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The SV600, SV800 Ventilators are intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilators are intended to provide ventilation assistance and breathing support for adult and pediatric patients with a minimum body weight of 10 kg (all pediatric subgroups except newborns (neonates)). The SV600, SV800 Ventilators should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.

The SV600 and SV800 Ventilators are pneumatically-driven and electronically-controlled ventilators. The Ventilators consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, display, CO2 module, SpO2 module), trolley and support arm.

This document outlines the substantial equivalence of the Mindray SV600 and SV800 Ventilators to a predicate device (Evita XL Ventilator K083050) and reference devices. The submission focuses on technical comparisons and various types of performance testing to demonstrate safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly provide a table of acceptance criteria with corresponding device performance for specific thresholds. Instead, it states that "The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate." It also notes that the device "meets its accuracy specification and is substantially equivalent to the predicate device."

The closest to "acceptance criteria" are the technical characteristics compared to the predicate and reference devices, and the standards the device was tested against. The "reported device performance" is implied by the statement of compliance with these standards and equivalency to the predicate.

Here's an example of how one might infer "acceptance criteria" from the technical characteristics table:

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

The document mentions "functional and system level testing" and "bench testing" but does not specify the sample sizes for these tests. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective) for any of the testing. The nature of these tests (bench, functional, system level) generally implies laboratory or simulated environments, rather than patient data from a specific country or clinical setting.

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

This information is not provided in the document. The testing described (biocompatibility, software, EMC, electrical safety, bench testing) does not typically involve "experts establishing ground truth" in the way a clinical study would. These are generally engineering and performance evaluations against defined specifications and standards.

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

This information is not provided. Adjudication methods are typically relevant in clinical studies (e.g., for image interpretation or diagnosis) to resolve discrepancies between multiple evaluators. The types of testing described here (functional, system, bench, safety, EMC) do not involve such adjudication.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This document describes a ventilator (hardware and software for life support), not an AI-assisted diagnostic or interpretative device that would typically involve human "readers" or "AI assistance" in that context.

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

The document does not explicitly use the term "standalone" in the context of an algorithm. However, the majority of the testing described (software verification and validation, electromagnetic compatibility, electrical safety, bench testing) are inherently evaluations of the device's performance without continuous human intervention during the test itself, focusing on the device's adherence to specifications and standards. The "human factors testing" mentioned relates to the usability and user interface, ensuring safe and effective interaction for the intended users (medical personnel), rather than a "human-in-the-loop" performance study of an AI algorithm.

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

The concept of "ground truth" as typically understood in clinical or AI performance studies (e.g., pathology for a biopsy, expert consensus for an image diagnosis) is not directly applicable or explicitly stated for the types of testing described. For this device (ventilator), the "ground truth" for its performance is its adherence to:

• Engineering specifications (e.g., flow range, pressure range accuracy)
• Consensus standards (e.g., ISO, IEC for safety, EMC, performance characteristics)
• Functional requirements (e.g., does it deliver the correct ventilation modes)

These are verified through various physical and software tests against known engineering principles and standardized test methods.

8. The sample size for the training set

This information is not applicable/not provided. Ventilators are not typically "trained" using data sets in the way AI/ML algorithms are. This is a traditional medical device whose functionality is based on pre-programmed logic, control algorithms, and pneumatic/electronic design.

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

This information is not applicable/not provided for the same reason as point 8.

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The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/M9 Premium Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.

It is intended for use in fetal, abdominal, Intra-operative, Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-raginal, musculo-skeletal(conventional, superficial), 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 healtheare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended tc 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, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

The M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound data in 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, TDI, Color M, Elastography, Contrast imaging (Contrast agent for LVO), Smart 3D, 4D(Real-time 3D), Contrast imaging (Contrast agent for Liver).

This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array probe.

This document is a 510(k) Premarket Notification from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. for their M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System.

Based on the provided text, the device in question is a general diagnostic ultrasound system, and the submission is for the addition of a new transducer, P8-2s, to an already cleared system (K210416).

Therefore, the performance data provided is not for a new AI/ML-driven medical device requiring extensive clinical or standalone performance studies against set acceptance criteria, but rather for a modification to an existing device.

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

This indicates that a formal study proving the device meets specific acceptance criteria in the way a novel AI/ML device would is not present in this submission. Substantial equivalence for this modification is based on non-clinical tests and comparison to a predicate device.

