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The Site-Rite Vision™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Fetal Abdominal Intraoperative (semi-critical†) Pediatric Peripheral Vessel Small Organ (breast, thyroid, parathyroid, testicles, prostate, uterus, ovary) Musculo-skeletal (conventional and superficial) Cardiac (adult and pediatric) Typical examinations performed using the Site-Rite Vision™ Ultrasound System include: Vascular Assessment of carotid arteries, aorta, deep veins, superficial veins in the arms and legs, select small vessels supporting organs Vascular Access Guidance for PICC, CVC, dialysis catheter, port, PIV, and arterial line placement, and peripheral vein and artery access Abdominal Assessment of liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal vessels, appendix, and surrounding anatomical structures Interventional and Intraoperative Guidance for biopsy, drainage, peripheral nerve blocks, and intraoperative procedures (semi-critical†) Superficial Assessment of breast, thyroid, testicle, lymph nodes, hernias, musculo-skeletal procedures, soft tissue structures, and surrounding anatomical structures

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This document describes the Site-Rite Vision™ Ultrasound System and its indications for use. It's a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices, rather than establishing new performance criteria through clinical trials. Therefore, a study proving the device meets acceptance criteria as typically understood for a new diagnostic or AI-driven aid is not included.

Based on the provided text, the "acceptance criteria" here refer to the range of clinical applications and imaging modes for which the device is cleared, and its performance is considered substantially equivalent to existing, legally marketed ultrasound systems.

Here's the information extracted from the document, tailored to your request about acceptance criteria and study data where applicable within the context of a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an ultrasound system, the "acceptance criteria" are the broad range of clinical indications and imaging modes for which the device is deemed safe and effective, based on substantial equivalence to predicate devices. The "reported device performance" is implicitly that it functions comparably to these predicate devices for the listed applications.

Note: The "N" in the tables indicates a "new indication" for the specific predicate device comparison, implying that while it might not have been on that specific predicate, it is being cleared based on substantial equivalence within the broader class of ultrasound devices for these applications. The "P" (previously cleared by FDA) and "E" (added under this appendix) are not explicitly marked for individual modes in the provided tables, but are mentioned in the legend.

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

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. It does not present a clinical study with a "test set" in the sense of a new clinical trial designed to evaluate specific numerical performance metrics (e.g., sensitivity, specificity, accuracy). Therefore, there is:

• No specified sample size for a test set.
• No data provenance (country of origin, retrospective/prospective) for a performance study, as such a study is not detailed here. The submission relies on existing knowledge and performance of predicate devices.

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

Since no new clinical study with a "test set" requiring ground truth establishment is detailed here, this information is not applicable (N/A) to this 510(k) submission.

4. Adjudication Method for the Test Set

As no "test set" and corresponding ground truth establishment is described, an adjudication method is not applicable (N/A).

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or detailed in this 510(k) summary. This type of study would typically be conducted to evaluate the improvement in human reader performance with or without AI assistance, which is outside the scope of this ultrasound system's 510(k) submission, as it is a device for direct imaging, not an AI-assisted diagnostic algorithm.

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

No, a standalone performance study of an algorithm without human-in-the-loop performance is not described. The Site-Rite Vision™ is an ultrasound imaging system, not an autonomous algorithm.

7. The Type of Ground Truth Used

For a 510(k) clearance based on substantial equivalence, the "ground truth" is inherently tied to the established safety and effectiveness of the predicate devices that have already been cleared by the FDA for similar indications. The application argues that the new device performs comparably to these already-approved devices, therefore, its "ground truth" is implied by the FDA's previous clearances for the predicates. No new "ground truth" (e.g., pathology, outcomes data) was specifically generated for this submission in a new clinical study.

8. The Sample Size for the Training Set

As this is a traditional ultrasound system and not an AI/ML-driven device requiring a training set, the concept of a "training set" does not apply.

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

As explained above, there is no training set for this type of device, so establishing its ground truth is not applicable.

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