(110 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), Procedural Guidance, Small Organ (including thyroid, scrotum and breast), Cardiac, Abdominal, Urology, Fetal/Obstetric, Gynecological, Musculoskeletal (conventional), Musculoskeletal (superficial) and Ophthalmic. Modes of operation include: B-Mode + Color Doppler, B-Mode + M-Mode.
The subject device, 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 imaqing capabilities. The imaqes 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, B-Mode+ M-Mode.
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.
The provided text does not contain detailed information about the acceptance criteria and study proving the device meets those criteria in a format that allows for a direct population of all the requested fields. The document primarily focuses on FDA 510(k) clearance, asserting substantial equivalence to a predicate device.
Here's an attempt to extract and infer information based on the text:
1. Table of acceptance criteria and the reported device performance
The document broadly states that "All specifications for Exo Iris have been verified and validated... and the results demonstrated that the predetermined acceptance criteria were met." However, it does not provide a specific table of acceptance criteria with corresponding performance results. Instead, it lists the standards against which testing was conducted.
| Acceptance Criteria Category (Inferred from standards) | Reported Device Performance (General Statement) |
|---|---|
| Electrical Safety (per ANSI/AAMI ES60601-1) | Compliant with applicable electrical safety standards |
| Electromagnetic Compatibility (EMC) (per IEC 60601-1-2, FCC Part 15) | Compliant with applicable EMC standards |
| Ultrasound Safety and Performance (per IEC 60601-2-37, NEMA UD-2) | Meets safety and performance requirements for ultrasonic medical diagnostic and monitoring equipment; Meets standard for acoustic output measurement |
| Biocompatibility (per ISO 10993) | Compliant with ISO 10993 |
| Software Life Cycle Processes (per IEC 62304) | Compliant with Medical Device Software - Software Life Cycle Processes |
| Design Control and Risk Mitigation (per 21 CFR Part 820.30, ISO 14971) | All design verification and validation activities performed; predetermined acceptance criteria met; all risk mitigations satisfactorily verified and validated. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No human clinical data is provided to support substantial equivalence."
Therefore, there is no information on a specific "test set" in terms of patient data. The performance evaluations were primarily through bench testing against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no human clinical data (and thus no ground truth derived from it) was used for substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human clinical data (and thus no adjudication of ground truth) was used for substantial equivalence.
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 study was done, as the submission explicitly states "No human clinical data is provided to support substantial equivalence." The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the context of this submission that would require demonstrating an improvement in human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the device itself as a diagnostic ultrasound system. Its performance evaluation was done through bench testing to ensure it meets technical standards, not as an algorithm performing standalone diagnostics on patient cases.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is derived from its ability to meet the technical specifications and requirements defined by the various industry standards mentioned (e.g., electrical safety, acoustic output, software quality). There is no "ground truth" related to disease detection or diagnosis established through expert consensus, pathology, or outcomes data in this submission.
8. The sample size for the training set
Not applicable. The document describes a diagnostic ultrasound system, not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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.