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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The ACUSON Sequoia and Sequoia Select ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult and pediatric patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Origin and Origin ICE ultrasound imaging systems are intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Transesophageal, Intracardiac, Vascular, Adult Cephalic, and Peripheral Vascular applications.

The catheter is intended for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, cardiac, peripheral vessel, and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems (software version VC10) are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio- effect mechanisms. The function of these ultrasound systems is to transmit, receive, process ultrasound echo data (distance and intensities information about body tissue) in various modes of operation and display it as ultrasound imaging, anatomical and quantitative measurements, calculations, analysis of the human body and fluid flow, etc. These ultrasound systems use a variety of transducers to provide imaging in all standard acquisition modes and also have comprehensive networking and DICOM capabilities.

The provided FDA 510(k) clearance letter and summary discuss the ACUSON Sequoia, Sequoia Select, Origin, and Origin ICE Diagnostic Ultrasound Systems. This document indicates a submission for software feature enhancements and workflow improvements, including an "AI Measure and AI Assist workflow efficiency feature" and "Liver Elastography optimization."

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

Acceptance Criteria and Reported Device Performance

The submission focuses on enhancements to existing cleared devices rather than a de novo AI device. Therefore, the "acceptance criteria" discussed are primarily related to the performance of the Liver Elastography optimization using phantom testing.

Study Details for Liver Elastography Optimization (SWE Performance Testing)

The primary study mentioned in the document for performance evaluation is related to the Liver Elastography optimization.

1. Sample Size Used for the Test Set and the Data Provenance:

   • Test Set: Calibrated elasticity phantoms. The specific number of phantoms used is not stated beyond "calibrated elasticity phantoms."
   • Data Provenance: Not explicitly stated, but implies laboratory testing using commercially available or manufacturer-certified phantoms. Transducers listed were DAX, 5C1, 9C2, 4V1, and 10L4.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts:

   • Ground Truth Establishment: The ground truth for the test set (phantom stiffness) was established by the phantom manufacturer, as they were "calibrated elasticity phantoms certified by the phantom manufacturer."
   • Number/Qualifications of Experts: The document does not specify the number or qualifications of experts involved in the phantom's certification process or in the actual testing of the Siemens device. The testing appears to be objective, relying on the calibrated properties of the phantoms.

3. Adjudication Method for the Test Set:

   • Adjudication Method: Not applicable. Phantom testing typically relies on quantitative measurements against known phantom properties, not human adjudication of results.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • MRMC Study: No, an MRMC comparative effectiveness study was not conducted according to this document. The submission focuses on technical enhancements and phantom validation for elastography, and system safety/effectiveness.

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

   • Standalone Performance: The "SWE Performance Testing" with phantoms could be considered a form of standalone performance assessment as it evaluates the device's measurement capabilities against a known standard. However, the AI Measure and AI Assist features are described as "workflow efficiency features" where measurements are "automatically launched" after classification, implying an interaction with a human user rather than a fully standalone diagnostic output. No specific standalone performance metrics for the AI Measure/Assist components are provided.

6. The Type of Ground Truth Used:

   • Ground Truth: For the elastography testing, the ground truth was the known stiffness values of the calibrated elasticity phantoms.

7. The Sample Size for the Training Set:

   • Training Set Sample Size: The document does not provide information about a training set size for the AI Measure and AI Assist features or the elastography optimization. This type of 510(k) submission typically focuses on validation and verification of changes to an already cleared product, rather than detailing the initial development or training data for AI algorithms.

8. How the Ground Truth for the Training Set Was Established:

   • Training Set Ground Truth: Not applicable, as information on a specific training set is not provided in this document.

Summary regarding AI components:

While the document mentions "AI Measure" and "AI Assist" as workflow efficiency features (e.g., launching relevant measurements after cardiac view classification), it does not provide detailed performance metrics, test set sizes, ground truth establishment, or clinical study information specifically for these AI components. The 510(k) emphasizes that these are "software feature enhancements and workflow improvements" that, along with other changes, do not raise new questions of safety and effectiveness, leading to substantial equivalence with the predicate device. The only detailed "performance testing" described is for the Liver Elastography optimization using phantoms. This suggests that the AI features themselves might have been validated through internal software verification and validation activities that are not detailed in this public summary, or their impact on diagnostic performance was considered incremental and not requiring specific clinical comparative studies for this particular submission.

