Search Results

V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications.

ACUSON Antares Ultrasound System: The Acuson Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal. Great Vessel, 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.

ACUSON CV70 Cardiovascular System: The CV70 ultrasound imaging system is intended for the following applications: Abdominal. Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Gephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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.

ACUSON Cypress Ultrasound System: The Cypress platform is intended for use in the following applications: General Imaging and Cardiology for Fetal. Abdominal. Intraoperative (cardiac), Pediatrics, Neonatal Cephalic, Cardiac (adult, pediatric), Trans-esophageal, Peripheral Vessel, Intraluminal and Intra-cardiac applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes

ACUSON S1000/S2000 Ultrasound System: The S2000™ ultrasound imaging systems are intended for the following applications: Fetal. Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal(conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician 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."

ACUSON SC2000 Ultrasound System: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Intraoperative Neurological, Musculo-skeletal 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 typical examinations performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis, Vascular Imaging Applications and Analysis, Superficial Imaging Applications, Intraoperative Imaging Applications, Transcranial Imaging Applications.

ACUSON Sequoia Ultrasound System: The Siemens ACUSON Sequoia ultrasound imaging system is intended for the following applications: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid and penis), Neonatal/Adult Cephalic, Cardiac (adult, pediatric, and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-sceletal (superficial and conventional) applications, and intended uses as defined in the FDA quidance document. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

ACUSON X300 Ultrasound System: 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 measurement of anatomical structures and 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 reqarding 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 V5Ms Transesophageal Transducer consists of a gastroscope control housing where nosepiece articulation and transducer rotation are controlled. A flexible transesophageal guide tube with a nosepiece containing the acoustic array extends from one end of the control housing and the system cable/connector extends from the other end. The acoustic array has 64 elements and rotates 180 degrees to provide imaging planes from transverse view to inverse transverse view. Rotation is powered by a motor in the control housing and is controlled by the operator using a switch button on the control housing for clockwise and counterclockwise rotation. Nosepiece articulation is achieved by manipulating a vertebrae section adjacent to the nosepiece through a series of control wires attached to knobs on the control housing. The nosepiece can be articulated in both the anterior/posterior and left/right directions.

Here's a breakdown of the requested information, based on the provided document:

Acceptance Criteria and Study Details for V5Ms Transesophageal Transducer

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) submission document does not explicitly state quantitative acceptance criteria or specific device performance metrics in the way one might expect for a new or significantly modified device. Instead, the submission relies heavily on substantial equivalence to a previously cleared predicate device (Siemens V5Ms Transesophageal Transducer, K052021). The key "performance data" presented is that "Performance data is not required for this modification as there is no change to software or hardware." This implies that the device is expected to perform identically to its predicate because the changes are limited to patient contact materials.

Therefore, the acceptance criteria are implicitly met by demonstrating that the modifications do not negatively impact the established performance of the predicate device.

Implicit Acceptance Criteria and Reported Performance (Based on Substantial Equivalence):

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

• Sample Size for Test Set: Not applicable (N/A). The document explicitly states, "Performance data is not required for this modification as there is no change to software or hardware." Therefore, there was no clinical performance test set used. The evaluation centered on non-clinical tests for biocompatibility and asserting substantial equivalence.
• Data Provenance: N/A for clinical performance data. For biocompatibility testing, the data would typically originate from a laboratory (likely in the USA or a facility that adheres to international standards like ISO). The origin is not specified beyond "Nonclinical tests contained in this submission include biocompatibility testing per ISO10993-1 (cytotoxicity, sensitization, irritation)."

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

• N/A. As no clinical performance test set was conducted, there was no need for experts to establish ground truth. The primary "experts" involved in the submission would be Siemens' own regulatory and engineering teams, and subsequently, FDA reviewers.

4. Adjudication Method for the Test Set

• N/A. Since no clinical performance test set was conducted, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. No MRMC study was conducted. The submission is a 510(k) for substantial equivalence based on minor modifications (patient contact materials) to an existing device, not a new clinical effectiveness study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• N/A. The device is a diagnostic ultrasound transducer, not an AI algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

• N/A for clinical effectiveness. For biocompatibility, the "ground truth" is defined by the ISO10993-1 standard for cytotoxicity, sensitization, and irritation. This involves standardized biological tests.

8. The Sample Size for the Training Set

• N/A. This device is a hardware component (transducer) and does not involve machine learning or AI, and therefore does not have a "training set."

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

• N/A. As there is no training set for this device, this question is not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device