(70 days)
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:
- 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.
- 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.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information on adjudication methods is provided.
- 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.
- 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.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No information on how ground truth was established is provided.
- The sample size for the training set: No information regarding a training set or its sample size is present.
- 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.
§ 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.