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EPIQ Series Diagnostic Ultrasound System: The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.
The clinical environments where EPIQ Series Diagnostic ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.
When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Affiniti Series Diagnostic Ultrasound Systems: The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.
The clinical environments where the Affiniti diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

The purpose of this 510(k) Pre-market Notification is to introduce the SVS v2 Contrast software application with the EPIQ and Affiniti Series Diagnostic Ultrasound Systems as part of the VM13.0 program.
SVS v2 Contrast is an automated software feature that assists in the selection of images for analysis with the new Philips license options 2D Auto EF Advanced (Adv) developed by DiA Imaging Analysis (K243235), now part of Philips Ultrasound LLC, and existing Philips license options AutoStrain LV; or 2D Auto LV (both K240850) license application in Adult Echo Transthoracic (TTE) examinations.
As described in 510(k) K240850, this feature automatically classifies each acquired image by view and selects an appropriate set of images for Left ventricle (LV) analysis. The classification is based on a Deep Learning AI inference engine; the selection is a non-AI algorithm that considers the view classification and image depth to select the optimal set of images. The difference in SVS v2 Contrast from the predicate SVS v1 (K240850) is that the algorithm is revised to include the selection of optimal images for analysis when contrast is used in routine TTE exams.
Users can launch existing 2D Auto EF; 2D Auto EF Adv; AutoStrain LV; or 2D Auto LV with the set of images that have been automatically selected without the need to review the acquired images and manually select the views. Users may select 2D Auto EF Adv, to process the selected views by SVS v2 Contrast. SVS v2 Contrast prioritizes the contrast image pair; however, if an appropriate pair of contrast images is not found, then Auto EF Adv may select non-contrast images. The manual approach to select views is still available and the user can override automatically selected images from SVS v2 Contrast.
No hardware changes to the EPIQ or Affiniti Series Diagnostic Ultrasound Systems are required when using SVS v2 Contrast, and existing, cleared Philips TTE transducers.
The SVS v2 Contrast feature is supported by all EPIQ models running software version 13.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5. The SVS v2 Contrast feature is supported by the Affiniti models running software version VM13.0 or higher, including Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The SVS v2 Contrast feature is associated with the cardiac adult indication.

Acceptance Criteria and Study Details for SVS v2 Contrast Software

This document outlines the acceptance criteria and details of the study conducted to demonstrate that the Philips Ultrasound systems (EPIQ and Affiniti Series Diagnostic Ultrasound System) with the SVS v2 Contrast software application meet the established performance benchmarks.

1. Table of Acceptance Criteria and Reported Device Performance

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TINGS FINDERS 2 Color Doppler Diagnostic Ultrasound System is intended for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.

Modes of operation include: B,M, Color Doppler,PW Doppler, CW Doppler,Power Doppler; Combined modes: B/M,B/Color,B/M/Color, B/PWD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power.

The device is intended for use in Professional healthcare facility environment including echo lab, other hospital settings, operating room, Cath lab and EP lab.

The intended users of the Device is to be used exclusively by physicians who are appropriately trained personnel in a fully equipped electrophysiology or catheterization room or under their direct supervision.

The proposed TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System is a Track 3 diagnostic device designed for imaging intracardiac anatomical structures and blood flow dynamics in adult patients. It comprises two primary components: the ultrasound console and the TINGSN Sonic Eyes 10 Eco Disposable Intracardiac Echocardiography Catheter. The console features a 17.3-inch touch-enabled LCD screen, a control panel, and interfaces for connectivity, powered by a rechargeable battery or AC adapter, with optional peripherals including a cart and foot switch. The catheter, a sterile, single-use device with a 95 cm insertable length and 10Fr diameter, is equipped with a 64-element phased array transducer at its tip for high-resolution imaging. It connects to the console via the Finders 2 Sonic Eyes Connector, featuring a locking mechanism to ensure secure attachment during procedures. The system supports multiple imaging modes—B-Mode, M-Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Doppler, Power Doppler, and combined modes —along with advanced functionalities, displayed with real-time thermal (TI) and mechanical (MI) indices.

The provided text is a 510(k) Clearance Letter and 510(k) Summary for the TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System. This document describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.

Crucially, the document explicitly states under "8. CLINICAL DATA": "No clinical data was included in this submission."

