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The MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8/Nuda/Aquila/Malody Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic,adult cephalic,trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , Laparoscopic, trans-esoph(Cardiac) exams.

Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), 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 MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody 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, Power Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody 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 FDA 510(k) Clearance Letter states that clinical studies were Not Applicable for the Mindray Diagnostic Ultrasound System (K251192) to support substantial equivalence. Therefore, there is no information in this document about acceptance criteria or a study proving the device meets specific performance criteria through clinical data.

The letter explicitly states:
"8. Clinical Studies
Not applicable. The subject of this submission, MX7, MX7T, Vaus7, Zeus, ME7, Anesus ME7, Anesus ME7T, MX7P, MX7W, MX8, MX8T, Vaus8, ME8, Nuda, Aquila, Malody Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Instead, the submission relies on:

• Comparison with Predicate Devices: The document extensively details how the subject device is comparable and substantially equivalent to existing cleared predicate devices (e.g., MX7 (K241432), TEX20 (K241201), Resona I8W (K240115), TE Air (K240906), Consona N6 (K221300), QLAB (K190913)) in terms of intended use, imaging modes, features, functions, and technological characteristics.
• Non-clinical Tests: The device was evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, in compliance with various recognized standards (e.g., NEMA UD 2-2004, ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 14971, ISO 10993-1).

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device performance as they would apply to clinical efficacy/performance for a new AI/software component, because this information is not present in the provided 510(k) summary. The clearance is based on substantial equivalence to existing predicate ultrasound systems and non-clinical safety/performance testing.

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Recho R9W/Recho R9/Recho R9 Pro/Recho R9 Exp/Recho R9S/Recho R9T/Crius R9 CV/Anesus R9 CV/Recho R9 Super/Recho R9 Lumi/Recho R CV/Recho R CVx Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative(abdominal, thoracic, and vascular), 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.

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, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D, Matrix 4D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver)

The Recho R9W, Recho R9, Recho R9 Pro, Recho R9 Exp, Recho R9S, Recho R9T, Crius R9 CV, Anesus R9 CV, Recho R9 Super, Recho R9 Lumi, Recho R CV, Recho R CVx 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, Smart 3D, 4D, Matrix 4D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent for Liver).

The Recho R9W, Recho R9, Recho R9 Pro, Recho R9 Exp, Recho R9S, Recho R9T, Crius R9 CV, Anesus R9 CV, Recho R9 Super, Recho R9 Lumi, Recho R CV, Recho R CVx 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.

This FDA 510(k) clearance letter for the Mindray Diagnostic Ultrasound Systems (K250020) explicitly states that no clinical studies were required or performed to support substantial equivalence.

Therefore, based on the provided document, there is no information available regarding:

• Acceptance criteria based on clinical performance.
• A study proving the device meets clinical performance, as none was conducted.
• Sample size for test sets or their provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

The substantial equivalence determination for this ultrasound system was based on non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal/electrical/mechanical safety) and compliance with recognized medical safety standards.

The document highlights the following non-clinical tests and comparisons:

1. Acceptance Criteria & Reported Device Performance (Non-Clinical):

2. Sample Size and Data Provenance:
* Not applicable as no clinical studies were performed. The equivalence was based on engineering and performance testing against standards and predicate devices.

3. Number of Experts and Qualifications for Ground Truth:
* Not applicable as the substantial equivalence was not based on clinical performance studies involving expert interpretation.

4. Adjudication Method:
* Not applicable as no clinical studies were performed.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
* No MRMC study was done, as explicitly stated, "Clinical Studies: Not applicable."

6. Standalone Performance (Algorithm Only):
* Not applicable as this is a general-purpose diagnostic ultrasound system, and the clearance is for the device as a whole, not a specific AI algorithm with standalone clinical performance metrics. While AI/software features like "Auto Strain LV," "Auto Strain RV," "Auto VQ LA," "X-Vue," and "Quick View" are mentioned, their performance evaluation for 510(k) clearance was not based on a clinical trial but on comparison to cleared predicate devices that already have similar functionalities.

7. Type of Ground Truth Used:
* For the non-clinical tests, the "ground truth" was compliance with established engineering standards, regulatory limits (e.g., FDA acoustic output limits), and comparison to the technical specifications and performance of legally marketed predicate devices.

8. Sample Size for Training Set:
* Not applicable, as no information on specific machine learning model training sets or their sizes is provided for this 510(k) clearance. The focus is on the integrated ultrasound system's safety and effectiveness compared to predicates.

