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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, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), cardiac adult, cardiac pediatric, trans-esoph. (cardiac), 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, THI, TDI mode, 3D/4D mode, Color M mode, iScape mode, Strain Elastography, Contrast imaging(LVO and Liver), Ultrasound Fusion Imaging, V Flow, STE, STQ 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.

The provided document is a 510(k) Premarket Notification from Shenzhen Mindray Bio-Medical Electronics Co., Ltd. to the FDA regarding their Resona 7 Diagnostic Ultrasound System. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily for proving novel clinical claims or improved clinical effectiveness through extensive clinical trials.

Therefore, the document does not contain information on acceptance criteria for an AI/CADe device's performance, nor does it detail a study proving such performance in the way a clinical study for a novel AI algorithm would. Instead, it focuses on demonstrating that a modified ultrasound system remains substantially equivalent to its predicate.

However, based on the structure of your request and assuming this was a document from which one hoped to extract such information about a theoretical AI/CADe device, I will explain why most of your requested points cannot be answered from this document and what information is relevant to the device's acceptance.

This document is for an ultrasound imaging system, not an AI/CADe device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to traditional ultrasound device performance and safety, not AI algorithm performance.

Here's an analysis based on the provided document:

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

The document does not provide a table of acceptance criteria for AI performance. The acceptance criteria for this ultrasound system are related to its safety, electrical performance, acoustic output, and imaging capabilities being equivalent to the predicate device. The performance is "proven" by compliance with recognized standards and comparison to the predicate.

• Acceptance Criteria (Implicit for a traditional ultrasound device K-submission):

  • Substantial equivalence to predicate device in terms of intended use, technology, safety, and effectiveness.
  • Compliance with recognized safety standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37).
  • Acoustic output levels below FDA limits.
  • Biocompatibility of patient-contacting materials (for new transducers/brackets).
  • Effective cleaning and disinfection.
  • Software lifecycle processes compliance (IEC 62304).
  • Risk management (ISO 14971).
  • Imaging modes and features perform similarly to predicate.

• Reported Device Performance: The document states that the device "has been found to conform with applicable medical safety standards" and "is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market." It doesn't present specific quantitative performance metrics like sensitivity, specificity, or AUC as one would expect for an AI/CADe device, but rather confirms compliance with established engineering and safety benchmarks relevant to ultrasound systems.

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

This document is for a traditional ultrasound imaging system submission (510(k)), not an AI/CADe device. Therefore, it does not describe a "test set" or "data provenance" in the context of an AI algorithm being evaluated on a dataset of patient images.

The "testing" mentioned refers to engineering and safety tests on the physical device and its software, not performance on a clinical image dataset for diagnostic accuracy.

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

Not applicable. This is not an AI/CADe device that requires expert-established ground truth for a test set. The "ground truth" for the device's function is its ability to produce images and measurements according to its specifications and to operate safely, which is verified through engineering tests and comparison to the predicate.

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

Not applicable, for the same reasons as point 3.

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 a 510(k) for an ultrasound system, not an AI-assisted device. The "multi-reader multi-case" study design is typical for evaluating the impact of AI on human reader performance, which is not relevant to this submission.

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

Not applicable. This is not an AI algorithm. Its performance is inherent in its operation as an imaging system.

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

Not applicable for an AI/CADe device. The "ground truth" for this ultrasound system relates to its technical performance and safety, which are evaluated against engineering standards and comparison to a predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/CADe device that has a "training set."

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

Not applicable. This is not an AI/CADe device that has a "training set."

Summary from the document's perspective:

The document describes a 510(k) submission for a Diagnostic Ultrasound System (Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB). The core of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices (primarily K162267, Resona 7, and others like DC-8, ZS3).

The "acceptance criteria" and "study" are therefore focused on:

• Safety and Effectiveness: Ensuring the new/modified device is as safe and effective as the predicate.
• Compliance with Standards: A list of recognized consensus standards is provided (e.g., AAMI/ANSI ES60601-1 for electrical safety, IEC 60601-1-2 for EMC, IEC 60601-2-37 for ultrasonic equipment, ISO 14971 for risk management, ISO 10993 for biocompatibility, NEMA UD 2 for acoustic output). The "study" is the non-clinical testing performed to show compliance with these standards.
• Functional Equivalence: The device employs the same underlying technology (ultrasonic energy transmission and processing), has the same intended uses (e.g., fetal, abdominal, cardiac exams), and generally the same basic operating modes as its predicate. New transducers and features are added, but they are evaluated in the context of the device remaining substantially equivalent.

The document explicitly states under "8. Clinical Tests: Not Applicable," which further confirms that no clinical studies (like those evaluating AI diagnostic performance or human reader improvement with AI) were conducted or required for this particular 510(k) submission.