Given this, I cannot provide the detailed information requested regarding acceptance criteria, test set sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these types of studies were not deemed necessary for this particular 510(k) submission.

The "acceptance criteria" for this submission are fundamentally satisfied by demonstrating:

1. Technological Characteristics Similarity: The new P8-2s transducer has comparable design principles and parameters to existing transducers.
2. Safety Compliance: The device and the new transducer comply with recognized electrical, physical, and acoustic safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, ISO 10993-1, IEC 62366-1, IEC 60601-1-6).
3. Biocompatibility: Materials used are biocompatible (specifically Valox 3706, MLG-34-G/MLG-34-N, RTV162, RTV167 for the P8-2s probe shell, acoustic lens, and mucilage glue).
4. Cleaning, Disinfection, and Sterilization Effectiveness: The design allows for effective reprocessing.
5. Acoustic Output: The acoustic output is below the FDA limits (Ispta.3 < 720mW/cm2 and either MI=1.9 or Isppa.3 < 190W/cm2).

To summarize from the provided document:

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

• Acceptance Criteria (Implicit for a modification based on substantial equivalence):
  • Maintain performance characteristics and safety profile of the predicate device.
  • Compliance with recognized industry standards for medical ultrasound devices.
  • Biocompatibility of new components.
  • Acceptable acoustic output.
• Reported Device Performance:
  • New P8-2s transducer (5MHz, Phased, 96 elements) is designed to acquire and display ultrasound data in various modes (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined Modes, Tissue Harmonic Imaging, iScape, Color M, Smart 3D, TDI) for specific indications (Abdominal, Pediatric, Neonatal Cephalic, Adult Cephalic, Musculo-skeletal (Conventional), Cardiac Adult, Cardiac Pediatric).
  • Acoustic output is "below Ispta.3 = 720mW/cm2 and either MI=1.9 or Isppa.3 = 190W/cm2".
  • Compliance with various medical device safety and performance standards (listed in section 7).

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

• Not applicable for this type of submission. No clinical test set data from patients is described. The testing performed was non-clinical (e.g., electrical safety, acoustic output measurements) on the device itself.

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

• Not applicable. No clinical ground truth establishment or expert review of images is mentioned.

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

• Not applicable. No clinical image review or adjudication was performed for this submission.

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 submission is for a diagnostic ultrasound system and a new transducer, not an AI/ML-assisted image interpretation device.

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

• Not applicable. This submission is for a diagnostic ultrasound system and a new transducer, not an AI/ML algorithm.

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

• Not applicable. Ground truth in the context of clinical performance evaluation is not relevant here as no such evaluation was conducted. The "ground truth" for this submission relates to engineering verification and validation against known standards and specifications.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. As above.

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Resona R9/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9/Nuewa R9 Pro/Nuewa R9 Pro/Nuewa R9S/Resona 7/ Resona 7CV/Resona 7EXP/Resona 7OB/Resona 7OB/Resona Y / Resona R9W/ Resona R9W/ Resona R7W/ Nuewa R9W/ Nuewa R7W Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel,urology exams.

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

Modes of operation include: B, M, PWD(Pulse wave Doppler), CWD(Continuous wave Doppler), Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 4D(Real-time 3D), iScape View, TDI(Tissue Doppler Imaging), Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO(Left Ventricular Opacification)), V Flow(Vector Flow), STE(Sound Touch Elastography), STQ(Sound Touch Quantification), Contrast imaging (Contrast agent for Liver).

The Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y, Resona R9W, Resona R7W, Nuewa R9W. Nuewa R7W Diagnostic Ultrasound System is a general purpose. mobile, software controlled, ultrasonic diagnostic system.

This system is a Track 3 device that employs an array of probes that include linear array, Phased array, pencil phased and convex array.

The provided text describes a 510(k) premarket notification for the Resona R9 series Diagnostic Ultrasound System, which introduces modifications and new features to an already cleared predicate device (Resona R9, K202785). The submission focuses on demonstrating substantial equivalence to the predicate devices, rather than comprehensive clinical studies on the device's diagnostic performance for specific conditions.

The study presented here is a non-clinical validation of new features against predefined engineering performance criteria, primarily using phantom studies.

