To be used with adults, 18 years of age or older, with speech/voice impairments that result in inadequate vocal loudness or control of loudness due to other neurological disorders or injury including stroke, traumatic brain injury, multiple sclerosis, ataxia, vocal fold paralysis or other causes.

To be used for voice/speech impaired adults, 18 years of age and older, who are able to follow the directions of a Speech-Language pathologist.

This device is sold only to licensed practitioners who have also completed a 2 day certification workshop on the LSVT (Lee Silverman Voice Treatment) behavioral therapy protocol. This certifies them to provide LSVT for patients with Parkinson's disease and other communicative impairments. The following specific labeling, therefore, is provided on the product: Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.

The LSVT Companion is designed as a technical aid for this behavioral intervention to increase communicative effectiveness. A "home study" function allows patients to complete voice exercises either under direct supervision by the practitioner in the clinic environment or at home, with feedback of performance provided to the clinician by results reporting via e-mail.

Device Description

The sound produced by an individual's voice is received by a calibrated microphone and converted to a visual display which consists of different visual and auditory feedback. The individual is given a target range of both vocal intensity (loudness) and fundamental frequency (pitch) and instructed to maintain a given loudness and or pitch for a given duration. Increases in the complexity of the spoken material are combined with these targeted vocal parameters. In this way, individuals are trained to increase both vocal loudness and variations in pitch through a series of exercises. This approach is designed for speech and hearing impaired adults, over the age of 18, who are unable to speak at a consistent and audible level of loudness such as those with Parkinson's disease and other causes.

The device consists of software that allows clinicians to manage speech therapy for clients as well as allow clients to perform speech "homework" on their home PC The Graphical User Interface (GUI) contains two modes of operation - client and clinician. In each mode, the speech therapy tasks are presented to the user and feedback is continually being given. The device collects data on the variables trained (vocal sound pressure level, fundamental frequency, and duration of phonation) and directs individuals through a series of speech exercises, while providing online feedback.

These data are recorded to a file that can be downloaded and analyzed by the clinician. Targets for vocal loudness, F0 and duration can be individualized and revised as often as needed. The interface was developed to be simple to use, while carefully considering the specific visual, motor, cognitive and voice/speech needs of individuals with Parkinson's disease and other communicative impairments. The backgrounds were designed in bright contrasting colors which have common meaning (e.g., green means "go") to make the targeted goals easier to identify. In addition, the visual displays utilize concrete, familiar objects (e.g., thermometer, piano, clock) which are designed to be intuitive and require little interpretation. Due to the fact that the device is intended to be used without a face to face clinician, feedback emulates what would be received from a clinician in a therapy session. Thus, in addition to the written comments shown on the screen, a wide variety of auditory feedback phrases, such as "Good job!", "Let's get louder," "Great!", "Can you go any higher?", and short instructions at the beginning of each exercise have been incorporated.

The Sound Server works with the GUI in that it sends it data from the microphone at regular intervals so that graphs can be created, feedback can be given to the user, and results for the speech tasks can be written.

AI/ML Overview

Here's an analysis of the provided text regarding the LSVT Companion device's acceptance criteria and the supporting study:

LSVT Companion Device: Acceptance Criteria and Supporting Study

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K091682) outlines the acceptance criteria by claiming substantial equivalence to a predicate device (RSQ, LLC Visivox, Model V-2). The acceptance criteria are implicitly defined by establishing that the new device has "similar technological characteristics" and achieves "therapeutic gains similar to those following classically/traditionally administered speech therapy" with "no adverse effects."

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (LSVT Companion)
Intended Use: - Assistive device and training aid complementing person-to-person speech therapy. - Improve vocal loudness for those with speech/hearing impairments. - Address impairments due to various neurological conditions (e.g., Parkinson's, stroke). - For patients able to follow directions of a speech therapist/audiologist.	Intended Use: - Technical aid complementing person-to-person speech therapy to improve vocal loudness in Parkinson's disease. - For adults (18+) with speech/voice impairments causing inadequate vocal loudness or control due to neurological disorders (stroke, TBI, MS, ataxia, vocal fold paralysis, etc.). - For adults (18+) able to follow Speech-Language Pathologist directions.
Target Population: Persons of any age (Predicate)	Target Population: Adults, 18 years of age and older (LSVT Companion)
Technological Characteristics: - Microphone converts acoustic signals to visual feedback (LEDs). - Goal: maintain vocal loudness at appropriate levels. (Predicate)	Technological Characteristics: - Calibrated microphone with PC-based software. - Visual and auditory feedback through series of speech tasks. - Hardware replaced by computer, GUI, and software. - Enables targeted vocal ranges for loudness and fundamental frequency.
Performance Data: - Two speech language pathologists reported utility of visual feedback for improving vocal loudness. (Predicate)	Performance Data: - Preliminary clinical investigation explored efficacy and user satisfaction. - Therapeutic gains similar to traditional therapy. - Significant gains from pre to post and pre to follow-up. - No adverse effects. - High user enthusiasm.

