(34 days)
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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.