(59 days)
Yes
The device description explicitly states that the purpose of the 510(k) is to introduce the "Auto Measure Artificial Intelligence-Machine Learning software feature" and that this feature "utilizes machine learning". The document also repeatedly mentions AI and ML in the "Mentions AI, DNN, or ML" section.
No.
The intended use of the device is for diagnostic ultrasound imaging, not for therapy. It provides semi-automated and editable measures for cardiac analysis to aid in diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are for "diagnostic ultrasound imaging and fluid flow analysis of the human body" and the clinical environments are for "diagnosis of patients." The device description further clarifies that the software feature is added to existing "Diagnostic Ultrasound Systems."
No
The device described is a software feature (Auto Measure) that is integrated into existing hardware (5000 Compact Series Ultrasound Systems). While the submission focuses on the software feature, it is not a standalone software-only medical device; it is an addition to a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic ultrasound imaging and fluid flow analysis of the human body." This describes a device that interacts directly with the patient's body to produce images and data, which is characteristic of an in vivo diagnostic device.
- Indications for Use: The list of indications for use covers various anatomical sites and clinical applications, all of which involve imaging the human body directly.
- Device Description: The device is described as an "ultrasound system" and the new feature is "Auto Measure Artificial Intelligence-Machine Learning software feature onto the 5000 Compact Series Ultrasound Systems." Ultrasound systems are in vivo diagnostic devices. The software feature enhances the analysis of the ultrasound images, but the core function remains in vivo imaging.
- Input Imaging Modality: The input is "Diagnostic Ultrasound imaging," which is an in vivo imaging technique.
- Anatomical Site: The listed anatomical sites are all parts of the human body being imaged directly.
- Clinical Environment: The clinical environments listed (physicians' offices, clinics, hospitals, surgical suites, and clinical point-of-care) are where in vivo diagnostic procedures are performed.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on bodily specimens.
While the device uses AI/ML to process and analyze images obtained from the body, the primary diagnostic information is derived from the in vivo ultrasound imaging process itself. The Auto Measure feature is a tool to assist in the interpretation of those in vivo images.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The provided text only indicates "Control Plan Authorized (PCCP) and relevant text: Not Found".
Intended Use / Indications for Use
The intended use of the 5000 Compact series ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:Abdominal, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral Vascular, Cephalic (Adult),Cephalic (Neonatal), Fetal Echo, Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Lung, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Parts, Transesophageal (Cardiac), Transrectal, Transvaginal, and Urology.
The clinical environments where the systems can be used include physicians' offices, clinics.hospitals, surgical suites, and clinical point-of-care for diagnosis of patients. The System is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed.
However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX, QIH
Device Description
The Auto Measure feature utilizes machine learning to provide a subset of semi-automated and editable measures during an echocardiography or when reviewing an already acquired echocardiography. When Auto Measure Version 2 is enabled, the healthcare professional performs an echocardiography with a workflow that provides the user with a semi-automated measurement that can be edited, accepted, or rejected.
Philips has designed Auto Measure as a "locked" algorithm prior to marketing. As defined by FDA in the discussion paper Proposed Requlatory Framework for Modifications to AI/ML Based Software as a Medical Device (SaMD) published April 2, 2019, this "locked" algorithm provides the same result each time the same input is applied to it and does not change with use.
The Auto Measure software feature does not introduce new modes, presets, measurements, or system components (e.g. transducers) to the Philips 5000 Compact Series Ultrasound Systems K222648.
No hardware changes to the 5000 Compact Series Ultrasound Systems K222648 are required when using the Auto Measure feature, and existing, commercialized Philips transducers are used for the Auto Measure feature.
5000 Compact Series Ultrasound Systems are part of the VM platform product family, The Auto Measure Version 1 feature was originally cleared (K211597) on EPIQ and Affiniti models running software version 9.0 (VM9.0). The Auto Measure feature is also available to all software releases following VM9.0.
Since the initial Auto Measure feature initial clearance (Version 1.0), a subset of integrated measurement detectors has been trained with additional training data in the Auto Measure feature (Version 2) which is scope of this submission
Auto Measure for this premarket notification utilizes the same software version platform VM as the Reference Device, Affiniti Diagnostic Ultrasound Systems K211597.
Mentions image processing
Yes, Automated Radiological Image Processing Software (Product Code QIH)
Mentions AI, DNN, or ML
Yes
"The Auto Measure feature utilizes machine learning to provide a subset of semi-automated and editable measures"
"Philips has designed Auto Measure as a "locked" algorithm prior to marketing. As defined by FDA in the discussion paper Proposed Requlatory Framework for Modifications to AI/ML Based Software as a Medical Device (SaMD) published April 2, 2019"
"Auto Measure is an optional software feature on the 5000 Compact Series Ultrasound System that provides the end user with semiautomated echocardiography 2D and Doppler measurements through an AI-algorithm, training via machine-learning techniques."
"As this feature has been designed to accelerate the manual measurement procedure with high success rates, no additional automated image quality assessment prevents the application of an automated measurement to inadequate images."
"The Auto Measure software feature was developed to provide automated measurements in echocardiography that align closely with the accuracy of manual measurements, the current gold standard."
"User selects an adult echocardiography 2D or Doppler measurement to perform then the caliper positions are initialized based on the output of the AI detection algorithm."
"Semi-automated adult echocardiography 2D and Doppler measurements are generated using an artificial intelligence (AI) detection algorithm without user interaction."
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal Echo, Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Lung, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Parts, Transesophageal (Cardiac), Transrectal, Transvaginal, and Urology.
Indicated Patient Age Range
Adult, Neonatal, Pediatric, Fetal. Not specified for all indications.
However, in the performance study, it states: "Automated measurements are designed to operate on transthoracic acquisitions of adult subjects with typical diagnostic image quality" and "Data pool for semi-automated cardiac measurement consists of anonymized transthoracyc echocardiography DICOM data and metadata. The data was recorded by multiple sonographers and physicians qualified in echocardiography in a large sample of adults of various ethnicities."
Intended User / Care Setting
Trained healthcare professionals including sonographers, physicians, and biomedical engineers who operate and maintain the product
Clinics, hospitals, and clinical point-of-care for diagnosis of patients.
