(257 days)
AmCAD-US is a software device intended to visualize the statistical distributions of backscattered signals echoed by tissue compositions in the body. The backscattered signals are subject to the RF or Envelope data made available by an FDA-cleared general-purpose ultrasound system. The US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation.
AmCAD-US (model number 1.0) is intended to visualize and analyze the statistical distributions of backscattered signals echoed by tissue compositions in the body. AmCAD-US, which uses the proprietary technology and algorithms, is a software package designed to quantify and visualize the backscattered statistics contained in ultrasound image data obtained from an FDA-cleared general purpose ultrasound system. The device provides dual mode images, including conventional B-mode ultrasound image in gray scale and color-mapped US (ultrasound structure) mode image. The US-mode provides a means for viewing and displaying the backscatter statistical values. The device uses parametric model or nonparametric statistics that best describes the distribution curve of the backscattered signals. The parameters vary by the US method (backscattered statistics) selected. The preferences include options to set the parameters mapped onto the image and US method options applied to the data. The user can also select a specific region of interest (ROI) on the image for quantification analysis. The histogram view of the data provides a different view to accommodate the variation between tissue and tissue states. AmCAD-US has a data export function to record and save the analysis results. Note that the US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation.
The provided text describes AmCAD-US, a software device for visualizing and analyzing statistical distributions of backscattered signals from ultrasound data. However, the text does not include specific quantitative acceptance criteria for the device's performance that would typically be found in a 510(k) submission (e.g., specific accuracy, sensitivity, or specificity targets). Instead, it focuses on demonstrating that the device functions as intended and is safe and effective as compared to its predicate device.
Therefore, I cannot generate a table of acceptance criteria and reported device performance with specific metrics like sensitivity, specificity, etc., as these are not provided in the document. The document describes types of studies performed to validate the device's utility and safety, but not specific quantitative performance targets or results against those targets.
Below is a summary of the information that is available in the provided text, structured according to your request, with an explicit note where information is not present.
Acceptance Criteria and Study for AmCAD-US
The provided 510(k) summary for AmCAD-US does not explicitly list quantitative acceptance criteria (e.g., specific accuracy, sensitivity, or specificity thresholds). Instead, the studies demonstrate the utility and functionality of the device for its intended use, focusing on its ability to analyze various tissue compositions and showing a correlation between its output and physiological changes. The conclusion of the submission states that the data demonstrates the proposed device is as safe and effective as the primary predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Not Explicitly Stated as Quantitative Criterion in Document) | Reported Device Performance (Summary from Studies) |
|---|---|---|
| Utility in analyzing cell compositions | Device should demonstrate utility in analyzing various cell compositions. | Demonstrated utility in analyzing various cell compositions in phantom studies. |
| Correlation with physiological changes | Device should show utility in analyzing tissue composition variation and correlation with induced physiological changes. | Demonstrated strong correlation between backscattered statistics and dosage of DMN injections in animal liver fibrosis model, showing utility in analyzing tissue composition variation. |
| Applicability to human body parts and various ultrasound systems | Device should be applicable to various tissue parts in the human body and capable of using data from various FDA-cleared ultrasound systems. | Indicated applicability to various tissue parts in the human body (thyroid and abdomen modes) and usability with RF/Envelope data from two different FDA-cleared ultrasound systems in human tissue validation study. |
| Software Functionality and Specification Compliance | Software should meet all functional and specifications for its indication for use. | Software unit, integration, and system tests were conducted, ensuring the device meets functional and specification requirements. |
| Safety and Effectiveness Equivalence to Predicate | Device should be as safe and effective as the predicate device. | Concluded to be as safe and effective as the predicate device, with technological differences not raising new questions of safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Phantom Study: Not specified, but involved "cell phantoms with different concentrations of one cell type and with different constitutions of mixed cell types."
- Animal Study: 6 rats with liver fibrosis induced by dimethylnitrosamine (DMN) injection.
