The Noddle™ is indicated for use by patients who have physical limitations, weaknesses and/or limited communication abilities in order to assist them with summoning and communicating with their caregiver by controlling other devices such as the nurse call and speech generation devices. To use the noddle™ patients should be sufficiently cognitively intact so that they can produce intentional gestures and intend to communicate with caregivers.

Device Description

The Voxello noddle™ is a patient assistive communication device that accepts signals from a sensor to determine when a disabled patient is attempting to intentionally gesture for control of a device or system. The Voxello noddle™ interprets the signals from the sensor to allow the user to control up to three output switches. These outputs may be connected via hardwire or Bluetooth connection to control or access devices such as nurse call stations, and/or speech generation devices.

AI/ML Overview

Based on the provided text, the Noddle™ device is a powered communication system intended to assist patients with physical limitations in communicating with caregivers by controlling other devices (e.g., nurse call, speech generation devices). The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics.

Therefore, much of the requested information regarding acceptance criteria, specific study design (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance), and detailed ground truth establishment is not available in this document. The document describes a comparison to a predicate device rather than a de novo clinical performance study against defined acceptance criteria.

However, I can extract and infer some information:

Table of acceptance criteria and reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. Instead, it relies on demonstrating compliance with safety standards and substantial equivalence to a predicate device.

Acceptance Criteria	Reported Device Performance
Compatibility with predicate device characteristics	"The Voxello noddle™is substantially equivalent to the commercially available Comfort Keyboard. These devices assist the patient in communicating and have similar characteristics."
Meeting relevant safety standards	The Voxello noddle™ complies with all relevant EN/IEC 60601-1 Safety Standards, Particular and Collateral Standards, including:- AAMI ES60601-1 BEI Issued: 2006/03/09 (R2012) Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; Amd. C1: 2009, Amd. 2:2010- CSA C22.2#60601-1 DEI Issued: 2014/03/01 Ed: 3 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance- IEC 60601-1:2005 Ed.3+A1;C1:2014 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance- IEC 60601-1-2 Issued 2007/03/02 Ed: 3.0 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance; - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests- ISO 14971 Issued: 2007/10/01 Ed:2 Medical Devices - Application of Risk Management to Medical Devices
Not introducing new safety hazards and effectiveness	"The Voxello noddle does not introduce any new indications for use, nor does the use of the systems result in any new potential hazard. Voxello believes the noddle to be substantially equivalent with the predicate device with respect to safety and effectiveness."

Sample size for the test set and data provenance:
Not explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence through engineering and design comparisons, and compliance with safety standards, rather than a clinical performance study using a test set of patient data.
Number of experts used to establish the ground truth for the test set and their qualifications:
Not applicable (N/A) as no clinical "test set" and associated ground truth determination by experts are described in this 510(k) summary.
Adjudication method for the test set:
N/A.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
N/A. This 510(k) summary does not describe a clinical comparative effectiveness study, especially one involving human readers and AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) study was done:
N/A. This device is a powered communication system that accepts signals from a sensor to allow a user to control other devices. Its evaluation appears to be technical and safety-focused, rather than algorithm performance in a standalone AI context.
The type of ground truth used:
The "ground truth" implicitly used for this type of submission is:
- Predicate device characteristics and performance: The Comfort Keyboard (K930044) serves as the benchmark for functionality and safety.
- Safety and performance standards: Compliance with international and national medical electrical equipment and risk management standards (e.g., IEC 60601-1 series, ISO 14971).
- Engineering and design documentation: Verification and validation activities demonstrating that the device design meets its specifications and doesn't introduce new risks.
  No clinical 'ground truth' based on expert consensus, pathology, or outcomes data from a patient cohort is mentioned for a new study.
The sample size for the training set:
N/A. The document does not describe a machine learning algorithm that requires a training set. The device interprets signals from a sensor based on its design, not a learned model from a training dataset.
How the ground truth for the training set was established:
N/A, as no training set for a machine learning component is described.

Summary

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

January 18, 2017

Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. R. Rives Bird CEO 2500 Crosspark Road Ste W150 Coralville, Iowa 52241

Re: K162817

Trade/Device Name: Noddle™ Regulation Number: 21 CFR 890.3710 Regulation Name: Powered Communication System Regulatory Class: Class II Product Code: ILO Dated: October 3, 2016 Received: October 6, 2016

Dear R. Rives Bird:

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

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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 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/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.

Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162817

Device Name Noddle™

Indications for Use (Describe)

The Noddle™ is indicated for use by patients who have physical limitations, weaknesses, and/or limited communication abilities in order to assist them with summoning and communicating with their caregiver by controlling other devices such as the nurse call and speech generation devices. To use the Noddle™ patients should be sufficiently intact so that they can produce intentional gestures and intend to communicate with caregivers.

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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Voxello

510(k) SUMMARY

Company Name:	Voxello
Address:	2500 Crosspark RoadCoralville, IA 52241
Telephone No:	319-214-3023
Registration No.:	N/A
Contact person:	R. Rives Bird
Date Prepared:	29 November 2016
Device (trade) name:	Noddle™
Common/usual name:	Powered communication device
Classification Name:	System, communication, powered
Classification Panel:	Physical Medicine
CFR Section:	890.3710
Device Class:	Class II
Device Code:	ILQ

Predicate device:

Substantially equivalent to Comfort Keyboard (K930044)

Device description:

Intended use:

The noddle™ is intended to be used by patients who cannot either access a standard nurse call and/or communicate traditionally. The noddle™ is used for alternate access to a nurse call and/or access to assistive and augmentative communication devices (speech generation devices) to communicate with caregivers.

Indications for use:

The noddle™ is indicated for use by patients who have physical limitations, weaknesses and/or limited communication abilities in order to assist them with summoning and communicating with their caregiver by controlling other devices such as the nurse call and speech generation devices. To use the noddle™ patients should be sufficiently cognitively intact so that they can produce intentional gestures and intend to communicate with caregivers.

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Voxello

Comparison with Predicate Device:

It is the opinion of Voxello, that the noddle™ is similar to the Comfort Keyboard, Both . devices are used to increase access to control another, or multiple devices.

Substantial Equivalence:

The Voxello noddle™is substantially equivalent to the commercially available Comfort Keyboard. These devices assist the patient in communicating and have similar characteristics.

Safety information:

The Voxello noddle™ complies with all relevant EN/IEC 60601-1 Safety Standards, . Particular and Collateral Standards, including the following:
AAMI ES60601-1 *BEI Issued: 2006/03/09 (R2012) Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance; Amd. C1: 2009, Amd. 2:2010

CSA C22.2#60601-1 *DEI Issued: 2014/03/01 Ed: 3 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance

IEC 60601-1:2005 Ed.3+A1;C1:2014 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance

IEC 60601-1-2 Issued 2007/03/02 Ed: 3.0 Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance; - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

ISO 14971 Issued: 2007/10/01 Ed:2 Medical Devices - Application of Risk Management to Medical Devices

Conclusion:

The Voxello noddle™ does not introduce any new indications for use, nor does the use of the systems result in any new potential hazard. Voxello believes the noddle™ to be substantially equivalent with the predicate device with respect to safety and effectiveness.

Regulation Number and Section

§ 890.3710 Powered communication system.

(a)
Identification. A powered communication system is an AC- or battery-powered device intended for medical purposes that is used to transmit or receive information. It is used by persons unable to use normal communication methods because of physical impairment. Examples of powered communication systems include the following: a specialized typewriter, a reading machine, and a video picture and word screen.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.