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TEX20/TEX20 Pro/TEX20S/TEX20 Exp/TEX20 Elite/TEX10 Pro/TEX10S/TEX10S/TEX10T/TEX10 Exp/ TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-vaginal, musculo-skeletal(conventional, superficial), Thoracic/Pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.

The TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).

TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ The TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.

The provided text does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria related to an AI/algorithm feature.

The document is a 510(k) premarket notification for an ultrasound system (TEX20 series). It primarily focuses on demonstrating substantial equivalence to a predicate device (TEX20, K212265, and Resona I9, K210699).

Here's what the document does state, and why it doesn't fit the requested criteria for an AI performance study:

• New Added Features: The subject device introduces two new features: "AutoEF" and "AutoEF Plus."
  • "AutoEF" has been previously cleared in the predicate device Resona I9 (K210699).
  • "AutoEF Plus" is described as an "improved feature of the AutoEF... which could be used to automatically measure the systole or diastole views in real time."
• "Clinical Studies - Not Applicable": Crucially, the document explicitly states: "Not applicable. The subject of this submission, TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/ TEX10 Pro/TEX10 / TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence."

This indicates that the FDA clearance for this device, even with the "AutoEF Plus" feature, was based on non-clinical testing and substantial equivalence arguments, not a performance study that would typically involve acceptance criteria for an AI algorithm's diagnostic accuracy or performance against a ground truth. The "AutoEF Plus" feature, while automated, is treated as an improved feature of an already cleared function, rather than a novel AI diagnostic tool requiring extensive clinical validation against specific performance metrics for this particular submission.

Therefore, I cannot provide the requested table and details because the information is not present in the provided document. The document suggests that the device's clearance was not based on the type of clinical performance study you've described for an AI/algorithm.

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