(98 days)
Yes
The document explicitly mentions that several features (NerveTrack, BiometryAssist, ViewAssist, and HeartAssist) are based on AI and deep learning algorithms.
No.
The device is described as a "diagnostic ultrasound system" and its "Intended Use / Indications for Use" explicitly state it is "designed to obtain ultrasound images and analyze body fluids" for "clinical diagnosis of patients," rather than for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids." and "It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients." The "Device Description" also refers to it as a "diagnostic ultrasound system".
No
The device is described as a "diagnostic ultrasound system and probes" and a "general purpose, mobile, software controlled, diagnostic ultrasound system." This explicitly indicates the presence of hardware components (probes and the system itself) in addition to the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is a "diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids." While it mentions analyzing body fluids, the primary function described is obtaining and analyzing ultrasound images of anatomical structures within the body.
- Device Description: The device description focuses on the acquisition and display of ultrasound data in various modes and the ability to measure anatomical structures. It does not describe any components or processes that involve testing samples outside of the body (in vitro).
- Input Imaging Modality: The input modality is Ultrasound, which is an in vivo imaging technique, not an in vitro diagnostic method.
- Anatomical Site: The listed anatomical sites are all locations within the human body.
- AI Features: The AI features described (NerveTrack, BiometryAssist, ViewAssist, HeartAssist) are all designed to assist in the interpretation and analysis of ultrasound images obtained from within the body. They are not performing tests on biological samples outside the body.
In Vitro Diagnostics (IVDs) are medical devices that are used to perform tests on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. This device does not fit that description. It is an in vivo diagnostic imaging system.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, Muscular-Sketal (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, 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
Product codes
IYN, IYO, ITX
Device Description
The V8 / V7 are a general purpose, mobile, software controlled, diagnostic ultrasound system. Their 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 / V7 also give the operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The V8 / V7 have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Sketal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Thoracic, Trans-esophageal (Cardiac) and Peripheral vessel.
Indicated Patient Age Range
Neonatal, Adult, Pediatric (includes Fetal)
Intended User / Care Setting
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, private practices, clinics and similar care environment for clinical diagnosis of patients.
Description of the training set, sample size, data source, and annotation protocol
NerveTrack Algorithm Training Data:
The training data used for the training of the NerveTrack algorithm are independent of the data used to test the NerveTrack algorithm. (No further details on sample size, data source, or annotation protocol for the training set are provided for NerveTrack).
BiometryAssist Segmentation Algorithm Training Data:
Not Found (The document only mentions validation data for BiometryAssist segmentation).
ViewAssist Recognition Algorithm Training Data:
All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the images. The participating experts were composed of obstetricians with more than 20 years of experience and two sonographers with more than 10 years of experience; all in fetal cardiology. The entire process was supervised by another obstetrician with more than 25 years of experience. (Data source and sample size for training are not explicitly stated, only for testing).
HeartAssist View Recognition Algorithm Training Data:
(Fetus) All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the image. The participating experts were composed of an obstetrician with more than 20 years of experience and two sonographers with more than 10 years of experience, all in fetal cardiology. The entire process was supervised by another obstetrician with more than 25 years of experience.
(Adult) We employed the help of four professionals: two cardiologists with at least 10 years of experience and two sonographers with at least 10 years of experience. These experts manually traced the contours of the heart and the signal outline on the images.
(Data source and sample size for training are not explicitly stated, only for testing).
Description of the test set, sample size, data source, and annotation protocol
NerveTrack:
- Sample Size: 18 subjects (13 Females, 5 Males), 2,146 images (1,168 from Females, 978 from Males).
- Data Source: Not explicitly stated, but implied to be collected on Samsung ultrasound devices including V8.
- Annotation Protocol: Ten anesthesiologists and five sonographers with more than 10 years of experience participated to establish the ground truth (GT) for the location of 12 different kinds of nerves. One anesthesiologist who scanned the ultrasound directly drew the GT of nerve location, and two or more other anesthesiologists and sonographers reviewed and confirmed that it was correct. If there was any mistake during the review, it was revised again.
- Demographics: Age range: 22-68 years (Average 42.7); BMI range: 16-31.5 (Average 21.5); Ethnicity: All Koreans.
- Image Collection: Speed of the probe varies approximately from 1cm to 5cm per second. The orientation of the probe was short-axis imaging and perpendicular to the skin, obtained by sliding the probe in both the proximal and distal directions.
BiometryAssist:
- Sample Size: 320 fetal biometry images.
