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1. EchoSK and EchoSGyn Modules are additional software/hardware modules for EchoS Family devices and they are additions in terms of indication for use of the legally marketed EchoS Family.

2. EchoSK optional module for EchoS Family devices is intended to provide images of, or signals from, inside the body acquired by an appropriately trained professional in a clinical setting for musculoskeletal applications. The EchoSK module can be used both with a convex or a linear probe.

3. EchoSGyn optional module for EchoS Family devices is intended to provide images of, or signals from, inside the body acquired by an appropriately-trained professional in a clinical setting for Fetal and OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures) applications. The EchoSCyn module can be used both with a convex or with an endocavitary probe.

EchoSK and EchoSGyn are optional modules for EchoS Family devices.

EchoSK is an optional module of the EchoStudio software that allows the operator to visualize echographic images for musculoskeletal applications. The EchoSK module can be used both with a convex or a linear probe.

EchoSGyn is an optional module of EchoStudio that allows the operator to visualize echographic images for gynecological/obstetric applications. EchoSGyn module can be used both with a convex or with an endocavitary probe.

The provided FDA 510(k) summary (K212851) does not contain information regarding objective performance criteria that the device (EchoSK and EchoSGyn Modules for EchoS Family devices) meets through a specific clinical study with a test set, ground truth, and expert adjudication.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K202683 and K202514) based on:

• Intended Use: The new modules extend the existing EchoS Family devices to include musculoskeletal (EchoSK) and OB/GYN (EchoSGyn) applications, which are functions already performed by the primary predicate, the ACUSON Sequoia Diagnostic Ultrasound System.
• Technological Characteristics: The subject device shares similar hardware (EchoS and EchoStation) and software (EchoStudio) with the additional predicate device (EchoS Family K202514). It also operates similarly to the primary predicate in terms of transmitting, receiving, and displaying ultrasound echo data.
• Non-Clinical Performance Data: The summary lists non-clinical testing performed, including:
  • Biocompatibility (ISO 10993)
  • Electrical Safety and Electromagnetic Compatibility (EN 60601-1 and EN 60601-1-2)
  • Software Validation (ISO 62304)
  • Usability (IEC 62366-1:2015)

The document explicitly states "PERFORMANCE TESTING - CLINICAL: None" and "ANIMAL STUDIES: None". This indicates that the substantial equivalence determination for K212851 was not based on a clinical performance study with defined acceptance criteria for diagnostic accuracy, sensitivity, specificity, or other performance metrics typically associated with an AI-driven or diagnostic device.

Therefore, the requested information elements related to clinical performance criteria and studies cannot be extracted from this document. The device's acceptance is based on its similarity to legally marketed predicate devices, and the demonstration that any differences do not raise new questions of safety or effectiveness, as supported by the non-clinical testing mentioned above.

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