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The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, 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.

Diagnostic imaging or fluid flow analysis of the human body as follows: (followed by a table listing specific clinical applications and modes of operation for various transducers)

The Acuson X300 has been designed to meet the following product safety standards:

• UL 60601-1, Safety Requirements for Medical Equipment
• IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• I CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• 93/42/EEC Medical Devices Directive
• Safety and EMC Requirements for Medical Equipment
• EN/IEC 60601-1
• EN/IEC 60601-1-1
• EN/IEC 60601-1-2
• EN/IEC 60601-1-4
• EN/IEC 60601-1-6
• EN/IEC 60601-2-18
• EN/IEC 60601-2-25
• IEC 1157 Declaration of Acoustic Power
• ISO 10993-1 Biocompatibility

The Siemens ACUSON X300™ Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system.

Here's an analysis based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for a particular clinical application. Instead, it demonstrates compliance with recognized product safety and acoustic output standards. The "device performance" reported is the meeting of these standards, which serves as the acceptance criteria for regulatory approval.

• UL 60601-1, Safety Requirements for Medical Equipment
• IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• 93/42/EEC Medical Devices Directive (Safety and EMC Requirements for Medical Equipment, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, EN/IEC 60601-1-4, EN/IEC 60601-1-6, EN/IEC 60601-2-18, EN/IEC 60601-2-25)
• IEC 1157 Declaration of Acoustic Power
• ISO 10993-1 Biocompatibility |
  | Substantial Equivalence (Intended Use) | Equivalent to legally marketed predicate devices | Met: The submission device is substantially equivalent to the predicate with regard to intended use. The intended use includes applications such as General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for measurement of anatomical structures and analysis packages for clinical diagnosis. This is largely based on "P = previously cleared by K090276" for various modes and applications across numerous transducers. |
  | Substantial Equivalence (Technological Characteristics) | Equivalent to legally marketed predicate devices | Met: The submission device is substantially equivalent to the predicate with regard to technological characteristics. The document lists "Acuson X300 modifications are verified and validated according to the company's design control process." The predicate devices mentioned are other Siemens Acuson ultrasound systems: Siemens Acuson X300 (K090276, K071036, K061946), Siemens Acuson X500™ (K061980), and ACUSON X150 (K081121). |
  | New Indication (P4-2 Litho Phased Sector Array - Abdominal) | The Abdominal application for this transducer is cleared. | Met: For the P4-2 Litho Phased Sector Array Transducer, the "Abdominal" application is marked with "N" for new indication, meaning it was newly cleared (N) for this specific application with this transducer, in various modes (B, M, PWD, Color Doppler, Amplitude Doppler, Combined BMDC). This implies the performance for this new indication on this transducer met the necessary safety and efficacy for clearance. |
  | New Indication (BP9-4 Convex Array - Small Organ & Trans-rectal) | The Small Organ and Trans-rectal applications for this transducer are cleared. | Met: For the BP9-4 Convex Array Transducer, "Small Organ" and "Trans-rectal" applications are marked with "N" for new indication, meaning they were newly cleared (N) for this specific application with this transducer, in various modes (A, B, M, PWD, Color Doppler, Amplitude Doppler, Combined BMDC). This implies the performance for these new indications on this transducer met the necessary safety and efficacy for clearance. |

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 does not describe specific clinical test set sizes, data provenance, or study types (retrospective/prospective) in the context of typical clinical performance studies for AI/CAD devices. The submission primarily focuses on substantial equivalence to predicate devices and compliance with recognized safety and performance standards for diagnostic ultrasound systems. The "Performance Data" section states: "The Acuson X300 modifications are verified and validated according to the company's design control process." This indicates internal testing and validation against engineering specifications and regulatory standards rather than a clinical trial with a "test set" in the sense of patient data.

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 summary. As the submission relies on demonstrating substantial equivalence to predicate devices and compliance with general standards, a specific "ground truth" establishment process by external experts, as might be required for a novel AI/CAD device, is not detailed. The "ground truth" for compliance testing would be defined by the technical specifications of the standards themselves.

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

This information is not provided. Given the nature of the submission (demonstrating compliance with technical standards and substantial equivalence), a formal adjudication method for clinical test interpretations is not 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

An MRMC comparative effectiveness study was not mentioned or indicated in this 510(k) summary. This submission predates the widespread regulatory requirements for performance studies of AI/CAD-enabled devices that would typically necessitate such studies. The device is a diagnostic ultrasound system, not an AI/CAD product.