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

Sample Size: 16 individuals with Parkinson's Disease (PD).
Data Provenance: The study was a "preliminary clinical investigation" indicating it was prospective. The location or country of origin for the data is not explicitly stated but given the submitter's address in Tucson, AZ, and the typical regulatory context, it's highly likely to be US-based.

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

The document does not explicitly state that experts were used to establish a "ground truth" for the test set in the traditional sense (e.g., expert consensus diagnosing a condition). Instead, the study assessed "therapeutic gains," which implies a measurement of vocal parameters typically conducted by or under the supervision of a Speech-Language Pathologist. The "Anecdotal reports of the speech language pathologists participating in the study" suggest the involvement of multiple SLPs, but their specific number beyond "two practicing speech language pathologists" (mentioned for the predicate device's assessment) and their qualifications are not detailed for the LSVT Companion's study. The product is stated to be sold to "licensed practitioners who have also completed a 2 day certification workshop on the LSVT (Lee Silverman Voice Treatment) behavioral therapy protocol," implying these are the expected qualifications of clinicians using and potentially assessing the device.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the results of the preliminary clinical investigation. The "therapeutic gains" were measured, and "anecdotal reports" from participating SLPs were noted, suggesting a less formal consensus mechanism, if any at all for individual patient outcomes.

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 reported. This device is not an AI diagnostic tool and the study described does not fit the MRMC paradigm. The assessment was on the device's ability to facilitate therapeutic gains, not on human reader performance with or without AI assistance.

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

The device is explicitly described as a "technical aid complementing person speech therapy" and for use "with adults...who are able to follow the directions of a Speech-Language Pathologist." It also states "The device consists of software that allows clinicians to manage speech therapy for clients as well as allow clients to perform speech 'homework' on their home PC." This indicates a strong human-in-the-loop component. The preliminary clinical investigation explored device efficacy and user satisfaction but does not present data on an isolated algorithm's performance without human interaction or guidance. Therefore, a standalone performance study in the typical "algorithm only" sense was not reported.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the measurements of "therapeutic gains," specifically relating to vocal loudness and potentially fundamental frequency. This would be objective physiological measurements (sound pressure level, fundamental frequency, duration of phonation) combined with clinical assessment/outcomes data (improvement in speech/voice, user satisfaction). These measurements would typically be taken by or under the direct supervision of qualified Speech-Language Pathologists.

8. The Sample Size for the Training Set

The document does not provide any information about a training set for the LSVT Companion device. This device is described as software that provides feedback and collects data based on pre-defined therapeutic goals (vocal intensity and fundamental frequency), rather than a machine learning model that would require a dedicated training set.

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

Since no training set is mentioned or implied for a machine learning model, this point is not applicable. The device's functionality is based on established principles of speech therapy and biofeedback, not on a data-driven training process for an algorithm. The "ground truth" for its operation would be the established therapeutic targets for vocal parameters.

Summary

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K091682

21 CFR 807.92 (a) 1

AUG 20 2009

Submitter:

Submitter's Address:

LSVT Global LLC

6890 E. Sunrise Suite 120, #241 Tucson, AZ 85750

Submitter's Telephone Number:

Submitter's Fax Number:

Contact Person:

Date of Preparation of Summary:

1.888.438.5788

1.520.615.8559

David H. McFarland

December 18, 2008

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21 CFR 807.92 (a) 2

The Trade name of the device is LSVT Companion; the name LSVT is registered

trademark by the U.S. Office of Patents.

The Device Classification Name is AIDS, SPEECH TRAINING FOR THE

HEARING IMPAIRED as shown in 510 (k) number K982396 for the VISIVOX for which we claim equivalence.

