN Abdominal Intra-operative (abdominal organs and vascular) Intra-operative (Neuro.) Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Trans-esophageal (cardiac) Peripheral Vessel
The SonoSite Edge Ultrasound System is a portable laptop style, full featured, general purpose, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. Edge is a custom fabricated digital electronic design that readliy lends itself to be configured for specific ultrasound imaging applications through different system feature selections. Edge can operate on either battery or AC power.
The provided 510(k) summary for the SonoSite Edge Ultrasound System (K133454) states that clinical studies were not required to support the determination of substantial equivalence. The submission relies on non-clinical tests and a comparison of technological characteristics to predicate devices.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not explicitly mentioned in the provided text as they would typically stem from a clinical study.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical study was performed for this 510(k) submission, there are no specific performance criteria or reported performance results in the context of a clinical evaluation. The document focuses on compliance with established safety standards and equivalence to predicate devices.
The "acceptance criteria" here are implicitly the existing standards and the characteristics of the predicate devices. The "reported device performance" is that it conforms to these standards and shares similar features, functionality, and performance parameters with its predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Non-Clinical Tests) |
|---|---|
| Electrical safety compliance | Device evaluated for electrical safety and found to conform to applicable mandatory medical device safety standards (e.g., IEC 60601-1, AAMI / ANSI ES60601-1). |
| Thermal safety compliance | Device evaluated for thermal safety and found to conform to applicable mandatory medical device safety standards. |
| Mechanical safety compliance | Device evaluated for mechanical safety and found to conform to applicable mandatory medical device safety standards. |
| EMC safety compliance | Device evaluated for EMC safety and found to conform to applicable mandatory medical device safety standards (e.g., IEC 60601-1-2, CISPR 11, IEC 61000-4 pt 2-5). |
| Cleaning/Disinfection | Device evaluated for cleaning/disinfection procedures. |
| Biocompatibility | All patient contact materials are biocompatible (evaluated per ISO 10993-1). |
| Acoustic output compliance | Acoustic output evaluated and found to conform to applicable mandatory medical device safety standards (e.g., IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004). |
| Quality assurance | Assurance of quality established by employing Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, Clinical Validation, Human Factors Validation. |
| Overall Equivalence | Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. Device conforms to applicable electromedical device safety standards, shares indications for use, has biosafety equivalence, and is manufactured using the same ISO 13485 quality system as predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable, as no clinical study was performed. The evaluation relied on non-clinical testing and comparison to predicate devices, which implies leveraging existing data and regulatory clearances from those predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable, as no clinical study and associated ground truth establishment for a test set were conducted.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical study was performed.
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, as no clinical study, particularly an MRMC study, comparing AI assistance to human readers was performed. The device described is a general-purpose ultrasound system, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as the device is a diagnostic ultrasound system, which inherently involves a human operator (qualified physician) for its intended use. It is not an AI algorithm operating autonomously.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical study was performed requiring the establishment of ground truth for diagnostic accuracy. For non-clinical aspects like safety and performance, the "ground truth" is adherence to recognized standards and engineering specifications.
8. The sample size for the training set:
Not applicable, as no clinical study was performed, and the device is not described as utilizing a machine learning algorithm that would require a training set of patient data.
9. How the ground truth for the training set was established:
Not applicable, as no clinical study was performed and no machine learning training set is mentioned for the device.
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