(142 days)
The Accuro is intended for diagnostic ultrasound imaging of the human body in the following clinical applications: Abdominal, Musculoskeletal (conventional and superficial), Cardiac, Peripheral Vascular, Small Organs (e.g. thyroid, breast), and Pediatrics. A typical examination using the Accuro is guidance of neuraxial anesthesia.
The Accuro is a hand-held device that features real-time B-mode ultrasound imaging only. Additional features include a compact size and a simple user interface.
This document describes a 510(k) premarket notification for the "Accuro" ultrasonic pulsed echo imaging system. The submission expands the indications for use of a previously cleared device (Accuro 3000 Ultrasound Scanner, K132736). As such, the information provided focuses on the safety and performance validation against standards rather than a clinical study evaluating diagnostic accuracy with acceptance criteria.
Key takeaway: This 510(k) submission primarily focuses on expanding the indications for use of an existing device and demonstrates substantial equivalence through adherence to recognized standards and safety testing, rather than presenting a clinical study with specific diagnostic performance acceptance criteria. Therefore, many of the requested data points related to clinical study design (sample size for test set, expert ground truth, MRMC, etc.) are not explicitly available in this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are not in the form of diagnostic accuracy metrics (e.g., sensitivity, specificity) for a clinical algorithm. Instead, the device's performance is demonstrated through adherence to various international and national safety and performance standards for medical electrical equipment and diagnostic ultrasound.
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance |
|---|---|
| IEC60601-1:2005 (Medical Electrical Equipment - General Requirements for Safety and Essential Performance) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| IEC60601-1-2:2007 (Medical Electrical Equipment - General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| IEC60601-2-37:2007 (Medical Electrical Equipment - Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| ISO14971:2007 (Application of risk management to medical devices) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| NEMA UD-2:2004 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| NEMA UD-3:2004 (Standard for Real-Time Display of Thermal and Mechanical Acoustic Output indices on Diagnostic Ultrasound Equipment) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
| ISO 10993-1: (Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing Within a Risk Management Process) | "Verification and Validation activities were designed and performed to demonstrate that the Accuro met pre-determined performance specifications." (Implies compliance) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. The filing refers to "Verification and Validation activities" and "in-house protocols" but does not detail a clinical test set size, nor the provenance (country of origin, retrospective/prospective) of any data used for such testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text. As the submission focuses on standard compliance and expanded indications for an existing device rather than a new diagnostic accuracy study, the establishment of ground truth by clinical experts is not mentioned.
4. Adjudication Method (for the test set)
This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on the device's technical characteristics, safety, and performance standards adherence for expanding its indications of use.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "Accuro" is described as a "hand-held device that features real-time B-mode ultrasound imaging only." It is a diagnostic ultrasound system intended for use by a human operator for image guidance and diagnosis. It does not appear to be an AI algorithm with standalone performance, but rather a tool to be used by a clinician. Therefore, a standalone algorithm performance study as typically understood for AI/ML devices is not applicable and not mentioned.
7. The Type of Ground Truth Used
The text does not specify the type of ground truth used, as it does not detail a clinical study with diagnostic accuracy endpoints. The "ground truth" in the context of this submission would likely relate to the accurate measurement of physical parameters for the engineering validation required by the listed standards (e.g., acoustic output, electromagnetic compatibility, image quality phantoms).
8. The Sample Size for the Training Set
This information is not applicable/provided. The Accuro is an ultrasound imaging device, not an AI/ML algorithm that typically requires a large training set of clinical data. The "training" for such a device would involve its design and calibration against engineering specifications, not statistical learning from a dataset.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the same reasons as point 8.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.