The BrainPort V100 is an oral electronic vision aid that provides electro-tactile stimulation to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as the white cane or a guide dog.

Device Description

The BrainPort V100 design and components are the same as the previously granted BrainPort V100; the device continues to consist of the headset, controller (handset), intra-oral device (IOD), and battery charger. The camera unit in the headset captures the viewed scene as a digital image and forwards that image to the controller for processing. The IOD presents stimulation patterns representative of the camera image to the user's tongue. Same as in DEN130039, the BrainPort V100 is a fully wearable, battery operated device with no physical connections to external equipment during normal operation. The device includes a means for a sighted individual (e.g., instructor) to remotely view the camera and IOD images to assist in training through its vRemote software program.

AI/ML Overview

The provided text describes a 510(k) summary for the BrainPort V100, which is primarily focused on demonstrating substantial equivalence to a previously cleared predicate device (DEN130039). The submission highlights minor modifications related to cleaning/disinfection procedures and a software update, and verifies that these changes do not alter fundamental device performance or safety.

Therefore, the study described does not involve a traditional clinical performance study with acceptance criteria in the sense of accuracy, sensitivity, or specificity for a diagnostic device. Instead, the "acceptance criteria" and "device performance" relate to the validation of the changes made to the device and ensuring they meet established safety and functionality standards.

Here's an attempt to structure the information based on your request, understanding that "acceptance criteria" and "device performance" in this context will refer to the validation of the modifications rather than a clinical efficacy study.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard Adhered To	Reported Device Performance/Result
Cleaning/Disinfection Validation	AAMI TIR12:2010, AAMI TIR30:2011, ISO 17664:2004, ANSI/AAMI ST81:2004(R)2010, ANSI/AAMI ST58:2013 guidelines. No reduction in electrode functionality after cleaning/disinfection.	All results were passing, validating the cleaning and disinfection procedures. Performance testing verified no reduction in electrode functionality.
Electrical Safety/Electromagnetic Compatibility	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11	Results were passing. No changes in electronic hardware/technology compared to the predicate device.
Biocompatibility	- (Implicitly, established and low risk)	Established as low risk. No changes to device materials compared to the predicate.
Software	Software verification and validation testing for the minor update.	Results demonstrated that the software was appropriate for release, performing as intended.
Overall Substantial Equivalence	The modified BrainPort V100 maintains the same intended use, indications for use, and very similar technological characteristics and principles of operation as the predicate device (DEN130039), with no new safety or effectiveness questions raised by the minor changes.	The BrainPort V100 is substantially equivalent to its predicate device.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: The document does not specify a "test set" in the traditional sense of patient data.
- For Cleaning/Disinfection Validation: These studies typically involve a defined number of device units (or components) subjected to multiple cleaning/disinfection cycles. The specific sample size is not mentioned, but it would have been sufficient to meet the statistical requirements of the cited standards.
- For Electrical Safety, Biocompatibility, and Software Validation: These typically involve testing of device prototypes or software builds. Specific sample sizes are not provided but would be based on engineering validation practices.
Data Provenance: Not applicable in the context of clinical data. The validation activities are likely conducted in laboratory settings or by independent testing facilities according to regulatory standards. No country of origin for clinical data is mentioned as it's not a clinical study. All studies appear to be prospective in nature, as they involve actively conducting tests on the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable to the type of studies described. "Ground truth" in this context refers to established engineering and regulatory standards (e.g., AAMI, ISO, IEC) and the expertise of professionals in validation engineering, microbiology, electrical engineering, and software testing. The document states that cleaning/disinfection validation was conducted by an "independent laboratory."

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases. The studies described are technical validations against established standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The BrainPort V100 is an "oral electronic vision aid" that provides electro-tactile stimulation to aid profoundly blind patients in orientation, mobility, and object recognition. It's not an AI-assisted diagnostic imaging device that requires human "readers" in the conventional sense. The product does include "vRemote software program" to assist in training by allowing a sighted individual to remotely view camera and IOD images, but this is for training support, not for AI-assisted diagnostic interpretation.

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

Not applicable as described. The BrainPort V100 is a device for sensory substitution, not a standalone diagnostic algorithm. The "algorithm" (processing of visual input to electro-tactile patterns) is an integral part of the device's function, inherently designed for human interaction (the user's tongue). The software validation ensures the internal algorithms perform as intended.

7. The Type of Ground Truth Used

The "ground truth" for the validation studies was primarily established regulatory standards and engineering specifications.
- For Cleaning/Disinfection: Microbiological standards for reduction of pathogens, chemical compatibility, and maintenance of device functionality.
- For Electrical Safety: Compliance with specified voltage, current, and electromagnetic interference limits.
- For Software: Verification against software requirements and design specifications.
- For Biocompatibility: Standards for material safety in contact with biological tissues.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven diagnostic device that typically involves a "training set" of data. The device itself is the product undergoing technical validation.

9. How the Ground Truth for the Training Set was Established

Not applicable as there is no "training set" in the context of this device and its regulatory submission.

Summary

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

December 24, 2015

Wicab. Inc. c/o Steven B. Datlof, M.D., J.D. Partner Hogan Lovells US LLP 1835 Market Street, 2911 Floor Philadelphia, PA 19103

Re: K152851

Trade/Device Name: BrainPort V100 Regulation Number: 21 CFR 886.5905 Regulation Name: Oral electronic vision aid Regulatory Class: Class II Product Code: PIC Dated: September 29, 2015 Received: September 29, 2015

Dear Dr. Datlof:

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.

