The SureTouch Mobile Pressure Mapping System is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast examination. The SureTouch Mobile Pressure Mapping System is intended for use by a qualified healthcare professional trained in its use and is not for home use.

Device Description

The SureTouch Mobile Pressure Mapping System ("SureTouch") is a computer-based device that produces a pressure map, called a tactile image, of specific areas of the breast as an aid to document lesions detected during a clinical breast exam. SureTouch utilizes a rechargeable, battery-powered hand-held wand (sensor unit) that incorporates a 30 x 40 mm array of pressure sensing elements to collect tactile data as the device is moved across the breast. Data collected using the wand are wirelessly transferred to the tablet display where they are used to generate tactile images and provide information on a lesion's size, shape and hardness. The final report includes a tactile image of each lesion along with its user inputted location. The SureTouch System also includes a calibration and training phantom, a scale to ensure correct force applied during calibration procedures, and a holder for the wand.

AI/ML Overview

Here's an analysis of the provided text to fulfill your request, broken down by the specific points you asked for.

Please Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It usually does not contain a detailed report of clinical study results, particularly for a device like this that is for documentation rather than diagnosis or treatment. Therefore, some of your requested information, especially regarding clinical performance metrics (like sensitivity, specificity, or reader improvement with AI), will not be explicitly available in this document.

1. A table of acceptance criteria and the reported device performance

The document mentions that various tests "met all acceptance criteria" but does not explicitly list the quantitative acceptance criteria for most of the performance tests. It also doesn't provide specific numerical performance results beyond stating that criteria were met.

Test Type	Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Software Information	Met recommendations for minor level of concern software (FDA guidance)	Met recommendations
Cybersecurity Information	Met recommendations (FDA guidance)	Met recommendations
Electrical Safety	Per ANSI/AAMI EN60601-1:2006+A11:2013+A12:2014	Met all acceptance criteria
Electromagnetic Compatibility	Per IEC 60601-1-2:2007 (3rd edition)	Met all acceptance criteria
Wireless Technology Information	Met recommendations (FDA guidance)	Met recommendations
Intra and Inter-observer, and Inter-system Accuracy & Reproducibility Testing	Described in FDA "Class II Special Controls Guidance Document: Breast Lesion Documentation System"	Met all acceptance criteria
Force Gauge Validation	(Not explicitly stated in document)	Met all acceptance criteria (for accuracy and reproducibility)
Algorithm Output Sensitivity	(Not explicitly stated in document)	Met all acceptance criteria (to calibration errors)
Phantom Testing (Sensor Measurement Accuracy)	(Not explicitly stated in document)	Met all acceptance criteria (under uniform calibration force)
Phantom Testing (Aging of Calibration/Training Pad)	(Not explicitly stated in document)	Met all acceptance criteria (did not impact device calibration results)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on the sample size used for any specific test sets or the provenance of the data (country, retrospective/prospective). This type of information is typically found in more detailed study reports, not a 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide this information. It refers to "intra and inter-observer" testing, which implies multiple observers, but does not specify their number, qualifications, or how ground truth was established for these tests. For a Breast Lesion Documentation System rather than a diagnostic one, "ground truth" might refer to the actual physical properties of simulated lesions or consensus on manual palpation findings, rather than a diagnostic gold standard like pathology.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not provide this information.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance to improve diagnostic performance. The device is a "documentation system," not an AI diagnostic aid in the traditional sense discussed in MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document describes "Algorithm output sensitivity" testing, which suggests standalone algorithm performance was evaluated for sensitivity to calibration errors. However, it does not provide details on a standalone diagnostic performance (e.g., sensitivity/specificity of the algorithm alone to detect lesions) because the device's intended use is to document palpable lesions identified by a healthcare professional, not to independently detect them.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not explicitly state the type of ground truth used for its performance testing. Given the "phantom testing" and "intra and inter-observer" testing in the context of a "documentation system" for palpable lesions, the ground truth likely involved:

Physical characteristics of simulated lesions in phantoms: For tests related to accuracy of sensor measurements or calibration pad aging.
Expert consensus on palpable characteristics: For tests related to intra- and inter-observer reproducibility of documenting palpable lesions.
It is highly unlikely that pathology or outcomes data would be used as ground truth for a device whose indication is documentation of palpable findings.

8. The sample size for the training set

The document is a 510(k) summary for a medical device that processes sensor data rather than being a deep learning AI model that requires a "training set" in the machine learning sense. The term "training set" is not mentioned, and thus no sample size is provided. The device described appears to be a tactile sensor system, not an AI imaging interpretation system.

9. How the ground truth for the training set was established

As there is no mention of a "training set" in the context of machine learning, this information is not applicable and not provided.

Summary

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June 28, 2019

Sure, Inc. Laurence Harvey Senior Quality Engineer Certified Compliance Solutions 11665 Avena Place, Suite 203 San Diego, CA 92128

Re: K181672

Trade/Device Name: SureTouch Mobile Pressure Mapping System Regulation Number: 21 CFR§ 884.2990 Regulation Name: Breast Lesion Documentation System Regulatory Class: II Product Code: NKA Dated: May 17, 2019 Received: May 28, 2019

Dear Laurence Harvey:

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.