- Data Source: Collected at two hospitals.
- Annotation Protocol: All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the images. The participating experts were composed of obstetricians with more than 20 years of experience and two sonographers with more than 10 years of experience; all in fetal cardiology. The entire process was supervised by another obstetrician with more than 25 years of experience.
- Demographics: Gender: Female; Age: Reproductive age, specific age not collected; Ethnicity/Country: Americans and Koreans.
- Equipment & Protocols: Data set acquired with SAMSUNG MEDISON's ultrasound systems (W10, W9 and V8) to secure diversity. Mix of retrospective and prospective data. (Only V8 images have been used for the Performance Test).
ViewAssist:
- Sample Size: 680 fetal heart and fetal biometry images.
- Data Source: Collected at two hospitals.
- Annotation Protocol: All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the images. The participating experts were composed of obstetricians with more than 20 years of experience and two sonographers with more than 10 years of experience; all in fetal cardiology. The entire process was supervised by another obstetrician with more than 25 years of experience.
- Demographics: Gender: Female; Age: Reproductive age, specific age not collected; Ethnicity/Country: Americans and Koreans.
- Equipment & Protocols: Data set acquired with SAMSUNG MEDISON's ultrasound systems (W10, W9 and V8) to secure diversity. Mix of retrospective and prospective data. (Only V8 images have been used for the Performance Test).
HeartAssist:
- Sample Size: 888 fetal heart and adult heart images.
- Data Source: Collected at five hospitals.
- Annotation Protocol:
- (Fetus) All acquired images for training, tuning and validation were first classified into the correct views by three participating experts. Afterwards, corresponding anatomy areas were manually drawn for each of the image. The participating experts were composed of an obstetrician with more than 20 years of experience and two sonographers with more than 10 years of experience, all in fetal cardiology. The entire process was supervised by another obstetrician with more than 25 years of experience.
- (Adult) We employed the help of four professionals: two cardiologists with at least 10 years of experience and two sonographers with at least 10 years of experience. These experts manually traced the contours of the heart and the signal outline on the images.
- Demographics: Gender: Male and Female; Age: Reproductive age, specific age not collected; Ethnicity/Country: Americans and Koreans.
- Equipment & Protocols: Data set acquired with SAMSUNG MEDISON's ultrasound systems (W10, W9 and V8) to secure diversity. Mix of retrospective and prospective data. (Only V8 images have been used for the Performance Test).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
NerveTrack:
- Study Type: Standalone performance evaluation for AI algorithm. Non-clinical testing.
- Sample Size: 18 subjects (2,146 images).
- Standalone Performance:
- Accuracy (%): Average 90.3, Standard Deviation 4.8, 95% CI (88.6 to 92.0). Acceptance Criteria: >= 80%.
- Speed (FPS): Average 3.54, Standard Deviation 0.13, 95% CI (3.47 to 3.61). Acceptance Criteria: >= 2 FPS.
- Key Results: Performance for BMI subgroups showed very good generalizability, with average accuracy of all subgroups included within the confidence interval of the accuracy for the full dataset. Low correlation between BMI and maximum depth of nerves, indicating robustness.
BiometryAssist:
- Study Type: Not explicitly stated (validation of deep learning algorithm). Non-clinical testing.
- Sample Size: 320 fetal biometry images.
- Key Results:
- Segmentation Test: Average dice-score is 0.928 (threshold 0.8).
- Size Measurement Test: Error rate of circumference measured value is 8% or less. Error rate of distance measured value is 4% or less. Error rate of NT(Nuchal Translucency) measured value is 1mm or less.
ViewAssist:
- Study Type: Not explicitly stated (validation of deep learning algorithm). Non-clinical testing.
- Sample Size: 680 fetal heart and fetal biometry images.
- Key Results:
- View Recognition Test: Average recognition accuracy is 94.56% (threshold 89%).
- Anatomy Annotation (Segmentation) Test: Average dice-score is 0.898 (threshold 0.8).
HeartAssist:
- Study Type: Not explicitly stated (validation of deep learning algorithm). Non-clinical testing.
- Sample Size: 888 fetal heart and adult heart images.
- Key Results:
- View Recognition Test:
- (Fetus) Average recognition accuracy is 93.21% (threshold 89%).
- (Adult) Average recognition accuracy is 98.31% (threshold 84%).
- Segmentation Test:
- (Fetus) Average dice-score is 0.88 (threshold 0.8).
- (Adult) Average dice-score is 0.93 (threshold 0.9).
