(26 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testicle), Musculo-skeletal (Conventional), Musculo-sketal (Superficial). Invasive diagnosic or therapeutic procedures, Retroperitoneum, Female reproductive system and fetus. Superficial structures & pathologies, Peripheral Vessel, Magnetic Needle guidance
The eZono 4000 system is a portable, software-controlled sonography system based on a digital architecture. It supports linear and curvi-linear transducers. The eZono 4000 system has an ergonomic design optimized for stable handling without sharp edges and is very easy to carry with its low weight of 11.5lbs (5.2kg). The robust casing provided with an anti-slip bottom side. The brilliant 12-inch screen with more than 60 million colors makes it possible to acquire and display highresolution, real-time ultrasound images. The eZono Needle Guide System detects the position and orientation of magnetized needles in the presence of the probe and displays this information relative to the ultrasound image. This quides the operator to better visualize the needle in the ultrasound image during ultrasound guided needling procedures.
The provided document is a 510(k) Premarket Notification for the eZono™ 4000 Diagnostic Ultrasound System. It is a submission for a new medical device that seeks to demonstrate substantial equivalence to previously cleared predicate devices, rather than a study proving the device meets specific acceptance criteria through a clinical trial.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or directly available in this type of regulatory submission. The submission focuses on non-clinical tests to show conformity to standards and similarities in construction, operating principles, and specifications to predicate devices.
Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present in a 510(k) summary format:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria in the sense of performance metrics typically found in a clinical study report (e.g., sensitivity, specificity, accuracy). Instead, it lists the standards to which the device conforms and the quality assurance measures applied during its development.
| Acceptance Criteria (Type of Conformity/Measure) | Reported Device Performance (Nature of Conformity/Outcome) |
|---|---|
| System specifications | Conforms to system specifications |
| Thermal safety | Conforms to thermal safety standards |
| Electrical safety | Conforms to electrical safety standards |
| Electromagnetic safety | Conforms to electromagnetic safety standards |
| Mechanical safety | Conforms to mechanical safety standards |
| FDA consensus medical device safety standards | Conforms to FDA consensus medical device safety standards |
| International harmonized standards | Conforms to international harmonized standards |
| AAMI HE75:2009 Human factors engineering | Complies with AAMI HE75:2009 |
| IEC 60601-1 Medical electrical equipment | Complies with IEC 60601-1 |
| IEC 60601-1-2 EMC standard | Complies with IEC 60601-1-2 |
| IEC 60601-2-37 Ultrasonic medical diagnostic equipment | Complies with IEC 60601-2-37 |
| IEC 62304 Medical device software life cycle | Complies with IEC 62304 |
| IEC 62366 Usability engineering | Complies with IEC 62366 |
| ISO 10993-1 Biological evaluation (general) | Complies with ISO 10993-1; patient contact materials are biocompatible |
| ISO 10993-5 In vitro cytotoxicity | Complies with ISO 10993-5; patient contact materials are biocompatible |
| ISO 10993-10 Irritation & delayed-type hypersensitivity | Complies with ISO 10993-10; patient contact materials are biocompatible |
| ISO 14971 Risk management | Complies with ISO 14971 |
| Risk Analysis | Applied during development |
| Requirements Reviews | Applied during development |
| Design Reviews | Applied during development |
| Testing on unit level (Module verification) | Applied during development |
| Integration testing (System verification) | Applied during development |
| Final Acceptance Testing (Validation) | Applied during development |
| Performance testing (Verification) | Applied during development |
| Safety testing (Verification) | Applied during development |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not Applicable. No clinical studies or test sets (in the sense of patient data for performance evaluation) are mentioned as having been required or conducted for this 510(k) submission.
- Data provenance: Not Applicable.
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 test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring adjudication is described.
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
- MRMC study: Not Applicable. This is an ultrasound diagnostic system, and the submission is for substantial equivalence without clinical studies. It does not describe an AI component for interpretation or assistance that would necessitate an MRMC study.
- Effect size: Not Applicable.
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 a standalone AI algorithm for interpretation. Its needle guidance feature assists the human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No clinical studies requiring ground truth were conducted or referenced in this submission for device performance. The "ground truth" for the device's claims of safety and effectiveness relies on its conformance to established standards and its substantial equivalence to predicate devices.
8. The sample size for the training set
- Not Applicable. This submission describes a diagnostic ultrasound system and its software, not a machine learning model requiring a training set from patient data. The "training" for the device's development involved conformance to standards and engineering verification/validation.
9. How the ground truth for the training set was established
- Not Applicable. As no training set for a machine learning model is mentioned, no ground truth establishment method for it is relevant.
§ 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.