(7 days)
The Sonix Ultrasound Scanner is intended for the following applications: Ophthalmic, Abdominal, Cardiac, Intraoperative (specific), Intraoperative Neurological, Fetal, Pediatric, Small Parts, Neonatal / Adult Cephalic, OB/GYN, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculoskeletal conventional, Musculoskeletal superficial, Pelvic, Nerve block, Vascular Access, Transcranial,
The system also provides the ability to measure anatomical structures {fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peripheral vessel, musculo-skeletal} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.
The Sonix Ultrasound Scanner is a new multi-purpose mobile, software controlled diagnostic ultrasound system with on-screen thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed(PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic imaging on a Flat Panel Display. The user interface includes specialized controls, a minimized computer keyboard, and touch panel on an ergonomic console.
The system has an electrocardiography (ECG) display feature and support for a 3-lead ECG cable assembly. The systems provide measurement capabilities for anatomical structures and fetal biometry that provide information used for clinical diagnostic purposes. The system has a PW and CW audio output feature and cine review, image zoom, labeling, biopsy, measurements and calculations, image storage and review, printing, and recording capabilities. The systems include a Digital Imaging and Communications (DICOM) module which enables storage.
The system is designed for use in linear, convex and phased array scanning modes, and supports linear, convex, microconvex and phased array probes.
The biopsy kits are accessories to the Sonix Ultrasound Scanner. These accessories are made up of a polymeric bracket. There are features on the bracket that prevent the bracket from being oriented incorrectly when attached to the transducer. The brackets are not sterile and will be covered with a sterile sheath prior to use. These brackets are designed to accept and retain the needle quides in a mechanically secure way through the medium of the sterile sheath. The brackets are reusable. The needle guide is a separate sterile polymeric part that attaches to the bracket through a sterile sheath. The needle guides will support various sized needle guides are sold in sterile kits that contain multiple needle quides, sterile sheaths, ultrasound transmission gel, and bands.
The provided text is a 510(k) summary for the Sonix Ultrasound Scanner, specifically detailing the addition of two new transducers. It outlines general information about the device, its intended use, and a comparison to predicate devices, focusing on technological characteristics and safety considerations. Crucially, this document does not contain any information about a study proving the device meets acceptance criteria for clinical performance metrics (e.g., accuracy, sensitivity, specificity) of an AI algorithm.
The information provided is primarily for regulatory clearance based on substantial equivalence to existing devices, meaning it demonstrates that the new transducers on the Sonix Ultrasound Scanner perform as safely and effectively as other legally marketed devices with the same intended use. This typically involves performance bench testing, electrical safety, and biocompatibility, but not clinical performance studies for an AI component in the way you've described.
However, I can extract information related to safety and technical specifications, which are a form of acceptance criteria for regulatory bodies.
Here's a breakdown of what can be extracted or inferred based on the prompt's requirements, and what cannot be found in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are related to acoustic output limits and compliance with safety standards, rather than clinical performance metrics like accuracy, sensitivity, or specificity, as there is no AI algorithm being evaluated in a clinical context in this document.
| Acceptance Criteria (Acoustic Output Limits) | Reported Device Performance |
|---|---|
| ISPTA (d) ≤ 720mW/cm² | 720mW/cm² |
| TIS/TIB/TIC (Range) | 0.1-6.0 (Range) |
| Mechanical Index (MI) ≤ 1.9 | 1.9 (Maximum) |
| ISPPA (d) (Range) | 0 - 700W/cm² (Range) |
| Compliance with IEC 601-1 (1988) | Complies |
| Compliance with IEC 60601-2-37 | Complies |
| Compliance with AIUM AOL | Complies |
| Compliance with AIUM RTD | Complies |
Note: The document specifies that these limits are the same as predicate Track 3 devices, implying that the device performs within these established safe ranges.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Cannot be determined from the provided text. The document describes a regulatory submission for device clearance, not a clinical performance study involving a test set of data or patient images for an AI algorithm.
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)
Cannot be determined from the provided text. This information would be relevant for a clinical study evaluating an AI algorithm, which is not present in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Cannot be determined from the provided text. This information is pertinent to clinical studies with expert reviewers, not for a device's regulatory clearance based on substantial equivalence and safety standards.
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
No. A MRMC study was not done. The document does not describe the evaluation of an AI algorithm or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The document describes an ultrasound scanner and its transducers, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Cannot be determined from the provided text. Ground truth is relevant for evaluating the performance of an AI model against a known correct answer, which is not the subject of this document. The "ground truth" in this context would be the physical measurements of acoustic output and compliance with electrical safety standards.
8. The sample size for the training set
Cannot be determined from the provided text. This information is relevant for AI model development, which is not discussed.
9. How the ground truth for the training set was established
Cannot be determined from the provided text. This information is relevant for AI model development, which is not discussed.
In summary: The provided 510(k) summary focuses on demonstrating that the Sonix Ultrasound Scanner, with its new transducers, is substantially equivalent to previously cleared devices in terms of technology, intended use, and safety. It details compliance with acoustic output limits and international safety standards, which serve as "acceptance criteria" for the device's safe operation. However, it does not include any studies or data related to the clinical performance of an AI algorithm, a test set, expert adjudication, or training data for an AI model.
§ 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.