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Ultrasound imaging or fluid flow analysis of the human body as follows: Cardiac, Neonatal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skelctal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Siemens Sequoia™ Plus 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; IEC 1157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.

The provided text is a 510(k) summary for the Siemens Sequoia™ Plus Ultrasound System. It describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. However, it does not contain a detailed study proving the device meets specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the "Performance Data" section explicitly states: "The Sequoia™ Plus is designed, verified, and validated according to the company's design control process." This indicates that the validation relied on internal company processes and compliance with general safety and performance standards for diagnostic ultrasound systems, rather than a clinical study evaluating specific diagnostic accuracy against defined acceptance criteria.

The submission focuses on technological equivalence and adherence to established safety and performance standards (like UL, IEC, CSA, AIUM/NEMA, ISO for biocompatibility, and EMC requirements), which are the primary concerns for 510(k) premarket notifications for ultrasound systems like this one.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment from a diagnostic performance study is not present in the provided document.

To answer your request based on the available text:

Acceptance Criteria and Device Performance

This 510(k) summary does not contain specific acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, or accuracy) of the ultrasound system for specific clinical applications. The "acceptance criteria" referred to are primarily related to general safety, electromagnetic compatibility, acoustic output, and adherence to established technological standards, rather than direct clinical diagnostic efficacy.

The document indicates "Performance Data" means: "The Sequoia™ Plus is designed, verified, and validated according to the company's design control process." This implies that internal engineering and quality assurance processes were followed to ensure the device performs as intended and meets safety standards.

Table of Acceptance Criteria and Reported Device Performance:

• UL 60601-1 | Device designed to meet
• UL 60601-1 |
  | - IEC 60601-2-37 | - IEC 60601-2-37 |
  | - CSA C22.2 No. 601-1 | - CSA C22.2 No. 601-1 |
  | - AIUM/NEMA UD-3 (Acoustic Output Display) | - AIUM/NEMA UD-3 |
  | - AIUM/NEMA UD-2 (Acoustic Output Measurement) | - AIUM/NEMA UD-2 |
  | - 93/42/EEC Medical Devices Directive | - 93/42/EEC |
  | - EN/IEC 60601-1, 60601-1-1, 60601-1-2 (EMC & Safety) | - EN/IEC 60601-1, 60601-1-1, 60601-1-2 |
  | - IEC 1157 (Acoustic Power Declaration) | - IEC 1157 |
  | - ISO 10993-1 (Biocompatibility) | - ISO 10993-1 |
  | Substantial Equivalence:
• Intended Use | Substantially equivalent to Siemens Acuson Sequoia Ultrasound System (K063085, K051139) with regard to intended use (Cardiac, Neonatal Cardiac, Pediatric, Transesophageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculoskeletal). |
  | - Technological Characteristics | Substantially equivalent to Siemens Acuson Sequoia Ultrasound System (K063085, K051139) with regard to technological characteristics. |
  | Post-Clearance Acoustic Output (FDA Condition):
• Acoustic output within approved levels | A post-clearance special report containing complete information, including acoustic output measurements based on production line devices, is required to confirm compliance. |

Regarding a diagnostic performance study:

1. Sample size used for the test set and the data provenance: Not applicable. No test set for diagnostic performance is described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for diagnostic performance is described.
3. Adjudication method for the test set: Not applicable. No test set for diagnostic performance is described.
4. 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 device is an ultrasound system, not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an ultrasound system, not an algorithm, and the submission is not for standalone algorithm performance.
6. The type of ground truth used: Not applicable for diagnostic performance. Ground truth for safety and performance standards would be adherence to the specifications of those standards.
7. The sample size for the training set: Not applicable. The device is not an AI/ML algorithm that requires a training set in the conventional sense.
8. How the ground truth for the training set was established: Not applicable.

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