(49 days)
The ExactVu High Resolution Micro-Ultrasound System is intended for use by qualified medical professionals for diagnostic ultrasound imaging or fluid flow analysis of the human body. The indications for use are:
Small Organ (prostate) Transrectal
The system may be used with patients of all ages, but is not designed for pediatric or fetal use.
The ExactVu high resolution micro-ultrasound system is intended for use by qualified medical professionals for diagnostic ultrasound imaging, data processing and guidance of puncture and biopsy. The ExactVu System comprises transducers responsible for ultrasound signal generation and recording, needle guides and a main unit that controls the transducers, processes the acoustic data, and processes and displays images.
The provided text does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria with performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to various safety and performance standards.
However, based on the information provided, here's a breakdown of what can be inferred and constructed:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the nature of the submission (510(k) for an ultrasound system) and the provided text, the "acceptance criteria" appear to be compliance with relevant safety and performance standards, and comparison to existing legally marketed devices. As no specific performance metrics are given in the provided text, the table is structured to reflect this.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Electrical Safety | Conformance to IEC 60601-1 (general requirements for basic safety and essential performance of medical electrical equipment). | The device (ExactVu System) has been evaluated for electrical safety and found to conform to IEC 60601-1. This compliance was verified through independent evaluation. |
| Thermal Safety | Conformance to relevant standards for thermal safety. | The device has been evaluated for thermal safety. |
| Mechanical Safety | Conformance to relevant standards for mechanical safety. | The device has been evaluated for mechanical safety. |
| EMC Safety | Conformance to IEC 60601-1-2 (Electromagnetic compatibility). | The device has been evaluated for EMC safety and found to conform to IEC 60601-1-2 (Edition 3). |
| Acoustic Output | Conformance to NEMA UD 2-2004 (Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment) and NEMA UD 3-2004 (Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices). | Acoustic output has been evaluated, and the device found to conform to applicable mandatory medical device safety standards, including NEMA UD 2-2004 and NEMA UD 3-2004. |
| Biocompatibility | Conformance to AAMI/ANSI/ISO 10993-1 (Biological evaluation of medical devices). | All patient contact materials are biocompatible and either used in other legally marketed devices or meet ISO 10993-1. |
| Cleaning/Disinfection | Conformance to relevant standards for cleaning and disinfection. | Cleaning/disinfection has been evaluated. |
| Software Verification | Comprehensive software verification as part of product development. | Assurance of quality was established by employing elements of product development including System and Software Verification. |
| Performance Equivalence | Substantial equivalence to the predicate device (ExactVu 1.0, K162972) in terms of intended use, indications for use, modes of operation, MI/TI indications, center frequency range, transducer types, and measurements. | The subject device (ExactVu 2.0) is substantially equivalent to its predicate device (ExactVu 1.0, K162972) with the same fundamental scientific technology and general ultrasound principles, and both are Track 3 devices. Differences in DICOM and MRI fusion capabilities are noted, and compared to a reference device (TRINITY/3D-PROSTATE SUITE, K170521). |
| Track Device Status | Classification as a Track 3 device. | Both the subject device and the predicate device are Track 3 devices. |
| Quality System | Manufacturing under an ISO 13485 quality system. | The device is manufactured using the same ISO 13485 quality system as the predicate. |
2. Sample size used for the test set and the data provenance:
The document explicitly states: "The ExactVu System, transducers and needle guides, subject of this submission, did not require clinical studies to support the determination of substantial equivalence. An analysis of clinical literature, adverse event and recall data is provided in the clinical evaluation justifies the safety and efficacy of the functionality of the ExactVu device without pre-market clinical investigation."
Therefore, no specific test set or clinical study data (including sample size or data provenance) is provided for the subject device (ExactVu 2.0) in this submission. The determination of substantial equivalence relies on non-clinical tests and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
As per point 2, no specific clinical test set was used to establish ground truth because clinical studies were not required for this submission.
4. Adjudication method for the test set:
As per point 2, no specific clinical test set was used, so no adjudication method is described.
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:
No MRMC comparative effectiveness study was done, nor is there any mention of AI assistance in improving human reader performance. The submission is for an ultrasound system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This submission is for an ultrasound imaging system, which inherently involves human operation and interpretation. There is no mention of a standalone algorithm or AI performance.
7. The type of ground truth used:
Given the absence of clinical studies for this submission, the "ground truth" for demonstrating safety and effectiveness relied on:
- Conformance to recognized industry standards: (e.g., IEC 60601-1, ISO 10993-1, NEMA UD 2 & 3). Third-party testing and certification against these standards serve as the "ground truth" for the device's adherence to established safety and performance benchmarks.
- Substantial equivalence to a legally marketed predicate device: The predicate device (ExactVu 1.0, K162972) implicitly provides the "ground truth" of a device that has already been deemed safe and effective for its intended use. The submission argues that the new device is sufficiently similar to share this established safety and effectiveness profile.
8. The sample size for the training set:
Not applicable. There is no mention of machine learning or AI components requiring a training set in this submission.
9. How the ground truth for the training set was established:
Not applicable. As no training set is mentioned (see 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.