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21 CFR 807.92 (a) 3

IDENTIFICATION OF THE LEGALLY MARKETED DEVICE TO WHICH LSVT . GLOBAL LLC IS CLAIMING EQUIVALENCE

The legally marketed device to which LSVT Global, LLC is claiming equivalence

is the

RSQ, LLC Visivox, Model V-2

which was approved for marketing on September 14, 1998 under 510(k) K982396

RSQ, LLC is the assignee of the following patent:

Patent number: 5774558 Filing date: Oct 24, 1996 Issue date: Jun 30, 1998 Inventor: Doris Drucker Assignees: RSQ, LLC

U.S. Classification 381/56; 340/573; 381/58

International Classification H04R 2900

Device Classification Name: AIDS, SPEECH TRAINING FOR THE HEARING IMPAIRED (AC POWERED AND PATIENT CONTACT)

Applicant: LSVT Global, LLC

Product Code: LEZ

Classification Advisory Committee: EAR, NOSE & THROAT

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21 CFR 807.92 (a) 4

DESCRIPTION OF THE DEVICE

These data are recorded to a file that can be downloaded and analyzed by the clinician. Targets for vocal loudness, F0 and duration can be individualized and revised

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as often as needed. The interface was developed to be simple to use, while carefully considering the specific visual, motor, cognitive and voice/speech needs of individuals with Parkinson's disease and other communicative impairments. The backgrounds were designed in bright contrasting colors which have common meaning (e.g., green means "go") to make the targeted goals easier to identify. In addition, the visual displays utilize concrete, familiar objects (e.g., thermometer, piano, clock) which are designed to be intuitive and require little interpretation. Due to the fact that the device is intended to be used without a face to face clinician, feedback emulates what would be received from a clinician in a therapy session. Thus, in addition to the written comments shown on the screen, a wide variety of auditory feedback phrases, such as "Good job!", "Let's get louder," "Great!", "Can you go any higher?", and short instructions at the beginning of each exercise have been incorporated.

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SUMMARY OF THE NEW DEVICE COMPARED TO THE PREDICATE

DEVICE

Intended Use [21 CFR 807.92 (a) 5]

The intended use of the predicate device is as follows: "To be used as an assistive device and training aid, complementing person-to-person speech therapy:

1. For the deaf, and for people with hearing impairments who do not perceive the loudness of their speech.
1. For people with speech impairments who are unable to speak at a consistent and audible level of loudness. The impairments may be due to stroke, Parkinson's, traumatic head or spine injuries, cleft palate, laryngectomies or other causes.
1. For speech-and/or hearing impaired people of any age who are able to follow the directions of a speech therapist or audiologist"

The intended use of the new device the LSVT Companion is as follows:

To be used as a technical aid complementing person speech therapy to improve the vocal loudness of persons with Parkinson's disease.

To be used with adults, 18 years of age and older, with speech/voice impairments that result in inadequate vocal loudness or control of loudness due to other neurological disorders or injury including stroke, traumatic brain injury, multiple sclerosis, ataxia, vocal fold paralysis or other causes.

To be used for voice/speech impaired adults, 18 years of age or older, who are able to follow the directions of a Speech-Language Pathologist.

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The following specific labeling, therefore, is provided on the product:

Caution: Federal Law restricts this device to sale by or on the order of a licensed practitioner.

Technological Characteristics [21 CFR 807.92 (a) 6]

The New Device has similar technological characteristics as the predicate with the modernization that the device uses hardware and software as opposed to just hardware in the predicate device to transduce and provide feedback for vocal loudness.

In the new device, a calibrated microphone is used with a PC based software program to receive a speaker's acoustic signals. Targeted visual and auditory feedback is provided through a series of speech tasks. In the legally marketed device a microphone is attached to a hardware device imbedded in a box. Acoustic signals are converted to LED displays is logarithmic 3 db steps that vary with the individual's vocal loudness. The overall goal is to enable individual's to maintain vocal loudness at appropriate levels through this targeted visual feedback. This is extremely similar to the new device which adds auditory feedback to visual feedback and enables targeted vocal ranges to be established to improve both vocal loudness and fundamental frequency. The hardware device in the legally marketed device is substituted by a graphical user interface and other software components as described above. These differences are not critical to the intended therapeutic use of the device.

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807.92 (b) (1, 2, 3)

ASSESSMENT OF NON-CLINICAL AND CLINICAL PERFORMANCE DATA

The only assessment known to the applicant that refers to the predicate legally marketed device is that provided in their previous 510(k) summary document and refers to the opinions of two practicing speech language pathologists of the utility of using the visual feedback instrument to improve vocal loudness in speech disordered and other individuals.