Description of the training set, sample size, data source, and annotation protocol
All detector models were trained from the ground up and no pre-trained model weights were used. Training of the detectors was based on manual measurements performed by human experts done for diagnostic purpose. No additional non-standard was required.
Data pool for semi-automated cardiac measurement consists of anonymized transthoracyc echocardiography DICOM data and metadata. The data was recorded by multiple sonographers and physicians qualified in echocardiography in a large sample of adults of various ethnicities. Echocardiographic recordings were acquired according to guideline-standard echocardiographic procedures between 2010 and 2021 in 20 centers and 16 countries. Qualified medical in echocardiography using TTA software (versions TTA2.31.00 and TTA2.50.00) or various Philips ultrasound systems annotation and following established quideines (Mitchel et al 2019),
The total training pool comprises more than 6000 studion, cardially healthy individuals as well as from patients having indications for receiving an echocarding our standard operating procedure for Al based algorithm development, validation data have been randomly sampled from then separated before detector development. Remaining data have been used for training and tuning in a cross-validation framework.
Description of the test set, sample size, data source, and annotation protocol
Performance validation data have been extracted from a total auf 500 studies, one study per subject. Of these 500 studies, 200 are known normal subjects and 300 patients had a confirmed pathology). In clinical routine, not all measurements are performed in all studies. The available data per detector are listed in column 3 of the performance results table.
Demographic distribution for all validation studies is as follows:
Age: 52.4 ± 15.5 years
Gender: Male: 49.6 % Female: 50.4 %
Ethnicity: Asian: 30.2 % Black: 26.4 % White: 36.2 Other: 7.3 %
Body Surface Area: 1.9 m^2 ± 0.2 m^2
Weight: 76.8 kg ± 17.0 kg
In our evaluation, Auto Measure analyzed a set of new, previously images, and its automated results were compared to ground truth measurements established by clinical experts during routine care. Both the manual and automated measurements were performed on the same images without any adjustments to the siftware's output or the clinical data used as ground truth. The limits of agreement (LoA) used to assess performance were derived from published human interobserver variability data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Study type: Software verification and validation study comparing automated measurements to manual ground truth measurements established by clinical experts.
Sample size: 500 studies total (200 normal, 300 pathological). Individual detector sample sizes range from 53 to 469.
Key results: All detectors met the acceptance criteria informed by clinical literature, supporting the accuracy and reliability of the Auto Measure feature. Measured Limits of Agreement (LoA) for each detector were within the Checked Limits of Agreement (LoAs) derived from human-human interobserver variability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measured Limits of Agreement (LoA)
Checked Limits of Agreement (LoAs)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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November 15, 2024
Philips Ultrasound LLC Suresh Kumar Alagarsamy Senior Specialist I - Regulatory Affairs 22100 Bothell Everett Highway Bothell, Washington 98021
Re: K242800
Trade/Device Name: The 5000 Compact Series Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX, QIH Dated: September 16, 2024 Received: September 17, 2024
Dear Suresh Kumar Alagarsamy:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
The 5000 Compact Series Ultrasound Systems
Indications for Use (Describe)
The intended use of the 5000 Compact series ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use:Abdominal, Cardiac Adult, Cardiac Pediatric, Carotid, Cerebral Vascular, Cephalic (Adult),Cephalic (Neonatal), Fetal Echo, Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Lung, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Pediatric, Peripheral Vessel, Small Parts, Transesophageal (Cardiac), Transrectal, Transvaginal, and Urology.
The clinical environments where the systems can be used include physicians' offices, clinics.hospitals, surgical suites, and clinical point-of-care for diagnosis of patients. The System is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information, and only for the purposes for which it was designed.
However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in blue letters. The letters are bold and sans-serif. The background is white.
510(k) Summary
This summary of safety and effectiveness information is submitted in accordance with 21 CFR § 807.92.
510(k) Number: K242800
Date Prepared: September 16, 2024
l. Submitter
| Manufacturer Name and
Address | Philips Ultrasound LLC
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information | Suresh Kumar Alagarsamy
Senior Specialist I - Regulatory Affairs
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA
+91 97401 63840 |
| Secondary Contact | Erdit Gremi
Director, Regulatory Affairs - Software & Al
22100 Bothell Everett Hwy
Bothell, WA 98021-8431 USA
1-617-798-8092 |
II. Device
| Proprietary Name | 5000 Compact Series Ultrasound Systems
Auto Measure | | |
|------------------------|---------------------------------------------------------------------|----------|--------------|
| Common Name | Diagnostic Ultrasound System and Transducers | | |
| Regulation Description | Classification Description | 21 CFR § | Product Code |
| | Primary | | |
| | System, imaging, pulsed doppler, ultrasonic | 892.1550 | IYN |
| | Secondary | | |
| | System, imaging, pulsed echo, ultrasonic | 892.1560 | IYO |
| | Transducer, ultrasonic, diagnostic | 892.1570 | ITX |
| | Automated Radiological Image Processing Software | 892.2050 | QIH |
| Device Class | Class II | | |
| Review Panel | Radiology | | |
| Predicate Device | K222648 5000 Compact Series Diagnostic Ultrasound Systems | | |
| Reference Device | K211597 Philips Affiniti Series Diagnostic Ultrasound System VM 9.0 | | |
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Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is a light gray or white color, providing contrast to the blue text.
III. Device Description
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce the Auto Measure Artificial Intelligence-Machine Learning software feature onto the 5000 Compact Series Ultrasound Systems.
The Auto Measure feature utilizes machine learning to provide a subset of semi-automated and editable measures during an echocardiography or when reviewing an already acquired echocardiography. When Auto Measure Version 2 is enabled, the healthcare professional performs an echocardiography with a workflow that provides the user with a semi-automated measurement that can be edited, accepted, or rejected.
Philips has designed Auto Measure as a "locked" algorithm prior to marketing. As defined by FDA in the discussion paper Proposed Requlatory Framework for Modifications to AI/ML Based Software as a Medical Device (SaMD) published April 2, 2019, this "locked" algorithm provides the same result each time the same input is applied to it and does not change with use.
The Auto Measure software feature does not introduce new modes, presets, measurements, or system components (e.g. transducers) to the Philips 5000 Compact Series Ultrasound Systems K222648.