9. How Ground Truth for Training Set was Established:
* Not applicable, as no information on specific machine learning model training or associated ground truth establishment is provided.

In summary, the 510(k) clearance for this Mindray Diagnostic Ultrasound System was granted based on demonstrating substantial equivalence to predicate devices through non-clinical performance and safety testing, and compliance with recognized standards, rather than through new clinical performance studies.

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MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2 BW Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in ophthalmic, fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional), musculo-skeletal(superficial), thoracic/pleural, cardiac adult, cardiac pediatric, peripheral vessel and urology, intra-operative(abdominal, thoracic, and vascular) , trans-esoph(Cardiac) 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, CWD, Color Doppler, Amplitude Doppler, Combined mode (B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2 BW 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, iScape View, TDI, color M, Smart 3D, 4D(Real-time 3D), Strain Elastography, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver).

The MX6, MX6S, MX6T, MX6 Exp, MX6 Pro, MX6 Super, MXG, Emerus MX6, Emerus MX6 Exp, Anesus MX6, Anesus MX6 Exp, Crius MX6, Crius MX6 Exp, MX5, MX5S, MX5T, MX5 Exp, MX5 Pro, MX5 Super, MXI, Emerus MX5, Emerus MX5 Exp, Anesus MX5, Anesus MX5 Exp, Crius MX5, Crius MX5 Exp, MX3, MX3S, MX3T, MX3 Exp, MX3 Pro, MX3 Super, MXC, MX3 BW, MX2, MX2 BW 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.

This FDA clearance letter for the Diagnostic Ultrasound System (MX6 series, MX5 series, and MX3 series) does not describe acceptance criteria for specific device performance, nor does it detail a study that proves the device meets such criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices primarily through non-clinical tests related to general safety and design conformance.

Here's an analysis of why the requested information cannot be extracted from this document:

1. Table of acceptance criteria and reported device performance: This document explicitly states "Not applicable" for clinical studies and focuses on showing substantial equivalence based on comparison with predicate devices and conformance to general safety and design standards. There are no specific performance metrics (e.g., sensitivity, specificity, accuracy for a particular diagnostic task) or corresponding acceptance criteria presented.

2. Sample size, data provenance for test set: Since no clinical or performance study with a test set (in the context of AI/algorithm performance) is described, these details are not present.

3. Number of experts, qualifications for ground truth: Not applicable for the same reason as above. No ground truth establishment for a diagnostic performance test is mentioned.

4. Adjudication method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. The document states "Clinical Studies: Not applicable." This type of study would typically be performed for devices with AI assistance measuring diagnostic performance.

6. Standalone (algorithm only) performance study: Not applicable. The device is a "general purpose diagnostic ultrasound system," implying human operation, and no mention of an "algorithm only" performance is made.

7. Type of ground truth used: Not applicable, as no external "ground truth" (like pathology or outcomes data) was used to assess diagnostic performance of the device itself in a clinical study. The equivalence is based on technical features and safety.

8. Sample size for training set: Not applicable. The document does not describe the development or training of any AI/ML models that would typically require a training set.

9. How ground truth for training set was established: Not applicable, as no training set is mentioned.

Summary of what the document does provide regarding acceptance criteria and "proof":

The "acceptance criteria" for this device's clearance are primarily conformance to established medical device safety standards and substantial equivalence to legally marketed predicate devices (Consona N9 (K221300) as the main predicate, and MX7 (K241432), Resona I9 (K241432), and Resona I9 (K210699) as reference devices).

The "study that proves the device meets the acceptance criteria" is a series of non-clinical tests and a comparison study.

1. Table of Acceptance Criteria (Inferred from the document) and "Reported Device Performance" (Comparison to Predicate):

Study that Proves the Device Meets the Acceptance Criteria:

The "study" presented is a collection of non-clinical tests conducted to ensure the device meets safety and performance standards, and a comparison against predicate devices to demonstrate substantial equivalence.