Therefore, based on the provided text, a study that proves the device meets acceptance criteria through clinical data (either standalone or MRMC comparative effectiveness) was not performed, or at least, not included in this submission. The entire submission relies on non-clinical testing and comparison to predicate devices to establish substantial equivalence.

As the request specifically asks for information about a "study that proves the device meets the acceptance criteria" and mentions clinical outcomes, it is impossible to provide the requested details from the given text.

However, I can extract the information related to the non-clinical tests that were performed to verify the device met design specifications and was substantially equivalent, which serve as the basis for clearance in lieu of clinical data.

Here's an interpretation based on the non-clinical data presented:

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

The TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System established its substantial equivalence (SE) based primarily on non-clinical testing and comparison to predicate devices, as no clinical data was included in the submission. The acceptance criteria and "performance" are therefore framed in terms of compliance with relevant standards and demonstration of functional equivalence.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

• Sample Size: Not explicitly stated for specific non-clinical tests. General statements indicate "non-clinical tests were conducted."
• Data Provenance: The tests were conducted internally by Jiangsu Tingsn Technology Co., Ltd. The document refers to "non-clinical tests (integration and functional) were conducted on the TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System during product development."

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

• Not applicable for non-clinical testing. The "ground truth" for non-clinical tests typically refers to engineering specifications, regulatory standards, and established physical principles, not expert interpretations of clinical data.

4. Adjudication Method for the Test Set

• Not applicable for non-clinical testing. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases to establish ground truth or compare diagnostic performance, which was not part of this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. The submission explicitly states: "No clinical data was included in this submission." MRMC studies inherently involve human readers evaluating clinical cases.

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

• Not applicable as an AI/algorithm-only device. The TINGSN FINDERS 2 is a diagnostic ultrasound system that produces images for human interpretation, not an AI algorithm performing diagnosis independently. The software features listed are for image optimization, measurements, and display, assisting the human user, not replacing them in a "standalone" diagnostic role.

7. The Type of Ground Truth Used

• For non-clinical testing: The "ground truth" was established by performance specifications, engineering requirements, and compliance with the international and national standards listed (e.g., IEC, ISO, NEMA, ASTM, FDA guidance). This includes electrical safety, mechanical robustness, image quality parameters (resolution, penetration, consistency), acoustic output levels, and software functionality validation against design requirements.

8. The Sample Size for the Training Set

• Not applicable. This device is a traditional ultrasound system, not an AI/ML product that undergoes "training."

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

• Not applicable. See point 8.

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V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System:

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) and Peripheral vessel. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients. Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.

V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System:

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac), Peripheral vessel and Dermatology. It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients. Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode, MV-Flow Mode.

■ V8/cV8, V7/cV7, V6/cV6
The V8/cV8, V7/cV7, V6/cV6 Diagnostic Ultrasound Systems are general purpose, mobile, software controlled, diagnostic ultrasound systems. Its function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode. The V8/cV8, V7/cV7, V6/cV6 also give the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The V8/cV8, V7/cV7, V6/cV6 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

■ V5/cV5, V4/cV4
The V5/cV5, V4/cV4 Diagnostic Ultrasound Systems are general purpose, mobile, software controlled, diagnostic ultrasound systems. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, Pulsed wave (PW) Doppler, Continuous wave (CW) Doppler, Color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), Power Amplitude Doppler, Pulse Inversion Harmonic Imaging (S-Harmonic), Directional Power Doppler (S-Flow), Color M-Mode, 3D Imaging Mode, 4D Imaging Mode, Elastoscan+ Mode, Tissue Harmonic Imaging, MV-Flow Mode or as a combination of these modes. The V5/cV5, V4/cV4 diagnostic ultrasound systems also give the operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The V5/cV5, V4/cV4 diagnostic ultrasound systems have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided FDA 510(k) clearance letter describes the Samsung Medison Ultrasound Systems (V8/cV8, V7/cV7, V6/cV6, V5/cV5, V4/cV4) and their AI-powered features: BiometryAssist, ViewAssist, HeartAssist (fetus), and EzNerveMeasure of NerveTrack.

Below is a breakdown of the acceptance criteria and study details for each AI feature, based on the provided text.

BiometryAssist

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Individual Patients: 52 (17 from South Korea, 35 from the US)
• Images: 320 static images
• Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
• Qualifications:
  • One obstetrician with over 20 years of experience in fetal cardiology.
  • Two sonographers, each with more than 10 years of experience.
  • One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).