No hardware changes to the 5000 Compact Series Ultrasound Systems K222648 are required when using the Auto Measure feature, and existing, commercialized Philips transducers are used for the Auto Measure feature.
5000 Compact Series Ultrasound Systems are part of the VM platform product family, The Auto Measure Version 1 feature was originally cleared (K211597) on EPIQ and Affiniti models running software version 9.0 (VM9.0). The Auto Measure feature is also available to all software releases following VM9.0.
Since the initial Auto Measure feature initial clearance (Version 1.0), a subset of integrated measurement detectors has been trained with additional training data in the Auto Measure feature (Version 2) which is scope of this submission
Auto Measure for this premarket notification utilizes the same software version platform VM as the Reference Device, Affiniti Diagnostic Ultrasound Systems K211597.
IV. Intended Use and Indications for Use
5000 Compact Series Intended Use_
The intended use of 5000 Compact Ultrasound System is diagnostic ultrasound imaging and fluid flow analysis of the human body.
5000 Compact Series Indications for Use:
The 5000 Compact Series Ultrasound Systems (Ultrasound System 5500G, Ultrasound System 5500P, Ultrasound System 5500W, Ultrasound System 5500CV, Ultrasound System 5300G, Ultrasound System 5300P, Ultrasound System 5300W) are intended for diagnostic Ultrasound imaging in B (or 2D), 3D/4D, Color Doppler, Continuous Wave Doppler, Tissue Doppler, Tissue Doppler, M-mode (including anatomical M-mode), Harmonics (Tissue and Contrast), Color Power Angio (CPA), and Combined modes.
The intended use of the 5000 Compact series ultrasound system is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following indications for use: Abdominal. Cardiac Adult. Cardiac Pediatric, Carotid, Cerebral Vascular, Cephalic (Adult) , Cephalic (Neonatal),Fetal Echo, Fetal/Obstetric, Gynecological, Intraoperative(Vascular),Lung, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Peripheral Vessel, Small Parts, Transesophageal (Cardiac), Transrectal, Transvaginal and Urology.
The clinical environments where the 5000 Compact Series Ultrasound Systems can be used include physicians' office, clinics, hospitals, surgical suites and clinical point-of-care for diagnosis of patients.
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Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background behind the word is white, providing a strong contrast that makes the brand name stand out.
The systems are intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions given in the product user information. However, nothing stated in the user information reduces the user's responsibility for sound clinical judgment and best clinical procedure. Systems are to be operated only by appropriately trained healthcare professionals for the purposes for which they were designed.
However, nothing stated in the user information reduces your responsibility for sound clinical judgment and best clinical procedure
Note: There are no changes to the 5000 Compact Ultrasound System Indications for Use due to the introduction of the Auto Measure Version 2
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V. Comparison of Technological Characteristics with the Predicate
The purpose of the submission is to introduce the Auto Measure Version 2 feature to the 5000 Compact Series Ultrasound System. The subject devices are substantially equivalent to the predicate devices K222648 & Reference Device K211597
| Feature | 5000 Compact
Ultrasound Systems with Auto
Measure Version 2 | Series 5000 Compact
(K 222648 )
Primary predicate device | Series Affiniti Diagnostic Ultrasound
System VM9.0
(K211597)
Reference Device | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | Abdominal,
Cardiac Adult,
Cardiac Pediatric,
Carotid,
Cerebral Vascular,
Cephalic (Adult),
Cephalic (Neonatal),
Fetal Echo,
Fetal/Obstetric,
Gynecological,
Intraoperative (Vascular),
Lung,
Musculoskeletal (Conventional),
Musculoskeletal (Superficial),
Ophthalmic,
Pediatric,
Peripheral Vessel,
Small Parts
Transesophageal (Cardiac),
Transrectal,
Transvaginal, and
Urology. | Abdominal,
Cardiac Adult,
Cardiac Pediatric,
Carotid,
Cerebral Vascular,
Cephalic (Adult),
Cephalic (Neonatal),
Fetal Echo,
Fetal/Obstetric,
Gynecological,
Intraoperative (Vascular),
Lung,
Musculoskeletal (Conventional),
Musculoskeletal (Superficial),
Ophthalmic,
Pediatric,
Peripheral Vessel,
Small Organ (Breast, Thyroid,
Testicle),
Transesophageal (Cardiac),
Transrectal,
Transvaginal, and
Urology. | Abdominal,
Cardiac Adult,
Cardiac Other (Fetal),
Cardiac Pediatric,
Cerebral Vascular,
Cephalic (Adult),
Cephalic (Neonatal),
Fetal/Obstetric,
Gynecological,
Intraoperative (Vascular),
Intraoperative (Cardiac),
Musculoskeletal (Conventional),
Musculoskeletal (Superficial),
Other:
Urology,
Pediatric,
Peripheral Vessel,
Small Organ (Breast, Thyroid,
Testicle),
Transesophageal (Cardiac),
Transrectal,
Transvaginal,
Lung | Identical to Predicate
Small Parts and Small Organs are
same. To align with terminology in
Compact 5000 Systema and User
Manual,
Updated to Small Parts |
| Intended
Users | Trained healthcare professionals
Intended for sonographers, | Trained healthcare professionals
Intended for sonographers, | Trained healthcare professionals
Intended for sonographers, | Identical to Predicate |
| Feature | 5000 Compact
Ultrasound Systems with Auto
Measure Version 2 | Series 5000 Compact
(K 222648 )
Primary predicate device | Series Affiniti Diagnostic Ultrasound
System VM9.0
(K211597)
Reference Device | Comparison |
| | physicians, and biomedical
engineers who operate and
maintain your product.
Trained healthcare Professional | physicians, and biomedical
engineers who operate and
maintain your product.
Trained healthcare Professional | physicians, and biomedical
engineers who operate and
maintain your product.
Trained healthcare Professional | |
| | Before use of the system and
user information, the user must
be familiar with ultrasound
techniques. Sonography training
and clinical procedures are not
included in the User Manual or
with the 5000 Compact Series
Ultrasound Systems. | Before use of the system and
user information, the user must
be familiar with ultrasound
techniques. Sonography training
and clinical procedures are not
included in the User Manual or
with the 5000 Compact Series
Ultrasound Systems. | Before use of the system and user
information, the user must be
familiar with ultrasound techniques.