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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,

Sharon M. Andrews Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181672

Device Name SureTouch Mobile Pressure Mapping System

Indications for Use (Describe)

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

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510(k) Summary K181672 - SureTouch Mobile Pressure Mapping System

Submitter:	Sure, Inc
Address:	1404 Granvia AltamiraPalos Verdes Estates, CA. 90274
Phone number:	(833) 787-3642
Contact person:	David Ables, CTO
Phone number:	(833) 787-3642 x 701
Date prepared:	June 25, 2019
Trade name:	SureTouch Mobile Pressure Mapping System
Common Name:	Documentation System for Breast Lesions
Regulation Number:	21 CFR 884.2990
Regulation Name:	Breast Lesion Documentation System
Product Code:	NKA (System, Documentation, Breast Lesion)
Regulatory Class:	Class II

Predicate Device: BreastView Visual Mapping System (DEN020001). This predicate device has not been subject to any design related recalls.

Device Description:

Indications for Use:

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Parameter	Subject DeviceSureTouch SystemK181672	Predicate DeviceBreastView VisualMapping System(DEN020001)	Comparison
Indications for Use	The SureTouchMobile PressureMapping System isintended to produce asurface pressure mapof the breast as anaid in documentingpalpable breastlesions identifiedduring a clinicalbreast examination.The SureTouchMobile PressureMapping System isintended for use by aqualified healthcareprofessional trainedin its use and is notfor home use.	The Breast ViewVisual MappingSystem is intendedfor use in producinga surface map of thebreast as an aid todocument palpablebreast lesionsidentified during aclinical breastexamination.	The subject andpredicate deviceshave the sameintended use.
Sensor	Handheld sensor unitcontaining a 30 x 40mm rectangular arrayof 192 sensors.	Handheld sensor unitcontaining a 25 x 40mm array of 416sensors.	Different – Thepredicate device has agreater number ofsensors than thesubject device.Differences in sensornumbers do not raisedifferent questions ofSafety andEffectiveness (S&E)
Display	Android-basedtouchscreen tabletthat controls devicefunctions anddisplays examinformation.	Windows-based PCthat controls devicefunctions anddisplays examinformation.	Different - Thesubject and predicatedevices use differentdisplay types. Thisdifference does notraise differentquestions of S&E.
Calibration/TrainingPad and Scale	Yes – pad includessimulated lesions fortraining and is also	No	Different - Thesubject device isprovided with a
	used for devicecalibration inconjunction with theprovided scale.		standalone pad andscale that are used forcalibrating the device.These differences donot raise differentquestions of S&E.
LesionDocumentation	Lesion size,hardness, shape anduser-inputtedlocation	Lesion size, stiffness,shape, and location.	Different – Thepredicate deviceincludes an automatedlesion locationposition system that isnot part of the subjectdevice that requiresthe user to manuallyidentify the locationof a specific lesion onthe display screen.This difference doesnot raise differentquestions of S&E.
Detectable LesionSize	5mm to 25x 35 mm	5-40 mm	Similar
Disposable Sheathand Lotion Use	Device to be usedwith a polyurethanesheath and lotion.Specifications forsuitable,commercially-available sheaths andlotion provided inlabeling	Device to be usedwith a polyurethanesheath and lotion.	Same

Comparison of Subject and Predicate Devices:

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As shown above, the indications for use of the subject and predicate devices are not identical; however, their intended uses are the same (i.e., documenting palpable breast lesions detected during a clinical breast exam).

Regarding technological characteristics, the subject and predicate devices have similarities in their general designs. However, differences do exist as described in the table above (e.g., sensor number, display types, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.

Performance Testing:

The following tests have been conducted to ensure reliable design and performance under the specified testing parameters. These tests include:

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. Software information that met the recommendations for a minor level of concern software per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Cybersecurity information that met the recommendations in the FDA guidance document, . "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
Electrical safety testing per ANSI/AAMI EN60601-1:2006+A11:2013+A12:2014 .
Electromagnetic compatibility testing per IEC 60601-1-2:2007 (3rd edition) .
Wireless technology information that met the recommendations in the FDA guidance ● document "Radio Frequency Wireless Technology in Medical Device."
. Intra and inter-observer, and inter-system accuracy and reproducibility testing as described in the FDA "Class II Special Controls Guidance Document: Breast Lesion Documentation System." Testing met all acceptance criteria.
Force gauge validation: Testing to assess the accuracy and reproducibility of the force gauge ● shown on the device display that is used for device calibration and to assess force applied during an exam. Testing met all acceptance criteria.
Algorithm output sensitivity: Testing to assess sensitivity of the device algorithms to ● calibration errors. Testing met all acceptance criteria.
Phantom testing:
- Testing to assess accuracy of sensor measurement when placed under a uniform O calibration force as compared to calibration force applied using the phantom and scale. Testing met all acceptance criteria.
- Testing to demonstrate that aging of the calibration and training pad did not impact o device calibration results. Testing met all acceptance criteria.

Conclusion:

The results of the performance testing described above demonstrates that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.2990 Breast lesion documentation system.

(a)
Identification. A breast lesion documentation system is a device for use in producing a surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast examination.(b)
Classification. Class II (special controls). The device, when it is a breast examination recording sheet, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See § 884.1(e) for the availability of this guidance document.