Search Results

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.

The TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite/TEX10 Pro/TEX10S/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX201/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11T/Eagus TEX11T/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional), Thoracic/Pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).

The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/Eagus TEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).

The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/Eagus TEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance. The document describes a general purpose diagnostic ultrasound system and its substantial equivalence to predicate devices, focusing on technical specifications, safety standards, and intended use rather than AI/ML performance metrics.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information. The document explicitly states "Not applicable" for clinical studies to support substantial equivalence.

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 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.

Ask a specific question about this device

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.

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.

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.

Ask a specific question about this device