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The G20 ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The G20 is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. lts function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, a combination of modes, 3D imaging or Harmonic Imaging on a CRT display.

The provided document is a 510(K) summary for the Siemens SONOLINE G20 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a predicate device for safety and effectiveness, rather than establishing performance against specific, quantitative acceptance criteria through new clinical efficacy studies.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and the reported device performance: This submission relies on demonstrating equivalence to predicate devices, not on a new set of performance metrics.
• Sample size used for the test set and the data provenance: Clinical performance studies with test sets are not described.
• Number of experts used to establish the ground truth for the test set and their qualifications: As no specific test set is described, this information is absent.
• Adjudication method for the test set: Not applicable as there is no described test set requiring adjudication.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No such study is mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as this is a diagnostic ultrasound system, not an AI algorithm.
• The type of ground truth used: No ground truth establishment for a new performance study is described.
• The sample size for the training set: Not applicable as this is not an AI/ML device that requires a training set.
• How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Intended Use: The G20 ultrasound imaging system is intended for numerous applications including General Radiology, Abdominal, Fetal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Pediatric, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular. It also provides measurement of anatomical structures and analysis packages for clinical diagnosis.
• Technological Comparison to Predicate Device: The device is deemed substantially equivalent to the SONOLINE Adara (K946179) and other SONOLINE G20/G50/G60 S systems (K042833, K040502, K020353). The basis for this equivalence is that "All systems transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen display of anatomic structures and fluid flow within the body. All systems allow for specialized measurements of structures and flow, and calculations."
• Compliance with Safety Standards: The device has been designed to meet several product safety standards, including UL 60601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 61157, and ISO 10993. This compliance demonstrates that the device functions safely and effectively within established industry benchmarks, which serves as a form of acceptance criteria for the safety aspects of the device.

In summary, this 510(k) submission establishes the safety and effectiveness of the G20 Diagnostic Ultrasound System by demonstrating its substantial equivalence to previously cleared predicate devices and its adherence to relevant safety and performance standards. It does not present new clinical study data with specific acceptance criteria and performance metrics for an AI/ML-based device.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, abdominal, intra-operative (abdominal organs, neurological, and vascular), laparoscopic, pediatric, small organ (breast, thyroid, testicles), neonatal cephalic, trans-rectal, transvaginal, musculoskeletal (conventional and superficial), cardiac (adult and pediatric), and peripheral vessel applications. The TITAN™ Ultrasound System has been additionally cleared for adult cephalic applications. The systems provide imaging for biopsy guidance, imaging to assist in the placement of needles and catheters in vascular or other anatomical structures, and imaging guidance for peripheral nerve block procedures.

The devices referenced in this Submission are highly portable. software-controlled, diagnostic ultrasound systems with accessories. This Submission does not include any technological or feature changes from the previously cleared SonoSite devices or transducers.

The provided text is a 510(k) summary for SonoSite ultrasound systems. It describes the addition of a new clinical application ("intra-operative (neurological)") to existing ultrasound devices. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity for a diagnostic algorithm.

Instead, the "Testing" section (Section 7 on page 3) states:

• "Each of the referenced SonoSite systems has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical and mechanical safety, and has been found to conform to applicable medical device safety standards, as referenced in Section 4. Reports were previously included in the referenced predicate submissions."
• "No additional clinical testing is required, as the added indication for use is not a novel indication as shown by the predicate devices in Section 3."

This indicates that the acceptance criteria for this 510(k) submission are related to:

1. Compliance with general medical device safety standards (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, mechanical safety). These were already met and documented in previous predicate submissions (K030949 and K014116), for which this document serves as an update adding a new indication for use.
2. Substantial equivalence to predicate devices that already have 'intra-operative (neurological)' as a clinical application. The argument is that since the new indication is not novel and the anatomical site is amenable to the systems' existing technology, no additional clinical testing is needed to prove effectiveness for this specific added use.

Therefore, the requested information components (table of acceptance criteria and performance, sample size, ground truth, adjudication, MRMC studies, standalone performance, training set size, etc.) are not available in this document because the submission relies on substantial equivalence and prior safety testing, rather than a new performance study proving diagnostic accuracy for the added indication.