Here's the breakdown of the information requested, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are specified for three new features: FH Tissue Tracking QA, UltraSound ATtenuation analysis, and HepatoRenal Index Plus. These are performance metrics related to the accuracy of quantitative measurements.

Additional Information on the Study:

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

   • FH Tissue Tracking QA: 10 fetal heart B-mode image samples. Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but the context of non-clinical testing with "image samples" suggests these were likely existing or specifically generated images, not new prospective patient data for this submission.
   • UltraSound ATtenuation analysis: Four groups of phantoms.
   • HepatoRenal Index Plus: Four groups of H/R-ROIs in a phantom.
   • Data Provenance: For the quantitative features, the testing primarily involved phantoms or existing image samples rather than new prospective patient data. The document does not specify country of origin for any human data or the retrospective/prospective nature of image samples.

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

   • FH Tissue Tracking QA: Ground truth was established by "manual-obtained values." The number of experts and their qualifications (e.g., "radiologist with 10 years of experience") are not specified.
   • UltraSound ATtenuation analysis & HepatoRenal Index Plus: Ground truth was established by the "calibrated value of the phantom" or "target value of the phantom." This implies a reference standard from the phantom's known properties, not human experts.

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

   • For the quantitative measurements using phantoms, adjudication is generally not applicable as the phantom itself provides the ground truth.
   • For "FH Tissue Tracking QA" where "manual-obtained values" are compared, the adjudication method is not specified.

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 MRMC comparative effectiveness study was done. The document explicitly states: "Clinical Studies: Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." The studies described are non-clinical engineering performance assessments of new features.

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

   • The tests for "FH Tissue Tracking QA", "UltraSound ATtenuation analysis", and "HepatoRenal Index Plus" assessed the performance of the algorithm/system in extracting quantitative measurements, comparing them to ground truth (manual measurement or phantom values). This is essentially a standalone (algorithm only) performance evaluation for these specific features.

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

   • FH Tissue Tracking QA: Manual-obtained values (presumably from an expert, though not detailed).
   • UltraSound ATtenuation analysis & HepatoRenal Index Plus: Calibrated/target values of phantoms (physical reference standards).

7. The sample size for the training set:

   • The document does not provide information regarding the sample size for any training set. This submission is for a modification/upgrade to an existing device, and the focus is on the performance of added features rather than the development of the core algorithm from fresh training data.

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

   • Since information on a training set is not provided, how its ground truth was established is also not specified.

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Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates.

It is intended for use in fetal, abdominal, Intra-operative, 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, Trans-esoph., peripheral vessel and urology exams.

Modes of operation include: B, M, PWD, 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(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, STE, STQ, 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.

Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T 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(Real-time 3D), iScape View, TDI, Color M, Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver). Subject device can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or reported device performance metrics for the Consona N9/N8/N7 series Diagnostic Ultrasound System. The submission is a 510(k) premarket notification for substantial equivalence, not a performance study against specific acceptance criteria.

The document primarily focuses on demonstrating that the subject device is substantially equivalent to legally marketed predicate devices (primarily the Mindray MX7, K212900) in terms of intended use, imaging modes, features, functions, and technological characteristics.

Instead of a table of specific performance metrics, the document highlights:

• Indications for Use: The subject device's indications are comparable to the predicate.
• Patient Contact Materials: Same as predicate or tested under ISO 10993-1.
• Acoustic Power Levels: Below FDA limits and same as the predicate (MX7).
• Electrical and Physical Safety Standards: Complies with FDA recognized standards, same as the predicate (MX7).
• Features and Functions: Same as predicate devices, with new options being either improvements or enhancements of cleared functions, with no new intended uses or clinical risks introduced.

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

The document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."

Therefore, there is no test set, no sample size, and no data provenance (e.g., country of origin, retrospective/prospective) related to clinical performance for this submission. The evaluation is based on non-clinical tests and comparison to predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

As there were no clinical studies conducted and no test set, this information is not applicable. Ground truth for clinical performance was not established by experts for this particular submission.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used for performance evaluation.

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

No MRMC study was done, as the document states that clinical studies were not required and were not performed. Therefore, there's no reported effect size of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone performance study of an algorithm was conducted or reported, as this is a general-purpose diagnostic ultrasound system, not an AI-driven diagnostic algorithm. The new features like "Smart Calc" are described as semi-automatic tools that assist the user, implying a human-in-the-loop design, but no performance study specific to this feature is detailed.

