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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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The Accuro 3S is a diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. Accuro 3S is intended to be used in a hospital or medical clinic environment at the point of care.

Accuro 3S supports B-mode imaging and a SpineNav-AI™ image processing software. Accuro 3S clinical applications include: musculoskeletal conventional and superficial, and guidance for needle or catheter placement. A typical examination using Accuro 3S is guidance of neuraxial anesthesia.

The Accuro® 3S is an ultrasound imaging device intended for use by qualified and trained healthcare professionals in hospital or medical clinic environments. The device offers B-mode imaging and a SpineNav-AI™ image processing software.

The Accuro 3S is a portable system with a small footprint that can be easily maneuvered within the intended use environment and at the point of care. The device features a touchscreen interface and articulated monitor arm to optimize viewing angle. An integrated battery pack allows the system to operate without wall power. Accuro 3S interfaces with healthcare IT networks to implement DICOM-based patient and image archival workflows, with image storage in an external PACS. The device utilizes a Dual-Array™ convex probe.

SpineNav-AI is an automated software tool that utilizes machine learning technologies to facilitate workflows associated with musculoskeletal imaging assessments of the lumbar spine.

The Accuro 3S Dual-Array probe comprises a side-by-side convex transducer array design. Each convex array has identical specifications: 64 elements, 3.5 – 4.0 MHz nominal center frequency, 480-micron pitch, and 50 mm radius of curvature.

Here's a breakdown of the acceptance criteria and the study that proves the Accuro 3S device meets them, based on the provided FDA 510(k) clearance letter.

Important Note: The provided document is an FDA 510(k) clearance letter, not a detailed study report. Therefore, some information, especially regarding the specifics of the AI study design (e.g., adjudication method beyond concensus, full statistical analysis of MRMC), is inferred or not explicitly stated in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document states that "success criteria for each anatomical annotation produced with SpineNav-AI were derived via a preliminary survey with intended users." For the Epidural Region Indicator's accuracy, specific numerical acceptance criteria are not explicitly stated in the same manner as the per-frame and per-sequence detection rates. The reported values are presented as the results of the evaluation against the radiologist panel ground truth.

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

• Sample Size (Test Set): 120 sequences and 10,080 image frames obtained from a total of 81 individuals.
• Data Provenance:
  • Country of origin: Not explicitly stated, but collected at "seven (7) geographically diverse sites," implying multi-site collection.
  • Retrospective or Prospective: Not explicitly stated, but the description of "test dataset comprising a diverse range of demographic variables" and being "collected at seven (7) geographically diverse sites" suggests data collected specifically for this validation, making it likely prospective or a carefully curated retrospective collection. The phrase "completely distinct from the test dataset used for validation" for the training data further supports the idea of a dedicated test set.

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

• Number of Experts: Three board-certified radiologists.
• Qualifications: "Board certified radiologists." No specific years of experience or subspecialty are detailed beyond board certification.

4. Adjudication Method for the Test Set

• Adjudication Method: The ground truth for anatomical labels was "established from a panel of three board certified radiologists." This strongly implies a consensus method where the three radiologists collectively determined the ground truth. The specific nature of how disagreements were resolved (e.g., majority vote, discussion-based consensus, or presence of a tie-breaker) is not explicitly detailed but falls under a consensus approach. It is not a 2+1 or 3+1 setup, but rather a direct panel consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, an MRMC comparative effectiveness study was not explicitly stated as having been done. The study focuses on the standalone performance of the AI against expert ground truth. Assistance to human readers is not mentioned as part of the validation design.
• Effect size of improvement: Not applicable, as an MRMC study comparing human readers with and without AI assistance was not described.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes. The "AI Summary of Tests" section exclusively describes the performance of the SpineNav-AI™ software tool against ground truth established by experts, without human intervention or interaction. Metrics like per-frame accuracy, per-sequence detection success rate, and DICE scores are typical for standalone algorithm performance evaluation.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert Concensus. The ground truth for anatomical labels was "established from a panel of three board certified radiologists." This means the truth was defined by the agreement of multiple human experts.

8. Sample Size for the Training Set

• Sample Size (Training Set): 25,536 images from 147 subjects.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: The document states that the training data and test data are "completely distinct." While it explicitly mentions how ground truth was established for the test set (panel of three board-certified radiologists), it does not explicitly state how the ground truth for the training set was established. It is a common practice for training data ground truth to also be established by experts, potentially with varying levels of expert involvement or adjudication compared to a highly scrutinized test set, but this specific detail is not provided in the submitted text.

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