Specifically, for the questions asked:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on regulatory compliance and substantial equivalence to predicate devices for the new indication, not a new performance study with specific metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No new clinical test set was used for the added indication. The submission relies on the fact that existing systems already meet safety standards, and the new indication is covered by predicate devices without requiring new clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth was created for this submission.
4. Adjudication method for the test set: Not applicable.
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 an ultrasound system, not an AI-powered diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a new performance study in this submission.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm submission requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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Ultrasound imaging or fluid flow analysis of the human body as follows: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN. Cardiac. Transesophageal. Pelvic. Neonatal/Adult Cephalic. Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

The Antares with 4D Basic Imaging is substantially equivalent to the predicates listed herein. The Antares is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PWD) Doppler Mode, Continuous (CWD) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, 3D imaging, and 4D Basic Imaging on a CRT display.

The provided document is a 510(k) summary for the SONOLINE Antares Diagnostic Ultrasound System, dated November 20, 2002. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials and predefined acceptance criteria against a specific reported performance.

Therefore, the document does not contain information on acceptance criteria for device performance, nor details of a study proving a device meets such criteria in the way requested by the prompt for a new or significantly modified device. Instead, it focuses on demonstrating that the Antares system is substantially equivalent to existing cleared devices and meets relevant safety and technical standards.

Here's why the requested information cannot be fully provided from this document:

• Acceptance Criteria for Performance: In a 510(k) for an ultrasound system, the "performance" typically refers to meeting technical standards (e.g., acoustic output, EMC) and showing that image quality and functionality are comparable to predicate devices. There are no specific clinical performance metrics (like sensitivity, specificity, accuracy) provided with acceptance criteria because it's not a study to establish clinical efficacy or effectiveness for a new indication or technology.
• Study Proving Acceptance Criteria: The document lists the design and safety standards the device meets, but it does not describe a clinical study to "prove" the device meets specific clinical performance acceptance criteria. It mentions "applications" (intended uses) for which the device is cleared, but not the clinical outcomes or performance metrics observed in a study.

Given these limitations, here is a breakdown of the available information in the format requested, with explicit notes about what is not present in the document:

Acceptance Criteria and Device Performance Study (Based on 510(k) Summary)

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission for substantial equivalence of an ultrasound system, the "acceptance criteria" are primarily related to safety and technical standards, and its performance is deemed acceptable if it is substantially equivalent to predicate devices for its stated intended uses. There are no quantitative performance metrics (e.g., sensitivity, specificity, accuracy) or discrete acceptance criteria like those found in a clinical performance study.

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

• Sample Size: Not applicable/not provided. This document describes a premarket notification for substantial equivalence, not a clinical performance study of the device against a test set of patient data to measure clinical metrics. The focus is on technical specifications and comparison to predicates.
• Data Provenance: Not applicable/not provided for clinical performance testing. The "data" provided generally relates to technical design and regulatory compliance.

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

• Not applicable. There is no mention of a test set of patient data with ground truth established by experts in this 510(k) submission.

4. Adjudication Method for the Test Set:

• Not applicable. No test set requiring adjudication is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not described or referenced in this 510(k) summary. The submission focuses on substantial equivalence based on technical characteristics and intended use, not on demonstrating improved diagnostic effectiveness with or without AI assistance.

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, which inherently involves human operation and interpretation. There is no mention of a standalone algorithm or AI component being evaluated for standalone performance.

7. The type of ground truth used:

• Not applicable. No clinical ground truth is described as part of assessing the device for clearance in this document. The equivalence relies on the device meeting established standards and having similar performance characteristics and intended uses to previously cleared devices.

8. The sample size for the training set:

• Not applicable. This document pertains to the regulatory clearance of a diagnostic ultrasound system based on substantial equivalence, not the development or evaluation of an AI algorithm with a training set.

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

• Not applicable. No training set is described.

Summary of Information from the Document:

The 510(k) summary for the SONOLINE Antares Diagnostic Ultrasound System primarily focuses on demonstrating substantial equivalence to predicate devices (SONOLINE® Elegra Millennium Enhanced, Voluson 730 4D Diagnostic Ultrasound System) for its safety, technology, and intended uses.

• Acceptance Criteria: Compliance with various safety and technical standards (e.g., UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, European Medical Devices Directive, IEC 1157, ISO 10993) is the primary "acceptance criterion" type mentioned. The post-clearance requirement for acoustic output measurements also implies adherence to specific acoustic safety limits.
• Study/Evidence: The "study" mentioned isn't a clinical trial with performance metrics but rather the demonstration that the device's design, technology, and intended uses are substantially equivalent to currently marketed devices and that it meets established safety standards. The document states, "The Antares has been designed to meet the following product safety standards."
• Clinical Performance Data: No clinical performance data, test sets, or ground truth information relevant to clinical metrics (like sensitivity or specificity) are provided in this 510(k) summary. The clearance is based on technological characteristics being similar to predicate devices and adherence to recognized standards.

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