(95 days)
Exo Iris is indicated for use by qualified and trained healthcare professionals in environments where healthcare is provided to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients for the following clinical applications: Peripheral Vessel (including carotid, deep vein thrombosis and arterial studies), Small Organ (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial). Modes of operation include: B-mode, B-mode + Color Doppler.
Exo Iris is a hand-held, general purpose diagnostic imaging system used to enable visualization of anatomical structures and fluid of adult and pediatric patients. The system is intended to be used by trained healthcare professionals.
The system generates 2D images using a single ultrasound transducer with broad imaging capabilities. The images are displayed on a commercial off-the-shelf mobile device (iPhone) by means of a proprietary mobile application (Exo Iris app) provided by Exo Imaging. Images can be displayed in the following modes: B-Mode, B-Mode + Color Doppler.
The mobile application's user interface includes touchscreen menus, buttons, controls, indicators, and navigation icons that allow the operator to control the system and to view ultrasound images.
This document is an FDA 510(k) clearance letter for the Exo Iris Ultrasound System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report on acceptance criteria for an AI/ML-driven device.
Based on the provided text, the Exo Iris is a general diagnostic ultrasound system, not explicitly described as having integrated AI/ML functionality that would necessitate specific performance studies for AI/ML algorithms. The letter states "Clinical data were not required for this type of device." and "Software testing, consisted of verification and validation testing including test cases related to off the shelf software, as well as cybersecurity features." This suggests the software component is more for device control and data display rather than for diagnostic AI/ML algorithms.
Therefore, many of the requested details regarding AI/ML study components (such as expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not present in this document because the device, as described for this 510(k), does not appear to involve a diagnostic AI/ML algorithm requiring such evaluations.
However, I will extract and present the information available regarding acceptance criteria and performance data for the device itself, acknowledging that it's from a device safety/performance perspective rather than an AI/ML algorithm's diagnostic performance.
Acceptance Criteria and Device Performance (as per general device clearance):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety | Yes, compliant with applicable electrical safety standards (IEC 60601-1, IEC 60601-1-2) |
| Mechanical Safety | Meets mechanical safety standards for a Class II medical device |
| Biocompatibility | Yes, compliant with ISO 10993 |
| Acoustic Output | Compliant with NEMA UD-2 and applicable FDA Guidance |
| Software Functionality | Verification and validation testing, including test cases related to off-the-shelf software and cybersecurity features, demonstrated meeting predetermined acceptance criteria. |
| Risk Management | Potential risks identified per ISO 14971, analyzed, mitigations implemented and tested. All risk mitigations satisfactorily verified and validated. |
| Design Control | All specifications verified and validated per company's Design Control Process (in compliance with 21 CFR Part 820.30); results demonstrated predetermined acceptance criteria were met. |
| Substantial Equivalence | Demonstrated substantial equivalence to the predicate device (Butterfly iQ Ultrasound System, K202406) based on indications for use and technological characteristics. |
Information NOT Available in the Document (due to the nature of the device and submission):
As the document indicates, clinical data were not required for this type of device, and the focus is on device safety and operational performance compared to a predicate, not AI/ML diagnostic performance. Therefore, the following are not applicable or not provided:
- Sample size used for the test set and the data provenance: Not applicable for a standalone AI/ML performance study as this device is a general diagnostic ultrasound system. Device testing involved bench testing and software verification, not a clinical test set of images for an AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no AI/ML specific diagnostic test set requiring expert ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what is present:
The document describes the regulatory clearance for a diagnostic ultrasound system (Exo Iris). The performance data presented are primarily technical and safety verifications required for medical devices (electrical safety, mechanical safety, biocompatibility, acoustic output, software functionality, and risk management) to demonstrate substantial equivalence to a predicate device, rather than the performance of a diagnostic AI/ML algorithm.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.