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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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Deborah L. Falls -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number : K152851

Device Name

BrainPort V100

Indications for Use (Describe)

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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510(k) SUMMARY (K152851)

Wicab Inc.'s BrainPort V100

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Wicab. Inc. 8313 Greenway Blvd. Suite 100 Middleton, WI 53562 Phone: 608-829-4500 Facsimile: 608-829-4501 Contact Person: Robert Beckman, President and CEO

Date Prepared: December 21, 2015

Name of Device and Name/Address of Sponsor

BrainPort V100 Wicab, Inc. 8313 Greenway Blvd., Suite 100 Middleton, WI 53562

Common or Usual Name/Classification

Oral Electronic Vision Aid

21 CFR 886.5905, product code PIC, class II

Predicate/Reference Devices

Predicate Device: Wicab, Inc. BrainPort V100 (DEN130039)

Intended Use / Indications for Use

The BrainPort V 100 is an oral electronic vision aid that provides electro-tactile stimulation to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as the white cane or a guide dog.

Technological Characteristics

The BrainPort V100 has the same intended use and indications for use as previously granted for the BrainPort V100 (DEN130039). In addition, the device has very similar technological characteristics and operating principles as the predicate. The BrainPort V100 design and components are the same as the previously granted BrainPort V100; the device continues to consist of the headset, controller (handset), intra-oral device (IOD), and battery charger. The

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camera unit in the headset captures the viewed scene as a digital image and forwards that image to the controller for processing. The IOD presents stimulation patterns representative of the camera image to the user's tongue. Same as in DEN130039, the BrainPort V100 is a fully wearable, battery operated device with no physical connections to external equipment during normal operation. The device includes a means for a sighted individual (e.g., instructor) to remotely view the camera and IOD images to assist in training through its vRemote software program.

Similarities and differences from the predicate device are described below:

Modified IOD may be used by multiple users in the training period:

Similarities: No change in the IOD component. No change in how the user uses the device during and after the training period. Testing verified that there is no change in the electrode function of the modified device.

Differences: Validated cleaning and disinfection procedures, described below. If multiple users use the IOD during the training period, the BrainPort V100 device must be returned to Wicab for high level disinfection between users according to instructions provided in the device manual.

Minor software change:

Similarities: No change in how the device is used. The modified device functions in the same manner as the predicate device. Verification testing ensured that the updated software performs as intended.

Differences: Minor update changes the location of the audio .wav files. No other hardware or software changes were made.

Therefore, the technological characteristics of the device remain very similar to the device previously de novo granted in DEN130039.

Performance Data

Cleaning/Disinfection Validation: Cleaning and disinfection validation testing for the IOD component of the BrainPort V100 was conducted by an independent laboratory in accordance with guidelines outlined in AAMI TIR12:2010, AAMI TIR30:2011, ISO 17664:2004, ANSVAAMI ST81:2004(R)2010, and ANSI/AAMI ST58:2013. All results were passing, validating the cleaning and disinfection procedures. Results from performance testing also verified that the cleaning and disinfection procedures do not reduce electrode functionality.

Electrical Safety and Electromagnetic Electrical Safety/Electromagnetic Compatibility: Compatibility testing were conducted in accordance with the applicable standards IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11. Results were passing. There have been no changes in electronic hardware/technology compared to the predicate device.

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Biocompatibility: The biocompatibility of the BrainPort V100 was established, and further supports the low risk of the BrainPort V100. There have been no changes to the device materials compared to the predicate.

Software: Software verification and validation testing was conducted, and results demonstrated that the software was appropriate for release.

Substantial Equivalence

The BrainPort V100 and the predicate device have the same intended use and indications for use. The BrainPort V100 system presents very similar technological characteristics and principles of operation as its predicate device. The minor difference in the software does not present any new types of safety or effectiveness questions since the BrainPort V100 performance and energy outputs remain the same. In addition, the cleaning and disinfection test reports validate the procedures for multiple patient use. Thus, the BrainPort V100 is substantially equivalent to its predicate (DEN130039).

Conclusions

The BrainPort V100 is substantially equivalent to its predicate device. Results from the cleaning and disinfection tests support multiple patient use of the BrainPort V100 during the training period. Furthermore, results from prior testing also demonstrate that the BrainPort V100 functions as intended. Therefore, Wicab believes the provided information is sufficient to demonstrate the substantial equivalence of the BrainPort V100 to its predicate device in support of clearance.

Regulation Number and Section

§ 886.5905 Oral electronic vision aid.

(a)
Identification. An oral electronic vision aid is a battery-powered prescription device that contains an electrode stimulation array to generate electrotactile stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as a white cane or a guide dog.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate an acceptable adverse event profile, including adverse events involving the mouth, tongue, and gums and demonstrate the effect of the stimulation to provide clinically meaningful outcomes. The clinical performance testing must also investigate the anticipated conditions of use, including potential use error, intended environment of use, and duration of use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including simulated moisture ingress, device durability, and battery reliability.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Analysis/testing must validate electromagnetic compatibility.
(5) Analysis/testing must validate electrical safety.
(6) Analysis/testing must assess and validate wireless coexistence concerns.
(7) Any elements of the device that contact the patient must be demonstrated to be biocompatible.
(8) Training must include elements to ensure that the healthcare provider and user can identify the safe environments for device use, use all safety features of the device, and operate the device in the intended environment of use.
(9) Labeling for the trainer and user must include a summary of the clinical testing including adverse events encountered under use conditions, summary of study outcomes and endpoints, and information pertinent to use of the device including the conditions under which the device was studied (
e.g., level of supervision or assistance, and environment of use).