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SmartUs EXT-1M/3M ultrasound imaging system is intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid, testicles), adult cefalic, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, peripheral vessel (B and M-mode, combined modes imaging, including imaging for needle guidance). It is possible to provide diagnostic information outside of an imaging lab, including at thebedside systems, for navigatedmedical application, in operating rooms/critical care units.

SmartUs EXT-1M/3M system is intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. SmartUs EXT-1M/3M 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. Its basic function is to acquire ultrasound echo data and to display the image in ultrasound B-Mode, M-Mode or combined modes. The system is designed for imaging with transducer ranges of 2 to 15 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, M-Mode or combined modes, inclusive of the predicate devices so claimed. SmartUs EXT-1M/3M only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the SmartUs EXT-1M/3M via USB 2.0/3.0. Minimum requirements are given for the PC. All echo-images (sonograms) are saved on the PC and can there be evaluated, printed and archived. The Echo Wave II software was especially designed for the TELEMED devices. Software able to reside in a Windows-based PC. The device modifications are: - SmartUs EXT-1M ultrasound system utilizing as hardware an ultrasound ● engine contained in a small standalone enclosure for connection to a host PC via a USB port with external power supply; - SmartUs EXT-3M ultrasound system -modification with 3 probe ports ● The SmartUs EXT-1M/3M can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 15MHz probes). - . probe L15-7L40H-5, linear array, at a central ultrasonic frequency of approx. 12 MHz; - probe C5-2R60HI-5, convex array at a central ultrasonic frequency of approx. 3.5 MHz; ● - probe P5-1L15SI-6, phased array at a central ultrasonic frequency of approx. 4 MHz. ●

The provided document describes a 510(k) premarket notification for the SmartUs EXT-1M/3M ultrasound imaging system.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The submission makes a case for substantial equivalence to predicate devices. This means the primary "study" proving the device meets acceptance criteria is a comparison to already cleared devices and adherence to relevant safety and performance standards, rather than a standalone clinical efficacy study for novel indications.

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1: 2005 (General safety & essential performance)
• IEC 60601-1-2: 2007 (EMC)
• IEC 60601-2-37:2007 (Ultrasonic medical diagnostic equipment)
• ISO 14971:2012 (Risk management)
• ISO-10993-1:2009, ISO-10993-5:2009, ISO-10993-10:2010 (Biocompatibility)
• IEC 62304: 2006 (Software life cycle processes)
• NEMA UD 2-2004 (Acoustic Output Measurement)
• NEMA UD 3-2004 (Real-time display of thermal/mechanical indices)
• AIUM MUS: 2002 (Medical Ultrasound Safety)
• Essential Requirements of Council Directive 93/42/EEC (Medical Device Directive)
  Reported Performance: All devices designed to be in full compliance. Maximum acoustic output level is under FDA recommended limit and power level is displayed. |
  | Effectiveness | Demonstrated by "substantial equivalence" to predicate devices (TELEMED LS128 K113184 and SAMSUNG MEDISON SONOACE R7 K112646).
  The submission states: "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."
  Reported Performance: A basic diagnostic tool for real-time imaging (ultrasound B-Mode, M-Mode, combined modes) across various clinical applications as specified in the Indications for Use tables (fetal, abdominal, pediatric, small organ, adult cephalic, musculo-skeletal, cardiac, peripheral vessel). |
  | Biocompatibility | Materials in patient contact (Acoustic Lens Cover, Housing, Handle & Nosepiece, Silicone Elastomer, ABS) tested against ISO-10993-1, ISO-10993-5, ISO-10993-10. |
  | Acoustic Output | In accordance with ALARA principle and NEMA UD 2-2004, NEMA UD 3-2004, AIUM MUS: 2002. Maximum acoustic output level reported to be under FDA recommended limit. |
  | Software Functionality | Collects and pro-processes 'rough' data, sends via USB to a Windows-based PC running Echo Wave II software for processing, displaying images/data, and storing. |
  | Cleaning and Disinfection | Devices are tested and determined to be full compliance with cleaning and disinfection effectiveness. |

2. Sample Size Used for the Test Set and the Data Provenance

The document does not describe a test set with patient data for clinical performance evaluation. The "study" here is primarily a demonstration of compliance with national and international safety and performance standards and a comparative analysis to predicate devices.

• Sample Size: Not applicable in the context of a clinical test set. The evaluation focuses on engineering and regulatory compliance, and a comparison to predicate devices, which implies the predicate devices' prior clinical performance supports the current device's claims.
• Data Provenance: Not specified, as no clinical data set is referenced for the SmartUs EXT-1M/3M itself beyond the compliance with standards. It relies on the established performance of the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts

Not applicable. There is no specific test set requiring expert-established ground truth for the SmartUs EXT-1M/3M itself for efficacy. The "ground truth" for substantial equivalence rests on the established regulatory classifications and performance of the predicate devices and general consensus on ultrasound imaging principles.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated 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. The device described is a general diagnostic ultrasound imaging system, not an AI-powered diagnostic system requiring an MRMC study to evaluate AI assistance.

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

Not applicable. The system is an ultrasound imaging device, which requires a human operator (sonographer/clinician) to acquire and interpret images. There is no mention of a standalone algorithm for automated diagnosis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the SmartUs EXT-1M/3M, the "ground truth" for its acceptance is based on adherence to established engineering and medical device safety standards, and the precedent set by predicate devices that have already demonstrated safety and effectiveness in clinical use. No new specific clinical "ground truth" (e.g., pathology, outcomes) was generated for this 510(k) submission for efficacy claims.

8. The Sample Size for the Training Set

Not applicable. This device is an ultrasound machine, not a machine learning or AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm.

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