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510(k) Data Aggregation
(14 days)
The SonixTouch Ultrasound Imaging System 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, Intravascular, Laparoscopic.
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 SonixTouch 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 SonixTouch 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 quides will support various sized needle guides are sold in sterile kits that contain multiple needle guides, sterile sheaths, ultrasound transmission gel, and bands.
The provided document is a 510(k) Summary for the SonixTouch Ultrasound Scanner, which primarily focuses on establishing substantial equivalence to predicate devices and detailing general safety considerations for an ultrasound system. It is not a study proving device performance against specific acceptance criteria in the manner typically seen for AI/ML-enabled diagnostic devices that generate quantifiable results (e.g., sensitivity, specificity for disease detection).
The document details the device's technical specifications and clinical applications for various transducers. It mentions "Elastography verification data" which points to a verification protocol, but this is described as verifying the algorithm's ability to differentiate different structures with different rigidity, rather than a clinical performance study with acceptance criteria.
Therefore, much of the requested information (like quantitative acceptance criteria, sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and training set details) is not present in the provided text, as this type of information is usually associated with studies validating a diagnostic claim or quantitative performance, which is not the primary focus of this 510(k) submission for a general ultrasound imaging system.
However, I can extract information related to the device's safety acceptance criteria and the methods used to demonstrate compliance.
1. Table of Acceptance Criteria and Reported Device Performance
The document describes compliance with specific acoustic output limits as a safety consideration.
| Acceptance Criteria (Acoustic Output Limits) | Reported Device Performance |
|---|---|
| ISPTA(d) <= 720 mW/cm² | 720 mW/cm² |
| TIS/TIB/TIC Range | 0.1 - 4.0 |
| Mechanical Index (MI) <= 1.9 | 1.9 |
| ISPPA(d) Range | 0 - 700 W/cm² |
Note: These are safety limits, not diagnostic performance metrics. The document states these limits are "the same as predicate Track 3 devices," implying equivalence rather than a specific performance target.
2. Sample size used for the test set and the data provenance
For the safety acceptance criteria related to acoustic output, the document does not specify a "test set" in the context of patient data or clinical images. Compliance with acoustic output limits typically involves engineering measurements and testing of the device hardware and software, rather than interpretation of medical images.
For Elastography, the document mentions:
- Sample Size: Not specified.
- Data Provenance: Not specified, but implied to be generated during "verification protocol" using different rigidity structures. The data seems to be synthetic or phantom-based rather than clinical patient data. The report "00.046.088_Ultrasonix_OP-SP_2.7.0_Release_Validation_Protocol_B_061308_ElastoValidation_Corina" is referenced, but its contents are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for the acoustic output safety criteria.
For Elastography: Not specified. The "verification data" for Elastography describes verifying the algorithm's ability to "differentiate different structures with different rigidity," which sounds more like a technical performance test using phantoms or controlled materials, rather than a clinical study requiring expert ground truth on patient diagnoses.
4. Adjudication method for the test set
Not applicable for the acoustic output safety criteria.
For Elastography: Not specified.
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, an MRMC comparative effectiveness study was not done or reported in the provided text. The submission is for a general diagnostic ultrasound system, not an AI-assisted diagnostic algorithm in the typical sense of providing a specific interpretation or improving human reader performance. The Elastography feature is described as an "imaging mode" that color-codes stiff vs. softer structures, and states "the clinical benefits of elastography imaging are still under evaluation and no clinical diagnosis claim can be made other than being able to tell whether or not a structure inside the patient is stiffer than another one." This explicitly limits any diagnostic claims, precluding the need for MRMC studies for diagnostic effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this type of standalone performance evaluation (for a diagnostic algorithm) was not performed or reported. The Elastography feature is part of a real-time imaging system, not a standalone algorithm providing independent diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for the acoustic output safety criteria. This is typically determined through direct measurement and compliance testing.
For Elastography: The ground truth seems to be established based on materials with "different rigidity" for a technical verification test (likely phantom-based or controlled environment testing), rather than clinical ground truth (e.g., pathology) for diagnostic accuracy.
8. The sample size for the training set
Not applicable. The document describes a traditional ultrasound imaging system with an Elastography imaging mode. It does not describe an AI/ML system that requires a "training set" in the context of machine learning model development. The algorithm mentioned for Elastography is described as extracting strain value information and color-coding, indicating a signal processing algorithm rather than a learned AI model.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML model is described.
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