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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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The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.

Electromagnetic tracking tool kit works in conjunction with images gathered by OEM imaging devices to provide physicians with a tool for image registration and/or tracking of instruments. This is accomplished by utilizing attachment brackets, needle guides, adhesive skin markers or fiducial markers, needles and other housings that are specially configured to contain an electromagnetic sensor. The electromagnetic sensor in the tracked instrument is used within an EM field introduced by OEM equipment. The position and orientation can be thus detected and combined with the acquired imaging to assist with navigating a tracked instrument. The system also utilizes accessories in conjunction with the system to allow the users additional options for protecting the equipment from contamination, needle guidance, and image registration.

The provided text describes a 510(k) summary for an Electromagnetic Tracking System. However, it does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or performance data.

The document primarily focuses on:

• Intended Use: Electromagnetic tracking of instruments with respect to image data.
• Device Description: EM sensor within tracked instruments, used with OEM imaging devices, and various accessories (EMT sensor covers, EMT slot guide, skin markers).
• Predicate Devices: A list of previously cleared devices to which the current device claims substantial equivalence.
• Substantial Equivalence Claim: Based on equivalent intended uses, manufacturing materials, operating principles, and physical/operational specifications compared to predicate devices, with the only noted difference being qualification with the GE Logiq E9 system.
• FDA Clearance Letter: Confirming the 510(k) clearance and regulatory details.
• Indications for Use: Reiterating the intended use.

Therefore, I cannot provide the requested table and study details as they are not present in the input text. The document states that "There are no significant differences between the proposed and predicate devices except that they have now been qualified with the GE Logiq E9 system," which implies that the substantial equivalence argument, rather than a new performance study against specific acceptance criteria, was the primary basis for clearance.

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ABARIS is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Position Emission Tomography (PET), Single Photon Prosonan Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target psy noeans, guidewire and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-onerative guidant for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.

The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to ano inchier.

The ABARIS is a computer assisted, image guided surgery system. It guides a surgical instrument to a target that has been defined by the physician. The target can be indicated either preoperatively or intraoperatively using images or relative to an indicated position on the patient.

The ABARIS provides real-time, three-dimensional visualization and navigation tools for all stages of surgery including preoperative planning and intra-operative navigation. ABARIS transforms two-dimensional patient images (scan sets), derived from Computed Tomography (CT), Magnetic Resonance Imaging (MR), Position Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Ultrasound (US), Fluoroscopy etc. into dynamic representations on which a tool can be navigated. The system performs spatial mapping from one inage space to another image space or from image space to physical space ("vegistation") allowing the physician to correlate scan sets with each other and to the patient The system facilitates minimally invasive surgical procedures. Like other commercially available image guided surgery systems, the ABARIS also offers computer assisted image-free and registration free navigation using the same instrumentation.

Targeted use areas for ABARIS include hospital operating rooms, outpatient surgery centers and procedure rooms.

The K053610 submission for ABARIS describes a computer-assisted image-guided surgery system. The submission does not contain a study to prove acceptance criteria in the format requested. Instead, it relies on substantial equivalence to predicate devices. It states that "The technological characteristics of the ABARIS are the same or similar to those found in the predicate devices."

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The submission is a 510(k) premarket notification, which often demonstrates substantial equivalence rather than presenting new clinical study data with explicit acceptance criteria. The FDA's letter (APR 19 2006) confirms this by stating, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".

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The UltraGuide USG 2000sa system is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system.

The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.

The UltraGuide USG 2000sa provides visual enhancement of the interventional needle by overlaying the image of the insertion device and its predicted future path on the ultrasound scan image of the internal organs, all displayed on the monitor of a personal computer.

The device uses magnetic transmitters and receivers, sold under the trade name "PC Birds," to determine the location and orientation of the interventional needle. These devices have been used on medical devices cleared by the FDA. The positions and orientations of the interventional device and the video of the US image, are transmitted to a Personal Computer, which makes the necessary calculations to provide the overlay of the video image and the interventional device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the UltraGuide USG 2000sa device:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document is a 510(k) summary for a medical device cleared in 2002. At that time, explicit quantifiable acceptance criteria (e.g., specific accuracy metrics, sensitivity, specificity) for device performance as we often see in modern submissions were not always explicitly stated or required in the same way for "substantial equivalence" claims. The focus here is on demonstrating equivalence to a legally marketed predicate device.

2. Sample Size Used for the Test Set and Data Provenance

No specific test set or sample size for a clinical study is mentioned. The submission states, "Since this system uses the same technology as the predicate device, a clinical test is not necessary." This indicates that no new clinical data was generated for the USG 2000sa for its 510(k) clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable, as no new clinical test set was used for the submission.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "a clinical test is not necessary."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is described as enhancing the ultrasonic image and predicting the needle path for display on a computer monitor. This implies a human-in-the-loop interaction, where the user interprets the enhanced image. A standalone (algorithm-only) performance evaluation, separate from human interaction, is not indicated or discussed for this type of device. The clearance is based on the technology being equivalent to a predicate, not on a new standalone performance claim.

7. The Type of Ground Truth Used

No new ground truth from clinical data was established for the USG 2000sa's 510(k) clearance. The basis for safety and efficacy was the substantial equivalence to the predicate device, UltraGuide 1000. For the bench tests, the "ground truth" would have been established by engineering standards for electrical safety and electromagnetic compatibility rather than medical ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that typically requires a large training set in the modern sense. Its function relies on established physical principles of magnetic tracking and visual overlay, rather than learning from a large dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention or implication of a training set for an AI/ML model.

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