- Human Tissue Validation Study: Not specified, but involved "two common ultrasound scanning modes, e.g. thyroid and abdomen modes."
- Data Provenance: Not explicitly stated for each study, but the submitting company (AmCad BioMed Corporation) is located in Taiwan, ROC, suggesting the studies likely originated there. The studies appear to be prospective in nature, designed specifically for the validation of this device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth for the test sets in the phantom, animal, or human tissue validation studies.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for establishing ground truth in the test sets.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly mentioned or performed. The indications for use explicitly state: "The US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation," implying it is an assistive tool rather than a standalone diagnostic.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described (phantom, animal, human tissue validation) appear to be standalone evaluations of the algorithm's performance in analyzing backscattered signals and demonstrating correlation with tissue compositions, rather than evaluations of human reader performance with or without the device. The device's output (color-coded images and statistical values) is presented as a visualization and quantification tool.
7. The Type of Ground Truth Used
- Phantom Study: Ground truth was based on controlled "different concentrations of one cell type and with different constitutions of mixed cell types" in the phantoms.
- Animal Study: Ground truth was based on the "dosage of DMN injections" to induce liver fibrosis and likely confirmed by histological examination (though not explicitly stated, this is standard for fibrosis models).
- Human Tissue Validation Study: Ground truth was derived from the "tissue compositions in the human body" as seen through "two common ultrasound scanning modes" (thyroid and abdomen). The exact method for confirming tissue composition ground truth (e.g., pathology, clinical diagnosis) is not detailed.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set. It mentions the "proprietary technology and algorithms" but does not detail the development or training process.
9. How the Ground Truth for the Training Set was Established
The document does not describe how the ground truth for any training set was established. It focuses on the validation studies, not the development or training phase of the algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2017
AmCad BioMed Corporation % Chiu S. Lin, Ph.D. President Lin & Associates, LLC 5614 Johnson Avenue BETHESDA MD 20817
Re: K162574
Trade/Device Name: AmCAD-US Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 27, 2017 Received: April 28, 2017
Dear Dr. Lin:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162574
Device Name AmCAD-US
Indications for Use (Describe)
AmCAD-US is a software device intended to visualize the statistical distributions of backscattered signals echoed by tissue compositions in the body. The backscattered signals are subject to the RF or Envelope data made available by an FDA-cleared general-purpose ultrasound system. The US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation.
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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Image /page/3/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized "A" with a circle inside. The text includes the company name in both Chinese and English, followed by the address: FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-27152181.
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is submitted as part of the Premarket Notification in compliance with requirements of CFR Part 807, Subpart E and Section 807.92
1.1 Identification of Submitter:
| Submitter: | AmCad BioMed Corporation |
|---|---|
| Address: | FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, R.O.C. |
| Phone: | 886-2-2713-6227 |
| Fax: | 886-2-2715-2181 |
| Contact: | Jack Yang |
| Title: | Vice President |
| Phone: | 886-2-2713-6227 ext.2358 |
| Fax: | 886-2-2715-2181 |
| Email: | jack.yang@amcad.com.tw |
| Manufacturer: | AmCad BioMed Corporation |
| US Agent and Contact: | Chiu S. Lin, Ph.D.Lin & Associates, LLC |
| Address: | 5614 Johnson AvenueBethesda, MD 20817 |
| Phone: | (0) 301-591-3895 |
| E-mail: | cslin@lin-associates.com |
- April 27, 2017 Date prepared:
1.2 Identification of Product
| Device Trade Name: | AmCAD-US |
|---|---|
| Model number: | 1.0 |
| Common and Usual Name: | Medical Image Processing and Analysis Software |
| Device Classification Name: | Picture Archiving and Communications System |
| Regulation Number: | 21 CFR 892.2050 |
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Image /page/4/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized "A" with a circle inside. The text includes the company name in both Chinese and English, followed by the address: FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-27152181.
| Classification Product Code: | LLZ |
|---|---|
| Classification: | Class II |
| Classification Panel: | Radiology Devices |
| Manufacturer: | AmCad BioMed Corporation |
1.3 Predicate Device
This subject software medical device is substantially equivalent to the devices listed below:
Primary Predicate Device Model: Q LAB Quantification Software.
