iBreastExam™ device is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast exam. iBreastExam™ device is intended for use by a qualified healthcare professional trained in its use and is not for home use.

Device Description

The iBreastExam system consists of a group of hardware and software components. The hardware component(s) consist of: iBreastExam Scanhead, Computer System, USB Wall Charger and Charging Cables. The software component(s) consist of: iBEConnect Software Program.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria and a comprehensive study showing the device meets those criteria. However, I can extract the available information and highlight what is missing based on your request.

Here's a breakdown of the information present and absent:

Information Present in the Document:

Device Name: iBreastExam
Intended Use: To produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast exam. It is a documentation tool, not for diagnosis.
Predicate Device: BREASTVIEW® VISUAL MAPPING SYSTEM (K010514)
Performance Testing Mentioned:
- Electrical safety tests
- Electromagnetic compatibility tests
- Biocompatibility tests
- Side-by-side performance test between iBreastExam and the predicate device (BreastView).
- Validation and verification performed on software and hardware subsystems.
Conclusion: All test results were satisfactory and did not raise any additional safety or effectiveness concerns, leading to a substantial equivalence determination.

Information NOT Present in the Document (and therefore cannot be provided in the tables/sections you requested):

Specific Acceptance Criteria: The document mentions "Performance tests were conducted per Class II Special Controls Guidance Document: Breast Lesion Documentation System," but it does not list the specific quantitative acceptance criteria for these tests (e.g., a required sensitivity, specificity, accuracy, or a threshold for deviation from the predicate).
Reported Device Performance against specific criteria: While it states "all test results were satisfactory," it lacks numerical performance data for the iBreastExam against any defined acceptance criteria.
Detailed Study Information:
- Sample size for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Standalone algorithm performance (algorithm only without human-in-the-loop).
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.

Given the limited information, I will present what can be inferred or directly stated, and clearly mark the missing details.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	"All test results were satisfactory" (per electrical safety, EMC, biocompatibility, and side-by-side performance tests). Specific quantitative performance against acceptance criteria is not provided.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the document.
Data Provenance: Not specified in the document. (The document mentions a "side-by-side performance test" but gives no details on the study population or context.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not specified in the document. The document refers to the device aiding in documenting "palpable breast lesions identified during a clinical breast exam," implying clinical examination as the basis, but does not detail how ground truth for the testing was established or how many experts were involved.

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

Not specified in the document.

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

Was a MRMC study done? The document describes a "side-by-side performance test" with a predicate device, but it does not indicate a multi-reader multi-case (MRMC) comparative effectiveness study with human readers improving with AI assistance. The iBreastExam is described as a "documentation tool" for lesions already palpated.
Effect size of human readers improving with AI vs without AI assistance: Not applicable/not provided based on the studies described.

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

The document implies a standalone performance for the device in capturing pressure maps, but it is explicitly stated that the device's output is an "aid in documenting palpable breast lesions identified during a clinical breast exam," and it's not for diagnosis. It's used by a "qualified healthcare professional." No specific standalone performance metrics (e.g., sensitivity/specificity for detecting lesions) are provided, only its ability to collect data and produce a map.

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

The document implies the ground truth for the "palpable breast lesions" would be based on clinical breast exam findings, as the device is intended to document such lesions. However, the specific method for establishing ground truth for the performance testing is not detailed. It does not mention pathology or outcomes data for the performance study.

8. The sample size for the training set

Not specified in the document.

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

Not specified in the document.

In summary, the provided FDA 510(k) letter and summary describe the device's intended use, technological characteristics, and a general statement about performance testing leading to substantial equivalence. However, it lacks the detailed quantitative performance criteria, study design parameters (sample sizes, expert roles, ground truth establishment methods), and specific results that would be required to fully answer your request regarding acceptance criteria and their proven fulfillment. The document focuses on establishing substantial equivalence to a predicate device rather than providing a detailed performance study with explicit acceptance criteria.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 23, 2015

UE LifeSciences, Inc. Mihir Shah CEO 3711 Market Street, Suite 800 Philadelphia, PA 19104

Re: K142926 Trade/Device Name: iBreastExam Regulation Number: 21 CFR 884.2990 Regulation Name: Breast lesion documentation system Regulatory Class: II Product Code: NKA Dated: March 16, 2015 Received: March 20, 2015

Dear Mihir Shah,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K142926

Device Name

iBreastExam

Indications for Use (Describe)

iBreastExam™ device is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breastExam™ device is intended for use by a qualified healthcare professional trained in its use and is not for home use.