• Non-Clinical Tests: These tests confirmed adherence to various international and national standards:

  • Acoustic Output: NEMA UD 2-2004 (R2009)
  • Electrical Safety & Essential Performance: ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
  • Electromagnetic Disturbances: IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, IEC TR 60601-4-2 Edition 1.0 2024-03
  • Usability: IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION
  • Basic Safety & Performance of Ultrasonic Equipment: IEC 60601-2-37 Edition 2.1 2015
  • Risk Management: ISO 14971 Third Edition 2019-12
  • Biocompatibility: ISO 10993-1 Fifth edition 2018-08
  • Software Life Cycle Processes: IEC 62304 Edition 1.1 2015-06

• Comparison to Predicate Devices: The submission details a systematic comparison of the subject device (MX6/MX5/MX3 series) with its main predicate (Mindray Consona N9, K221300) and several reference predicates. This comparison covered:

  • Intended Use: Minor differences were covered by reference predicates.
  • Imaging Modes: Stated to be comparable.
  • Features and Functions: Stated to be comparable.
  • Technological Characteristics: Stated to be comparable.
  • Patient Contact Materials: Verified to be the same or tested under ISO 10993-1.
  • Acoustic Power Levels: Shown to be the same as predicate devices and within FDA guidance.
  • Electrical and Physical Safety Standards: Device design shown to comply with the same standards as the predicate.

Additional Information (as requested, but N/A for this document):

• Sample sized used for the test set and the data provenance: N/A (no clinical performance test set mentioned)
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (no ground truth for performance study mentioned)
• Adjudication method: N/A
• 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: N/A (explicitly states "Clinical Studies: Not applicable." This is not an AI-assisted diagnostic device where such a study would be expected.)
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is a diagnostic ultrasound system, implying human operation, not a standalone algorithm.)
• The type of ground truth used (expert concensus, pathology, outcomes data, etc): N/A
• The sample size for the training set: N/A (no AI/ML model training mentioned)
• How the ground truth for the training set was established: N/A (no training set mentioned)

In conclusion, this document demonstrates that the Diagnostic Ultrasound System adheres to general safety and design standards and is substantially equivalent to existing cleared devices, rather than providing specific diagnostic performance metrics from a clinical study.

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The Acclarix AX3 series/Acclarix LX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinical applications include:Abdominal. Gvnecology, Obstetric. Cardiac, Small parts. Urology, Musculosketal . Peripheral vascular. Intraoperative, Pediatric, Neonatal , Adult Cephalic.

Acclarix AX3 Series/ Acclarix LX3 Series 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. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

The provided text describes a 510(k) premarket notification for a Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a new study to prove a device meets those criteria for novel technology.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not available in this document. The document primarily focuses on explaining how the new device is similar to already approved ultrasound systems and transducers.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly stated in terms of specific performance metrics with acceptance criteria and their corresponding reported values. Instead, the document claims substantial equivalence to predicate devices based on:

• Intended Use/Indications for Use
• Mode of Operations
• Design principles
• Hardware and software platforms
• Transducer types
• Acoustic Output (stated to be below FDA limits)
• Materials of transducers and needle guide brackets

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

• Test Set Sample Size: Not provided. The document states "Clinical testing is not required" and primarily relies on non-clinical tests and comparison to predicate devices.
• Data Provenance: The document implies that the "clinical applications" and "imaging modes" added to the new device are based on what was already cleared for the Acclarix LX9 series (K192879) and other predicate devices (K200232 and K201693). This suggests a reliance on retrospective data and established performance of predicate devices, rather than new prospective clinical trials for this specific submission. The origin of the data for the predicate devices is not specified in this document.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• Not applicable. Since clinical testing was not required for this submission, there was no separate test set requiring new ground truth establishment by experts for specific AI algorithm performance.

4. Adjudication method for the test set:

• Not applicable. No specific adjudication method is mentioned as there was no dedicated clinical test set described for new performance evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

• No, an MRMC study was NOT done. The document explicitly states "Clinical testing is not required" and focuses on substantial equivalence based on technical specifications and previously cleared indications. There is no mention of human readers or AI assistance.

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

• Not applicable. This document is for a diagnostic ultrasound system, not an AI algorithm. While the system may employ internal processing (which could include algorithmic components), the submission does not detail testing of standalone AI performance against a ground truth.

7. The type of ground truth used:

• Not applicable for novel performance claims. The "ground truth" implicitly relies on the established and cleared performance of the predicate diagnostic ultrasound systems and their associated transducers. The "Acoustic output testing" was done "as per the guideline 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' dated June 27, 2019," which suggests adherence to industry standards and regulatory guidance for ultrasound device performance, rather than clinical ground truth for a specific medical condition.

8. The sample size for the training set:

• Not applicable. This document does not describe the development or training of a new AI algorithm. It refers to a diagnostic ultrasound system and its transducers.

