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Echo Blaster 128 / Echo Blaster 64 ultrasound imaging systems are intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid and testicles), cephalic (neonatal and adult), musculoskeletal (conventional), musculoskeletal (superficial), cardiac adult and peripheral vessel (including imaging for needle guidance, see ch.1.3). It is possible to provide diagnostic information (B, B+M and M-mode imaging) outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

Echo Blaster 128 / Echo Blaster 64 systems are intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. Echo Blaster 128 / Echo Blaster 64 system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The System is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 10 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode or M-Mode, inclusive of the predicate devices so claimed. The Echo Blaster 128 / Echo Blaster 64 only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Echo Blaster 128 / Echo Blaster 64 via USB 2.0. Minimum requirements are given for the PC. The probes are connected to the Echo Blaster 128 / Echo Blaster 64. All Sonograms are saved on the PC and can there be evaluated, printed and archived. The Echo Wave software was especially designed for the Echo Blaster 128 / Echo Blaster 64. Software able to reside in a Windows-based PC. The Echo Blaster 128 / Echo Blaster 64 can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 10MHz probes can work simultaneously for Echo Blaster 128 2Z modifications.

The Telemed Echo Blaster 64 and 128 are ultrasound imaging systems. This 510(k) submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices by demonstrating compliance with safety and performance standards. The information provided does not detail a study involving clinical performance metrics typically associated with AI/algorithm-driven devices, as the product is a general-purpose ultrasound system.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are compliance with established international and national safety and performance standards for medical electrical equipment and diagnostic ultrasound, rather than specific clinical performance metrics like sensitivity or specificity. The "reported device performance" is the assertion of full compliance with these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission does not describe a clinical performance study with a "test set" in the context of an AI/algorithm-driven device. The device is a general-purpose ultrasound system. The "testing" involved compliance with established engineering, safety, and performance standards. Therefore, information about clinical test set sample size, country of origin, or retrospective/prospective nature is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, this submission doesn't describe a clinical performance study requiring expert-established ground truth for a test set. Evaluation was against technical standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudications for a clinical test set are mentioned.

5. 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

No. This submission describes a general-purpose ultrasound imaging system, not an AI-assisted diagnostic algorithm. Therefore, no MRMC study comparing human reader performance with and without AI assistance was conducted or is relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a hardware and software system for real-time ultrasound imaging operated by a human, not a standalone algorithm performing diagnostic tasks.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this type of device (general-purpose ultrasound), "ground truth" relates to compliance with engineering specifications, safety limits and image quality parameters defined by industry standards, rather than clinical diagnostic accuracy against a specific pathology.

8. The sample size for the training set

Not applicable. This device is an ultrasound system; it does not involve AI model training on a "training set" of medical data in the way a diagnostic AI algorithm would.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a "training set" for an AI model in this submission.

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