Manufacturer: Philips Ultrasound, Inc.
510(k) Number: K021966, cleared on July 02, 2002.
In terms of technology, the reference device is listed below. Model: The software used on Volcano IVUS System. Manufacturer: Volcano Therapeutics, Inc. 510(k) Number: K042188, cleared on November 10, 2004.
1.4 Device Description
AmCAD-US (model number 1.0) is intended to visualize and analyze the statistical distributions of backscattered signals echoed by tissue compositions in the body. AmCAD-US, which uses the proprietary technology and algorithms, is a software package designed to quantify and visualize the backscattered statistics contained in ultrasound image data obtained from an FDA-cleared general purpose ultrasound system. The device provides dual mode images, including conventional B-mode ultrasound image in gray scale and color-mapped US (ultrasound structure) mode image. The US-mode provides a means for viewing and displaying the backscatter statistical values. The device uses parametric model or nonparametric statistics that best describes the distribution curve of the backscattered signals. The parameters
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Image /page/5/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a white circle inside. The text includes the company name in both Chinese and English, followed by the address: FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-27152181.
vary by the US method (backscattered statistics) selected. The preferences include options to set the parameters mapped onto the image and US method options applied to the data. The user can also select a specific region of interest (ROI) on the image for quantification analysis. The histogram view of the data provides a different view to accommodate the variation between tissue and tissue states. AmCAD-US has a data export function to record and save the analysis results. Note that the US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation.
1.5 Indications for Use
AmCAD-US is a software device intended to visualize and analyze the statistical distributions of backscattered signals echoed by tissue compositions in the body. The backscattered signals are subject to the RF or Envelope data made available by an FDA-cleared general-purpose ultrasound system. The US-mode images displayed on AmCAD-US must not be used alone for primary diagnostic interpretation.
1.6 Comparison with Predicate Devices
The proposed device is specifically intended for use as a PACS software device for viewing and quantifying the ultrasound image data and is substantially equivalent to the predicate, Q LAB Quantification Software, K021966, with the same intended use for viewing and quantifying ultrasound image data. They both provide statistical analysis of the intensity data or the image content obtained from the ultrasound machine. Both devices are classified as Picture Archiving and Communication System, 21 CFR 892.2050. Minor technological characteristics differences do not raise any new questions of safety and effectiveness. In terms of technology, the reference device is the software used on the Volcano IVUS system.
The comparison table 1.6.1 between our device and the predicate devices and reference device is provided below:
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Image /page/6/Picture/0 description: The image contains the logo of AmCad BioMed Corporation. The logo consists of a blue stylized letter 'A' with a circle at the top, followed by the company name in both Chinese and English. The Chinese characters are '安克生醫股份有限公司', and the English name is 'AmCad BioMed Corporation'.
