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The Sonix 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.

The system also provides the ability to measure anatomical structures (fetal, abdominal, pediatric, small organ, cardiac, transvaginal, peribheral 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 Morde, 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 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.

I am sorry, but the provided text does not contain specific acceptance criteria, study details, or performance metrics for the Sonix Ultrasound Scanner as you requested. The document is primarily a 510(k) summary for premarket notification, focusing on:

• Device Description: General features and function of the ultrasound system and its accessories.
• Intended Uses: A broad list of clinical applications for the system and various transducers.
• Comparison to Predicate Devices: Establishing substantial equivalence based on intended use, principles of operation, and technological characteristics.
• Safety Considerations: Compliance with general safety standards and acoustic output limits.
• Transducer Specifications: Detailed tables outlining the modes of operation and new/previously cleared indications for each transducer.

There is no mention of:

• Specific acceptance criteria (numerical thresholds for performance).
• Any particular study (e.g., clinical trial, bench study with performance data) to prove device meets acceptance criteria.
• Sample sizes used for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications to establish ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth was established for the training set.

The document highlights the device's compliance with general safety and acoustic output standards, but these are not presented as performance acceptance criteria in the context of clinical efficacy or diagnostic accuracy.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

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