The Digimamo D ® Full-Field Digital Mammography System is a device intended to produce planar digital x-ay images of the entire breast. The Digimamo D is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Digimamo D is intended to be used in the same clinical applications as traditional film/screen systems.

Device Description

This is a mammography system available in only a digital version. The main characteristics are: Operation Panel/Console, X-ray tube information, Filter Selection, Window Material and thickness, Focal Spot Sizes, Operating principle, Radiological Characteristics, Column and Gantry, Flat Panel Detector, Workstation.

AI/ML Overview

The provided text describes the Digimamo D Full-Field Digital Mammography System and its comparison to a predicate device (Adani MammoScan K172027) and a reference device (DRTECH RSM2430C K170930). The information primarily focuses on the device's technical specifications and a summary of non-clinical and clinical testing performed to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a table format with specific quantitative thresholds. Instead, the document states that the device was tested to establish "substantial equivalence" to a predicate device, meaning it is "as safe and effective." The performance is deemed acceptable if the images are of "sufficiently acceptable quality for mammographic usage."

However, we can infer some "acceptance" from the successful outcome of the comparison and the conclusion of substantial equivalence. The key is that the new device's performance aligns with the predicate device and that the images were found to be diagnostic quality by experts.

Acceptance Criteria Category	Description of Performance/Evidence Provided in Document
Device Safety	Passed various IEC 60601 series standards (60601-1, 60601-1-2, 60601-1-3, 60601-2-28, 60601-2-45) by 3rd party Nationally Recognized Testing Laboratories. Complies with 21 CFR 1020.30 and 1020.31. Firmware validated per FDA Guidance (May 11, 2005). Cybersecurity recommendations observed.
Device Effectiveness (Image Quality)	Clinical image evaluation by expert radiologists determined that the clinical images were of "sufficiently acceptable quality for mammographic usage." The device employs the same imaging panel/software cleared by DRTECH in RSM2430C (K170930), and it "worked properly and produced diagnostic quality mammographic images."
Substantial Equivalence to Predicate Device	The document concludes that "the new Digimamo D System is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device." This implicitly means the performance is comparable to the predicate for all relevant aspects (e.g., image quality, dose, functionality).
Indicated Use	The device's Indications for Use are stated to be "SAME" as the predicate device: "intended to produce planar digital x-ray images of the entire breast. The Digimamo D is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Digimamo D is intended to be used in the same clinical applications as traditional film/screen systems." Performance meets this stated intended use.
Hardware & Software Requirements	The manufacturer states they "meet the hardware and software requirements expressed in that submission" (referring to the DRTECH submission K170930). This implies their system's components and software function as expected and are comparable to a cleared device.

Study Details:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: "Sixty images" were evaluated. The document further clarifies "Totally, there are 12 sets of images presented in this review." Each set consists of four standard views (right CC, right MLO, left CC, left MLO), so 12 sets * 4 views/set = 48 images initially. However, it also states "If requested by the radiologist, additional image with magnification was taken." This suggests more than 48 images could have been evaluated, up to 60 total. It's not explicitly clear if all "sixty images" were unique patient cases or if "12 sets of images" corresponds to 12 patient cases, each with multiple views. The phrasing "Sixty images were evaluated" followed by "Totally, there are 12 sets of images" could be interpreted as 60 individual images selected from these 12 sets, or 60 total images including any additional magnification views for the 12 cases.
- Data Provenance: Images were taken during the "standard screening procedure in Fundação Municipal de Saúde de Macaé, Rio de Janeiro, Brazil." This indicates the data is retrospective as it was already acquired.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Three Board Certified US based radiologists."
- Qualifications of Experts: "US-based MQSA qualified radiologists." MQSA (Mammography Quality Standards Act) qualification ensures competence in mammography interpretation.
Adjudication method for the test set:
- The document states, "Images were reviewed by US-based MQSA qualified radiologists. The results of clinical image evaluation determined that the clinical images reviewed by the expert radiologists were of sufficiently acceptable quality for mammographic usage."
- There is no explicit description of an adjudication method (e.g., 2+1, 3+1 consensus). It sounds like a qualitative assessment by individual radiologists, and the collective outcome was that the images were acceptable. It doesn't describe a process for resolving disagreements or reaching a formal consensus for a specific ground truth label.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The study described is a clinical image evaluation by human readers of images produced by the device to confirm diagnostic quality, not a study comparing human performance with vs. without AI assistance. The device itself is a full-field digital mammography system, not an AI-based reading aid.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly described as a standalone algorithm study. The device is an imaging system (hardware + software for image acquisition and display). The "clinical testing" refers to human readers evaluating the image output of the system, not an algorithm's classification performance. The "digital panel software employed was already reviewed by FDA in the reference submission list," which implies its performance characteristics (e.g., image quality metrics) would have been assessed as part of its original clearance. This is an assessment of the entire system's output through human review.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the clinical image evaluation was the qualitative assessment by the three Board Certified US-based MQSA qualified radiologists that the images were of "sufficiently acceptable quality for mammographic usage." This is a form of expert opinion/consensus on image quality for diagnostic purposes. It is not described as being based on pathology or clinical outcomes.
The sample size for the training set:
- The document does not mention a training set sample size as this device is a mammography imaging system (hardware and associated acquisition/processing software), not an AI algorithm requiring a training set in the conventional sense (e.g., for classification or detection). The software involved (digital panel software) was from a previously cleared device (DRTECH RSM2430C K170930), implying its development and validation were part of that prior submission.
How the ground truth for the training set was established:
- As no "training set" for an AI algorithm is described for this device's new performance evaluation, the method for establishing ground truth for a training set is not applicable/not provided in this document.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

