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The SQNOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of contrast agent imaging will not add any new applications or intended uses.

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 SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.

The Siemens SONOLINE Elegra diagnostic ultrasound system, with the addition of Contrast Agent Imaging (CAI), did not involve specific acceptance criteria and performance data like a typical AI/ML medical device. This 510(k) submission (K981528) focuses on demonstrating substantial equivalence to a predicate device for an updated functionality (CAI and Harmonic Imaging) on an existing ultrasound system.

Therefore, many of the requested elements for AI/ML device studies are not applicable to this submission.

Here's a breakdown of what can be extracted and why other parts are not available:

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

This information is not provided in the 510(k) summary. For a traditional medical device like an ultrasound system, the "acceptance criteria" are typically related to meeting performance standards specified by the FDA (e.g., image quality, safety, acoustic output levels) rather than statistical performance metrics like sensitivity/specificity for a diagnostic AI algorithm. The 510(k) process focuses on demonstrating equivalence to a legally marketed predicate device.

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

Not applicable. This device is an imaging system, not an AI/ML algorithm that processes data for diagnostic output based on a test set of cases. The "testing" for such a system would involve validating its functionality and safety according to engineering and performance specifications, likely using phantoms and potentially clinical images, but not in the format of a "test set" for diagnostic performance validation.

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)

Not applicable. Ground truth establishment for a test set of diagnostic cases is relevant for AI/ML devices, not for the core functionality of an ultrasound imaging system in this context.

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

Not applicable. This pertains to AI/ML diagnostic performance evaluation.

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 applicable. This is not an AI-assisted diagnostic device, but rather an imaging system with an enhanced imaging mode (Contrast Agent Imaging). The submission does not describe a MRMC study.

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

Not applicable. This is not a standalone algorithm; it's a feature integrated into an ultrasound system, used by a human operator.

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

Not applicable. Ground truth for diagnostic performance is not the focus of this submission. The "ground truth" for an ultrasound system's performance typically refers to physical measurements and imaging of known structures (e.g., phantoms) to verify image quality and system accuracy.

8. The sample size for the training set

Not applicable. This refers to AI/ML model training data.

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

Not applicable. This refers to AI/ML model training data.

Summary of the Study and Device Information Provided (relevant to the 510(k) submission):

Device Name: SONOLINE Elegra Advanced / SONOLINE Elegra Diagnostic Ultrasound system (with Addition of Contrast Agent Imaging)

Study/Evaluation: The submission is a 510(k) Premarket Notification to demonstrate substantial equivalence to predicate devices for the addition of Contrast Agent Imaging (CAI) and Harmonic Imaging to an existing ultrasound system.

Predicate Devices:

• Acuson Sequoia™ Ultrasound System and Harmonic Imaging with Contrast Option (K973767, 12/23/97)
• SONOLINE Elegra (K945072, 11/21/95)

Technological Comparison (indicating how it meets implicit "acceptance criteria" for substantial equivalence):
The document states that both the SONOLINE Elegra and the predicate Acuson system are "full-featured, high-end diagnostic ultrasound systems capable of B-mode, M-mode, CW Doppler, Color Doppler, Amplitude Doppler, and combined imaging modes utilizing a number of transducers with varying center frequencies."

Crucially, "Both systems are modified to optimize images obtained with the use of diagnostic ultrasound and ultrasound contrast agents. Both systems employ modified transmit/receive functions which allow for enhanced imaging of tissues and structures which reflect the transmitted ultrasound at a harmonic, or multiple, of the transmit frequency."

This direct comparison of technological features and functions demonstrates that the new functionality of the SONOLINE Elegra (Contrast Agent Imaging and Harmonic Imaging) is substantially equivalent to that already cleared in a predicate device (Acuson Sequoia). The "acceptance criteria" here are essentially meeting the safety and efficacy profiles of the predicate device.

Safety Standards Endorsed:
The SONOLINE Elegra is designed to meet several safety standards, which implicitly serve as acceptance criteria for its overall operation:

• UL 2601-1. Safety Requirements for Medical Equipment
• CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment
• Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment, AIUM/NEMA, 1992.
• 93/42/EEC Medical Devices Directive EN60601 = (IEC 601-1+ IEC 601-1-2). Safety and EMC Requirements for Medical Equipment

Post-Clearance Requirement:
The FDA's clearance letter includes a condition that the manufacturer submit a post-clearance special report with "complete information, including acoustic output measurements based on production line devices." This indicates that safety (specifically acoustic output) is a key performance metric that must be continuously met, acting as an ongoing acceptance criterion.

This submission is a regulatory filing for an incremental upgrade to an existing ultrasound system, focusing on equivalence rather than detailed performance metrics for a novel diagnostic accuracy claim.

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The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal. Superficial Musculoskeletal, and Peripheral Vascular applications. The addition of 3-D Imaging will not add new indications for use to the Elegra. It will allow the user to display regions of interest in 3-dimensional format, either by showing views in three orthagonal planes or allowing surface rendering of objects.

