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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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Esaote's Model 6400 is a mainframe ultrasound system diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Other: Urologic. The 6400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Esaote's Model 7400 is a compact ultrasound system used to perform diagnostic general ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic, Small organs, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric and Other: Urologic. The 7400 system provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

Model 6400 is a mainframe system equipped with wheels allowing them to move the system. Model 7400 is a portable system equipped with a handle. The system size and weight allow it to be carried using its handle. The primary modes of operation are for both models: B-Mode, M-Mode, Tissue Enhancement Imaging (TEI), XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping (CFM), Amplitude Doppler (AD) and Tissue Velocity Mapping (TVM). Both 6400 and 7400 are equipped with a LCD color display where acquired images and advanced image features are shown. Both 6400 and 7400 can drive Phased, Convex, Linear array and Doppler probes. 6400 control panel is equipped with a pull-out qwerty alphanumeric keyboard that allows data entry. On 7400 model the touchscreen has an emulation of the qwerty alphanumeric keyboard that allows data entry. Both 6400 and 7400 models are equipped with wireless capability. Model 7400 was designed to be powered by battery.

Both 6400 and 7400 have been cleared via K111302.

6400 and 7400 Upgrade, defined herein, combine the cleared features of both 6400 and 7400 systems with other new software capabilities, listed below:

• 1. Management of motorized probes (Bi-Scan probes) that allow volumetric acquisition.
• 2. Management of 3D/4D mode of operation.
• 3. Management of the acquisition of consecutive ultrasound images on extended surface. The final image is composed of the consecutive frames placed side (Panoramic View or VPan).

The 6400 and 7400 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

This 510(k) summary for the Esaote 6400 and 7400 Ultrasound Systems (K132231) indicates that no clinical tests were performed to establish acceptance criteria or demonstrate device performance.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices and conformity to applicable medical device safety and performance standards.

Therefore, most of the requested information regarding acceptance criteria and performance studies, if they were based on clinical data, cannot be extracted from this document as such studies were explicitly stated as not performed.

However, I can extract information related to the device's technological characteristics and the non-clinical tests performed.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical studies were performed, there are no specific performance metrics (e.g., sensitivity, specificity, accuracy) or quantitative acceptance criteria for diagnostic capability that can be reported from this document.
The acceptance criteria are implicitly based on:

• Substantial Equivalence: The new features and devices (6400 and 7400 Upgrades) are deemed substantially equivalent to previously cleared predicate devices (Esaote 6200, 7340, 6400, 7400 models). This means their performance is expected to be no worse than the predicate devices, which were already deemed safe and effective.
• Conformity to Safety Standards: The devices meet various international and national safety standards.

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

• Not Applicable. No clinical test set data was used as "No clinical tests were performed." The submission relies on comparative data with predicate devices and non-clinical engineering tests.

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

• Not Applicable. No clinical tests were performed, so no expert ground truth for a clinical test set was established as part of this submission.

4. Adjudication Method for the Test Set:

• Not Applicable. No clinical tests were performed.

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 device is an ultrasound imaging system, not an AI-assisted diagnostic tool in the sense of software interpreting images for human readers. No MRMC comparative effectiveness study was done for AI assistance. The submission focuses on hardware and software feature upgrades to existing ultrasound systems.

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

• Not Applicable. This is an ultrasound imaging system, not a standalone algorithm.

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

• Not Applicable. For the purpose of establishing clinical performance, no ground truth data from clinical trials was used, as no clinical trials were performed. The "ground truth" for substantial equivalence is based on the cleared status and established safety and effectiveness of the predicate devices and conformity to engineering standards.

8. The sample size for the training set:

• Not Applicable. No clinical data was used for training purposes, as no clinical tests or AI/machine learning components requiring such training are described.

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

• Not Applicable. No clinical training set was used.

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