VMI Tecnologias LTDA % Daniel Kamm Principal Engineer Kamm and Associates 8870 Ravello Ct NAPLES FL 34114

Re: K210151

March 1, 2022

Trade/Device Name: Digimamo D Regulation Number: 21 CFR 892.1715 Regulation Name: Full-Field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: January 26, 2022 Received: January 28, 2022

Dear Daniel Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jessica Lamb, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210151

Device Name DIGIMAMO D

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary: 510(k) Number K210151 VMI Tecnologias LTDA Rua Prefeito Elizeu Alves Da Silva, 400 -Dist. Ind. Genesco Aparecido De Oliveira, Lagoa Santa, Minas Gerais, Brazil Date Prepared: February 24, 2022 Contact: Siele Santos Tel: Tel: +55 (31) 3681-6388

Identification of the Device: Trade/Device Name: Digimamo D Regulation Number: 892.1715 Regulation Name: Full Field Digital, System, X-Ray, Mammographic Regulatory Class: = Product Code: MUE Common/Usual Name: Digital Mammography System

1. Equivalent legally marketed device: K172027, Adani Trade/Device Name: MammoScan Regulation Number: 892.1715 Full Field Digital, System, X-Ray, Mammographic Regulation Name: Regulatory Class: = Product Code: MUE Common/Usual Name: Digital Mammography System
Reference Devices: We employ the imaging panel/software cleared by DRTECH in RSM2430C (K170930). 3. We meet the hardware and software requirements expressed in that submission. Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system and Picture archiving and communications system Regulatory Class: II Product Code: MUE
Indications for Use: The Digimamo D ® Full-Field Digital Mammography System is a device intended to 4. produce planar digital x-ray images of the entire breast. The Digimamo D is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Digimamo D is intended to be used in the same clinical applications as traditional film/screen systems. .
1. Description of the Device: This is a mammography system available in only a digital version. The main characteristics are:

Operation Panel/Console:

Natively, the Digimamo D Generator operation panel is integrated into the imaging system so that all indications and technical selections for radiographic exposure will be shown on the monitor, in conjunction with the image acquired.

{4}------------------------------------------------

X-ray tube information:

The X Radiation Emitters (Target) are available in Tungsten.

Filter Selection:

Tungsten Target: For radiation beam filter selection, there is a choice of Silver (50μm) or rhodium (50um) filters, use the key to select the desired filter.
Molybdenum Target: For radiation beam filter selection, there is a choice of Molybdenum (30μm) or rhodium (25μm) filters, use the key to select the desired filter.

The type in use is indicated on the operation panel, and there is the option of automatic selection based on kV.

