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The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatic and neonatal patients); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (Including Urology and Prostate) (TR); Transvaginal (TV).

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD display, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.

The provided text is related to a 510(k) premarket notification for the GE Healthcare Voluson P6 and Voluson P8 ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets specific acceptance criteria through clinical studies.

Therefore, the document explicitly states: "The subject of this premarket submission, Voluson P6 / Voluson P8, did not require clinical studies to support substantial equivalence."

This K-submission demonstrates equivalence based on:

• Identical Intended Use: The Voluson P6/P8 has the same general-purpose ultrasound system indications for use as the previously cleared predicate (K160162 Voluson P Series; Voluson P6/P8 Diagnostic Ultrasound System).
• Similar Technology: It employs the same fundamental scientific technology.
• Comparison to Predicates: The systems are determined to be substantially equivalent in intended use, imaging capabilities, technological characteristics, safety, and effectiveness. This includes having the same clinical intended use, imaging modes, identical transducers, same indications for use, similar capabilities in measurements, digital image capture, review, and reporting.
• Compliance with Safety Standards: The device has undergone non-clinical tests for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, and conforms to applicable medical device safety standards. It also complies with voluntary standards like AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2, ISO14971, and NEMA PS 3.1 - 3.20 (DICOM).
• Quality Assurance Measures: The development included risk analysis, requirements reviews, design reviews, unit-level testing, integration testing, performance testing, and safety testing.
• Biocompatibility: Transducer materials and other patient contact materials are biocompatible.

Since no clinical studies were performed, there is no information available in this document to populate the following requested sections:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics for clinical accuracy are provided as clinical studies were not required. Acceptance criteria would primarily relate to safety and functionality matching the predicate device.
2. Sample sizes used for the test set and the data provenance: No test set of clinical images/data was used for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth was established from experts for a clinical test set.
4. Adjudication method: Not applicable as no clinical images were adjudicated.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable as this is an ultrasound system, not an AI algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as there's no mention of an algorithm or training set for clinical performance.
9. How the ground truth for the training set was established: Not applicable.

In summary, this document is a 510(k) premarket notification for a general-purpose ultrasound system. Its "acceptance criteria" for FDA clearance are primarily based on demonstrating substantial equivalence to existing devices through non-clinical testing and shared intended use, not on specific performance metrics derived from clinical studies or AI algorithm validation.

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The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TV).

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal / Obstetrics; Abdominal (including renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (includes urology/prostate); Transvaginal (includes infertility monitoring of follicle development).

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.

This document describes the GE Healthcare Voluson S8/S10/S10 Expert ultrasound system and its equivalence to predicate devices, but it does not provide acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined for AI/ML performance evaluation.

Instead, this is a 510(k) premarket notification summary from the FDA, focusing on:

• Substantial Equivalence: Comparing the new device to existing legally marketed devices (predicates).
• Safety and Effectiveness: Ensuring the device meets recognized safety standards and performs as intended.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not contain a table of numerical acceptance criteria or reported specific device performance metrics for AI/ML algorithms as typically seen in studies evaluating diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, it asserts "substantial equivalence" to predicate devices, meaning its performance characteristics are deemed similar enough that it doesn't raise new questions of safety or effectiveness. The "performance" discussed is related to its ability to perform diagnostic ultrasound imaging and fluid flow analysis, offering various imaging modes, and complying with safety standards.

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

• Sample Size for Test Set: Not applicable / Not provided. This document specifies that "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." Therefore, no specific test set of patient data was used for performance evaluation of new AI/ML features in what would typically be considered an AI/ML clinical study.
• Data Provenance (country of origin, retrospective/prospective): Not applicable / Not provided.

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

• Number of Experts: Not applicable / Not provided. Since clinical studies for substantial equivalence were not required, there was no separate ground truth establishment process involving external experts for performance evaluation. The ground truth for general ultrasound imaging is established through standard medical practice and expert interpretation.
• Qualifications of Experts: Not applicable / Not provided specifically for this submission.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable / Not provided. No specific test set performance evaluation was described.

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

• MRMC Study Done: No. The document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence."
• Effect Size of Human Readers with vs. without AI Assistance: Not applicable / Not provided.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study Done: No. The document states that clinical studies were not required. The "improved version of existing software feature IOTA LR2 model called IOTA Simple Rules," "3D Analysis feature of the endometrial cavity called SonoMetrium," "enhanced feature of existing software feature HDlive called HDlive Silhouette," and "enhanced feature of existing software feature SRI called VSRI" are mentioned as being "previously cleared with K172342" or are enhancements of existing features. This indicates that these features were likely evaluated in the context of substantial equivalence to previous versions or predicate devices, rather than as new standalone AI detections requiring their own independent performance studies for this specific submission.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated or required for this type of submission. For ultrasound imaging systems, ground truth is typically established by medical professionals through established diagnostic protocols, expert interpretation, and potentially correlation with other diagnostic modalities or pathology where applicable. However, no specific ground truth was established for a new clinical performance study for this submission.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable / Not provided. As this submission focuses on substantial equivalence of an ultrasound system and enhancements to existing software features, specific AI model training data sizes are not detailed in this regulatory document.

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

• How Ground Truth Was Established: Not applicable / Not provided.

Summary of AI/ML Specifics from the Document:

The document mentions several "improved" or "enhanced" software features that could potentially involve AI/ML components (e.g., IOTA Simple Rules, SonoMetrium, HDlive Silhouette, VSRI, Radiantflow). However, for this specific 510(k) submission (K180374), these features are explicitly stated to be either:

• "previously cleared with K172342" (a reference predicate).
• "an improved version of existing software feature" or "an enhanced feature of existing software feature."

This implies that the novelty of these features for this particular submission was not in their initial safety and effectiveness evaluation as new AI/ML tools, but rather in their inclusion or minor enhancement within the Voluson S8/S10/S10 Expert system, aligning with existing predicate clearances. Therefore, detailed performance studies for these specific AI/ML components are not provided within this document, as they were likely addressed in previous clearances (like K172342 for the Voluson E Series).

Conclusion: This document is a 510(k) premarket notification for an ultrasound system, demonstrating substantial equivalence to predicate devices and adherence to general safety and performance standards. It does not contain the detailed AI/ML specific acceptance criteria or performance study data that you requested, as the submission strategy relied on substantial equivalence rather than novel clinical performance data for new AI/ML features.

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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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