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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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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.

Ask a specific question about this device

The Resona 7/Resona 7CV/Resona 7S/Resona 7S/Resona 7OB 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-vaginal,musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB 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 represents an FDA 510(k) clearance letter for an ultrasound system, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for an AI algorithm.

Therefore, many of the requested details about acceptance criteria, study sample sizes, expert involvement, and ground truth for an AI device are explicitly stated as "Not Applicable" or cannot be extracted from this document, as this is for a general diagnostic ultrasound system and not specifically an AI-powered diagnostic algorithm.

Here's the information that can be extracted and a clear indication where the requested information is not available in this document:

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

This document does not provide specific performance acceptance criteria with numerical targets (e.g., sensitivity, specificity, or image quality metrics) or reported device performance for an AI algorithm. The device, a Diagnostic Ultrasound System, is cleared based on substantial equivalence to predicate devices and compliance with safety and performance standards. The "performance" described is largely about its functional capabilities and safety.

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

This information is not provided in the document. The document states "Non-clinical Tests:" and lists compliance with standards, but no details on specific test sets for performance evaluation (especially for an AI component) are given. Clinical tests are explicitly stated as "Not Applicable."

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)

This information is not provided in the document. No clinical test data or expert-adjudicated ground truth is mentioned.

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

This information is not provided in the document, as no specific test set requiring adjudication is described.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not mentioned in this document. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool needing such a study for this clearance.

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

This information is not provided and is not applicable to this type of device clearance. The device described is a diagnostic ultrasound system that produces images for human interpretation, not a standalone AI algorithm.

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

This information is not provided in the document. Clinical tests are explicitly stated as "Not Applicable."

8. The sample size for the training set

This information is not provided in the document. No AI algorithm development with a training set is discussed.

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

This information is not provided in the document. No AI algorithm development with a training set and corresponding ground truth establishment is discussed.

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