Window Material and thickness: 0.5mm Be

Focal Spot Sizes: Small focus: 0,1mm, Large Focus: 0,3mm

Operating principle:

The general sequence of events in the patient examination procedure and the flow of image data from detector to the final image: (This operating principle is identical to the predicate)

1. User turns on the power.
1. User turns on the collimation light.
1. Patient is positioned.
1. Breast compression is done.
1. Operator initiates the exposure.

Initiation of the exposure turns on the x-ray source and the digital image panel acquires the x-ray and breast is decompressed.
Image is converted by the panel to digital image format, which in turn is transferred to the internal processor for storage and subsequent display.

Radiological Characteristics:

Power: 5 kW kV's range: 20 to 40, with increments in AEC mode of 0.1 kV and digital mode of 1 kV. mA Ranges (25, 32, 80, 125, 140) with automatic selection depending on focus and selected kV and exposure mode.

Selection of automatically defined times according to the selected Mas and mA. Synchronized system between the emitter and the X-ray receiver. mAs ranges (0.25 to 630) and (5 to 400) in Manual and AEC modes respectively.

Automatic exposure Control (AEC) provides: Auto mode: The system automatically calculates the kV and mAs Semi-Automatic mode: The system automatically calculates the mAs. The kV is selected by the operator.

Manual mode: The kV and the mAs are selected by the operator. The density selection: Adjustable in 11 levels (from-5 to + 5) being the default density (0). Adjustments are made directly to the Control Panel.

{5}------------------------------------------------

All control is accomplished through a CPU (workstation) integral part of Digimamo D.

Column and Gantry

The column and arm tube Assembly of Digimamo D, was designed to offer all the comfort and safety in performing mammography exams. Smooth movements with fast and accurate acceleration and deceleration ramps.

The control panels located on the right and left sides enable: Position the arm automatically at 45 degrees clockwise and counterclockwise.

Rotate the arm left and right (-180 º, 0 º, + 180 º).

Move the arm vertically.

Select the positioning of the AEC (automatic exposure control).

Light the collimator lamp.

Select to more or less breast compression stop point.

Removable face protector.

Informative display.

Compression fine adjustment knobs (both sides).

Handles for hands (both sides).

Emergency button (both sides).

Support attachment points for magnification factors of 1.5 and 1.8 times.

Bucky/Digital Panel 24x30 cm, equipped with 335 l/pol. anti-diffuser grids and 5:1 ratio in carbon fiber.

Flat Panel Detector

Csl Scintillator Active area of 291.8 x 233.5 mm Resolution of 3,840(W) x 3,072(L) pixels Pixel size: 76 µm. Depth (A/D): 16 bits. Carbon fiber cover. Synchronized drive system with the X-ray emitter assembly. Fully integrated image detection system (native) to the equipment platform and digital imaging acquisition and treatment software.

Workstation

Core i7 processor; 1 TB capacity hard drive; 8 GB RAM memory; Windows Professional operating system; . 23-inch, high-resolution, touchscreen LED Monitor; Reader unit and CD/DVD burner; Digital Image Acquisition Software.