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Esaote's Model 6200 is a mainframe 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, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6200 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 6250 is a mainframe 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, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6250 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.

The Virtual Navigator software option for Esaote models 6200 and 6250 is intended to support a radiological clinical ultrasound examination (first modality) and follow percutaneous procedures or surgical operations providing additional image information from a second imaging modality (CT, MR, US and PET). The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Gynecological, Musculo-skeletal, Obstetrics, Pediatric, Urologic, Small Organs, Peripheral Vascular and Transcranial for radiological examinations only.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

Both 6200 and 6250 models are mainframe ultrasound systems used to perform diagnostic general ultrasound studies. The primary modes of operation are for both systems: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). Both 6200 and 6250 are equipped with an LCD color display where acquired images and advanced image features are shown.

The Virtual Navigator is a software option designed to support a radiological clinical ultrasound examination (first modality) and follow a percutaneous procedure providing additional image information from a 2nd imaging modality (CT, MR or US). The user is helped in assessing the patient anatomy by displaying the image generated by the 2nd modality.

6200 models including Virtual Navigator software option have been cleared by K100931; 6250 models including Virtual Navigator software option have been cleared by K103152. Virtual Navigator has also been cleared for use with 6100 and 6150 models by K081386.

The purpose of this submission is to introduce an upgrade to both Esaote 6200 and 6250 models to add additional software capabilities. 6200 and 6250 Upgrades, defined herein, combine the cleared features of both 6200 and 6250 models with other new software capabilities related to the Virtual Navigator software option and listed below:

• Navigation Software new user interface .
• Tracking System new Ascension tracking module managing also needle and motion . sensors
• Second Modality Data Acquisition multi dataset management (MRI, PET, CT, US via . Dicom - US including acquisition and navigation)
• New Indications: Gynecological, Obstetrics, Pediatric, Small Organs, Transcranial .
• Registration Techniques added one point registration .
• Target Definition introduced intelligent positioning .
• Planning updated needle table .
• 3D Panoramic ●

The 6200 and 6250 Upgrades are manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

The provided text is a 510(k) Summary for the Esaote 6200 and 6250 Ultrasound Systems, specifically for upgrades and additional software capabilities, including the Virtual Navigator. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or clinical study results for novel performance claims.

Here's a breakdown of why many sections of your request cannot be fulfilled based on the provided text:

• No new performance claims: The core of this submission is to demonstrate that the upgraded devices have "substantially equivalent" technological characteristics and intended uses to previously cleared devices. This means that explicit "acceptance criteria" and "device performance" in terms of clinical accuracy or effectiveness for new features are generally not established or reported in such a submission. Instead, the upgrades are deemed equivalent to existing cleared devices and features.
• No clinical tests performed: The document explicitly states: "No clinical tests were performed." Therefore, there will be no information on sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance for the current submission.
• "Ground Truth" not applicable for a substantial equivalence submission of this nature: Since clinical performance is not being newly established, there's no need for "ground truth" to be defined for primary performance endpoints in this context. The substantial equivalence argument relies on the safety and performance characteristics being similar to already cleared devices.

Based on the provided text, here is the information that can be extracted or deduced:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as it is a 510(k) submission focused on substantial equivalence to predicate devices, not on establishing new performance claims with specific acceptance criteria. The submission states that the "6200 and 6250 Upgrades are substantially equivalent to the legally marketed devices and conform to applicable medical device safety and performance standards."

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

Not applicable/Not provided. The document explicitly states: "No clinical tests were performed." Therefore, there is no test set, sample size, or data provenance from clinical trials to report for this submission.

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

Not applicable/Not provided. As no clinical tests were performed and no new performance claims requiring ground truth establishment were made, this information is not relevant to this submission.

4. Adjudication Method for the Test Set

Not applicable/Not provided. As "No clinical tests were performed," there was no test set or adjudication method.

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

No. The document explicitly states: "No clinical tests were performed." Therefore, no MRMC study was conducted for this submission.

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

No. The document explicitly states: "No clinical tests were performed." Given that the submission focuses on upgrades to an ultrasound system and its software (Virtual Navigator), the "algorithm only" performance would typically refer to the Virtual Navigator's accuracy, but this was not evaluated in a standalone clinical fashion as part of this submission. Its equivalence is based on prior clearances and comparison to a predicate device's feature.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided. As "No clinical tests were performed," a new ground truth was not established for performance assessment in this submission. The device's safety and effectiveness are established through conformance to standards and substantial equivalence to predicate devices that would have had their performance and safety previously evaluated.

8. The Sample Size for the Training Set

Not applicable/Not provided. This submission is for an upgrade to existing ultrasound systems and software, asserting substantial equivalence to previously cleared devices. It does not describe a new algorithm that would have a distinct training set. The upgrades relate to user interface, tracking systems, multi-dataset management, new indications, registration techniques, target definition, and 3D Panoramic features, which are presented as either previously cleared features or substantially equivalent to features on predicate devices.