4. Adjudication Method for Test Set

• Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar, though not explicitly stated as a formal (X+Y) method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

• Yes, performance metrics (Dice-score, error rates) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

• Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.

8. Sample Size for Training Set

• Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

• All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.

ViewAssist

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Individual Patients: 102 (42 from South Korea, 60 from the US)
• Images: 680 static images
• Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
• Qualifications:
  • One obstetrician with over 20 years of experience in fetal cardiology.
  • Two sonographers, each with more than 10 years of experience.
  • One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).

4. Adjudication Method for Test Set

• Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

• Yes, performance metrics (sensitivity, specificity, Dice-score) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

• Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.

8. Sample Size for Training Set

• Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

• All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.

HeartAssist (fetus)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Individual Patients: 70 (26 from South Korea, 44 from the US)
• Images: 280 static images
• Data Provenance: Mix of retrospective and prospective data collection from hospitals in South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 (one obstetrician, two sonographers) + 1 senior obstetrician for supervision.
• Qualifications:
  • One obstetrician with over 20 years of experience in fetal cardiology.
  • Two sonographers, each with more than 10 years of experience.
  • One senior obstetrician with over 25 years of clinical experience (supervised and corrected annotations).

4. Adjudication Method for Test Set

• Expert reviewers manually performed view classification and measurements following the same protocol as used during actual device operation. The entire process was supervised by a senior obstetrician who reviewed and corrected all annotations to ensure consistency and accuracy. This implies an expert consensus-based adjudication, likely 3+1 or similar.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

• Yes, performance metrics (sensitivity, specificity, Dice-score, error rates) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

• Expert Consensus: Ground truth was established by expert reviewers manually classifying views and performing measurements, supervised and corrected by a senior obstetrician. This closely reflects the clinical use environment.

8. Sample Size for Training Set

• Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

• All images used for training and tuning were first classified into the correct ultrasound views by three participating experts. Following view classification, the corresponding anatomical structures were manually annotated for each image.

EzNerveMeasure of NerveTrack

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Individual Patients: 20 (10 from South Korea, 10 from the US)
• Images: 200 static images (10 static images per patient from a 2D sequence)
• Data Provenance: Prospective data collected in clinical practice using Samsung ultrasound systems (RS80A and V8) from South Korea and the United States.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: 3 anesthesiologists + 1 senior anesthesiologist for resolution.
• Qualifications: All three anesthesiologists had over 10 years of experience. The senior anesthesiologist had over 10 years of extensive clinical experience in regional anesthesia and ultrasound-guided procedures.

4. Adjudication Method for Test Set

• The ground truth (GT) for median nerve locations was initially drawn by one anesthesiologist performing the ultrasound scans, then verified by the other two anesthesiologists. Disagreements were resolved by a senior anesthesiologist. This is a consensus-based adjudication process, effectively a 3+1 method for resolving disagreements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not explicitly mentioned. The study focuses on standalone algorithm performance against expert ground truth.

6. Standalone Performance (Algorithm Only)

• Yes, performance metrics (average error rate, confidence interval, standard deviation) are reported for the algorithm's output compared to established ground truth.

7. Type of Ground Truth Used

• Expert Consensus: Ground truth (median nerve locations, FR, CSA measurements) was established by three anesthesiologists, with disagreements resolved by a senior anesthesiologist. A clinical evaluation was also conducted by experienced doctors to assess clinical significance.

8. Sample Size for Training Set

• Not specified. The document only states that data used for training, tuning, and validation were completely separated.

9. How Ground Truth for Training Set Was Established

• Not explicitly detailed for the training set itself, but it implies a similar expert annotation process as described for validation, with clear separation between data sets.

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Intended Use / Indications for Use

EPIQ:

The intended use of Philips EPIQ series diagnostic ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use:

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.

The clinical environments where Philips EPIQ diagnostic ultrasound systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients.

When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgement and best clinical procedure.

Affiniti:

The intended use of the Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:

Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

Modes of operation include: B Mode, M Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Power Doppler, and Harmonic Imaging.

The clinical environments where the Affiniti Diagnostic Ultrasound Systems can be used include Clinics, Hospitals, and clinical point-of-care for diagnosis of patients.

The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed. However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.

The purpose of this Special 510(k) Pre-Market Notification is to expand the Smart View Select (SVS) software application onto the Affiniti Series Diagnostic Ultrasound Systems and to modify the Smart View Select software application onto both the EPIQ Series Diagnostic Ultrasound Systems.