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

• Not applicable. As no new AI algorithm development is described, there is no training set or ground truth specific to an algorithm's training.

Summary of what the document does provide:

The document serves as a 510(k) submission arguing for the substantial equivalence of the new Edan Instruments Diagnostic Ultrasound Systems (Acclarix AX3 series and Acclarix LX3 series) to existing cleared predicate devices. The arguments are based on:

• Non-clinical performance tests demonstrating compliance with relevant electrical safety, EMC, and acoustic output standards (ANSVAAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 10993-5, ISO 10993-10).
• Comparison of intended use, indications for use, mode of operations, design principles, hardware/software platforms, and transducer types to previously cleared Edan Instruments ultrasound systems (K192791, K192879) and other predicate devices (K200232, K201693).
• The argument is that the differences are minor and do not raise new questions of safety or effectiveness. For example, new clinical applications, transducers, and imaging/measurement modes have already been cleared on other predicate devices.

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The Acclarix AX3 series Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluations in hospitals and clinical applications include:

• Abdominal
• Gynecology
• Obstetric
• Cardiac
• Small parts
• Urology
• Musculoskeletal
• Peripheral vascular
• Adult Cephalic

Acclarix AX3 Series 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. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Acclarix AX3 Series Diagnostic Ultrasound System:

Based on the provided FDA 510(k) summary, the device in question, the Acclarix AX3 Series Diagnostic Ultrasound System, is a diagnostic ultrasound system. For this type of device, the "acceptance criteria" and "device performance" in the context of FDA clearance typically refer to compliance with recognized performance standards and safety requirements rather than a specific algorithmic performance metric. Similarly, "proving the device meets acceptance criteria" is primarily demonstrated through non-clinical testing.

The document explicitly states: "Clinical testing is not required." This is a critical piece of information. Since no clinical testing was performed for the purpose of this 510(k) clearance, many of the requested bullet points, particularly those related to human readers, ground truth establishment, and training/test set details for AI-based performance, are not applicable.

Acceptance Criteria and Reported Device Performance

Study Details (Based on available information)

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

   • No test set for clinical performance was used as clinical testing was not required.
   • For non-clinical performance (electrical safety, EMC, acoustic output, biocompatibility), the "sample size" would refer to the number of devices or components tested. This specific number is not provided in the summary, but it would typically involve a statistically relevant sample or a representative unit for each test.
   • Data Provenance: Not applicable in the context of clinical data for performance evaluation. For non-clinical testing, the testing was conducted by Edan Instruments, Inc. as part of their verification and validation process (implied by "Verification and validation testing has been conducted").

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as clinical testing (which would involve expert review for ground truth) was not required for this 510(k) submission.

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

   • Not applicable as no clinical test set requiring adjudication 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:

   • No. The device is a diagnostic ultrasound system, not an AI-assisted interpretation device in the context of this 510(k) submission. This type of study is not relevant to its clearance.

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

   • No. This is a hardware-based diagnostic imaging system, not an AI algorithm requiring standalone performance evaluation in the typical sense.

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

   • For the non-clinical tests, the "ground truth" would be established by the specifications defined in the relevant international standards (e.g., electrical safety limits in ANSI/AAMI ES60601-1, acoustic output limits as per FDA guidelines). Compliance with these standards serves as the "ground truth" for safe and effective operation.

7. The sample size for the training set:

   • Not applicable as no AI training set was used for this device for the purpose of 510(k) clearance.

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

   • Not applicable as no AI training set was used.

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The diagnostic ultrasound system (DUS-5000) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

The DUS-5000 Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to11 MHz.

The DUS-5000 Diagnostic Ultrasound System is a medical device intended for diagnostic ultrasound imaging and fluid flow analysis. The acceptance criteria and the study proving the device meets these criteria are outlined below, derived from parts {0} through {15} of the provided text.

Based on the provided information, clinical testing was not required for this device, as stated in section {2}. This implies that the device's performance was evaluated through non-clinical means and comparison to a predicate device. Therefore, details regarding test sets, ground truth establishment, expert adjudication, or MRMC studies for clinical performance are not available in this document. The "acceptance criteria" in this context refer to the successful completion of non-clinical safety and performance standards and demonstrating substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that clinical testing was not required, the acceptance criteria are primarily related to non-clinical safety and performance standards, and comparison to the predicate device. The performance is assessed by confirming the device meets these standards and functions identically or equivalently to the predicate.