Sonography training and clinical
procedures are not included in the
User Manual or with the Affiniti
Diagnostic Ultrasound
System. | |
| Intended User
Environment | Clinics, hospitals, and clinical
point-of-care for diagnosis of
patients. | Clinics, hospitals, and clinical
point-of-care for diagnosis of
patients. | Clinics, hospitals, and clinical point-
of-care for diagnosis of patients. | Identical to Predicate |
| USA
FDA
Classification | Class II | Class II | Class II | Identical to Predicate |
| Primary
Product Code | IYN | IYN | IYN | Identical to Predicate |
| Primary
Regulation
Number | 21 CFR 892.1550 | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to Predicate |
| Secondary
Product
Codes | ITX
IYO
QIH | ITX
IYO | ITX
IYO
QIH | Identical to Predicate |
| Feature | 5000 Compact Ultrasound Systems with Auto Measure Version 2 | Series 5000 Compact Ultrasound Systems (K 222648 ) Primary predicate device | Series Affiniti Diagnostic Ultrasound System VM9.0 (K211597) Reference Device | Comparison |
| Secondary Regulation Name | System, imaging, pulsed echo, ultrasonic Transducer, ultrasonic, diagnostic Automated Radiological Image Processing Software | System, imaging, pulsed echo, ultrasonic Transducer, ultrasonic, diagnostic Automated Radiological Image Processing Software | System, imaging, pulsed echo, ultrasonic Transducer, ultrasonic, diagnostic Automated Radiological Image Processing Software | Identical to Predicate |
| Secondary Regulation Number | 21 CFR 892.1570
21 CFR 892.1560
21 CFR 892.2050 | 21 CFR 892.1570
21 CFR 892.1560 | 21 CFR 892.1570
21 CFR 892.1560
21 CFR 892.2050 | Identical to Predicate |
| Software Platform | VM | VM | VM | Identical to Predicate |
| Auto Measure Software Version | 2 | Not available | 1 | Difference No.1
The detectors for a subset of measurements available with the Auto Measure feature have undergone additional training since the original release of the feature on Affiniti Series Ultrasound SystemVM9.0.
Architecture of all detectors training procedure and acceptance criteria for the additional training data are identical to Auto Measure Version 1 |
| Reusable | Yes | Yes | Yes | Identical to Predicate |
| | 5000
Compact Series | Compact | Series Affiniti Diagnostic Ultrasound | |
| Feature | Ultrasound Systems with Auto Ultrasound Systems
Measure Version 2 | (K 222648 )
Primary predicate device | System VM9.0
(K211597)
Reference Device | Comparison |
| Duration of use | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Limited (≤ 24 hours) | Identical to Predicate |
| Application
Description | Auto Measure is an optional
software feature on the 5000
Compact Series
Ultrasound System that
provides the end user with
semiautomated
echocardiography 2D and
Doppler measurements through
an Al-algorithm, training via
machine-learning techniques. It is
intended to be used with an Adult
Cardiology Transthoracic
transducer and acquisitions that
include an ECG
These measurements are
routinely collected during a
transthoracic ECG, per The
American Society of Echo
cardiography (ASE)
recommendations
2D modes include the following:
IVSd
LVIDd
LVPWd
LVIDs
Asc Ao Diam
LVOT Diam | The healthcare professional
performs 2D and Doppler
measurements during a
transthoracic echocardiogram
with Manually positioning the
adult calipers on the ultrasound's
and system waveform or image.
2D modes include the following:
IVSd
LVIDd
LVPWd
LVIDs
Asc Ao Diam | Auto Measure is an optional
software feature on the Affiniti
Series
Diagnostic Ultrasound System that
provides the end user with
semiautomated adult
echocardiography 2D and Doppler
measurements through an Al-
algorithm, training via machine-
learning techniques. It is intended
to be used with an Adult Cardiology
Transthoracic transducer and
acquisitions that include an ECG.
These measurements are routinely
collected during a transthoracic
ECG, per The American Society of
Echo
(ASE)
cardiography
recommendations
2D modes include the following:
IVSd | Difference No.2
Auto Measure is being included in
the subject submission with 5000
Compact Series Ultrasound
Systems |
| Feature | 5000 Compact
Ultrasound Systems with Auto
Measure Version 2 | Series 5000 Compact
Ultrasound Systems
(K 222648 )
Primary predicate device | Series Affiniti Diagnostic Ultrasound
System VM9.0
(K211597)
Reference Device | Comparison |
| Ao STJ Diam
RV Base, RV Mid, RV Length
TV Annulus
Doppler modes include the
following:
MV Peak E Vel, MV Peak A Vel
MV Inflow (MV Dec Time, MV
Peak E Vel, MV Peak A Vel)
LVOT VTI, LVOT Vmax
AV VTI, AV Vmax
PV VTI, PV Vmax
TR Vmax
Lat E' Vel, Lat A' Vel
Lat Vel (Lat E' Vel, Lat A' Vel)
Med E' Vel, Med A' Vel
Med Vel (Med E' Vel, Med A' Vel)
RV S Vel | Ao Sinus Diam
Ao STJ Diam
RV Base, RV Mid, RV Length
TV Annulus
Doppler modes include the
following:
MV Peak E Vel, MV Peak A Vel
MV Inflow (MV Dec Time, MV
Peak E Vel, MV Peak A Vel)
LVOT VTI, LVOT Vmax
AV VTI, AV Vmax
PV VTI, PV Vmax
TR Vmax
Lat E' Vel, Lat A' Vel
Lat Vel (Lat E' Vel, Lat A' Vel)
Med E' Vel, Med A' Vel
Med Vel (Med E' Vel, Med A' Vel)
RV S Vel | LVPWd
LVIDs
Asc Ao Diam
LVOT Diam
Ao Sinus Diam
Ao STJ Diam
RV Base, RV Mid, RV Length
TV Annulus
Doppler modes include the
following:
MV Peak E Vel, MV Peak A Vel
MV Inflow (MV Dec Time, MV
Peak E Vel, MV Peak A Vel)
LVOT VTI, LVOT Vmax
AV VTI, AV Vmax
PV VTI, PV Vmax
TR Vmax
Lat E' Vel, Lat A' Vel
Lat Vel (Lat E' Vel, Lat A' Vel)
Med E' Vel, Med A' Vel
Med Vel (Med E' Vel, Med A' Vel)
RV S Vel | | |
| Compatible
transducers
for
Auto
Measure | S5-1 and S4-2 | S5-1 and S4-2 | S5-1 and S4-2, x5-1, x5-1c | Identical to Predicate |
| Feature | 5000 Compact Series
Ultrasound Systems with Auto
Measure Version 2 | 5000 Compact Series
(K 222648 )
Primary predicate device | Affiniti Diagnostic Ultrasound
System VM9.0
(K211597)
Reference Device | Comparison |
| Version2 | | | | |
| User
Interface
Presentation | User selects an adult
echocardiography 2D or Doppler
measurement to perform then the
caliper positions are initialized
based on the output of the AI
detection algorithm.