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

Not applicable/Not provided. As there is no described training set for a new algorithm in this submission, the method for establishing ground truth for such a set is not relevant or provided.

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Esaote's Model 6250 is a mainframe ultrasound system used to perform diagnostic general ultrasound studies including Cardiac. Transesophageal, Peripheral Vascular, Neonatal Cephalic, Adult Cephalic. Small organ, Musculoskeletal (Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal, Pediatric, Intraoperative (Abdominal), Laparoscopic and Other: Urologic. The 6250 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.

The Virtual Navigator is a MyLab optional license that provides additional image information from a second modality like CT or MR, during a clinical ultrasound session. The second modality provides additional security in assessing the morphology of the ultrasound image.

Virtual Navigator can be used in the following application: Abdominal, Musculo-skeletal, Urologic, and Vascular.

The second modality image is not intended to be used as a standalone diagnostic image since it represents information of a patient that could not be congruent with the current (actual) patient position and shall therefore always been seen as an additional source of information.

The Virtual Navigator tracking system should not be used on or around persons with a cardiac pacemaker, and should not be used around life supporting equipment.

The 6150 is a mainframe ultrasound system, used to perform diagnostic general ultrasound studies. Its primary modes of operation are: B-Mode, XView, Multi View (MView), Trapezoidal View (TPView), Doppler, Color Flow Mapping, Amplitude Doppler (AD), Tissue Velocity Mapping (TVM) and Tissue Enhancement Imaging (TEI). The system is equipped with a LCD Color Display, a control panel and is capable of operating Linear, Convex, and Phased array probes.

The modified 6150, with respect to the cleared version 6150 via K051308, K052805, K060827, K081386 and K091009, is due to the improvements of the system. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• a. New keyboard (control panel), where some control keys (knobs and keys) have been replaced by a touch screen.
• b. New plastic housing of the system both to include the touch screen and to give a new style
• c. New keyboard group PCBs lay out to interface the touch screen and to match the new organization of the panel keys.
• Software/Firmware modification to translate the touch screen information for the d. software: main software characteristics and performances have not been changed.

The 6250 is the model name of the modified 6150. The set of probes of the 6150 is exactly the same.

The 6250 system is manufactured under an ISO 9001:2000 and ISO 13485 certified quality system.

The provided Special 510(k) Summary for the Esaote 6250 System describes modifications to a previously cleared ultrasound system (6150). The document does not describe a new study to establish acceptance criteria or device performance, but rather attests that the modifications do not alter the fundamental scientific technology or intended use. Therefore, the device meets the previously established acceptance criteria by demonstrating substantial equivalence to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a Special 510(k) for device modifications, explicit "acceptance criteria" for a new study are not presented. Instead, the justification relies on the modified device (6250) maintaining the same performance and safety characteristics as the predicate devices (6150 cleared via K051308, K052805, K060827, K081386 and K091009). The "performance" assessment is based on the nature of the modifications not affecting clinical functionality.

The document implicitly refers to the performance of the predicate device for all clinical applications. The "Reported Device Performance" for the 6250 system is therefore considered to be equivalent to the previously cleared 6150 system, as the modifications were primarily cosmetic (new keyboard, plastic housing, PCB layout) and software/firmware changes not affecting main software characteristics and performances.

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

The document does not describe a new test set or a new study with a specific sample size. The modifications are justified based on their nature, not requiring new clinical performance data to demonstrate equivalence. Therefore, there is no mention of sample size or data provenance (country of origin, retrospective/prospective). This is typical for a Special 510(k) submission where changes are considered minor and do not impact safety or effectiveness.

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

Since no new test set or clinical study is described, there is no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set

As no new test set or clinical study is described, no adjudication method is mentioned.

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

No MRMC comparative effectiveness study was performed or is mentioned in this Special 510(k) summary, as the modifications did not warrant a new clinical efficacy trial. The submission seeks to demonstrate substantial equivalence based on the nature of the changes.

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

This device is an ultrasound imaging system with optional features (Virtual Navigator). It is not an "algorithm-only" or AI-driven diagnostic device as understood in the context of standalone performance studies for AI. The modifications described pertain to hardware and user interface elements, and minor software updates that did not change the core performance. Therefore, a standalone performance study is not applicable and not described.

7. Type of Ground Truth Used

No new ground truth was established for this Special 510(k). The regulatory approval relies on the ground truth previously established for the predicate 6150 system, which would have been based on established clinical and technical standards for ultrasound imaging.

8. Sample Size for the Training Set

Since no new algorithms or machine learning components are introduced that require a training set, the document does not mention any sample size for a training set.

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

Not applicable, as no new training set or machine learning algorithms are described in this Special 510(k) submission.

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