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510(k) Data Aggregation
(77 days)
The V8 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids. The clinical applications include: Fetal/Obsterics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-raginal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) and Peripheral vessel.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode
The V8 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode. The V8 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 V8 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
The provided document is a 510(k) Summary for the Samsung Medison V8 Diagnostic Ultrasound System. It details the device's intended use, technological comparison to predicate devices, and non-clinical testing. However, it explicitly states that no clinical studies were required to demonstrate substantial equivalence.
Therefore, I cannot provide information on acceptance criteria and a study proving the device meets those criteria from this document. The document primarily focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing predicate devices, rather than a clinical study with defined performance metrics and acceptance criteria.
The relevant section from the document is:
12. Summary of Clinical Tests
The proposed device V8 Ultrasound System did not require clinical studies to demonstrate substantial equivalence.
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(121 days)
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel and Lung.
It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals (includes emergency room), private practices, clinics and similar care environment for clinical diagnosis of patients.
Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.
The HM70 EVO is a general purpose, mobile, 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 Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging(S-Harmonic). Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70 EVO 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 HM70 EVO has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
This document pertains to the 510(k) Premarket Notification of the HM70 EVO Diagnostic Ultrasound System by Samsung Medison CO., LTD. As specified in section 12, "Summary of Clinical Tests: The subject of this premarket submission, HM70 EVO, is not required clinical studies to support substantial equivalence."
Therefore, I cannot provide details regarding acceptance criteria for clinical performance or a study demonstrating device performance based on the provided text, as no clinical studies were deemed necessary for this submission. The submission relies solely on non-clinical tests to establish substantial equivalence to predicate devices.
Here's the breakdown of the information that can be extracted from the document regarding non-clinical acceptance criteria and their assessment:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reference/Standard | Reported Device Performance |
|---|---|---|
| Acoustic Output | NEMA UD 2-2004 (R2009) | Acoustic power levels are below the applicable FDA limits. |
| Biocompatibility | ISO 10993-1:2009/(R)2013 | System is manufactured with materials which have been evaluated and found to be safe for the intended use. |
| Software Function | Not explicitly stated, implied by overall safety and effectiveness. | Software functionality contributes to the device performing as intended. |
| Cleaning & Disinfection Effectiveness | Not explicitly stated, implied by overall safety and effectiveness. | The device meets requirements for cleaning and disinfection. |
| Thermal Safety | IEC 60601-1 | Device conforms to applicable FDA guidance and medical device safety standards. |
| Electrical Safety | IEC 60601-1 | Device conforms to applicable FDA guidance and medical device safety standards. |
| Electromagnetic Safety (EMC) | IEC 60601-1-2: 2014 (4th Edition) | Device conforms to applicable FDA guidance and medical device safety standards. |
| Mechanical Safety | IEC 60601-1, IEC 60601-2-37 | Device conforms to applicable FDA guidance and medical device safety standards. |
| Risk Management | ISO 14971:2007 | Application of risk management to medical devices has been followed. |
| Basic Safety and Essential Performance (General) | IEC 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 | Device conforms to applicable FDA guidance and medical device safety standards. |
| Basic Safety and Essential Performance (Ultrasonic Specific) | IEC 60601-2-37 Edition 2.0 2007 | Device conforms to applicable FDA guidance and medical device safety standards. |
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, as no clinical studies were performed or required for this 510(k) submission. The evaluation was based on non-clinical testing against established engineering and safety standards.
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, as no clinical studies were performed or required. Ground truth in this context refers to compliance with established technical specifications and safety standards, evaluated by qualified engineers and testers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies were performed or required.
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 HM70 EVO is a diagnostic ultrasound system, and while it may incorporate advanced imaging techniques (e.g., ElastoScan), the provided document does not indicate the presence of AI assistance requiring an MRMC study. No clinical studies were required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The HM70 EVO is a diagnostic ultrasound system and its performance is inherently tied to human operation and interpretation. The document does not describe any standalone algorithm performance separate from the device itself. No clinical studies were required.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" was compliance with established national and international recognized standards and FDA guidance documents for medical devices (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, NEMA UD 2-2004). This involves objective measurements and tests to verify specified performance and safety parameters.
8. The sample size for the training set
Not applicable, as no clinical studies or AI algorithm training are described or required for this submission.
9. How the ground truth for the training set was established
Not applicable, as no clinical studies or AI algorithm training are described or required for this submission.
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