The user can edit, accept, or
reject the measurements.
Alternately The healthcare
professional performs 2D and
Doppler measurements during a
transthoracic echocardiogram by
Manually positioning the calipers
on the ultrasound's system
waveform or image. | The healthcare professional
performs 2D and Doppler
measurements during
transthoracic echocardiogram by
Manually positioning the calipers
on the ultrasound's system
waveform or image. | User selects an adult
echocardiography 2D or Doppler
measurement to perform then the
caliper positions are initialized
based on the output of the AI
detection algorithm.
The user can edit, accept, or reject
the measurements.
Alternately The healthcare
professional performs 2D and
Doppler measurements during a
transthoracic echocardiogram by
Manually positioning the calipers
on the ultrasound's system
waveform or image. | Difference No.2
Auto Measure is being included in
the subject submission with 5000
Compact Series Ultrasound
Systems |
| Feature | 5000 Compact Series Ultrasound System
Subject Devices | Affiniti Diagnostic Ultrasound System
(K211597)
Reference Device | Comparison | |
| USA FDA Classification | Class II | Class II | Identical to Predicate | |
| Primary Product Code | IYN | IYN | Identical to Predicate | |
| Secondary Product
Codes | IYO
ITX
*QIH | IYO
ITX
QIH | Identical to Predicate
*QIH is new for 5000 Compact Series Ultrasound
Systems | |
| Primary Regulation
Number | 21 CFR 892.1550 | 21 CFR 892.1550 | Identical to Predicate | |
| Software Version
Baseline | Compact 2.0 (VM11.0) | VM9.0 | Similar, 5000 Compact Series Ultrasound systems
moving to VM11.0 software to gain access to Auto
Measure feature. | |
| Marketing Name of
Application | Auto Measure Version 2 | Auto Measure Version 1 | Similar. No new measurements are
introduced in Auto Measure v2. Subset of
integrated measurement detectors have been
trained with additional training data. CNN
architecture of all detectors, training procedure and
all acceptance criteria for the additional training
data are identical to Auto Measure v1. | |
| Application Description | Auto Measure is an optional
software feature on the 5000 Compact Series
Ultrasound Systems that provides the end user
with semiautomated adult echocardiography 2D
and Doppler measurements through an Al-
algorithm, training via machine-learning
techniques. It is intended to be used with an Adult
Cardiology Transthoracic transducer and
acquisitions that include an ECG. These
measurements are routinely collected during a
transthoracic ECG, per The American Society of
Echo
cardiography (ASE) recommendations
(Attachment 049_Literature References)
2D modes include the following:
IVSd
LVIDd
LVPWd | Auto Measure is an optional
software feature on the 5000 Compact Series
Ultrasound Systems that provides the end user with
semiautomated adult echocardiography 2D and
Doppler measurements through an Al-algorithm,
training via machine-learning techniques. It is
intended to be used with an Adult Cardiology
Transthoracic transducer and acquisitions that
include an ECG. These measurements are
routinely collected during a transthoracic ECG, per
The American Society of Echo
cardiography (ASE) recommendations
(Attachment 049_Literature References)
2D modes include the following:
IVSd
LVIDd
LVPWd
LVIDs | Identical to Predicate | |
| Feature | 5000 Compact Series Ultrasound System
Subject Devices | Affiniti Diagnostic Ultrasound System
(K211597)
Reference Device | Comparison | |
| | LVIDs
Asc Ao Diam
LVOT Diam
Ao Sinus Diam
Ao STJ Diam
RV Base, RV Mid, RV Length
TV Annulus | Asc Ao Diam
LVOT Diam
Ao Sinus Diam
Ao STJ Diam
RV Base, RV Mid, RV Length
TV Annulus | | |
| | Doppler modes include the
following:
MV Peak E Vel, MV Peak A Vel
MV Inflow (MV Dec Time, MV
Peak E Vel, MV Peak A Vel)
LVOT VTI, LVOT Vmax
AV VTI, AV Vmax
PV VTI, PV Vmax
TR Vmax
Lat E' Vel, Lat A' Vel
Lat Vel (Lat E' Vel, Lat A' Vel)
Med E' Vel, Med A' Vel
Med Vel (Med E' Vel, Med A' Vel)
RV S Vel | Doppler modes include the
following:
MV Peak E Vel, MV Peak A Vel
MV Inflow (MV Dec Time, MV
Peak E Vel, MV Peak A Vel)
LVOT VTI, LVOT Vmax
AV VTI, AV Vmax
PV VTI, PV Vmax
TR Vmax
Lat E' Vel, Lat A' Vel
Lat Vel (Lat E' Vel, Lat A' Vel)
Med E' Vel, Med A' Vel
Med Vel (Med E' Vel, Med A' Vel)
RV S Vel | | |
| User Interface
Presentation | User selects an adult echocardiography 2D or
Doppler measurement to perform then the caliper
positions are initialized based on the output of the
Al detection algorithm.
The user can edit, accept, or reject the
measurements. | User selects an adult echocardiography 2D or
Doppler measurement to perform then the caliper
positions are initialized based on the output of the
Al detection algorithm.
