(144 days)
TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal，abdominal, pediatric , small organ，neonatal and adult cephalic, musculo-skeletal(Conventional and Superficial)，thoracic/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, Peripheral vessel and urology exams.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Modes of operation include: B, M, PWD, Color Doppler, Power Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI.
The TE Air Diagnostic Ultrasound System is a general purpose, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PWD, Color Doppler, Power Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI mode.
TE Air consists of an app which can be installed on iOS or Android devices, and probes which use wireless technology for communication. The iOS or Android devices could be mobile platform available from the market, or the Mindray's customized Android platform called AirSight.
This FDA clearance letter for the "TE Air Diagnostic Ultrasound System" (K250024) indicates a medical device rather than an AI-powered diagnostic system requiring specific performance metrics like sensitivity, specificity, or AUC. The clearance is based on substantial equivalence to a predicate device, focusing on similar technological characteristics and intended uses.
Therefore, many of the requested details about acceptance criteria, study design for performance, expert qualifications, and AI-specific metrics are not provided or applicable in this document.
Here's an assessment based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, the acceptance is based on:
| Acceptance Criteria Category | Reported Device Conformance/Performance |
|---|---|
| Technological Characteristics | - Similar to predicate device (TE Air K240906), including imaging modes (B, M, PWD, Color Doppler, Power Doppler, Combined mode, Tissue Harmonic Imaging, TDI). |
| - Acoustic power levels are below FDA limits, same as predicate. | |
| Intended Use | - Identical clinical indications for use as predicate (fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, musculo-skeletal, thoracic/pleural, adult and pediatric cardiac, peripheral vessel, urology exams). |
| Safety and Effectiveness Features | - Comparable to predicate device. |
| Non-clinical Testing | - Evaluated for acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical, and mechanical safety. |
| - Conforms to relevant medical safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, ISO 10993-1, IEC 62366-1, IEC 60601-1-6). | |
| Quality Systems | - Design, development, and quality process conform to 21 CFR 820, ISO 9001, and ISO 13485. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document describes the clearance of an ultrasound system, not an AI/ML-powered diagnostic algorithm that would typically require a test set of patient data to evaluate algorithmic performance. The clearance is based on equivalence to a predicate device and adherence to safety and performance standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As per point 2, there is no mention of a test set requiring expert-established ground truth for evaluating a diagnostic algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication related to diagnostic performance is detailed in this clearance letter.
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:
- Not Applicable. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant to this clearance document. The TE Air system is a general-purpose diagnostic ultrasound system that interfaces with mobile devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a general diagnostic ultrasound system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. Ground truth in the context of diagnostic performance evaluation for an algorithm is not mentioned, as this is a device clearance based on equivalence and safety standards.
8. The sample size for the training set:
- Not Applicable. There is no mention of an AI/ML algorithm or a training set for such an algorithm in this clearance document.
9. How the ground truth for the training set was established:
- Not Applicable. As per point 8, there is no mention of an AI/ML algorithm or a training set.
In summary:
The provided FDA clearance letter is for a "TE Air Diagnostic Ultrasound System" which is described as a general-purpose diagnostic ultrasound system. The clearance is based on demonstrating substantial equivalence to a previously cleared predicate device (TE Air K240906) and adherence to a comprehensive set of non-clinical safety and performance standards. The modifications primarily involve the addition of an "AirSight" platform (a customized Android device), which has reportedly passed related bench tests with no safety risk introduced.
The documentation explicitly states in section 7, "Clinical Studies: Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This reinforces that the clearance is not based on a clinical performance study involving diagnostic accuracy metrics or AI algorithm evaluation.
§ 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.