Smart View Select is an automated software feature that assists the user in selection of images for analysis with the existing Philips AutoStrain LV or 2D Auto LV application in Adult Echo Transthoracic (TTE) examination. This feature automatically classifies each acquired image by view and selects an appropriate set of images for left ventricle (LV) analysis. The classification is based on a Deep Learning AI interface engine; the selection is a non-AI algorithm that considers the view classification and image depth to select the optimal set of images.

No hardware changes to the EPIQ or Affiniti systems are required when using SVS, and existing, cleared Philips TTE transducers are used with these software applications.

The SVS v2 feature is supported by all EPIQ models running software version 13.0 or higher including EPIQ CVx/CVxi, EPIQ Elite Advanced, EPIQ Elite, EPIQ 7, EPIQ 5. The SVS v2 feature is supported by the Affiniti models running software version VM13.0 or higher, including Affiniti CVx, Affiniti 70, Affiniti 50, and Affiniti 30. The SVS and SWM software features are associated with the cardiac adult indication.

The provided document details the 510(k) clearance for Philips Ultrasound's EPIQ and Affiniti Series Diagnostic Ultrasound Systems with the Smart View Select (SVS) v2 software. The SVS feature is an automated software that assists users in selecting images for Left Ventricle (LV) analysis using existing Philips AutoStrain LV or 2D Auto LV applications in Adult Echo Transthoracic (TTE) examinations. It classifies acquired images by view using a Deep Learning AI interface and then uses a non-AI algorithm to select an optimal set of images.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The study aimed to demonstrate agreement between LV analysis outputs (Ejection Fraction - EF, and Global Longitudinal Strain - GLS) derived from manually selected clips (ground truth) and automatically selected clips by the SVS software.

2. Sample Size and Data Provenance

• Test Set Sample Size: The exact number of patients or cases in the test set is not explicitly stated as a single number. However, the demographic characteristics section indicates n=71 for various demographic variables like Sex, Age, Height, Weight, BMI, Race, LV systolic function, RWMA, Known CAD, Previous reported MI Location, and LV Hypertrophy, suggesting the test dataset comprised data from at least 71 unique patients.
• Data Provenance: The data was collected from a US-based medical center. The study was a retrospective data analysis.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Three (3) reviewers (clinical experts) participated in establishing the ground truth.
• Qualifications of Experts: They are referred to as "clinical experts." No further specific qualifications (e.g., years of experience, specific board certifications like radiologist/cardiologist) are provided in the document.

4. Adjudication Method for the Test Set

The adjudication method used to establish ground truth was consensus/averaging. For each output (GLS and EF), the average across the three reviewers was used as the ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was described. The study focused on comparing the AI-selected clips' performance (GLS and EF) against the ground truth established by human experts using manually selected clips. There is no information provided regarding how much human readers improve with AI vs. without AI assistance. The study evaluates the AI's ability to select optimal clips, a step that precedes human analysis with AutoStrain LV.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The performance of the SVS software was evaluated solely based on its ability to automatically select appropriate clips, and then the subsequent, un-edited evaluation of GLS and EF through AutoStrain LV using these SVS-selected clips was compared against the human-selected clips. This represents the algorithm's performance in its specific task (clip selection) without direct human intervention in the selection process.

7. Type of Ground Truth Used

The ground truth used was expert consensus. Specifically, it was the average of GLS and EF measurements obtained from clips manually selected and subsequently semi-automatically processed by three clinical experts using the AutoStrain LV software.

8. Sample Size for the Training Set

The document does not provide the sample size used for the training set of the deep learning AI model for image classification. It only states that "the neural network of the subject device was revised as described in attachment 002," implying updates to an existing model rather than a completely new one, but no training data details are given.

9. How Ground Truth for Training Set was Established

The document does not explicitly state how the ground truth for the training set was established. It mentions that the "classification is based on a Deep Learning AI interface engine," but details regarding the training data annotation and ground truth establishment are not provided within the excerpt.

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TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal，abdominal, pediatric , small organ，neonatal and adult cephalic, musculo-skeletal(Conventional and Superficial)，thoracic/pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, Peripheral vessel and urology exams.

This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.

Modes of operation include: B, M, PWD, Color Doppler, Power Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI.

The TE Air Diagnostic Ultrasound System is a general purpose, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in B, M, PWD, Color Doppler, Power Doppler, Combined mode (Color+B, Power+B), Tissue Harmonic Imaging, and TDI mode.