| Device | Proposed Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| AmCAD-US | Q LAB Quantification Software | The software used on VolcanoIVUS System | |
| Manufacturer | AmCad BioMed Corp. | Philips Ultrasound, Inc. | Volcano Therapeutics, Inc. |
| 510(k) Number | Pending | K021966 | K042188 |
| Device CommonName | Picture archiving andcommunications system | Same | Ultrasonic pulsed echo imagingsystem and Picture archivingand communications system |
| RegulationNumber | 21 CFR 892.2050 - Class II | Same | 21 CFR 892.1560 - Class II |
| Regulation Name | Picture archiving andcommunications system | Same | Ultrasonic pulsed echo imagingsystem (892.1560) |
| Product Code | LLZ | LLZ | IYO |
| Indications forUse/Intended Use | AmCAD-US is a softwaredevice intended to visualizeand quantify the statisticaldistributions ofbackscattered signalsechoed by tissuecompositions in the body.The US-mode imagesdisplayed on AmCAD-USmust not be used alone forprimary diagnosticinterpretation.The software deviceprovides color-coded | QLAB Quantification software isa software application package.It is designed to view andquantify image data acquired onPhilips Healthcare ultrasoundproducts.The Q LAB software provides ameans for creating region ofinterest figures overlaid on theimage data displayed by thesoftware. The Q LAB softwareprovides a means of analyzingthe content of the image datacontained within the ROI figure. | The Volcano Therapeutics, Inc.Volcano IVUS System isintended to be used inconjunction with imagingcatheters during diagnosticultrasound imaging of theperipheral and coronaryvasculature. The Volcano IVUSSystem is intended tosemi-automatically visualizeboundary features andperform spectral analysis of RFultrasound signals of vascularfeatures that the user may |
| Table 1.6.1 – The substantial equivalence comparison table |
|---|
| ------------------------------------------------------------ |
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Image /page/7/Picture/0 description: The image shows the logo for AmCad BioMed Corporation. The logo consists of a blue stylized letter "A" with a circle inside it, followed by the company name in both Chinese and English. The Chinese name is "安克生醫股份有限公司", and the English name is "AmCad BioMed Corporation". The text is in a clear, bold font.
| Table 1.6.1 The substantial equivalence comparison table | |||
|---|---|---|---|
| Device | Proposed Device | Primary Predicate Device | Reference Device |
| AmCAD-US | Q LAB Quantification Software | The software used on VolcanoIVUS System | |
| parametric images ofbackscattered statistics.The color-coded parametricimages of the backscatteredstatistics signals may beuseful in assisting theassessment of tissue statesof any scanned tissues. Thehistogram view of the dataprovides a different view toaccommodate the variationin tissue compositions. | The Q LAB software provides ameans of presenting the ROIdata in an XY graphic format.The Q LAB software provides ameans to perform a curve fitoperation on a data setgenerated by the ROI analysissoftware. The Q LAB softwareprovides a means of exportingthe data generated by the pluginmodules in a form accessible tothe end user. | wish to examine more closelyduring routine diagnosticultrasound imagingexaminations. | |
| FunctionalCapability | AmCAD-US is a softwarepackage designed toquantify and visualize thebackscatter statisticscontained in ultrasoundimage data obtained froman FDA-cleared generalpurpose ultrasound system.The device provides dualmode images, includingconventional B-modeultrasound image in grav | QLAB is a software applicationthat is available either as astand-alone product that canfunction on a standard PC, adedicated workstation, andon-board Philips' ultrasoundsystems. It can be used for theon-line and off-line review andquantification of ultrasoundstudies.The Region of InterestQuantification (ROI) Q-App is a | The second software programis called IVUSLabVH. Thisprogram analyzes each of theslices. These images arevisually reviewed and thecontrol points are manuallyadjusted until they appear inthe proper location on thevessel inner and outer borders.Once all the control pointshave been properly locatedthe software produces a set of |
| Device | Proposed Device | Primary Predicate Device | Reference Device |
| AmCAD-US | Q LAB Quantification Software | The software used on VolcanoIVUS System | |
