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The TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes is intended for diagnostic ultrasoundimaging or fluid flow analysis of the human body; specific indications for use a tabulated in Section 4.3 of this submission.

Technical specifications for the Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes are as follows: System Transducer frequencies: 2-4 MHz (4C2 and 4V2), 4-8 MHz (8EC4, 8L4) Frame rate: 15 - 58 fps (Imaging only) Ultrasound lines/frame: 128 Fields of View: 2.5 - 24 cm External Video Output: Composite Video, VGA Monitor Display: 15.7" SXGA TFT Liquid-Crystal Size: 13.125" Width: 11.25" Height: 1.62" Depth: 8.6 lb. Weight: Laptop Computer 10 oz Smart Probe Electrical Input: 115-250 VAC, Output: 19 VDC @ 4A External Power: Li-Ion battery pack (70 Whr) Battery: Leakage Current: 50 µA maximum Primary Breakdown Voltage: greater than 1500 V AC Safety Standards: IEC 601-1, UL 2601, Can/CSA C22.2 601.1 Protection Class: Class I: per IEC 601-1 Degree of Protection: Type BF: per IEC 601-1 Environmental Mechanical Shock (Smart Probe): IEC 68-2-27 compliant (Smart Probe only) Mechanical Vibration: Sinusoidal: IEC 68-2-6 (Smart Probe only) Drop Test (to concrete): 3 feet Operating Temperature: 0 to 50 C (Smart Probe only) Humidity: 20 to 80% RH, non-condensing Water Resistance: Transducer array watertight to the strain relief Altitude: 0 -- 12,500 feet (operating) Refer to computer manufacturer's documentation for relevant environmental specifications. Storage Temperature: -25 to 60 C Humidity: 15 to 98% RH, non-condensing

The provided document does not contain acceptance criteria or details of a study that proves the device meets specific acceptance criteria in the way described by the prompt. This document is a 510(k) summary for a medical device (TERATECH Model 2000 Handheld Ultrasound System), which focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against a set of quantitative or qualitative acceptance criteria through a dedicated study.

Specifically:

• There is no table of acceptance criteria and reported device performance.
• There are no details of sample sizes used for test sets, data provenance, number of experts for ground truth, or adjudication methods.
• There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of human readers with/without AI.
• There is no mention of a standalone algorithm performance study.
• The type of ground truth used for any performance evaluation is not specified, nor are training set details.

Instead, the document states:

"The TERATECH Model 2000 Handheld Ultrasound System with Doppler and Harmonic Imaging Modes is substantially equivalent to Deppter and Sequoia™ and Aspen™, which are currently in commercial distribution in the United States, since the subject device has intended uses and modes of operation which are a subset of those of the predicates."

This indicates that the primary method for clearance was demonstrating substantial equivalence based on similar intended uses and operational modes to existing, legally marketed predicate devices (Acuson Sequoia™ Ultrasound System and Harmonic Imaging (K97367), Acuson Aspen™ Ultrasound System (K991805)). This approach relies on the predicate devices having already met the necessary performance and safety standards, and the new device being sufficiently similar that it does not raise new questions of safety or effectiveness.

The tables presented in the later sections outline the intended uses and modes of operation for different transducers with the system, indicating which applications are "new indications" (N) or "previously cleared by FDA" (P) under other 510(k)s. This is about defining the scope of the device's permissible use, not about performance metrics against specific criteria.

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