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The LogicScan 64 / LogicScan 128 systems and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The applications are: cardiac (adult), fetal, abdominal, pediatric, small organ, transrectal, neonatal cephalic, peripheral vessel and musculo-skeletal (conventional and superficial). It is possible to provide diagnostic information outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.

LogicScan 128 / LogicScan 64 color diagnostic systems are intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. LogicScan 128 / LogicScan 64 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 12 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. USB 2.0 connection between the beamformer and PC is a novel feature for ultrasound systems. The LogicScan 128 / LogicScan 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 LogicScan 128 / LogicScan 64 via USB 2.0. Minimum requirements are given for the PC. The probes are connected to the LogicScan 128 / LogicScan 64. All sonograms are saved on the PC and can there be evaluated, printed and archived. The Echo Wave II software was especially designed for the LogicScan 128 / LogicScan 64. Software able to reside in a Windows-based PC. The LogicScan 128 / LogicScan 64 can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 12MHz probes). Two probes can work simultaneously for LogicScan 128 2Z modifications.

This 510(k) submission for the TELEMED LogicScan 64/LogicScan 128 ultrasound systems is a predicate device comparison and does not describe an AI/ML device or present specific acceptance criteria and a study to prove performance metrics in the typical sense of AI/ML device evaluations.

Instead, the submission focuses on demonstrating substantial equivalence to already legally marketed predicate devices by showing compliance with established safety and performance standards for diagnostic ultrasound equipment. The "acceptance criteria" here are the regulatory and safety standards, and the "study" is the design and testing for compliance with these standards.

Therefore, the requested information elements related to AI/ML performance, ground truth, sample sizes for AI training/testing, expert adjudication, or MRMC studies are not applicable to this document.

Here's a breakdown of the relevant information provided in the document:

1. A table of (not applicable to AI/ML performance, but regulatory compliance):

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

• Not applicable. This submission is based on engineering design, compliance with international standards, and comparison to predicate devices, not on a clinical performance study with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set with ground truth established by experts is described for performance evaluation in this 510(k) submission.

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

• Not applicable. No clinical test set is described.

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

• Not applicable. This is not an AI-assisted device.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable. The "ground truth" for this submission are the established regulatory and safety standards for ultrasound devices, against which the device's design and physical properties were evaluated for compliance.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" to prove the device meets acceptance criteria, in this context, is the demonstration of compliance with a comprehensive set of international and national safety and performance standards for medical devices, particularly diagnostic ultrasound equipment. This includes:

• Design and Engineering Compliance: The LogicScan family was designed to meet standards such as IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, AIUM MUS, ISO 10993 series (for biocompatibility), IEC 62304 (for software), and ISO 14971 (for risk management).
• Verification and Testing: The document states that "Prior release for manufacturing, all such devices, so designed, are tested and determined to be in full compliance with acoustic output, biocompatibility, cleaning and disinfection effectiveness." This indicates internal verification and validation testing against the specified standards.
• Predicate Device Comparison: The core of a 510(k) submission for this type of device is the argument of "substantial equivalence" to legally marketed predicate devices (SAMSUNG MEDISON CO., LTD MySono U5 Diagnostic Ultrasound System K100186 and SonoAce R7 Diagnostic Ultrasound System K112646). The applicant asserts that there are "no technological characteristics or features or indications for use in this Submission that are not previously evaluated and approved in the predicate devices, nor are there such technologies, features and indications for use not commonly used in the practice of diagnostic ultrasound." This comparison serves as the primary "proof" for market clearance, rather than a novel clinical effectiveness study for a new technology.
• No Additional Clinical Testing Required: The submission explicitly states, "No additional clinical testing is required, as the indications for use are not a novel indication as shown by the predicate devices."

In conclusion, the TELEMED LogicScan 64/LogicScan 128's acceptance criteria are regulatory and safety standards, and the proof of meeting these criteria is via design for compliance, internal validation testing, and demonstration of substantial equivalence to existing, legally marketed ultrasound devices.

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