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.

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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for UE LifeSciences. The logo consists of a circular design with overlapping rings in shades of blue, gray, and pink. Below the circular design, the text "UE LifeSciences" is written in a simple, sans-serif font.

510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Applicant and Official Correspondent:

UE LifeSciences. Inc. C/o Mihir B. Shah 3711 Market St, Suite 800 Philadelphia, PA 19104

Contact Person:	Mihir Shah
Tel:	631-980-8340
Email:	mihir@uelifesciences.com

April 23, 2015 Date Prepared:

Name of Device:

iBreastExam Classification Name: Breast Lesion Documentation System (12 CFR 884.2990) Regulation Class: Class II Product Code: NKA

Predicate Device:

BREASTVIEW® VISUAL MAPPING SYSTEM (K010514 granted through de novo process)

Intended Use:

The device is intended to produce a surface map of the breast as an aid in documenting size, shape, and location of breast lesions identified during a clinical breast exam. It is a documentation tool. It is not intended for diagnosis. The device should only be used to document a lesion already palpated on clinical breast exam. Clinical management decisions should only be made on the clinical and diagnostic examinations (e.g. ultrasound or mammography). If there is a disagreement between the examination and the record produced by the device, decisions should be made on the basis of the clinical examination.

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

Image /page/4/Picture/0 description: The image shows the logo for UE LifeSciences. The logo consists of a circular design with overlapping rings in blue, pink, and gray. Below the circular design, the text "UE LifeSciences" is written in a simple, sans-serif font.

Indications for Use:

iBreastExam™ (iBreastExam) device is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast exam. iBreastExam™ device is intended for use by a qualified healthcare professional trained in its use and is not for home use.

Technological Characteristics:

The iBreastExam system consists of a group of hardware and software components. The hardware component(s) consist of:

iBreastExam Scanhead
Computer System
USB Wall Charger and Charging Cables .

The software component(s) consist of:

iBEConnect Software Program ●

Performance Testing:

Performance tests were conducted per Class II Special Controls Guidance Document: Breast Lesion Documentation System, including electrical safety tests, electromagnetic compatibility tests as well as biocompatibility test. In addition, a side-by-side performance test was conducted between iBreastExam™ and the predicate device (BreastView).

Complete validation and verification was performed on all software and hardware subsystems. In summary, all test results were satisfactory and did not raise any additional safety or effectiveness concerns.

Substantial Equivalence:

Parameter	Subject device	Predicate device – BreastView Visual Mapping System
Intended use	Same as the predicate	is intended to produce a surface pressure map ofthe breast as an aid to document palpable breastlesions identified during a clinical breast exam.
Processing unit	Same as the predicate	Computer with software, Windows basedoperating system
Data acquisition method	Same as the predicate	Array of pressure sensors mounted on hand-held scanhead
Lesion documentation	Same as the predicate	Lesion size, location, stiffness, shape
Detectable lesion size	≥5mm	5-40mm
Number of sensors in imaging	16	416
Pressure sensor array size	28mm × 28mm	40mm×25mm

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

Image display	Same as the predicate	Yes
Image storage	Same as the predicate	Yes
Comparison to previous images	Same as the predicate	No
Final report	Same as the predicate	Color tactile maps
Patient contacting component	Reusable scanhead made ofacrylonitrile butadiene styrene	Disposable, single use cover (made ofpolyurethane) attached to the scanhead
Use with lotion	Not needed	Needed

Substantial Equivalence Discussion

Intended use The subject and predicate devices have the same intended use. .
Technological characteristics Similarities between the subject and predicate devices ●
- ★ They use computer with software. Windows based operating system.
- - They used the same data acquisition method - Array of pressure sensors mounted on handheld scanhead.
- - They provide the same lesion documentation lesion size, location, stiffness, and shape.
- ★ They detect the similar lesion sizes.
- ★ They have the same features regarding image display, image storage, image comparison, and format of final report.
Technological characteristics Differences between the subject and predicate devices ●
- ★ The subject imaging component contains 16 sensors whereas the predicate imaging component has 416 sensors. Also, the subject device has a smaller pressure sensor array size. The differences raise an effectiveness concern, but there is no new type of question. Bench testing data showed that the subject device is effective.
- - The subject device uses different material (ABS vs. polyurethane used in the predicate device), raising a safety concern. However, safety related to material is not a new type of question and can be assessed by accepted biocompatibility testing. Biocompatibility data demonstrated that the subject device is safe.

In conclusion, the subject device is substantial equivalent in terms of safety and effectiveness.

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.