7. Type of Ground Truth Used

Given the absence of clinical studies, there is no mention of ground truth established through expert consensus, pathology, or outcomes data. The basis for substantial equivalence relies on technical specifications, compliance with safety standards, and functional comparison to predicate devices, rather than clinical performance data against a defined ground truth.

8. Sample Size for the Training Set

Not applicable. This submission concerns a diagnostic ultrasound system and does not involve an AI model with a distinct "training set" in the conventional sense of machine learning algorithms requiring large datasets for training. The "new options" like Smart Calc are described as improvements or enhancements but not as standalone AI algorithms whose performance requires training and validation datasets.

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

Not applicable, as there was no training set for an AI model.

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

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

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ The TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

The provided text does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria related to an AI/algorithm feature.

The document is a 510(k) premarket notification for an ultrasound system (TEX20 series). It primarily focuses on demonstrating substantial equivalence to a predicate device (TEX20, K212265, and Resona I9, K210699).

Here's what the document does state, and why it doesn't fit the requested criteria for an AI performance study:

• New Added Features: The subject device introduces two new features: "AutoEF" and "AutoEF Plus."
  • "AutoEF" has been previously cleared in the predicate device Resona I9 (K210699).
  • "AutoEF Plus" is described as an "improved feature of the AutoEF... which could be used to automatically measure the systole or diastole views in real time."
• "Clinical Studies - Not Applicable": Crucially, the document explicitly states: "Not applicable. The subject of this submission, TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10 / TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

This indicates that the FDA clearance for this device, even with the "AutoEF Plus" feature, was based on non-clinical testing and substantial equivalence arguments, not a performance study that would typically involve acceptance criteria for an AI algorithm's diagnostic accuracy or performance against a ground truth. The "AutoEF Plus" feature, while automated, is treated as an improved feature of an already cleared function, rather than a novel AI diagnostic tool requiring extensive clinical validation against specific performance metrics for this particular submission.

Therefore, I cannot provide the requested table and details because the information is not present in the provided document. The document suggests that the device's clearance was not based on the type of clinical performance study you've described for an AI/algorithm.

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TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite/TEX10 Pro/TEX10S/TEX10S/TEX10T/TEX10 Exp/ TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), ThoracicPleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.

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

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ The Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X TEX10 Lite 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 document does not contain information about acceptance criteria or a specific study proving the device meets those criteria. The provided text is a 510(k) summary for a Mindray diagnostic ultrasound system, focusing on demonstrating substantial equivalence to predicate devices rather than reporting on a study with acceptance criteria.

The document states: "Not applicable. The subject of this submission, TEX20/TEX20 Pro/TEX20S/ TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 / TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, I cannot provide the requested information.

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The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic.adult cephalic.trans-rectal, trans-vaginal, musculo-skeletal(supertional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.

DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, PW-mode, PW-mode, CW mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, TDI mode, Color M mode, Biopsy Guidance, Elastography, or the combined mode (i.e. B/M-Mode). This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 10.0MHz.

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System. It describes the device's intended use and compares it to predicate devices to establish substantial equivalence. However, it explicitly states that clinical studies were not required or performed to demonstrate substantial equivalence for this device. Therefore, a study proving the device meets specific acceptance criteria based on clinical performance data is not detailed in this document.

The acceptance criteria mentioned are general safety and performance standards rather than specific clinical performance metrics. The document instead focuses on demonstrating that the new device is substantially equivalent to previously cleared devices through non-clinical testing.

Here's a breakdown of the requested information based on the provided text, with a clear indication when the information is not present or not applicable due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission asserting substantial equivalence based on non-clinical testing and comparison to predicates, the "acceptance criteria" are compliance with recognized standards and similarity to predicate devices. Specific performance metrics (e.g., sensitivity, specificity for a particular clinical task) are not provided as acceptance criteria for this type of submission.

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

• Not applicable for clinical performance data. The submission states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."
• For non-clinical tests (acoustic output, biocompatibility, electrical safety, etc.), the sample sizes are not specified in this summary. Data provenance would be from internal lab testing conducted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. in China.

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

• Not applicable. No clinical test set with ground truth established by experts is mentioned in this 510(k) summary.

4. Adjudication method for the test set

• Not applicable. No clinical test set and thus no adjudication method is mentioned.

