Search Results

The Acclarix AX8 Series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics.
The Acclarix AX8 Series Diagnostic Ultrasound System clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Peripheral vascular, Musculoskeletal, Pediatric, Neonatal, Adult Cephalic, Thoracic/Pleural and Trans-esophageal Cardiac.
The Modes of Operation for Acclarix AX8 Series include B mode, M mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.
The Acclarix AX9 Series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics.
The Acclarix AX9 Series Diagnostic Ultrasound System clinical applications include Abdominal. Gynecology, Obstetric, Cardiac, Small parts, Urology, Peripheral vascular, Musculoskeletal, Pediatric, Neonatal, Adult Cephalic, Thoracic/Pleural and Trans-esophageal Cardiac.
The Modes of Operation for Acclarix AX9 Series include B mode, M mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.

The Acclarix AX8 Series & Acclarix AX9 Series Diagnostic Ultrasound System is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinics. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

The provided text focuses on the 510(k) summary for the Edan Instruments Inc. Acclarix AX8 and AX9 Series Diagnostic Ultrasound Systems. It primarily addresses the substantial equivalence to a predicate device and outlines non-clinical performance data. It explicitly states "Clinical data: Not applicable," which means that no clinical studies were performed to establish acceptance criteria or demonstrate device performance against clinical metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because such a study involving clinical data and performance metrics is explicitly stated as "Not applicable" in the document.

However, I can extract information about the non-clinical testing performed:

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

Since no clinical acceptance criteria or performance metrics were reported, this table cannot be created as requested in the context of clinical performance. The document only states that the device complies with certain electrical safety, EMC, and performance standards.

Regarding the other requested information, the document states "Clinical data: Not applicable." Therefore, the following points cannot be addressed from the given text:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable due to lack of clinical data.
• 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 due to lack of clinical data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable due to lack of clinical data.
• 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. The device is a diagnostic ultrasound system, and the document doesn't mention AI assistance or MRMC studies.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an ultrasound system, not an AI algorithm intended for standalone performance.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable due to lack of clinical data.
• 8. The sample size for the training set: Not applicable as no clinical training data is mentioned.
• 9. How the ground truth for the training set was established: Not applicable as no clinical training data is mentioned.

Ask a specific question about this device

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

Resona I9, Resona I9 Exp. Resona I9T. Resona I9 Easi, Resona I9 Nasa, Resona IV. Imagyn I9, Imagyn I9S, Imagyn 19 Easi, Nuewa 19, Nuewa 19T, Nuewa 19 Exp, Nuewa 19 Easi, Anesus 19, Anesus 19, Anesus 19, Resona 19W, Recho 19, Recho 19 Exp, Recho 19S, Recho 19T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, 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, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast agent for LVO), V Flow, STE, STO, Contrast imaging (Contrast agent for Liver).

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healtheare 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 Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus 19, Resona I9W, Recho 19, Recho 19 Pro, Recho 19 Exp, Recho 19S, Recho 19T 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, 4D(Realtime 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

The Resona 19, Resona 19 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T 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.

I'm sorry, but this document does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a diagnostic ultrasound system. It outlines the device's indications for use, its substantial equivalence to predicate devices based on non-clinical tests (acoustic output, biocompatibility, electrical/mechanical safety, etc.), and applicable safety standards it conforms to.

However, it explicitly states under "8. Clinical Studies": "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."

Therefore, there is no information in this document regarding:

• Acceptance criteria tables with reported device performance for an AI/algorithm-related study.
• Sample sizes for test sets or data provenance.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• MRMC studies or effect sizes of AI assistance on human readers.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

This document is a regulatory clearance for a general purpose diagnostic ultrasound system, not a document detailing the performance and validation of an AI/ML component within such a system.

Ask a specific question about this device

Resona I8W, Resona I8, Resona I8S, Resona I8S, Resona I8T, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa 18, Nuewa 18 Exp, Nuewa 18T, Imagyn 18, Imagyn 18T, Imagyn 18T, Imagyn 18 Exp, Nuewa 1Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. It is intended for use in fetal, abdominal, Intra-operative (includes abdominal, Laparoscopic, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatic 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, 4D(Reape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

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 Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY 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, 4D(Realtime 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

The Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY 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.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

Important Note: The provided document is a 510(k) Premarket Notification from the FDA, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving direct performance against specific numerical acceptance criteria for a new, breakthrough device. Therefore, the "acceptance criteria" here refer to the criteria for demonstrating substantial equivalence to the predicate device, primarily through non-clinical testing and comparison of features. The "study" refers to these non-clinical tests and comparisons.

Description of Acceptance Criteria and the Study that Proves the Device Meets Them

The Shenzhen Mindray Bio-medical Electronics Co., LTD's Resona I8W and associated systems (subject device) seek to prove substantial equivalence to predicate devices, primarily the Resona I9 (K210699). The acceptance criteria are largely focused on demonstrating that the subject device's intended use, technological characteristics, safety, and effectiveness are comparable to the legally marketed predicate devices.

1. Table of Acceptance Criteria and the Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not Applicable. The document explicitly states "Not applicable" for clinical studies. This submission relies on non-clinical performance data and comparison to predicate devices, rather than a clinical test set with patient data. The "test set" in this context refers to the device itself being tested for compliance with safety standards and functional equivalence.

3. 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" with patient data was used to establish ground truth, this information is not relevant to this 510(k) submission. Ground truth, in the traditional sense of medical image interpretation, was not established for this device's comparison.

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

• Not Applicable. No clinical test set requiring expert adjudication was conducted.

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. No MRMC study was conducted. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool. The submission does not describe any AI features that would necessitate an MRMC study to evaluate human reader improvement.

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

• Not Applicable. This is a diagnostic ultrasound system. While it has software controls and analysis packages, it does not represent a standalone "algorithm only" device that provides interpretations without human interaction. Its performance is demonstrated through its ability to acquire and display ultrasound images and facilitate measurements for human interpretation.

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

• Not Applicable (in the clinical sense). Ground truth, in this context, is established through compliance with recognized safety standards and functional equivalence to predicate devices, not through clinical diagnostic verification against pathology or outcomes data for new clinical claims. The "ground truth" for the device's acceptable performance is its adherence to industry standards and its comparability to existing, legally marketed ultrasound systems.

8. The sample size for the training set:

• Not Applicable. This document does not describe a machine learning algorithm that underwent training with a specific dataset. It refers to a diagnostic ultrasound system.

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

• Not Applicable. Since there is no described machine learning training set, the establishment of its ground truth is not relevant here.

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