- Size Measurement Test:
- (Fetus) Error rate of area measured value is 8% or less. Error rate of angle measured value is 4% or less. Error rate of circumference measured value is 11% or less. Error rate of diameter measured value is 11% or less.
- (Adult, B-mode) Pass if the PCC value is 0.8 or greater than the specification.
- (Adult, M-mode) Pass if the PCC value is 0.8 or greater than the specification.
- (Adult, Doppler-mode) Pass if the PCC value is 0.8 or greater than the specification.
- View Recognition Test:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
NerveTrack:
- Accuracy (%)
- Speed (FPS)
BiometryAssist:
- Average dice-score (for segmentation)
- Error rate of circumference measured value
- Error rate of distance measured value
- Error rate of NT (Nuchal Translucency) measured value
ViewAssist:
- Average recognition accuracy (for view recognition)
- Average dice-score (for anatomy annotation/segmentation)
HeartAssist:
- Average recognition accuracy (for view recognition)
- Average dice-score (for segmentation)
- Error rate of area measured value (Fetus)
- Error rate of angle measured value (Fetus)
- Error rate of circumference measured value (Fetus)
- Error rate of diameter measured value (Fetus)
- PCC value (for Adult, B-mode, M-mode, Doppler-mode)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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February 13, 2023
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Samsung Medison Co., Ltd. % Ju Jee Young Regulatory Affairs Specialist Samsung Medison Co. Ltd. 3366, Hanseo-ro, Nam-myeon Hongcheon-gun, Gangwon-do 25108 REPUBLIC OF KOREA
Re: K223387
Trade/Device Name: V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 16, 2023 Received: January 18, 2023
Dear Ju Jee Young:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223387
Device Name
V8 Diagnostic Ultrasound System
V7 Diagnostic Ultrasound System
Indications for Use (Describe)
The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-vaginal, 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, 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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K223387
510(K) Summary:
In accordance with 21 CFR 807.92, the following summary of information is provided:
-
Date Prepared November 04, 2022 1.
-
- Manufacturer SAMSUNG MEDISON CO., LTD. 3366, Hanseo-ro, Nam-myeon, Hongcheon-gun, Gangwon-do, Republic of Korea
-
- Primary Contact Person Ju, Jee-Young Regulatory Affairs Specialist Phone: +82.2.2194.0861 Fax: +82. 2.2194.0273 Email: jee.ju(@samsungmedison.com
-
Secondary Contact Person 4. Ninad Gujar Vice President Phone: +1.978.564.8632 Fax: +1.978.564.8677 Email: ngujar@neurologica.com
-
Proposed Device 5.
-
Common/Usual Name : Diagnostic Ultrasound System and Accessories -
- Proprietary Name : V8 Diagnostic Ultrasound System
- V7 Diagnostic Ultrasound System
- Regulation Name : Ultrasonic pulsed doppler imaging system
- Proprietary Name : V8 Diagnostic Ultrasound System
-
Regulatory Class : Class II -
-
Product Code : IYN, IYO, ITX -
-
-Regulation Number : 21 CFR 892.1550, 892.1560, 892.1570
-
Predicate Devices 6.
-
Device Description 7.
- The V8 / V7 are a general purpose, mobile, software controlled, diagnostic ultrasound system. Their 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 / V7 also give the operator the ability to measure anatomical structures and offer analysis packages that provide information that is used to make a
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diagnosis by competent health care professionals. The V8 / V7 have a real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
-
- Intended Use
The V8 / V7 diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.
- Intended Use
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Muscular-Sketal (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, 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.
-
Technological Comparison to Predicate Devices 9.
The V8 / V7 employ the same fundamental scientific technology as its predicate devices V8 / V7 (K220975), RS85/ RS80 EVO(K221117), HS50 / 60 (K210068) and HERA W9 / W10(K220043) System. -
- Determination of Substantial Equivalence
Comparison to Predicate: The V8 / V7 are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- Determination of Substantial Equivalence
-
The systems are all intended for diagnostic ultrasound imaging and fluid flow . analysis.
-
. The proposed V8 / V7 and the primary predicate V8 / V7 (K220975) have the same clinical intended use.
-
. The proposed V8 / V7 and the primary predicate V8 / V7 (K220975) have the same imaging modes and modes of operation.
-
. The proposed V8 / V7 have expanded the detection nerve type (Head: Greater Occipital / Leg : Sciatic, Common Peroneal, Tibial) of NerveTrack based on AI in the previously cleared V8/V7 (K220975)
-
. The proposed V8 / V7 have included the BiometryAssist and ViewAssist which are based on AI version from the previously cleared HERA W9/ HERA W 10 (K220043).