The user can edit, accept, or reject the
measurements. | Identical to Predicate | |
| Compatible transducers | S5-1 and S4-2 are already commercially available and
compatible with the 5000 Compact Series
Ultrasound Systems.
No new transducers.
Transducer modes for Auto Measure: 2D,
Doppler. No new transducer modes. | S5-1, X5-1, and S4-2 are already commercially
available and compatible with the Affiniti Ultrasound
System.
No new transducers.
Transducer modes for Auto Measure: 2D, Doppler,
No new transducer modes. | Identical, with exemption of X5-1 transducer,
which is not currently available to 5000 Compact
Series Ultrasound Systems. | |
| Feature | 5000 Compact Series Ultrasound System
Subject Devices | Affiniti Diagnostic Ultrasound System
(K211597)
Reference Device | Comparison | |
| Semi-Automation
Technology | Semi-automated adult
echocardiography 2D and Doppler
measurements are generated using
an artificial intelligence (AI)
detection algorithm without user
interaction. After measurement is
generated, the user can edit
(manually adjust the caliper
positions), accept, or reject the
measurements. The automation of measurements
is constrained to the specific imaging mode (2D,
Doppler) as recommended by ASE
guidelines (Attachment 049_Literature
References). | Semi-automated adult
echocardiography 2D and Doppler
measurements are generated using
an artificial intelligence (AI)
detection algorithm without user
interaction. After measurement is
generated, the user can edit
(manually adjust the caliper
positions), accept, or reject the
measurements. The automation of measurements
is constrained to the specific imaging mode (2D,
Doppler) as recommended by ASE
guidelines (Attachment 049_Literature
References). | Identical to Predicate | |
8
9
10
11
12
Comparison of subject device and secondary predicate with AI/ML capabilities
13
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14
15
VI. Safety Considerations
The proposed 5000 Compact Series Ultrasound Systems, including the Auto Measure, and compatible transducers and comply with the referenced standards as well as the FDA ultrasound guidance for Industry and FDA Staff – Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, issued in February 2023.
VII. Performance Data
The proposed introduction of the subject Philips Auto Measure with Philips internal processes.
The proposed modification of the 5000 Compact Ultrasound Systems (addition of Auto Measure) was tested in accordance with Philips internal procedures. Philips Ultrasound tested the subject devices to ensure the continued safe and effective performance:
- · IEC 62304 Medical device software Software life cycle processes, 2006 + A 2015
- · ISO 14971 Medical devices- Application of risk management to medical devices, 2019
Design Control activities to assure the safe and effective performance of the Auto Measure Version 2 include but are not limited to the following:
- Requirements Review .
- Risk Analysis and Management .
- Product Specifications .
16
- Design Reviews
- Software Verification
The software documentation is presented in accordance for Content of Premarket Submissions for Device Software Functions issued June 14, 2023.
Details of performance study
Since this is a software-only change and no new hardware was added, no acoustic output, cleaning and clectrical, electromagnetic, and mechanical safety testing were required. Biocompatibility testing is not needed for the subject 5000 Compact Series Diagnostic Ultrasound Systems with Auto Measure. The transducer patient contact materials and manufacturing processes are not impacted by the release of the Auto Measure.
The performance of Auto Measure in 5000 Compact Series is substantiated in Auto Measure Performance Report
Feature Performance
Automated measurements are designed to operate on transthoracic acquisitions of adult subjects with typical diagnostic image quality following known guidelines (Guidelines for Performing a Comprehensive Echocardiographic Examination in Adults: Recommendations from the American Society of Echocardiography or equivalent). Only trained personnel that is able to perform the selected automated measurement manually is supposed to use this feature as a workflow improvement. The operator is responsible for the final result and has to apply manual edits to the automated output whenever required. Automated must not be applied to images where an appropriate manual measurement cannot be performed. As this feature has been designed to accelerate the manual measurement procedure with high success rates, no additional automated image quality assessment prevents the application of an automated measurement to inadequate images.
The Auto Measure software feature was developed to provide automated measurements in echocardiography that align closely with the accuracy of manual measurements, the current gold standard. To verify its performance, we conducted testing based on humanhuman interobserver data from clinical studies, which serves as a benchmark by representing the tween expet clinicians. In our evaluation, Auto Measure analyzed a set of new, previously images, and its automated results were compared to ground truth measurements established by clinical experts during routine care. Both the manual and automated measurements were performed on the same images without any adjustments to the siftware's output or the clinical data used as ground truth. The limits of agreement (LoA) used to assess performance were derived from published human interobserver variability data. The table below presents the test reach measurement detector compaing the automated outputs to the clinical ground truth, along with the acceptance criteria for each detectors met the acceptance criteria informed by clinical literature, supporting the accuracy and reliability of the Auto Measure feature.
17
Detector performance results of Auto Measure detectors
| Parameter | Detector | N
(Sample
Size) | Z score (A.
Carkeet) | Measured Limits of Agreement (LoA)
(detector prediction vs manual ground
truth) " | Checked Limits
of Agreement
(LoAs) |
|----------------------|---------------------------------------------------|-----------------------|-------------------------|-----------------------------------------------------------------------------------------|------------------------------------------|
| Ao Sinus
Diameter | DETECTOR_ID_BMOD
E_AO_AOSV | 308 | 2.1320 | [-11.0022%, 11.2816%] | [-35.0%, 35.0%] |
| Ao STJ
Diameter | DETECTOR_ID_BMOD
E_AO_AOSTJ | 301 | 2.1342 | [-11.4181%, 13.1139%] | [-35.0%, 35.0%] |
| Asc Ao
Diameter | DETECTOR_ID_BMOD
E_AO_AOASC | 204 | 2.1769 | [-14.7794%, 15.9598%] | [-35.0%, 35.0%] |
| IVSd | DETECTOR_ID_BMOD
E_LV_LVDISTANCE_S
AME_LINE | 305 | 2.1330 | [-33.2114%, 28.1632%] | [-35.0%, 35.0%] |
| LVIDd | DETECTOR_ID_BMOD
E_LV_LVDISTANCE_S
AME_LINE | 457 | 2.0984 | [-14.1564%, 12.4223%] | [-35.0%, 35.0%] |
| LVIDs | DETECTOR_ID_BMOD
E_LV_LVID_ES | 469 | 2.0965 | [-23.4752%, 26.0242%] | [-35.0%, 35.0%] |
| LVOT
Diameter | DETECTOR_ID_BMOD
E_LV_LVOT | 453 | 2.0991 | [-17.729%, 16.1588%] | [-35.0%, 35.0%] |
| LVPWd | DETECTOR_ID_BMOD
E_LV_LVDISTANCE_S
AME_LINE | 305 | 2.1330 | [-33.1364%, 29.9544%] | [-35.0%, 35.0%] |
| RV Base | DETECTOR_ID_BMOD
E_RV_RVD_BASE | 302 | 2.1339 | [-16.1373%, 25.9079%] | [-35.0%, 35.0%] |
| RV Mid | DETECTOR_ID_BMOD
E_RV_RVD_MID | 243 | 2.1564 | [-25.0913%, 30.2573%] | [-35.0%, 35.0%] |
| RV Length | DETECTOR_ID_BMOD
E_RV_RVL | 117 | 2.2599 | [-14.6089%, 13.3871%] | [-35.0%, 35.0%] |
| TV Annulus | DETECTOR_ID_BMOD
E_RV_TVANN | 53 | 2.4511 | [-19.3628%, 18.0347%] | [-35.0%, 35.0%] |
| MV Decel.
