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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 tables detailing specific applications and modes of operation for various transducers).

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

• UL 60601-1, Safety Requirements for Medical Equipment
• I 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
• 1 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• 93/42/EEC Medical Devices Directive
• . Safety and EMC Requirements for Medical Equipment
  • 트 EN/IEC 60601-1
  • 요 EN/IEC 60601-1-1
  • 트 EN/IEC 60601-1-2
  • 트 EN/EC 60601-1-4
• 이 EN/EC 60601-1-6
• . EN/IEC 60601-2-18
• 피 EN/EC 60601-2-25
• I IEC 61157 Declaration of Acoustic Power
• ISO 10993-1 Biocompatibility

The provided document is a 510(k) summary for the ACUSON X300™ Ultrasound System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance studies (like test set sample size, provenance, expert qualifications, or adjudication methods), MRMC studies, standalone algorithm performance, or details about the training set.

The "Performance Data" section (Section E) simply states: "The ACUSON X300 modifications are verified and validated according to the company's design control process." This is a general statement and does not provide the specific details requested in your prompt.

Therefore, I cannot provide the requested information from the given text.

In summary:

• 1. A table of acceptance criteria and the reported device performance: Not provided in the document.
• 2. Sample sized used for the test set and the data provenance: Not provided in the document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
• 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 provided in the document. This is a diagnostic ultrasound system, not an AI-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided in the document. This is a diagnostic ultrasound system, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the document.
• 8. The sample size for the training set: Not provided in the document. This is a diagnostic ultrasound system, not an AI/ML model that undergoes "training."
• 9. How the ground truth for the training set was established: Not provided in the document.

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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: Fetal, Abdominal, Intraoperative (abdominal, vascular), Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Intravascular, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

The Siemens Acuson X300 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACUSON X300™ Ultrasound System, based on your requested information:

This device is a diagnostic ultrasound system and as such, the submission primarily focuses on meeting regulatory safety and performance standards for ultrasound devices, not on diagnostic accuracy for specific conditions (which AI/ML devices typically address). Therefore, many of your requested items regarding AI/ML clinical study specifics are not applicable or explicitly stated in this type of submission.

Acceptance Criteria and Reported Device Performance

Study Information (as applicable to a conventional ultrasound device 510(k) submission):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This submission does not describe a clinical study in the sense of testing image interpretations or diagnostic accuracy on a patient data set. The performance data mentioned is related to engineering verification and validation against regulatory safety and performance standards. Therefore, an explicit "test set" sample size or data provenance for patient data is not provided. The testing would involve engineering and physics measurements on the device itself.

2. 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):

   • Not applicable. This device is an ultrasound system, not an AI/ML diagnostic aid that relies on expert ground truth for image interpretation. The "ground truth" here would be established by validated engineering tests and compliance with recognized standards.

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

   • Not applicable. There is no clinical test set requiring adjudication in this type of submission.

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:

   • No MRMC study was done. This is not an AI/ML device, and no AI assistance is mentioned.

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

   • Not applicable. This is not an algorithm-only device. It's a complete ultrasound system.

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

   • The "ground truth" as described in the submission is compliance with established engineering, safety, and performance standards (e.g., UL, IEC, NEMA, ISO). These standards define acceptable acoustic output, electrical safety, EMC, and biocompatibility, as well as the system's ability to perform its intended imaging and measurement functions reliably.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set in that context. The "training" here refers to the engineering design and development process that ensures the device meets its specifications.

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

   • Not applicable. As above, there is no AI/ML training set. The "ground truth" for the device's design and development comes from the aforementioned regulatory and engineering standards.

Summary of the K072676 Submission:

This 510(k) submission for the Siemens ACUSON X300™ Ultrasound System is a "Special 510(k) Submission," indicating it's for modifications to an already cleared device (K071036, K061946). The core of the submission is to demonstrate that the modified device remains substantially equivalent to its predicate device in terms of intended use and technological characteristics.

The "Performance Data" section explicitly states: "The Acuson X300 modifications are verified and validated according to the company's design control process." This indicates that the performance criteria are primarily engineering and regulatory compliance, ensuring the device continues to meet all relevant safety (e.g., electrical, acoustic output, biocompatibility) and functional standards for diagnostic ultrasound systems. The FDA's clearance letter also emphasizes compliance with general controls, and notably, requires a post-clearance special report for acoustic output measurements, which is a critical safety parameter for ultrasound devices.

