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The HM70A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-esophageal (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel.

The HM70A is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode. M mode, Color Doppler imaging, Power Doppler imaging(including Directional Power Doppler mode; S-Flow), PW/CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HM70A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the HM70A Diagnostic Ultrasound System:

Summary of Acceptance Criteria and Device Performance

The acceptance criteria for the HM70A Diagnostic Ultrasound System are primarily tied to its substantial equivalence to previously cleared predicate devices. The core argument for acceptance is that the proposed device, HM70A V3.00, maintains the same safety and effectiveness as its predicate, HM70A V2.00 (K153408), and that newly added transducers or functionalities are comparable to those cleared in other predicates.

Study Details from the 510(k) Summary:

The provided document is a 510(k) summary, which is a premarket notification for demonstrating substantial equivalence rather than a detailed clinical study report for a novel AI device. Therefore, many of the typical AI/ML study components (like expert ground truth establishment, MRMC studies, training set details) are not applicable or not explicitly detailed in this type of submission.

Here's what can be extracted based on the information provided:

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Size: Not explicitly stated in terms of a specific number of images or cases. The evaluation relies on "non-clinical tests" and demonstrates equivalence to previously cleared devices.
   • Data Provenance: Not specified. The document states "All transducers proposed in the present submission were migrated from previously cleared systems," and "All Migrated probes and software functionality were evaluated using the same test criteria as the predicates for all applicable imaging modes." This implies that the testing leveraged existing validation methodologies for diagnostic ultrasound systems rather than a novel AI algorithm tested on a specific dataset. The company's origin is Republic of Korea.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • This information is not applicable in the context of this 510(k) summary. The submission focuses on substantial equivalence based on technical, safety, and performance characteristics compared to predicates, not on a new diagnostic algorithm requiring human expert ground truth for interpretation. Diagnostic ultrasound systems inherently involve human operators (competent health care professionals) making diagnoses.

3. Adjudication Method for the Test Set:

   • Not applicable. See point 2.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size:

   • No, an MRMC comparative effectiveness study was explicitly NOT done. The "Summary of Clinical Tests" section states: "The subject of this premarket submission, HM70A, is not required clinical studies to support substantial equivalence." This means no human-in-the-loop study comparing performance with and without AI assistance was performed or required for this submission.

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

   • No, an algorithm-only standalone performance study was not performed as part of this submission. This is a diagnostic ultrasound system, which is an imaging device. The "algorithm" here refers to the underlying signal processing and image formation techniques, not a separate AI-based diagnostic algorithm that would typically undergo standalone performance testing. The evaluation focuses on physical and electrical safety, acoustic output, and demonstration that migrated features maintain image quality similar to predicates.

6. The Type of Ground Truth Used:

   • Not applicable in the typical sense of AI/ML ground truth. For this type of device (a diagnostic ultrasound system), "ground truth" for performance is established through technical specifications, phantom testing, and comparisons to the performance of previously cleared devices. The "Indications for Use" section establishes the clinical applications for which the device is intended to be used by trained healthcare professionals for diagnosis.

7. The Sample Size for the Training Set:

   • Not applicable. This submission is for a conventional diagnostic ultrasound system, not an AI/ML product developed with large training datasets. The "software/Firmware-driven Functionality" was evaluated to ensure image quality was not compromised, which implies testing existing software and probes rather than training a new algorithm.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. See point 7.

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The HM70A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-esophageal (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac), Peripheral vessel.

The HM70A is a general purpose, hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging(including Directional Power Doppler mode; S-Flow), PW/CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HM70A has real time acoustic output display with two basic indices, a mechanical index, which are both automatically displayed.

The provided text is a 510(k) Summary for the Samsung Medison HM70A Diagnostic Ultrasound System. It details the device's intended use, technological characteristics, and compliance with safety standards, asserting substantial equivalence to predicate devices. However, this document does not contain acceptance criteria, device performance metrics, or information about specific studies, test set details, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set parameters.

Therefore, I cannot extract the requested information from the provided text. The document explicitly states: "Summary of Clinical Tests: Not applicable. The subject of this submission, HM70A, did not require clinical studies to support substantial equivalence." This means that no clinical studies (which would typically involve test sets, ground truth, expert review, etc.) were conducted or submitted for this particular 510(k) clearance based on this document.

The document focuses on establishing substantial equivalence through a comparison of technological characteristics and compliance with recognized safety standards, rather than through performance metrics derived from clinical trials or test sets.

Ask a specific question about this device