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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:

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.

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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, Amplitude 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.

This system is a Track 3 device that employs phased array probes.

This FDA 510(k) summary does not contain information about specific acceptance criteria or a study proving the device meets those criteria. Instead, it describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence without requiring clinical studies.

Here's a breakdown of the information that is and is not available in the provided text, based on your request:

1. A table of acceptance criteria and the reported device performance

• Not available in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices, not on setting and meeting specific performance acceptance criteria for a novel algorithm or diagnostic capability.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not available. Since no clinical studies were performed to prove the device meets acceptance criteria, there is no test set sample size or data provenance to report. The submission states, "Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not available. As no clinical studies were conducted, no ground truth was established by experts for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not available. No test set was used in clinical studies.

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/Not available. No clinical studies, including MRMC studies, were performed. The device is a general-purpose diagnostic ultrasound system, and the submission does not mention AI assistance for human readers or report any effect sizes. The new software options listed (iNeedle, Smart Calc, iWorks, iScanHelper, iTouch+, B-Hist) are functions cleared in predicate devices, not necessarily AI-driven assistance that would typically be evaluated in an MRMC study for improved reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable/Not available. No standalone performance study was conducted. The device is a diagnostic ultrasound system, implying human operation and interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not available. Since no clinical studies were performed, no ground truth was established or used.

8. The sample size for the training set

• Not applicable/Not available. The submission does not describe any training sets or machine learning models that would require one. The modifications primarily involve adding new intended uses and transducers, and incorporating software options already cleared in predicate devices, rather than a new AI algorithm requiring a dedicated training set.

9. How the ground truth for the training set was established

• Not applicable/Not available. As no training set is discussed, no ground truth establishment method for it is provided.

Summary of Device and Substantial Equivalence Justification:

The document is a 510(k) summary for the TE Air Diagnostic Ultrasound System (K240906). The submission aims to demonstrate substantial equivalence to a primary predicate device, the TE Air Diagnostic Ultrasound System (K231685), and several reference devices (Consona N9, MX7, Butterfly iQ).

The proposed device, K240906, introduces several modifications:

• New intended uses: Small organ, musculo-skeletal (Conventional and Superficial), and peripheral vessel exams, which have been cleared in the predicate Butterfly iQ (K202406).
• New transducers: z3P, z3Ps, z3Pt, e3P, e3Ps, e3Pt, a3Px, i5M, z5M, z5Ms, z5Mt, e5M, e5Ms, e5Mt, a5Mx.
• New software options: iNeedle, Smart Calc, iWorks, iScanHelper, iTouch+, B-Hist (Ellipse), B-Hist (Trace), B-Hist (Spline), B-Hist (Rectangle), which have been cleared in the predicate Consona N9 (K221300).
• Operating System update: Android 9 to Android 10.

The substantial equivalence is argued based on:

1. Similar technological characteristics to predicate devices.
2. Comparable key safety and effectiveness features.
3. Same intended uses and basic operating modes (with the added intended uses cleared in another predicate).
4. All systems transmit ultrasonic energy, perform post-processing, and allow for specialized measurements.
5. Acoustic power levels of the subject device are below FDA limits, similar to the predicate TE Air (K231685).
6. The software app and use of a mobile device screen are similar to the cleared TE Air (K231685).
7. OS changes passed related bench tests with no safety risk.

Non-clinical tests were performed for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable 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).

No clinical studies were deemed necessary to support substantial equivalence for this device.

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TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, pediatric , thoracc/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, neonatal and adult cephalic, 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, Amplitude 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, Amplitude 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.

This system is a Track 3 device that employs phased array probes.

The provided FDA 510(k) summary for the Mindray TE Air Diagnostic Ultrasound System (K231685) does not include any information about acceptance criteria or a study proving the device meets them.

The submission focuses on establishing substantial equivalence without clinical studies. It states: "Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Instead of performance criteria based on clinical outcomes, the submission relies on adherence to recognized safety and performance standards for non-clinical aspects, and comparison of technical features to a predicate device.

Therefore, for your request, I must report that the requested information (acceptance criteria, device performance table, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is not present in the provided document.

The document primarily discusses:

• Device Description: General purpose, software-controlled ultrasound system with B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI modes.
• Intended Use: Abdominal, pediatric, thoracic/pleural, adult and pediatric cardiac, neonatal and adult cephalic, and urology exams for adults, pregnant women, pediatric patients, and neonates.
• Comparison to Predicate: The subject device is compared to a primary predicate device (TE Air in K220051) and a reference device (TEX20 in K220242). The main changes from the primary predicate are the addition of "AutoEF" feature (cleared in TEX20) and support for Android OS and updated iOS.
• Non-clinical Tests: Evaluation for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety, conforming to various IEC and ISO standards. The document explicitly states these non-clinical tests support the determination of substantial equivalence.

Without clinical study data, none of the requested performance metrics related to clinical accuracy or effectiveness (e.g., sensitivity, specificity, clinical improvement with AI assistance) can be provided from this document.

Ask a specific question about this device

TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, pediatric , thoracic/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, neonatal and adult cephalic, 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, Amplitude 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, Amplitude 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 devices, and probes which use wireless technology for communication.

This system is a Track 3 device that employs phased array probes.

The provided FDA 510(k) summary for the TE Air Diagnostic Ultrasound System explicitly states "Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." Therefore, no clinical study was conducted to prove the device meets acceptance criteria.

The submission relies on non-clinical tests to demonstrate substantial equivalence to predicate devices. These non-clinical tests include acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable medical safety standards.

Below is a table summarizing what would typically be included if clinical performance data were available, based on the information provided, or indicating its absence.

Acceptance Criteria and Device Performance (Based on Non-Clinical Assessment):

Absence of Clinical Study Information:

1. Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was used to assess performance for substantial equivalence.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was used to establish ground truth for performance assessment.
3. Adjudication method for the test set: Not applicable, as no clinical test set was used.
4. 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, as no MRMC study or AI assistance performance evaluation was described. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of clinical decision support.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as no standalone algorithm performance was assessed for clinical endpoints.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical ground truth was established for performance assessment.
7. The sample size for the training set: Not applicable, as no clinical training set was described for performance assessment.
8. How the ground truth for the training set was established: Not applicable, as no clinical training set was described.

Summary of the FDA's Stance:
The FDA determined that the TE Air Diagnostic Ultrasound System is "substantially equivalent" to legally marketed predicate devices based on its similar technological characteristics, comparable key safety and effectiveness features (as demonstrated by non-clinical tests), and identical intended uses and basic operating modes. This determination did not require clinical studies to support substantial equivalence in this specific case.

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