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

Since clinical testing was not required (section {2}), there is no mention of a clinical "test set" in terms of patient data or provenance. The "test set" in this context refers to the device itself undergoing non-clinical technical evaluations and comparisons to the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as clinical testing was not required (section {2)} and no expert-based ground truth establishment for clinical performance is reported. The "ground truth" for the non-clinical evaluations would be the established engineering and biocompatibility standards themselves.

4. Adjudication method for the test set

Not applicable, as clinical testing was not required (section {2)} and no clinical test set requiring adjudication is described.

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 not explicitly stated to be an AI-assisted device. Furthermore, clinical testing was not required (section {2}), so no MRMC study or AI assistance evaluation was conducted or reported.

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

Not applicable, as the device is a diagnostic ultrasound system, not an algorithm-only device. Additionally, clinical testing was not required (section {2)}.

7. The type of ground truth used

For non-clinical evaluation, the "ground truth" is established through adherence to national and international safety standards (e.g., IEC 60601-1, IEC 60601-1-2, Acoustic Output Guidelines, ISO 10993 series) and by demonstrating identical or equivalent performance to the legally marketed predicate device (Model U50 Diagnostic Ultrasound System, K123249).

8. The sample size for the training set

Not applicable, as clinical testing was not required (section {2}). This device is a diagnostic ultrasound system, and the submission does not mention machine learning or AI components that would typically require a training set of data.

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

Not applicable, as clinical testing was not required (section {2}), and no training set is mentioned.

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The diagnostic ultrasound system (U50) is applicable for adults, pregnant women, pediatric patients' ultrasound evaluation in hospitals and clinics. It is intended for use in abdominal, obstetrics, gynecology, pediatric, small parts, urology, peripheral vascular, musculoskeletal (conventional and superficial), transvaginal and cardiac clinical applications, by or on the order of a physician or similarly qualified health care professional.

The U50 is a portable Diagnostic Ultrasound System, which applies advanced technologies such as Phased Inversion Harmonic Compound Imaging (eHCI), Multi-Beam-Forming (mBeam), Speckle Resistance Imaging (eSRI), and Spatial Compounding Imaging, etc. Various image parameter adjustments, 12.1 inch LCD and diverse probes are configured to provide clear and stable images. Its function is to acquire and display Ultrasound images in B-mode, M-mode, PW-mode, Color-mode, PDI/DPDI mode. This system provides a series of probes that include linear array, convex array, micro-convex array with a frequency range of approximately 2.5 MHz to 11 MHz.

This document is a 510(k) summary for the Edan Instruments, Inc. U50 Diagnostic Ultrasound System. It details the device's intended use and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "reported device performance" is implicitly that the device performs equivalently to the listed predicate devices in terms of its intended use, design, performance effectiveness, and safety.

Since the document doesn't provide specific numerical performance metrics, a table summarizing them as requested cannot be created. The "performance" is implicitly deemed acceptable because it meets the standards of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Clinical testing is not required." This indicates that no clinical test set was used for this submission. The evaluation was based on non-clinical testing and comparison to existing predicate devices. Consequently, there is no data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical testing was performed and thus no clinical test set was used, no experts were used to establish ground truth for a test set. The determination of substantial equivalence relies on non-clinical data and regulatory comparison.

4. Adjudication Method for the Test Set

As no clinical test set was used, there was no adjudication method for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The submission explicitly states "Clinical testing is not required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a diagnostic ultrasound system, which inherently involves a human operator to acquire and interpret images. It is not an AI algorithm that functions in a standalone manner without human-in-the-loop performance. Therefore, no standalone algorithm-only performance study was conducted or is applicable in this context. The "performance effectiveness" is evaluated in the context of the complete system, including human operation.

7. The Type of Ground Truth Used

Given that clinical testing was not required for this 510(k) submission, there was no clinical ground truth established or used in the way typically seen in AI/CAD device submissions (e.g., pathology, expert consensus, outcomes data). The "ground truth" for the device's acceptable performance is its compliance with recognized safety standards and its demonstrated substantial equivalence to predicate ultrasound devices through non-clinical testing.

8. The Sample Size for the Training Set

This document does not describe the development of an AI algorithm or a training set for machine learning. The device is a traditional diagnostic ultrasound system. Therefore, there is no training set sample size described in this submission.