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 ultrasound imaging or fluid flow analysis of the human body as follows: (followed by tables listing specific applications and modes of operation for different transducers)

The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode, M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, or in a combination of modes, on a CRT display.

This document is a 510(k) summary for the Addition of 3D Imaging to the SONOLINE Elegra Diagnostic Ultrasound system. It outlines the device's description, intended uses, and technological comparison to a predicate device, but it does not contain details about a clinical study with acceptance criteria and device performance.

The tables provided in the document list various clinical applications for different transducers (e.g., SONOLINE Elegra, 2.0 CW probe, 2.5PL20 Phased Array Transducer, etc.) and indicate whether each application is a "new indication" (N), "previously cleared by FDA" (P), or "added under Appendix E" (E) for certain imaging modes (A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined, Other). This information relates to the intended uses and regulatory clearance rather than a performance study.

Therefore, I cannot extract the requested information as it is not present in the provided text.

Here's a breakdown of the specific points you requested and why they cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: This document does not contain any such table or details of a performance study with acceptance criteria. It primarily focuses on regulatory clearance and intended uses.
2. Sample size used for the test set and the data provenance: Not available. The document does not describe a test set or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available. Ground truth establishment for a test set is not discussed.
4. Adjudication method for the test set: Not available. There is no mention of a test set or adjudication.
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 available. This document predates common AI applications in medical imaging and does not discuss such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. No details on algorithm performance are provided.
7. The type of ground truth used: Not available. The document does not discuss ground truth for performance evaluation.
8. The sample size for the training set: Not available. Training sets are not mentioned.
9. How the ground truth for the training set was established: Not available. Ground truth for a training set is not discussed.

This 510(k) summary is a regulatory filing focused on demonstrating substantial equivalence to previously cleared devices for new features (3D imaging) and expanded use of existing transducers, rather than a clinical performance study report.

Ask a specific question about this device

The SONOLINE Elegra ultrasound imaging system is intended for the following applications: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Pelvic, Neonatal/Adult Cephalic, 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 ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Abdominal, Intraoperative (Specify), Pediatric, Small Organ (Specify), Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
Mode of Operation: A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined (Specify) BMDC.

The SONOLINE Elegra is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for themal and mechanical indices related to potential bioeffect mechanisms. Its function is to acquire ultrasound data and display it in B-Mode. M-Mode, Color Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Dopper Mode, or in a combination of modes, on a CRT display.

This document is a 510(k) summary for the SONOLINE Elegra Diagnostic Ultrasound system, specifically for an update to include Superficial Musculoskeletal imaging. It describes the device, its intended uses, and its technological comparison to a predicate device, but it does not contain information about acceptance criteria or specific studies demonstrating device performance.

Based on the provided text, the following information is not available:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide specific quantitative acceptance criteria or detailed performance metrics. It primarily focuses on the device's technical specifications and intended use.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No information about test set sample sizes or data provenance is present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts or how ground truth was established for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information on adjudication methods is provided.
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 document predates widespread AI in medical imaging and does not describe MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As above, this document does not discuss standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No information on how ground truth was established is provided.
8. The sample size for the training set: No information regarding a training set or its sample size is present.
9. How the ground truth for the training set was established: No information regarding ground truth establishment for a training set is provided.

Summary of available information:

• Intended Use: The purpose of this submission is to receive clearance for the indication of Superficial Musculoskeletal imaging for the SONOLINE Elegra ultrasound system.
• Technological Comparison: The new indication is stated to be "equivalent to the small parts imaging indication for which the system is already cleared." This implies that the current device, with the new application, is substantially equivalent to a previously cleared device (Siemens SONOLINE Elegra Ultrasound System K945072).
• Standards Met: The original SONOLINE Elegra was designed to meet:
  • UL 2601. Safety Requirements for Medical Equipment.
  • CSA 22.2 No. 601-1, Safety Requirements for Medical Equipment.
  • Standard for Real Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound Equipment. AIUM/NEMA. 1992.
  • 93/42/EEC Medical Devices Directive EN60601 = (IEC 601-1-1 + IEC 601-1-2), Safety and EMC Requirements for Medical Equipment.
• Transducer: The specific transducer associated with this new indication is the 7.5L40 Linear Array Transducer.
• Modes of Operation for Superficial Musculoskeletal (New Indication - N): The new indication supports A, B, M, and Color Doppler modes, with combined mode BMDC(N). PWD and CWD (Continuous Wave Doppler) are not marked as supported for this specific new application. However, the table on page 5 seems to list N for PWD as well. There's a slight discrepancy between the two tables provided regarding the "Musculoskeletal Superficial" entry. Given that the first table is specifically for the 7.5L40 Linear Array Transducer and lists N for PWD, it's more likely that all listed modes (A, B, M, PWD, Color Doppler, and combined BMDC) are new for this application with this transducer.

Conclusion:

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device for a new indication (Superficial Musculoskeletal imaging), rather than providing detailed acceptance criteria and study results for device performance. It relies on the previously established safety and effectiveness of the base device and the assertion that the new indication is equivalent to an already cleared one. Therefore, the specific study details, sample sizes, and ground truth information requested are not present in this regulatory document.

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