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

A standalone performance study for an algorithm was not mentioned or indicated. The device is a complete ultrasound system, and the submission addresses its overall safety and performance as a diagnostic imaging tool.

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

For the new indications (Abdominal for P4-2 Litho, Small Organ and Trans-rectal for BP9-4), the "ground truth" would be the established diagnostic capabilities of comparable ultrasound systems for those applications, as demonstrated through predicate device equivalency and adherence to established medical imaging principles and performance standards (e.g., image quality, penetration, resolution, Doppler accuracy). The document does not specify a separate clinical "ground truth" generation process.

8. The sample size for the training set

This information is not applicable / not provided. The ACUSON X300 is a diagnostic ultrasound system, and the submission focuses on its hardware and software functionality and compliance with performance standards. The concept of a "training set" is typically relevant for machine learning or AI-driven devices, which this submission does not describe.

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

This information is not applicable / not provided for the reasons stated above.

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The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, 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 Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson X300 has been designed to meet the following product safety standards:

• UL 60601-1, Safety Requirements for Medical Equipment
• IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• 93/42/EEC Medical Devices Directive
• Safety and EMC Requirements for Medical Equipment
• EN/IEC 60601-1
• EN/IEC 60601-1-1
• EN/IEC 60601-1-2
• EN/IEC 60601-1-4
• EN/IEC 60601-1-6
• EN/IEC 60601-2-18
• EN/IEC 60601-2-25
• IEC 1157 Declaration of Acoustic Power
• ISO 10993-1 Biocompatibility

The provided 510(k) submission for the Siemens ACUSON X300 Diagnostic Ultrasound System does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the typical format of a clinical performance study with quantitative metrics (like sensitivity, specificity, or AUC) compared against a predefined threshold.

Instead, the submission primarily focuses on establishing substantial equivalence to legally marketed predicate devices, which is the primary pathway for 510(k) clearance. Substantial equivalence is demonstrated by showing that the new device has the same intended use and similar technological characteristics to the predicate device, or if there are differences, that these differences do not raise new questions of safety and effectiveness.

The "Performance Data" section (Section E) states: "The Acuson X300 modifications are verified and validated according to the company's design control process." This indicates that internal testing and verification/validation activities were performed to ensure the device functions as intended and meets its design specifications, but specific details of these tests, including acceptance criteria, sample sizes, ground truth establishment, or expert involvement, are not provided in this summary.

The document lists various product safety and biocompatibility standards that the device has been designed to meet. These standards themselves include acceptance criteria for their respective domains (e.g., electrical safety, acoustic output, biocompatibility). Compliance with these standards is a form of meeting acceptance criteria but doesn't involve clinical performance metrics in the way a comparative effectiveness study would.

The "Indications for Use Form" for the main system and each transducer lists the clinical applications and modes of operation ("P" for previously cleared, "N" for new indication). For the new indications, the assumption is that the new functionalities (like the Arterial Health Package) have been validated, but the details of this validation are not present in this document.

Therefore, based on the provided text, a table of acceptance criteria and reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, details of MRMC studies, or standalone algorithm performance, as requested in the input, cannot be extracted.

The document describes the intended use of the device for various applications and mentions the Arterial Health Package (AHP) software, which provides capabilities to measure Intima Media Thickness and reference normative tables "validated and published in peer-reviewed studies." This implies that the underlying science for AHP's clinical utility is derived from external, peer-reviewed research, rather than a de novo clinical study conducted for this specific 510(k) submission.

Summary of available information related to performance/validation:

• Acceptance Criteria & Device Performance: Not explicitly stated as quantitative metrics against a specific threshold in this summary. The general acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices, which implies similar safety and effectiveness.
• Study Type: No specific clinical study is described in detail for performance evaluation of the ACUSON X300 or its specific new features (beyond stating "modifications are verified and validated according to the company's design control process"). The AHP software references "normative tables that have been validated and published in peer-reviewed studies," indicating reliance on existing scientific literature for its clinical basis, not a new study.
• Sample Size (Test Set & Training Set): Not provided.
• Data Provenance: Not provided.
• Number of Experts/Qualifications (Test Set Ground Truth): Not provided.
• Adjudication Method: Not provided.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No such study is mentioned.
• Standalone Performance (Algorithm Only): Not mentioned, as this is an ultrasound system with associated software, not typically a standalone AI algorithm.
• Type of Ground Truth: Not specified for any performance evaluation in this summary. For AHP, the ground truth for normative tables is implicitly from "peer-reviewed studies."
• How Ground Truth for Training Set was Established: Not applicable as training set details are not provided.

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