| scale and color-mapped US(ultrasound structure)mode image. The US-modeprovides a means forviewing and displaying thebackscatter statisticalvalues. The device usesparametric model ornonparametric statisticsthat best describes thedistribution curve of thebackscattered signals. Theparameters vary by the USmethod (backscatteredstatistics) selected. Thepreferences include optionsto set the parametersmapped onto the imageand US method optionsapplied to the data. Theuser can also select aspecific region of interest(ROI) on the image forquantification analysis. | tool for analyzing the imagepixel content and the time orintensity data in the image.The analysis can display themean, median, standarddeviation, flow index, vascularityindex, vascularity flow index,and pixel intensity index forecho, color, and power images.Within the ROI drawn on theimage, the mean and medianpixel intensity values arecalculated for each frame of thesequence in the image file. Foreach mean intensity valuecalculated, the standarddeviation is calculated. If theexported data contains a singleframe, the mean intensity is asingle data point. If the exporteddata contains multiple frames,the mean intensity is graphed asa curve over time with a datapoint for each frame. | data files called "snaxel" fileswhich define the coordinatesof the control points. The blackand white IVUS files and thesnaxel files are loaded into theIVUSLabVH software whichprocesses the data to producethe five color bit mappedVolcano IVUS image files. Thesoftware uses radiofrequencybackscatter analysis of IVUSdata and producescharacterization of differenttissue types. | |
| Device | Proposed Device | Primary Predicate Device | Reference Device |
| AmCAD-US | Q LAB Quantification Software | The software used on VolcanoIVUS System | |
| AmCAD-US has a dataexport function to recordand save the analysisresults. | (derived from QLAB usermanual ) | ||
| Input (format) | RF or envelope data in twodimensional matrix. | Image data of proprietarymachine. | Raw data (containing RFsignals) of proprietarymachine. |
| Output (format) | The software can exportthe data generated by theanalysis of the image datain both text and imageformats accessible to theusers. The text format filecontains the statisticalvalue and histogram data.The image format file (.bmpor .jpeg) contains theprocessed image or datavisualization as shown onthe user interface. Theoutput information is thebackscattered statistics(distribution-relatedstatistics) rendered with | The software can export thedata generated by the pluginmodules in a form accessible tothe end user. The outputinformation includes thedescriptive statistics within auser-selected ROI and thespecific indices defined by thesoftware.The quantified values arerendered with color codes. Thecolor-coded image is thensuperimposed on the sonogram.The below exemplar imageshows the color-coded overlayimage and the trend | The five color bit-mappedVolcano IVUS image files. Thesoftware processes the dataand produces the five color bitmapped based on thequantified values ofbackscatter RF analysis and theclassified outputs. |
| Device | Proposed Device | Primary Predicate Device | Reference Device |
| AmCAD-US | Q LAB Quantification Software | The software used on VolcanoIVUS System | |
| color codes for visualizationand descriptive statistics ofultrasound backscattereddata. The below exemplarimage shows thecolor-coded overlay imageand the histogram providedby the software. | chart/descriptive statisticsprovided by the software. | ||
| Example | Image: Ultrasound image with color codes and histogram | Image: Q LAB Quantification Software | Image: Volcano IVUS System |
| Tools provided by | Statistical analysis based on | Strain analysis, ROI statistics of | Spectrum analysis of |
| the device | RF data, ROI statistics,distance measurement, | image data, distancemeasurement, data export, etc. | backscattered RF data, ROIstatistics, distance |
| data export. | measurement, etc. | ||
| Software Design | Based on statistical analysis | Based on ROI analysis of the | Perform radiofrequency (RF) |
| of ultrasound backscattered | image data | spectral analysis of ultrasound |
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Image /page/8/Picture/0 description: The image shows the logo of AmCad BioMed Corporation. The logo consists of a blue symbol on the left and the company name in both Chinese and English on the right. The English name is "AmCad BioMed Corporation", and the Chinese name is "
安克生醫股份有限公司". The symbol is a stylized blue shape.
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Image /page/9/Picture/0 description: The image contains the logo for AmCad BioMed Corporation. The logo consists of a blue stylized letter "A" with a circle inside it, followed by the company's name in both Chinese and English. The Chinese name is "安克生醫股份有限公司", and the English name is "AmCad BioMed Corporation".
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Image /page/10/Picture/0 description: The image contains the logo and name of AmCad BioMed Corporation. The logo is a blue stylized letter "A" with a circle containing the letter "C" at the top. The name of the company is written in both Chinese and English, with the Chinese characters appearing above the English text. The Chinese characters read "安克生醫股份有限公司".