Time | DETECTOR_ID_DOPPL
ER_MV_DECEL_E_DU
RATION | 136 | 2.2343 | [-23.5717%, 22.8591%] | [-25.0%, 25.0%] |
| MV Peak A
Vel | DETECTOR_ID_DOPPL
ER_MV_VMAX_A_VE
LOCITY | 229 | 2.1631 | [-12.3694%, 15.2363%] | [-24.0%, 24.0%] |
| MV Peak E
Vel | DETECTOR_ID_DOPPL
ER_MV_VMAX_E_VELOCITY | 136 | 2.2343 | [-9.2081%, 9.1223%] | [-24.0%, 24.0%] |
| AV VTI | DETECTOR_ID_DOPPL
ER_AV_VTI | 247 | 2.1546 | [-21.5393%, 19.8925%] | [-22.0%, 22.0%] |
| LVOT VTI | DETECTOR_ID_DOPPL
ER_LVOT_VTI | 234 | 2.1607 | [-17.267%, 17.2093%] | [-22.0%, 22.0%] |
| PV VTI | DETECTOR_ID_DOPPL
ER_PV_VTI | 66 | 2.3864 | [-20.6140%, 21.0567%] | [-22.0%, 22.0%] |
18
Performance validation data have been extracted from a total auf 500 studies, one study per subject. Of these 500 studies, 200 are known normal subjects and 300 patients had a confirmed pathology). In clinical routine, not all measurements are performed in all studies. The available data per detector are listed in column 3 above. Demographic distribution for all validation studies is as follows:
| Age | $52.4 \pm 15.5$ years |
|---|---|
| Gender | Male: 49.6 % Female: 50.4 % |
| Ethnicity | Asian: 30.2 % Black: 26.4 % White: 36.2 Other: 7.3 % |
| Body Surface Area | $1.9 m^2 \pm 0.2 m^2$ |
| Weight | $76.8 kg \pm 17.0 kg$ |
All detector models were trained from the ground up and no pre-trained model weights were used. Training of the detectors was based on manual measurements performed by human experts done for diagnostic purpose. No additional non-standard was required.
Data pool for semi-automated cardiac measurement consists of anonymized transthoracyc echocardiography DICOM data and metadata. The data was recorded by multiple sonographers and physicians qualified in echocardiography in a large sample of adults of various ethnicities. Echocardiographic recordings were acquired according to guideline-standard echocardiographic procedures between 2010 and 2021 in 20
19
Image /page/19/Picture/0 description: The image shows the word "PHILIPS" in blue, block letters against a white background. The font is bold and sans-serif, giving the word a strong and clear presence. The letters are evenly spaced and aligned, creating a balanced and professional look.
centers and 16 countries. Qualified medical in echocardiography using TTA software (versions TTA2.31.00 and TTA2.50.00) or various Philips ultrasound systems annotation and following established quideines (Mitchel et al 2019),
The total training pool comprises more than 6000 studion, cardially healthy individuals as well as from patients having indications for receiving an echocarding our standard operating procedure for Al based algorithm development, validation data have been randomly sampled from then separated before detector development. Remaining data have been used for training and tuning in a cross-validation framework.
VIII. Clinical Data
Clinical investigations were not required for this 500 Compact Series Diagnostic Ultrasound Systems with Auto Measure software feature
IX. Sterilization
Not applicable. The ultrasound transducers are not supplied sterile.
X. Conclusion
Results of the testing show that the proposed subject device and supports a determination that the proposed subject device does not raise new questions of safety or effectiveness.
Therefore, the subject device is substantially equivale device in terms of incications for use, design, technological characteristics, modes of operations, safety, and effectiveness.
XI. References
Human-human inter-observer variability:
Bannas P. Rybczynski M. Sheikhzadeh S. von Kodolitsch Y. Deriin T. Yamanura J. Lund G. Adam G. Groth M. Comparison of Cine-MRI and Transhoracy Echocadiography for the Assessment of Actions with Suspected Marfan Syndrome. Rot. 2015 Nov: 18 (11):102-8. doi: 10.1055(s-0035-1553224. Epub 2015 Jun 22. PMID: 26098252.
• Cawley PJ, Hamilton-Craig C, Owens DS, Kreger EV, Strugnell WE, Mitsunori L, D'Jang CL, Schwaegler RG, Nguyen B, Maki JH, Otto CM. Prospective comparison of valve regurgitation by cardias magnetic resonance imaging and transhoracy . Circ Cartiovasc lmaging. 2013 Jan 1;6(1):48-57. doi: 10.1161/CIRCIMAGING:112.975623. Epub 2012 Dec 4. PMID: 23212272.
· Carket A. Exact parametric confidence intervals for Bland-Alman Vis Sci. 2015 Mar,92(3):e7-80. doi: 10.1097/OPX.0000000000000000000000000013. PMID: 25650900.
