(15 days)
Diagnostic imaging or fluid flow analysis of the human body as follows: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, 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.
The G50/G60 S are general purpose, mobile, software-controlled, diagnostic ultrasound systems with on-screen displays for thermal and mechanical indices related to potential bioeffect mechanisms. Their function is to acquire primary or secondary harmonic ultrasound echo data (CW) Doppler Mode, Continuous (CW) Doppler Mode, and display in in. D Mode, in Mode, it node, a combination of modes, or Harmonic Imaging, or 3D/4D imaging, on a CRT display.
The provided text is a 510(k) summary for the SONOLINE G50/G60 Diagnostic Ultrasound Systems. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through clinical studies in the way a PMA (Premarket Approval) submission would.
Therefore, the document does not contain the detailed clinical study information you requested (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details). The acceptance criteria for a 510(k) are typically based on demonstrating that the new device has the same intended use and similar technological characteristics as the legally marketed predicate device, or that any differences do not raise new questions of safety and effectiveness.
Based on the provided text, here's what can be extracted and what cannot:
Acceptance Criteria and Device Performance (as stated in the 510(k) Summary)
The acceptance criteria for this 510(k) submission are implicitly the demonstration of substantial equivalence to predicate devices. This is achieved by showing that the SONOLINE G50/G60 S systems perform similarly to already cleared devices and comply with relevant safety standards.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (as stated) |
|---|---|
| Primary Function: Acquire primary or secondary harmonic ultrasound echo data mechanisms. | "Their function is to acquire primary or secondary harmonic ultrasound echo data mechanisms." |
| Display Modes: Operate in B Mode, M Mode, A Mode, Pulse Wave Doppler (PWD) Mode, Continuous Wave Doppler (CWD) Mode, and display in a combination of modes, or Harmonic Imaging, or 3D/4D imaging. | The device operates in B Mode, M Mode, A Mode, PWD, CWD, combination of modes, Harmonic Imaging, 3D/4D imaging, displayed on a CRT. Specific transducers also support Color Doppler, Amplitude Doppler, and Color Velocity Imaging (BMDC). |
| Intended Uses: General Radiology, Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. | The system is intended for these applications (listed as "Intended Uses") and is considered substantially equivalent to predicate devices for these purposes. |
| Measurement and Analysis: Provide for measurement of anatomical structures and analysis packages for clinical diagnosis. | "The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes." |
| Safety and EMC Compliance: Meet specific product safety standards (UL 2601-1, 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 1157, ISO 10993). | The G50/G60 S have been designed to meet these listed product safety standards. |
| Substantial Equivalence: Demonstrate substantial equivalence to predicate devices (K020353, K032111, K003125, K003525). | The document explicitly states: "The SONOLINE G50/G60 S are substantially equivalent to the SONOLINE G50 & G60 S, cleared via K020353; SONOLINE CV70, cleared via K032111; SONOLINE Elegra with Axius OB Calipers, cleared via K003125; and Medison Voluson 730, cleared via K003525." |
Study Details Not Available in a 510(k) Summary
As explained, a 510(k) submission primarily relies on demonstrating equivalence to predicate devices, rather than new clinical effectiveness studies. Therefore, the following information is not provided within this document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not described. The submission focuses on functional and technical equivalence, not patient study data for performance metrics.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described. Ground truth establishment is typically part of a de novo or PMA clinical study, which is not the basis of this 510(k).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not described.
- 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 device is a diagnostic ultrasound system from 2003, and the document does not mention any AI components or MRMC studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an imaging system requiring human operation and interpretation, and the document does not describe standalone algorithmic performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
- The sample size for the training set: Not applicable, as this is related to AI/algorithm development, which isn't described for this device in this context.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) document is a regulatory submission for substantial equivalence of a diagnostic ultrasound system. It outlines the device's technical specifications, intended uses, and compliance with recognized safety standards to demonstrate that it is as safe and effective as pre-existing, legally marketed devices. It does not include new clinical study data with performance metrics against a defined truth set, which would be expected for novel devices or those requiring a higher level of evidence (e.g., PMA).
§ 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.