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Image /page/11/Picture/0 description: The image shows the logo for AmCad BioMed Corporation. The logo consists of a blue stylized letter "A" with a circle inside it, followed by the company name in both Chinese and English. The Chinese name is "安克生醫股份有限公司", and the English name is "AmCad BioMed Corporation".
| Device | Proposed Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| AmCAD-US | Q LAB Quantification Software | The software used on VolcanoIVUS System | |
| signals contained in theimage data and statisticalanalysis in image data | backscattered signals | ||
| Operating System | Standard PC OperatingSystem | Same | Same |
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Image /page/12/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized letter "C" and a building-like shape. The text includes the company name in both Chinese and English, followed by the address: FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC. The telephone number is +886-2-27136227 and the fax number is +886-2-27152181.
1.7 Performance Standards
No performance standards for PACS systems or components have been issued under the authority of Section 514.
1.8 General Safety and Effectiveness Concerns
Software development for the AmCAD-US follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for this type of image viewing and quantification device. The device labeling contains operating instructions for use and necessary warnings and notes to provide the safe and effective use of the AmCAD-US.
1.9 Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Verification Tests:
AmCad BioMed Corporation has conducted the software verification tests, including software unit test, software integration test, and software system test, to evaluate the safety and effectiveness of AmCAD-US. The software verification testing was performed to ensure that AmCAD-US meets all functional and specifications for its indication for use.
Non-clinical Validation Tests:
The performance validation tests, including the phantom study, animal study, and human tissue validation study, were performed to validate the performance of the AmCAD-US for its intended use.
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Image /page/13/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a blue stylized letter "C" inside a blue shape resembling a house. Below the logo is the company name in both Chinese and English. The address is listed as FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-27152181.
● Phantom Study
In the phantom study, AmCAD-US was applied to cell phantoms with different concentrations of one cell type and with different constitutions of mixed cell types. The results of this study demonstrate the utility of the device in analyzing various cell compositions.
● Animal Study
In the animal study, AmCAD-US was applied on 6 rats with liver fibrosis induced by dimethylnitrosamine (DMN) injection. The results of this study demonstrate a strong correlation between the backscattered statistics provided by the device and the dosage of DMN injections. This study also demonstrates the utility of the device in analyzing the variation of the tissue compositions in small animals.
● Human tissue validation study
In the human tissue validation study, two common ultrasound scanning modes, e.g. thyroid and abdomen modes, were applied to demonstrate the utility of proposed device in analyzing backscattered-signal distribution of tissue compositions in the human body. In addition, two different FDA-cleared ultrasound systems were used in this study. The result of this study indicated that the device could be applied to various tissue parts in the human body and can be used with RF/Envelop data provided by various FDA-cleared ultrasound systems.
Clinical Validation Tests:
The subject of this 510(k) notification, AmCAD-US, did not require clinical studies to support safety and effectiveness of the software.
1.10 Conclusions
The software development for AmCAD-US followed documented processes for software design, software verification testing, and performance validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the quantification results. Appropriate steps have been taken to control all identified risks for the device. There is no known direct safety or health risk caused by, or related to, the use of the device. The safety and effectiveness of the device has been described in detail in the verification and
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Image /page/14/Picture/0 description: The image shows the logo and contact information for AmCad BioMed Corporation. The logo features a stylized blue "A" with a "C" inside the top portion. Below the logo is the company name in both Chinese and English. The address is listed as FL.3, NO.167, Fu Hsing N. RD., Taipei 105, Taiwan, ROC, and the telephone number is +886-2-27136227, while the fax number is +886-2-27152181.
validation document.
The data presented in this 510(k) application demonstrates that the proposed device, AmCAD-US, is as safe and effective as the primary predicate device. The intended use of AmCAD-US is similar to the primary predicate device. The technological differences do not raise any new questions regarding the safety and effectiveness of the device and the secondary referenced device is listed to reference the similar technological characteristics as that of the proposed device. Thus, AmCAD-US is substantially equivalent to the predicate device as a software device intended to view and quantifying the ultrasound image data. Both devices are classified as Picture Archiving and Communication Systems, 21 CFR 892.2050.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).