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- The proposed V8 / V7 have included the HeartAssist which is based on the AI ● version from the previously cleared HERA W9/ HERA W10 (K220043) and expanded the clinical application to adult.
- . The proposed V8 / V7 have included the QUS(TSI/TAI) and EzHRI from the previously cleared RS85/ RS80 EVO (K221117).
- . The proposed V8 / V7 have included the additional matching methods of S-Fusion in the previously cleared V8/V7 (K220975)
- The proposed V8 / V7 have included the EzPrep for work-flow improvement. .
- The proposed V8/V7 have included one new transducer miniER7. PA4-12B and . LA2-9S have been migrated from the predicate RS85/ RS80 EVO (K221117). Only V7 has included four new transducers LA4-18AD, EV2-11ARE, EV2-11AVE and CV1-8AE, and LA3-14AD has been migrated from the predicate HS50 / 60 (K210068). Biocompatibility test has been conducted for the new transducers, and image performance tests have been conducted for the new and migrated transducers.
- . The proposed V8 / V7 and primary predicate V8 / V7 (K220975) have the same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- . The proposed V8 / V7 and primary predicate V8 / V7 (K220975) have been designed in compliance with approved electrical and physical safety standards.
- The system is manufactured with materials which have been evaluated and found ● to be safe for the intended use of the device.
- . The system has acoustic power levels which are below the applicable FDA limits.
-
- Summary of Non-Clinical Testing
The device has been evaluated for acoustic output, biocompatibility, software function. cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable FDA guidances and medical device safety standards. The V8 / V7 and its applications comply with the following FDA-recognized standards.
| Reference No. | Title |
|---|---|
| IEC 60601-1 | AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 |
| and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - | |
| Part 1: General requirements for basic safety and essential performance | |
| (IEC 60601-1:2005, MOD) | |
| IEC 60601-1-2 | IEC60601-1-2: 2020-09(4.1 Edition) , Medical electrical equipment - Part |
| 1-2: General requirements for basic safety and essential performance - | |
| EMC | |
| IEC 60601-2-37 | IEC 60601-2-37 Edition 2.0 2007, Medical electrical equipment – Part 2- |
| 37: Particular requirements for the basic safety and essential performance |
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Image /page/6/Picture/0 description: The image shows the word "SAMSUNG" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white.
| of ultrasonic medical diagnostic and monitoring equipment | |
|---|---|
| ISO10993-1 | AAMI / ANSI / ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process |
| ISO14971 | ISO 14971:2019, Medical devices - Application of risk management to medical devices |
| NEMA UD 2-2004 | NEMA UD 2-2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3 |
[ The validation for expansion of the detection nerve of NerveTrack based on AI ]
These are the details on validation of the AI algorithm used for all the new and improved AI-based features that includes expansion of the use of NerveTrack feature and the information about the dataset the device was tested on.
Acceptance Criteria:
| Validation Type | Definition | Acceptance Criteria |
|---|---|---|
| Accuracy (%) | $ \frac{\text{Number of correctly detected frames}}{\text{Total number of frames with nerve}} \times 100 $ | ≥ 80% |
| Speed (FPS) | $ \frac{1000}{\text{Average latency time of each frame (msec)}} $ | ≥ 2 FPS |
Summary Performance data, Standard Deviations & Confidence Intervals:
| Validation Type | Average | Standard Deviation | 95% CI |
|---|---|---|---|
| Accuracy (%) | 90.3 | 4.8 | 88.6 to 92.0 |
| Speed (FPS) | 3.54 | 0.13 | 3.47 to 3.61 |
Testing Data Information:
| Females | Males | Total | |
|---|---|---|---|
| Number of Subjects | 13 | 5 | 18 |
| Number of Images | 1,168 | 978 | 2,146 |
| Age range | 32~68 | 22~50 | 22~68 |
| Average age | 45.7 | 35.0 | 42.7 |
| BMI range | 16~27.1 | 31.5 | 16~31.5 |
| Average BMI | 20.5 | 31.5 | 21.5 |
| Ethnicity | All Koreans |
The standalone performance of NerveTrack was evaluated for BMI (Body Mass Index) subgroups, which are potential subject and image confounder. For subgroup analysis, we divided BMI values into four groups according to the CDC (Centers for Disease Control and Prevention) definition for adult overweight & obesity. They are underweight (BMI