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Diagnostic imaging or fluid flow analysis of the human body as follows: 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 Siemens 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/EC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2; IEC 61157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.

The Siemens ACUSON X300 Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with various transducers. The provided text is a 510(k) Summary and Indications for Use forms, primarily focusing on establishing substantial equivalence to a predicate device and outlining the range of applications for the system and its various transducers. There is no performance data regarding acceptance criteria for an AI/CADe device, and no study is described to prove a device meets acceptance criteria.

The document indicates that "The Acuson X300 modifications are verified and validated according to the company's design control process." However, it does not provide details of specific performance metrics, acceptance criteria, or the study conducted to demonstrate compliance for any AI/CADe functionality. The tables provided are "Indications for Use" forms, not performance tables.

Therefore, for aspects related to AI/CADe acceptance criteria and studies, the requested information is not available in the provided text.

Here's a breakdown of what can be inferred from the text regarding the device and its regulatory submission, but no AI/CADe-specific performance claims or studies are present:

1. A table of acceptance criteria and the reported device performance

This information is Not Available in the provided text for any AI/CADe device. The tables shown are "Indications for Use" forms, indicating the clinical applications and modes of operation for various transducers, not performance metrics or acceptance criteria for an AI/CADe system.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is Not Available in the provided text. The submission is for an ultrasound system and its transducers, and no specific test set details for AI/CADe performance are mentioned.

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 Available in the provided text. No ground truth establishment related to AI/CADe performance is described.

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

This information is Not Available in the provided text. No adjudication method related to AI/CADe performance is 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

This information is Not Available in the provided text. The submission is for a diagnostic ultrasound system and its transducers, not explicitly for an AI-assisted diagnostic product. There are no mentions of MRMC studies or human reader improvement with AI assistance.

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

This information is Not Available in the provided text. There is no mention of a standalone algorithm performance evaluation.

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

This information is Not Available in the provided text. No ground truth definition related to AI/CADe performance is provided.

8. The sample size for the training set

This information is Not Available in the provided text. No training set details for an AI/CADe system are mentioned.

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

This information is Not Available in the provided text. No ground truth establishment for a training set is described.

Summary of Device and Safety Information (from the provided text):

• Device Name: ACUSON X300™ Diagnostic Ultrasound System / SONOVISTA X300 Diagnostic Ultrasound System
• Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound Division
• Submission Date: April 11, 2007
• Regulatory Status: Substantially Equivalent to predicate device Siemens Acuson X300 ultrasound system (K061946). This is a 510(k) submission, not a new AI/CADe device seeking market authorization based on clinical performance.
• Intended Use: Diagnostic imaging or fluid flow analysis of the human body for a wide range of clinical 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).
• Transducers covered in this submission (as listed on Page 2 of the FDA letter):
  • P4-2 Phased Sector Array
  • CH5-2 Convex Array
  • VF10-5 Linear Array
  • L9-5 Linear Array
  • EC9-4 Convex Array
  • EV9-4 Convex Array
  • VF13-5 Linear Array
  • P8-4 Phased Array
  • BE9-4 Convex Array
  • CW2 Continuous Wave Doppler
  • CW5 Continuous Wave Doppler
  • Acu Nav 8F Intracardiac
  • Acu Nav 10F Intracardiac
  • V5Ms TEE
  • 4V1c Phased Array
  • VF13-5SP Linear Array
  • C8-5 Tight Curved Array
  • 8L3 Linear "Regel"
  • 10V4 Phased Array Neonatal High Frequency
  • C7F2 Curved Array Mechanical 3D/4D
  • EV9F4 Curved Array Mechanical 3D/4D
  • L13F5 3D/4D Mechanical Wobbler Linear
  • VF8-3 Linear
• Performance Data Mentioned: "The Acuson X300 modifications are verified and validated according to the company's design control process." The FDA letter also requests a post-clearance special report containing acoustic output measurements based on production line devices, referencing "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." This indicates a focus on physical and acoustic safety performance standards rather than AI/CADe diagnostic accuracy.
• Safety Standards: The device has been designed to meet several safety standards including UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, IEC 61157, and ISO 10993-1.

The provided document describes the regulatory clearance for a diagnostic ultrasound system and its transducers, emphasizing its substantial equivalence to a previously cleared device and adherence to safety standards. It does not contain information about the performance or validation of an AI/CADe component.

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