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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 Visions PV 8.2F catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Visions PV 8.2F ultrasound imaging catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

The Visions PV 8.2F catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and defects the subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels. The Visions PV 8.2F catheter utilizes an internal lumen that allows the catheter to track over the 0.038" (0.97 mm) guide wire. The Visions PV 8.2F catheter is introduced percutaneously or via surgical cutdown into the vascular system.

The provided text is a 510(k) summary for the Volcano Corporation Visions® PV 8.2F Intravascular Ultrasound Imaging Catheter. It focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics, intended use, and performance data from internal testing.

Therefore, the document does not contain the information required to populate the fields related to acceptance criteria, specific study designs (like MRMC or standalone), ground truth establishment, sample sizes for test/training sets, or expert qualifications.

The text states:

• Performance Data: "Applicable testing was performed in accordance with the Validation Test Report and the Risk Analysis was reviewed to assess the impact of the change in materials to the device. The new material was tested for biocompatibility according to ISO 10993-1 and the results met the acceptance criteria. Shelf life testing of the device was performed due to this change in materials."
• Conclusion: "The Visions PV8.2F Intravascular Ultrasound Imaging Catheter has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device... Modifications to the device do not raise any new questions regarding safety or efficacy. The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence of the subject device to the predicate device."

This indicates that internal validation and risk analysis were performed, and biocompatibility and shelf-life tests met "acceptance criteria." However, the specific metrics for these acceptance criteria or the detailed results (beyond "met the acceptance criteria") are not provided.

Based on the provided text, the requested table cannot be fully completed, and most of the specific study details are not available.

Here's a breakdown of what can be inferred or what is explicitly missing:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The text only mentions "Applicable testing was performed" for biocompatibility and shelf life. There is no mention of a "test set" in the context of imaging performance, as this submission is for minor material and shelf-life changes to an already cleared device.

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)

• Not applicable/Not provided. Ground truth establishment for imaging performance is not described, as the submission focuses on substantial equivalence for material/shelf-life changes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided.

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. This is a 510(k) for an intravascular ultrasound catheter, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided in the context of imaging performance. For biocompatibility, the ground truth would be established by the ISO 10993-1 standard. For shelf-life, it would be stability data over time.

8. The sample size for the training set

• Not applicable/Not provided. This is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not applicable/Not provided.

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