(75 days)
The SonixTABLET Ultrasound Imaging System is intended for the following applications: Abdominal, Cardiac, 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 SonixTABLET 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. 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 optional electrocardiography (ECG) display feature and support for a 3lead 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 arrav scanning modes, and supports linear, convex, microconvex and phased array probes.
The biopsy kits are accessories to the SonixTABLET 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 guides 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 guides, sterile sheaths, ultrasound transmission gel, and bands.
The provided text is a 510(k) Summary for the SonixTABLET Ultrasound Scanner. It details the device's characteristics, intended uses, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, device performance metrics, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case (MRMC) comparative effectiveness studies, standalone performance studies, or the ground truth establishment for training sets.
Therefore, many parts of your request cannot be answered from the provided document.
The document focuses on demonstrating that the SonixTABLET Ultrasound Scanner is substantially equivalent to previously cleared predicate devices (Sonix Ultrasound Scanner (K093462), Sonix TOUCH Ultrasound Scanner (K083095), SONIX MDP Ultrasound Scanner (K080935)) in terms of intended use, principles of operation, and technological characteristics. This type of submission generally relies on demonstrating equivalence rather than conducting new performance studies with detailed acceptance criteria as would be expected for a novel device.
The "Safety considerations" section mentions compliance with standards related to acoustic output limits, but these are general safety standards, not performance acceptance criteria for diagnostic accuracy.
What can be extracted directly (or inferred) from the provided text:
- Device Name: SonixTABLET Ultrasound Scanner
- Predicate Devices: Sonix Ultrasound Scanner (K093462), Sonix TOUCH Ultrasound Scanner (K083095), SONIX MDP Ultrasound Scanner (K080935)
- Reason for Submission: New product clearance for SonixTABLET Ultrasound Scanner and supporting transducers, due to a name change request and new product clearance.
- Technological Characteristics: Substantially similar to predicate devices, using piezoelectric material, yielding real-time ultrasound images, and having similar modes (2D, PW Doppler, Color Flow Mapping Doppler, Power Doppler, Continuous Wave Doppler).
- Key Safety Standards: IEC 60601-1, IEC 60601-1-2, AIUM AOL, AIUM RTD1-2004, UD-3 of NEMA, and FDA's 510(k) Diagnostic Ultrasound Guidance regarding acoustic output.
- Acoustic Output Limits (reported performance in relation to safety standards):
- ISPTA (d): 720mW/cm²
- TIS/TIB/TIC: 0.1 - 4.0 (Range)
- Mechanical Index (MI): 1.9 (Maximum)
- ISPPA (d): 0-700W/cm² (Range)
- These limits are stated to be the same as predicate Track 3 devices.
Summary of Information NOT found in the provided text:
- A table of acceptance criteria and the reported device performance (in terms of diagnostic accuracy/efficacy). The document focuses on performance relative to safety standards and equivalence to predicates, not specific diagnostic accuracy metrics.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance. (This device is an ultrasound scanner, not an AI or CADe/CADx device mentioned in this context.)
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. (Again, not an AI device.)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set. (Not an AI device with a training set in the typical sense).
- How the ground truth for the training set was established. (Not an AI device with a training set in the typical sense).
Essentially, the provided document is a regulatory submission for substantial equivalence of an ultrasound device, which doesn't typically require the detailed performance study information you've requested for AI/CADx/CADe devices.
§ 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.