9. How the Ground Truth for the Training Set Was Established

Since no training set for an AI algorithm is mentioned, there is no information on how ground truth for a training set was established.

Summary of the Study:

The study proving the device meets acceptance criteria is a 510(k) Pre-market Notification submission, not a clinical trial. The acceptance criteria are based on demonstrating substantial equivalence to predicate devices. This is achieved through:

• Non-clinical testing: This includes electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), acoustic output testing (per FDA guidelines), and biocompatibility (ISO 10993-1, -5, -10). The document does not provide specific results or acceptance values for these tests, only that they were conducted according to the standards.
• Comparison to predicate devices: The submission asserts that the U50 Diagnostic Ultrasound System has the "same intended use, similar product design, same performance effectiveness, performance safety and the same needle-guide bracket material, property, and sterilization methods as the predicate devices." The differences are stated to "not affect the basic design principle, usage, effectiveness and safety of the subject device."

The FDA's letter (K123249) confirms that the device was deemed "substantially equivalent" to legally marketed predicate devices, thereby meeting the regulatory acceptance criteria for market clearance. This clearance specifically applies to the U50 system and a list of associated transducers for a wide range of clinical applications in B-mode, M-mode, PW-mode, Color-mode, and PDI/DPDI mode, including biopsy guidance and harmonic imaging.

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Diagnostic ultrasound imaging or Doppler analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organs (Thyroid, Testicles, Breast), Neonatal Cephalic, Adult Cephalic, Cardiac, Transvaginal, Peripheral Vascular, Musculo-skeletal Superficial and Musculo-skeletal Conventional, Transrectal.

The sarano is a mobile diagnostic ultrasound system. This system has flat linear array, convex and with a frequency range of approximately 2 to 15 MHz. It has B mode, M mode, or in a combination of modes. Also the sarano has two kinds of monitor; CRT and LCD. The former is standard model and latter is optional model.

This is a 510(k) Premarket Notification for a diagnostic ultrasound system (sarano) and its associated transducers. The document describes the device, its intended use, and conformance to safety standards. However, it does not contain any information about clinical performance studies, acceptance criteria for device accuracy, or expert evaluations of image quality or diagnostic capability.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them from the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document primarily focuses on the device's technical specifications, intended uses, and compliance with safety and measurement standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance information is provided as there are no clinical performance studies described.
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): No ground truth establishment information is provided as there are no clinical performance studies described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No adjudication method is described.
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 is mentioned, nor is any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is mentioned, nor is any AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth type is specified.
8. The sample size for the training set: No training set information is provided, as there is no mention of a machine learning or AI component.
9. How the ground truth for the training set was established: No ground truth establishment for a training set is provided.

The document discusses the device's adherence to voluntary and measurement standards like IEC 60601-1 (safety), UL60601-1 (safety), AIUM NEMA UD2 (acoustic output measurement), and AIUM NEMA UD3 (real-time display of thermal and mechanical acoustic output indices). These are safety and performance standards for the physical device and its acoustic output, not clinical performance or diagnostic accuracy.

The FDA's letter of substantial equivalence (K082224) is based on the device being substantially equivalent to a predicate device (Shimadzu Corporation sarano K061641), implying that its performance characteristics are similar to a previously cleared device, rather than requiring new clinical performance studies for diagnostic accuracy for this specific submission.

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Diagnostic Ultrasound
Fetal, Abdominal, Pediatric, Small Organ (Testes, adult female breast, and thyroid), Neonatal Cephalic, Cardiac, Peripheral Vascular

Model 1.0 Diagnostic Ultrasound System

The provided document is a 510(k) clearance letter from the FDA for a diagnostic ultrasound system, Model 1.0, and its transducers (214U and 218PA). It primarily focuses on the regulatory clearance for the device's intended uses, comparing it to legally marketed predicate devices.

This document does NOT contain information about acceptance criteria, device performance, study details (like sample size, data provenance, expert ground truth, or adjudication methods), or any comparative effectiveness studies (MRMC) or standalone algorithm performance studies.

The "Indications for Use Form" tables (pages 2-4) list various clinical applications and the modes of operation available for the Model 1.0 system and its transducers. "P" indicates a previously cleared indication, and "N" indicates a new indication (for the system or transducer). "E" means "Added under Appendix E," suggesting an expanded indication.

Therefore, I cannot provide the requested information. The document serves as an FDA clearance letter and the associated intended use statements, not a detailed technical report on a study proving device performance against acceptance criteria.

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