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The Accuro® 3S Needle Guide Kit is intended to be used with the Accuro® 3S diagnostic ultrasound imaging system.

The Accuro® 3S Needle Guide Kit supports alignment of a needle with the ultrasound imaging plane to assist the healthcare professional in placing the tip of a needle relative to a specific anatomical structure. The elastic bands on the Patient Drape are intended to stabilize the positioning of the Accuro® 3S Needle Guide.

The Accuro® 3S Probe Cover sheathes the transducer and isolates a needle insertion site from microbial and other contaminants.

The Accuro® 3S Needle Guide Kit consists of the following single use sterile disposable components: Accuro® 3S Needle Guide with integrated probe cover, conductive ultrasound gel, and a patient drape with two integrated probe elastic bands.

The kit components are assembled into a sterilized CSR Wrap then packaged in a sterile tray.

The final kit is sterilized under ethylene oxide.

This document describes the FDA 510(k) clearance for the Accuro® 3S Needle Guide Kit. The clearance is based on a determination of substantial equivalence to a legally marketed predicate device (K171348 Pinpoint™ GT Needle Guide Kits), supported by non-clinical testing.

Here's an analysis of the provided text in relation to acceptance criteria and study details:

Key Takeaway Points from the provided text:

• Device: Accuro® 3S Needle Guide Kit (needle guide for ultrasound-guided procedures).
• Clearance Type: FDA 510(k) (Premarket Notification).
• Basis for Clearance: Substantial Equivalence to a predicate device (K171348 Pinpoint™ GT Needle Guide Kits).
• Key Difference from Predicate: Inclusion of a patient drape with elastic bands to stabilize the needle guide.
• Study Type: Primarily non-clinical benchtop testing and simulated use evaluations. No clinical studies were required or performed to support this 510(k) submission. This means the acceptance criteria and performance data are entirely based on non-clinical methods.

Given that no clinical studies were performed, and the evaluation focused on non-clinical testing to demonstrate substantial equivalence, several of the requested points related to clinical studies, human-in-the-loop performance, and expert ground truth cannot be answered from this document.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of non-clinical tests performed but does not explicitly list quantitative acceptance criteria with corresponding performance results in a structured table. It states that "Design functionality of the subject device was tested to ensure that it meets the requirements of the intended end users" and lists various tests without specifying the target values or the measured outcomes.

However, based on the non-clinical tests listed, we can infer the categories of acceptance criteria and the nature of the "reported device performance" (which is implied to be successful since clearance was granted).

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

• Sample Size for Test Set: The document does not specify the sample sizes used for each non-clinical test. It generally states that "Design functionality...was tested" and lists the types of tests (e.g., "Needle guide dimensions," "Needle angulation accuracy").
• Data Provenance: The studies were non-clinical benchtop testing and simulated use evaluations. The document does not explicitly state the country of origin for the data collection, but it is implied to be internal testing by Rivanna Medical, Inc. (located in Charlottesville, Virginia, USA). The studies were prospective in nature, designed specifically to support this 510(k) submission.

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

• Number of Experts: For the "simulated use evaluations," the document mentions evaluations "performed by representative end users." It does not specify the number or detailed qualifications of these representative end users.
• Qualifications of Experts: The term "representative end users" implies healthcare professionals who would typically use such a device (e.g., radiologists, interventionalists, nurses who perform ultrasound-guided procedures). However, specific qualifications (e.g., "radiologist with 10 years of experience") are not provided. Given the non-clinical nature, this would likely be an engineering/usability assessment by medical professionals rather than a clinical "ground truth" derived from patient data.

4. Adjudication Method for the Test Set

Since the studies were non-clinical benchtop and simulated use evaluations, the concept of an "adjudication method" as typically applied to human readers or clinical image interpretation (e.g., 2+1, 3+1 consensus) is not applicable. The "ground truth" for these tests would be established by engineering specifications, physical measurements, and direct observation of functionality and usability by testers.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The subject of this premarket submission, Accuro® 3S Needle Guide Kit, did not require clinical studies to support the determination of substantial equivalence." An MRMC study is a type of clinical study involving human readers.

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

• Not applicable. The Accuro® 3S Needle Guide Kit is a physical medical device (a needle guide and cover), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to evaluate.

7. The Type of Ground Truth Used

• Given that no clinical studies were performed, the "ground truth" was established through non-clinical methods:
  • Engineering Specifications/Benchtop Measurements: For tests like dimensions, force, angulation, and depth accuracy.
  • Simulated Use Observations: For usability, attachment durability, and general functionality assessments by "representative end users."
  • Adherence to Standards: For sterility, biocompatibility, and packaging integrity, the “ground truth” is compliance with, or passing, specified international standards (e.g., ISO 10993 series, ASTM standards).

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical kit, not an AI/ML algorithm or software that requires a "training set" of data.

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

• Not applicable. As above, there is no "training set" for this type of device.

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