(14 days)
Diagnostic imaging or fluid flow analysis of the human body as follows: General Radiology, Abdominal, 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 Orchid 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 primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging, or 3D imaging on a CRT display.
The provided 510(k) summary for the Siemens SONOLINE Orchid M Diagnostic Ultrasound System is for a general purpose diagnostic ultrasound system. As such, the acceptance criteria and study information provided are primarily focused on its substantial equivalence to predicate devices, adherence to safety standards, and intended uses, rather than performance metrics in a clinical diagnostic study with ground truth.
Therefore, the following information will be structured to reflect the content available in the document.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (general-purpose diagnostic ultrasound), acceptance criteria are typically met through adherence to recognized national and international safety, performance, and acoustic output standards, as well as demonstration of substantial equivalence to already cleared devices. Clinical performance is implied by the successful implementation of these standards and the equivalence to predicate devices, rather than being expressed in specific diagnostic metrics like sensitivity or specificity from a diagnostic study.
| Acceptance Criteria Category | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Safety Standards Adherence | UL 60601-1, CSA C22.2 No. 601-1, AIUM/NEMA 1998 (Thermal and Mechanical Acoustic Output Indices), AIUM/NEMA UD-2 1998 (Acoustic Output Measurement), 93/42/EEC Medical Devices Directive, EN 60601-1, EN 60601-1-1, EN 60601-1-2, IEC 61157 (Acoustic Power), ISO 10993 (Biocompatibility) |
| Substantial Equivalence | Declared substantially equivalent to SONOLINE Antares (K033196), SONOLINE G50/G60 S (K040060), and SONOLINE G20 (K040502). All systems transmit ultrasound, post-process echoes for display, and allow specialized measurements and calculations. |
| Intended Use Compatibility | Capable of performing imaging for General Radiology, Abdominal, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications, with measurement and analysis packages. |
| Transducer Compatibility | Compatible with P4-2 Phased Sector Array, CH5-2 Convex Array, VF10-5 Linear Array, L9-5 Linear Array, EC9-4 Convex Array Endocavity, EV9-4 Convex Array, VF13-5 Linear Array, P7-4 Phased Array, BE9-4 Convex Array, each with specific approved clinical applications and modes. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary provided does not describe a clinical performance study with a "test set" of patient data in the way one would for an AI/CADe device. Instead, the "testing" relates to engineering verification and validation against safety standards and benchmarks established by predicate devices. Therefore, there is no specific sample size of patient data mentioned for a test set.
The data provenance is thus not applicable in the context of clinical images for a diagnostic performance validation. The information refers to compliance with performance specifications derived from engineering tests and comparisons to existing ultrasound systems, rather than clinical 'data'.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As there is no clinical performance "test set" of patient data described with specific diagnostic outcomes, the concept of "ground truth" established by experts for such a set is not applicable to this 510(k) summary. The ground truth, in a broader sense, for the predicates and the new device is the established medical utility and safety of diagnostic ultrasound as a modality.
4. Adjudication Method for the Test Set
Again, because no clinical test set with specific diagnostic outcomes is detailed, an adjudication method for establishing ground truth is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This document describes a traditional diagnostic ultrasound system, not an AI or CADe (Computer-Aided Detection/Diagnosis) device. Therefore, no MRMC comparative effectiveness study was done regarding human readers improving with AI assistance. The device itself does not incorporate AI for diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a diagnostic ultrasound system and does not implement a standalone algorithm for diagnostic interpretation without human input. Its function is to acquire and display real-time ultrasound data for a human operator to interpret.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For this type of device clearance, the "ground truth" is not clinical diagnostic ground truth for specific cases. Instead, the clearance hinges on the device meeting established performance parameters (e.g., image quality, acoustic output, measurement accuracy from phantom or engineering tests) that are considered safe and effective, and demonstrating substantial equivalence to predicate devices that have themselves established a safe and effective "ground truth" for diagnostic imaging.
The document implicitly relies on the proven clinical utility and safety of predicate diagnostic ultrasound devices, supported by adherence to recognized engineering and safety standards.
8. The Sample Size for the Training Set
As this is a traditional diagnostic ultrasound system and not an AI/ML powered device, the concept of a "training set" of data for an algorithm is not applicable. The device's functionality is based on established ultrasound physics and signal processing, not learned patterns from a training dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set mentioned, this point is not applicable.
§ 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.