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, an MRMC comparative effectiveness study was not done. The document explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." This device is a Diagnostic Ultrasound System, not an AI-assisted diagnostic tool that would typically undergo such studies.

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

• Not applicable. This device is a diagnostic ultrasound system; performance is inherently "human-in-the-loop" as it requires a trained operator to acquire and interpret images. There is no mention of a standalone algorithm's performance.

7. The type of ground truth used

• Not applicable for clinical performance. For non-clinical tests (e.g., electrical safety, acoustic output), ground truth is established by recognized standards and calibrated measurement equipment.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" for an algorithm, as this is a diagnostic ultrasound imaging system, not an AI/ML-based diagnostic device in the context of this submission.

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

• Not applicable. No training set for an algorithm is mentioned.

In summary, this 510(k) submission establishes substantial equivalence for a diagnostic ultrasound system primarily through a comparison to predicate devices and adherence to recognized non-clinical safety and performance standards. It does not involve clinical performance studies with specific acceptance criteria, test sets, expert ground truth, or AI algorithm validation.

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The Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), adult cephalic, trans-rectal, trans-vaginal,musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, PW-mode, CW mode, Color-mode, Power/Dirpower mode, TDI mode, 3D/4D mode, Color M-mode, iScape mode, Elastography, LVQ, Ultrasound Fusion Imaging, V Flow or the combined mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 13.5MHz.

This document describes a 510(k) premarket notification for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd.'s Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System. This submission is for modifications and new features to a previously cleared device (K152763).

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

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

The document does not explicitly present a table of acceptance criteria with reported device performance metrics in numerical terms (e.g., sensitivity, specificity, or image quality measures). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through compliance with recognized standards and verification that the added features function as intended and safely.

The key acceptance criteria appear to be:

• Identical Intended Use: The modified device has the same intended uses as the predicate device K152763.
• Safety Standards Compliance: The device meets recognized electrical, physical, and acoustic safety standards.
• Biocompatibility: Patient-contact materials of new transducers and needle-guided brackets meet ISO 10993-1.
• Acoustic Output Levels: Acoustic power levels are below FDA limits and are the same as the predicate device.
• Software Life Cycle Processes: Compliance with IEC 62304.
• Usability Engineering: Compliance with IEC 62366 and IEC 60601-1-6.
• Risk Management: Compliance with ISO 14971.
• Cleaning and Disinfection Effectiveness: Evaluated.
• Functionality of New Features: The newly added features are identical in function to those on predicate devices (implicitly meaning they perform as expected and no new safety/effectiveness concerns are introduced).

Reported Device Performance:
The document does not provide specific numerical performance data for these criteria (e.g., exact acoustic output levels, numerical results for electrical safety tests, or detailed biocompatibility reports). Instead, it states that the device has "been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety," and that it "has been designed to conform with applicable medical safety standards." For the new features, it states they are "identical as the predicated devices" in functionality.

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

The document explicitly states: "7. Clinical Studies - Not applicable. The subject of this submission, Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

Therefore, there is no clinical test set or associated data provenance (country of origin, retrospective/prospective) mentioned in this submission. The evaluation relies on non-clinical testing and comparison to predicate devices.

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)

Since no clinical studies were performed and no clinical test set was used, there is no mention of experts establishing ground truth for a test set.

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

As no clinical test set was used, 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 comparative effectiveness study was reported. This device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and the submission is for substantial equivalence based on hardware and software modifications, not AI performance.

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

No standalone algorithm performance study was done or reported as this is a diagnostic ultrasound system and not an AI algorithm.

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

Since no clinical studies were conducted, there is no ground truth established from clinical data (expert consensus, pathology, outcomes data). The "ground truth" for demonstrating substantial equivalence is adherence to recognized industry standards and direct comparison of specifications and functionality with previously cleared predicate devices.

8. The sample size for the training set

No training set is mentioned as this submission is not about an AI/machine learning model.

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

Not applicable, as no training set was used for an AI/machine learning model.

In summary, this 510(k) submission demonstrates acceptance through non-clinical testing and comparison to predicate devices rather than clinical performance studies. The core argument for acceptance is that the device, with its modifications, is substantially equivalent in safety and effectiveness to existing cleared devices based on compliance with established standards and the functional identity of its features.

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