• Ferrara F. Gargani L. Contaldi C. Argiento P. Armstrono WF. Bandera F. Catematiri F. Citadin A. Cocchia R. D'Alto M. D'Andrea A. Douschan P, Ghio S, Grünig E, Guazzi M, Guida T, Limongell G, Marra AM, Mazzola M, Mauro C, Moreo A, Pieri F, Pratali L, Pugliese NR, Raciti M, Ranieri B, Rudski L, Sara W, Stanziola AA, Vannan M, Voilliot D, Virz O, Wierzbowska-Drabik K, Naejie R, Bossone E; RIGHT Heat International NETwork (Rivetigators. A multicentric study of exercise Dopler echocardiography of the
20
Image /page/20/Picture/0 description: The image shows the word "PHILIPS" in blue letters. The letters are bold and sans-serif. The background is white.
right heart and the pulmonary croulation. The RIGHT Heart (RIGHT-NET). Cardiovac Utrasound. 2021 Jan 20,10(1):3. doi. 10.1186/s12947-021-00238-1. PMID: 33472662; PMCID: PMC7819251.
• Janos RA, Kahlet P, Picht B, Wendt D, Eggebrecht H, Erbel R, Buck T. Measurement of the antilus size by real-time three-dimensional transesphageal echocardiography. Minim Invasive Ther Allied Technol. 2011 Apr,20(2):85-94. doi: 10.3109/13646706.2011.557385. PMD: 21417841.
· Knight DS, Schwaiger JP, Krupickova S, Davar J, Muthurangu V, Coghlan JG, Accuracy and Test-Retest Reproductibility of Two-Dimensional Knowledge-Based Volumetic Reconstruction of the Right Venticle in Purnonay Hypetension. J Am Soc Echocardion, 2015 Aug.28(8):989-8. doi: 10.1016/j.echo.2015.02.020. Epub 2015 Apr 6. PMID: 25857546; PMCID: PMC4533235.
• Kopena D, Briongos S, Castillo H, Moreno C, Recio M, Narso-Gomez A, Obieta-Fresnedo I, Femández-Golfin C, Zanorano J., Jiménez D: PROTECT investigators, Interphsered realing and for promosication of normotensive patients with pulmonary embolism, Carliovasc Ultrasound. 2014 Aug 4:12:29. doi: 10.1186/1476-7120-12-29. PMID: 25092465; PMCID: PMC4126908.
· Lang RM, Addetia K, Miyoshi T, Kebed K, Blitz A, Schreckerberg M, Hitschich N, Mor-Avi V, Asch FM. Use of Machine Learning to Improve Echocardio mage Interpretation Workfow: A Disupive Paradigm Change? J Am Soc Echocardiogr. 2020 Dec 1:508947317(20)3072-0. doi: 10.1016/j.echo.2020.11.017. Epub ahead of print. PMID: 33276079.
· Medvedofsky D, Addetia K, Hamilton J, Leon Jimenez J, Lang RM, Mor-Avi V, Semi-automated echocardiographic quantification of right ventricular size and function. Int J Cardiovasc Imaging. 2015 Aug.31(6):1149-57. doi: 10.1007/s10554-015-0672-4. Epub 2015 May 7. PMD: 25948160.
· Mortach C, Gelbrich G, Breunig M, Tiffe T, Wagner M, Heuschmann PU, Störk S. Impact of acquisition on total inter-observer variability in echocardiggaphy: results from the quality assurance program of the STAAB cohor study. Int J Cardiovasc maging, 2018 July 2017-1005. doi. 10.1007/s10554-018-1315-3. Epub 2018 Feb 14. PMID: 29445974.
· Nejatian A. Yu J. Geva T. White MT. Prakash A. Anto Measurements in Patients with Aortopathy are Larger and More Reproducible by Cardia: Magnetic Resonance Compared with Echocardion 2015 Dec36(8):1761-73. doi: 10.1007/00246-015-1231-4. Epub 2015 Jul 15. PMID: 26174757.
· Paelinck BP, Van Herck PL, Rodrigus I, Clarizel PM, Vints CJ, Bosmans JM. Comparison of magnetic resonance imaging of antic valve stenosis and antic rot to multimodality imagineer actic valve implantation candidates. Am J Cardiol. 2011 Jul 1,108(1).92-8. doi: 10.1016/j.amjcard.2011.02.348. Epub 2011 Apr 27. PMID: 21529729.
· Pereira JB, Essa M, Ugonabo I, Hur DJ, Crandal I, Vaccarell M, Sugenq L. The feasibility of contrast echocardion in the assessment of right ventricular size and function. Echocardiography. 2019 Nov:36(11):1979-1988. doi: 10.1111/echo.14504. Epub 2019 Oct 21. PMD: 31633241.
· Ren B, de Groot-de Laat LE, McGhie J, Vetter WB, Ten Cate F, Geleinse M. Geometic errors of the pussitiving degenerative mitral valve regurgitation: a three-dingraphy study, J Am Soc Echocardiogr. 2013 Mar;26(3);261-9. doi: 10.1016/j.echo.2012.10.011. Epub 2012 Dec 7. PMID: 23228655.
· Schenk P. Globits S. Koller J. Brunner C. Arention O. Accuracy of echocardiographic right ventricular parameters in patients with different end-stage lung transplantation. J Heart Lung Transplant. 2000 Feb;19(2):145-54. doi: 10.1016/s1053-248(99)00/21-7. PMID: 10703690.
• Schoenmaker NJ, van der Lee JH, Groothoff JW, van beren GG, From •Muder IM. Low agrement between cardiologists diagnosing left ventricular hypertophy in childen with end-stage renal disease. BMC Nephrol. 2013 Aug 214:170. doi: 10.1186/1471-2369-14-170. PMID: 23915058; PMCID: PMC3737015.
• Snelder SM, Younge JO, Dereci A, van Velzen JE, Akkerhuis IM, de Groot-de Laat LE, Zilstra F, van Dalen BM, Feasibility of Transthoracic Echocardiography in Obese Patients. J Am Soc Echocardiogr. 2019 Nov 1493.65. doi: 10.1016/1, ecub 2019.019. Eub 2019 Sep 25. PMID: 31563438.
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DHILDS
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