TE Air consists of an app which can be installed on iOS or Android devices, and probes which use wireless technology for communication. The iOS or Android devices could be mobile platform available from the market, or the Mindray's customized Android platform called AirSight.

This FDA clearance letter for the "TE Air Diagnostic Ultrasound System" (K250024) indicates a medical device rather than an AI-powered diagnostic system requiring specific performance metrics like sensitivity, specificity, or AUC. The clearance is based on substantial equivalence to a predicate device, focusing on similar technological characteristics and intended uses.

Therefore, many of the requested details about acceptance criteria, study design for performance, expert qualifications, and AI-specific metrics are not provided or applicable in this document.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output. Instead, the acceptance is based on:

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

• Not Applicable. This document describes the clearance of an ultrasound system, not an AI/ML-powered diagnostic algorithm that would typically require a test set of patient data to evaluate algorithmic performance. The clearance is based on equivalence to a predicate device and adherence to safety and performance standards.

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

• Not Applicable. As per point 2, there is no mention of a test set requiring expert-established ground truth for evaluating a diagnostic algorithm.

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

• Not Applicable. No test set or expert adjudication related to diagnostic performance is detailed in this clearance letter.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant to this clearance document. The TE Air system is a general-purpose diagnostic ultrasound system that interfaces with mobile devices.

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

• Not Applicable. This is a general diagnostic ultrasound system, not an algorithm.

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

• Not Applicable. Ground truth in the context of diagnostic performance evaluation for an algorithm is not mentioned, as this is a device clearance based on equivalence and safety standards.

8. The sample size for the training set:

• Not Applicable. There is no mention of an AI/ML algorithm or a training set for such an algorithm in this clearance document.

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

• Not Applicable. As per point 8, there is no mention of an AI/ML algorithm or a training set.

In summary:

The provided FDA clearance letter is for a "TE Air Diagnostic Ultrasound System" which is described as a general-purpose diagnostic ultrasound system. The clearance is based on demonstrating substantial equivalence to a previously cleared predicate device (TE Air K240906) and adherence to a comprehensive set of non-clinical safety and performance standards. The modifications primarily involve the addition of an "AirSight" platform (a customized Android device), which has reportedly passed related bench tests with no safety risk introduced.

The documentation explicitly states in section 7, "Clinical Studies: Not applicable. The subject of this submission, TE Air Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence." This reinforces that the clearance is not based on a clinical performance study involving diagnostic accuracy metrics or AI algorithm evaluation.

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EPIQ: The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Affiniti: The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.

The R-Trigger algorithm software feature on Philips EPIQ and Affiniti Ultrasound System is intended to support detection of R-wave peak (R-trigger) as an input to certain TTE clinical applications, initially including AutoStrain LV, AutoEF, 2D Auto LV (collectively referred to as "AutoStrain"), and AutoMeasure applications. The R-trigger algorithm is planned to be implemented as workflow enhancement for transthoracic clinical applications on EPIQ and Affiniti Ultrasound Systems in the VM13 software release. The Auto-Measure and AutoStrain features support users during B-mode (2D), CW-, PW- and TDI-Doppler measurements by automating some of the measurements needed to complete a routine transthoracic echo (TTE) exam for adult patients. The R-trigger feature (non-ECG-based) has been developed to enable clinical users to use AutoMeasure and AutoStrain application without the R-trigger (ECG based) input, which is currently required. There are no hardware changes to the EPIQ and Affiniti systems due to change to the introduction of the R-Trigger software application. The software application is supported by all EPIQ and Affiniti models running software version 13.0 or higher.

The provided FDA 510(k) clearance letter describes the R-Trigger software application on Philips EPIQ and Affiniti Ultrasound Systems, which aims to provide an alternative method for detecting R-wave peaks (R-triggers) for cardiac clinical applications like AutoStrain and AutoMeasure, especially when the ECG signal is unavailable or unusable.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the R-Trigger algorithm are related to the agreement of its R-wave time stamp detection with the ground truth (ECG-based R-trigger) and the subsequent impact on the clinical outputs of AutoMeasure and AutoStrain. These are evaluated using Bland-Altman analysis (for agreement, specifically the Upper and Lower Limits of Agreement, LoA) and Pearson's correlation (for correlation, specifically the Lower Confidence Bound, LCB).

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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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