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The VascuView TAP Ultrasound System with probe Model #HL.7.5/40/64D is intended for diagnostic imaging of the human body for the following clinical applications, as illustrated in the Diagnostic Indications for Use Form which can be found in Attachment 5A: Pediatric, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Peripheral Vessels which include Intra-Venous and Perioherally-Inserted Central Catheters, as well as vascular structures and surrounding vascular regions such as nerve bundles and various structures for free hand placement of needles/catheters. The VascuView TAP Ultrasound System is not intended for fetal or ophthalmic applications.

The VascuView TAP Ultrasound System is a high-frequency ultrasonic imaging system intended to be used for assisted vascular access of veins and arteries, in addition to other vascular access applications such as the real-time viewing of perigheral vascular structures and their surrounding regions in order to provide quidance for the placement of needles and catheters within these structures. The system software runs on Windows XP Professional Operating System and utilizes features of the Windows interface to direct the operation of the system and maintain patient records; providing a user-friendly environment for clinical applications. The VascuView TAP System consists of the following components:

• UL and TUV 60950 Approved Tablet PC with Integrated Outer Enclosure . A Kiosk tablet oc is provided with a UL approved Medical-grade power supply and Medical-grade power cord. The VascuView TAP ultrasound system consists of an integrated carrying handle. probe holder, cord wrap, table stand, and shock absorbent corner bumpers. The pc includes a large 12.1" TFT XGA LCD wide angle display which facilitates an intuitive touch screen control interface with clear-cut functionality and preset settings to ameliorate image optimization. Additionally, the oc provides for the operation of the software, as well as the storage of archived images and video clips.
• . Ultrasound Beam-former PCB with 64-element Linear Array Probe The handheld ultrasound probe Model #HL7.5/40/64D and beam-former PCB consists of a sixtyfour element pulsed linear array capable of capturing both images and videos in four different modes of operation: B-Mode, Split Screen Dual B-Mode, Color Doppler (CFM), and B-Mode with Doppler (PWD). The probe is connected to the pc via the included SCSI cable and operates within a frequency range of 5MHz -- 10MHz, which allows for the visualization of surface vessels at scan depths up to 9cm. The transducer material is made of a gold plated polymer membrane and a biocompatible nose cone sufficient for its use (Silicon).
• . VascuView TAP System Software
  All features and controls of the system are provided for in the VascuView TAP software which comes pre-loaded onto the tablet pc. The software uses an icon-based interface whereby the user can select any of the primary functional screens at any time by clicking on an icon located on the screen, for that function. The software enables ultrasound image storage and display, measurement functions, enhancements, and printing. All parameters within the hard-coding of the VascuView TAP software program are fixed, therefore the user cannot make any adjustments to the operation of the transducer that will have an effect on the radiated field (i.e. center frequency, aperture, focus, field of view, sample rate, etc.)

Here's an analysis of the provided text regarding the VascuView TAP Ultrasound System, focusing on acceptance criteria and the study proving its performance.

Overview:

The provided document is a 510(k) summary for the VascuView TAP Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices (SONOACE PICO and SonoSite® iLook 25) rather than presenting a novel clinical study with new acceptance criteria. The performance data discussed is non-clinical for safety and measurement accuracy, and no clinical performance data was submitted. Therefore, many of the requested sections about clinical study design (sample size, experts, ground truth, MRMC, standalone performance, training set) will not be applicable or directly addressed in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are primarily regulatory compliance and demonstration of similar technical characteristics and performance to predicate devices. There are no explicit clinical performance metrics (e.g., sensitivity, specificity) with associated acceptance thresholds provided as would be typical for a de novo device or a device claiming superior performance.

• Intended for Pediatric, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Peripheral Vessels (including IV and PICC), and guidance for needle/catheter placement.
• Similar clinical applications to predicate devices.
• Probe: 64-element linear array, 5MHz-10MHz frequency range, scan depths up to 9cm. |
  | Equivalent Measurement Accuracy | Measurement accuracy confirmed via a measurement validation test protocol using an ATS model 539 phantom with 0.7 dB/cm-MHz attenuation. (Specific accuracy metrics are not provided in this summary but the test was performed). |
  | Software Validation | Software validated using a test protocol. (Details of validation metrics are not provided in this summary). |
  | Overall Safety and Effectiveness | "the VascuView TAP system has demonstrated that it is as safe, as effective, performs as well as or better than the predicate devices, and includes similar design characteristics and intended use. Furthermore, based on the comparison with the predicate devices... the Escalon Vascular Access VascuView TAP ultrasound system is deemed to be substantially equivalent to the proposed predicate devices." (Conclusion based on non-clinical data and comparison, not new clinical trial data). |

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

• Sample Size: Not applicable for a clinical test set, as no clinical performance data was submitted.
• Data Provenance: The document only mentions "Non-Clinical Performance Data" and "Measurement Accuracy Validation Report" using an "ATS model 539 phantom." This indicates engineered phantom data rather than patient data.

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

Not applicable. No clinical ground truth was established from experts for this 510(k) submission, as no clinical performance data was submitted. The non-clinical measurement accuracy used a phantom as ground truth.

4. Adjudication Method for the Test Set

Not applicable. No clinical adjudication method was used, as no clinical performance data was submitted.

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

Not applicable. No MRMC study was conducted or reported. This device is an ultrasound system intended for direct use by clinicians, not an AI-assisted diagnostic tool for image interpretation by readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is an ultrasound imaging system, not an AI algorithm. Its "performance" involves generating images for human interpretation and use in vascular access guidance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance data:

• The ground truth for measurement accuracy was an "ATS model 539 phantom with 0.7 dB/cm-MHz attenuation." This is a controlled, engineered standard for ultrasound measurement.
• The "software has been also been validated using a test protocol," suggesting internal testing against expected software functionality, but specific ground truth types are not detailed.

8. The Sample Size for the Training Set

Not applicable. The device is an ultrasound imaging system, not a machine learning model that requires a training set in the conventional sense. Software validation would involve testing against requirements, but not "training data."

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

Not applicable, as there is no training set for an AI model. For the non-clinical validation, the "ground truth" for measurement accuracy was inherent in the phantom used.

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