6. Substantial Equivalence Chart: See next page

{6}------------------------------------------------

Characteristic	K172027, Adani MammoScan	Reference Device DRTECH in RSM2430C(K170930).	Digimamo D
Indicationsfor Use:	The MammoScan® Full-Field DigitalMammography System is a device intendedto produce planar digital x-ray images of theentire breast. The MammoScan is indicatedfor generating mammographic images thatbreast cancer. The MammoScan is intendedto be used in the same clinical applicationsas traditional film/screen systems.	The RSM 2430C is a detector indicatedfor use in screening and diagnosticmammography.	The Digimamo D ® Full-Field DigitalMammography System is a device intended toproduce planar digital x-ray images of the entirebreast. The Digimamo D is indicated forgenerating mammographic images that can beused for screening and diagnosis of breast cancer.The Digimamo D is intended to be used in thesame clinical applications as traditionalfilm/screen systems. (SAME)
Photo	Image: Adani MammoScan	Image: DRTECH in RSM2430C	Image: Digimamo D
X-rayGenerator	High Frequency 10 kW	Not included	High Frequency 5 kW.
Characteristic	K172027, Adani MammoScan	Reference Device DRTECH in RSM2430C(K170930).	Digimamo D
kV Range	20-50 kV with 0.1 kV step	kVp 20 to 35(Mo), 28 to 39(Rh)	kV's range: 20 to 40, with increments in AEC modeof 0.1 kV and digital mode of 1 kV
mA Range	5-250 mA, From 5 mA to 80 mA in 0.1 mA stepsand from 80 mA to 250 mA in 1 mA steps	-	25, 32, 80, 125, 140 with automatic selectiondepending on focus and selected kV and exposuremode.
mAs Ranges	0.1 to 1200 mAs	3 to 500 mAs	0.25 to 630 and 5 to 400 in Manual and AEC modesrespectively
Detector Information
	Adani MammoScan (K172027)	DRTECH RSM2430C (K170930)	Digimamo D
Detector	Teledyne CCD LN-40-08K05-00-R	DRTECH RSM2430C (K170930)	DRTECH RSM2430TD (same detector as K170930in a different enclosure)
Configuration	Scanning imaging principle, 2x2 binning	Rectangular Flat Panel	Rectangular Flat Panel
Pixel Size	54 μm in normal operation mode	76 μm	76 μm
Pixel Matrix	8192 (H) x 256 (V) (Scanning required)	3072 x 3,840 (Single exposure, noscanning required)	3072 x 3,840 (Single exposure, no scanningrequired)
Detector Size	221 mm long active area	240 x 300 mm, Greater active area	240 x 300 mm, Greater active area
Scintillator	Csl	Csl SAME	Csl SAME
A/D	16 Bits	16 Bits. SAME	16 Bits. SAME
PanelInterface	Ethernet	Ethernet SAME	Ethernet SAME
Meets USPerformanceStandard	YES	N/A	YES
PowerSource	AC Line Only	SAME	SAME

{7}------------------------------------------------

{8}------------------------------------------------

1. The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness.
1. Safety and Effectiveness, comparison to predicate device. The results of bench testing AND clinical testing indicate that the new devices are as safe and effective as the predicate device. Proper system operation is fully verified upon installation. We verified that this combination of components worked properly and produced diagnostic quality mammographic images. The key image acquisition component is the RSM2430TD digital x-ray receptor panel (K170930) manufactured by DRTECH. It is electronically identical to the RSM2430C panel cleared in K170930 (different enclosure) with the SAME PRODUCT CODE: MUE.
1. Summary of non-clinical testing: Systems were assembled and found to be operating properly. Firmware was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. We also observed the requirements of this guidance document: Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Full-Field Diqital Mammoqraphy System Document issued on: November 5, 2010.

Because the system uses Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff. In addition, we reviewed the FDA guidance Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff and added a supplement to our user manual. The digital panel software employed was already reviewed by FDA in the reference submission list, above. Labeling is in accordance with the US Performance Standard. This device complies with all applicable requirements of 21 CFR 1020.30, and 1020.31

Digimamo D has been tested by 3rd party Nationally Recognized Testing Laboratories to be in compliance with the following International Standards:

IEC 60601-1: 2010 + Aml:2016 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
IEC 60601-1-2:2010 Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and tests
IEC 60601-1-3: 2011 + Aml:2016 Medical Electrical Equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment;
IEC 60601-2-28:2012 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
IEC 60601-2-45: 2013 + Aml:2017 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-Ray equipment and stereotactic mammographic devices.

{9}------------------------------------------------

1. Summary of clinical testing: Clinical testing was required to establish substantial equivalence because of the requirement in the FDA Guidance Document cited above. Sixty images were evaluated by three Board Certified US based radiologists. Images were taken during the standard screening procedure in Fundação Municipal de Saúde de Macaé, Rio de Janeiro, Brazil. Totally, there are 12 sets of images presented in this review. Images were selected in order to represent different categories in density and BIRADS categories. Each set consists of four standard views (right CC, right MLO, left CC, left MLO.) If requested by the radiologist, additional image with magnification was taken. Images were reviewed by US-based MQSA quaified radiologists. The results of clinical image evaluation determined that the clinical images reviewed by the expert radiologists were of sufficiently acceptable quality for mammographic usage.
1. Conclusion: After analyzing bench and clinical tests, it is the conclusion of VMI Tecnologias LTDA that the new Digimamo D System is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.