The new device in PDA form was the subject of a preliminary clinical investigation designed to explore device efficacy and user satisfaction. Sixteen individuals with PD were able to independently use the new device and showed therapeutic gains similar to those following classically/traditionally administered speech therapy. These gains were significant from pre to post and pre to follow-up and absolutely no adverse effects of using the assistive technology to improve vocal loudness. Individuals were highly enthusiastic about the use of the assistive technology. References to published abstracts referring to the new device are provided below. Anecdotal reports of the speech language pathologists participating in the study reveal that they were highly encouraged by the results and thus reported similar satisfaction as those referenced in the predicate device. We suggest, therefore, that performance data are highly similar between the New Device and the predicate.

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References

Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., & Will, L. (2005). Technology supported speech treatment for Parkinson's disease. Movement Disorders. 20(10), p. S134.

Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., Bennett, J. LSVTC- A PDA Supported Speech Treatment for Parkinson's Disease. Presented at the Coleman Institute for Cognitive Disabilities, "Research Frontiers & Partnerships in Cognitive Disability and Technology" Conference, October 9-10, 2003, Aurora, Colorado.

Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., Bennett, J. LSVTC- A PDA Supported Speech Treatment for Parkinson's Disease. Presented at the Twelth Biennial Conference on Motor Speech, March 18-21, 2004, Albuquerque, New Mexico.

Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., Bennett, J., Will, L. LSVTC- A PDA Supported Speech Treatment for Parkinson's Disease, Presented at the International Association of Logopedics and Phoniatrics, Brisbane, Australia, 2004.

Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., Cole, R., Yan, J., Will, L. Technology Supported Speech Treatment for Parkinson's Disease. Poster presented at the 9th International Congress of Parkinson disease and Movement disorders, March 5-8, 2005, New Orleans, Louisiana.

Halpern, A., Matos, C., Ramig, L., Petska, J., Spielman, J., Will, L. LSVTC- A PDA Supported Speech Treatment for Parkinson's Disease. Presented at the Annual Conference of the American Speech-Language Hearing Association, Philadelphia, Pennsylvania, 2004.

Halpern, A., Matos, C., Ramig, L., Spielman, J., Bennett, J. PDA-Enhanced Speech Treatment for Parkinson's Disease, Presented at the Fifth Annual Meeting of the American Society for Experimental NeuroTherapeutics, Washington DC, March 13-15, 2003.

Halpern, A., Matos, C., Ramig, L., Spielman, J., Bennett, J. PDA-Enhanced Speech Treatment for Parkinson's Disease. Presented at the Eleventh Biennial Conference on Motor Speech, March 14-17, 2002, Williamsburg, Virginia.

Matos, C., Halpern, A., Ramig, L., Spielman, J., Bennett, J. Updates to PDA-Enhanced Speech Treatment for Parkinson's Disease. Presented at the Coleman Institute for Cognitive Disabilities, "Research Frontiers & Partnerships in Cognitive Disability and Technology" Conference, September 26-27, 2002, Boulder, Colorado.

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Substantial Equivalence Table (see also Substantial Equivalence Flow Chart as Attachment II)

Characteristic	Predicate	LSVT C or LSVT Companion
Intended Use:	"To be used as an assistive device and training aid, complementing person-to-person speech therapy:1. For the deaf, and for people with hearing impairments who do not perceive the loudness of their speech.2. For people with speech impairments who are unable to speak at a consistent and audible level of loudness. The impairments may be due to stroke, Parkinson's, traumatic head or spine injuries, cleft palate, laryngectomies or other causes.3. for speech-and/or hearing impaired people of any age who are able to follow the directions of a speech therapist or audiologist"	The LSVT Companion Device is designed:To be used as a technical aid complementing person-to-person speech therapy to improve the vocal loudness of persons with Parkinson's disease.To be used with adults, 18 years of age and older, with speech/voice impairments that result in inadequate vocal loudness or control of loudness due to other neurological disorders or injury including stroke, traumatic brain injury, multiple sclerosis, ataxia, vocal fold paralysis or other causes.To be used for voice/speech impaired adults, 18 years of age or older, who are able to follow the directions of a Speech-Language Pathologist.
Target Population	Persons of any age	Adults, 18 years of age and older
Physical Characteristics:	A microphone is attached to a hardware device imbedded in a box. Acoustic signals are converted to LED displays in logarithmic 3 db steps that vary with the	A calibrated microphone is used with a PC based software program to receive a speaker's acoustic signals. Targeted visual and auditory feedback is provided through a series of
	individual's vocal loudness.The overall goal is to enableindividual's to maintainvocal loudness atappropriate levels throughthis targeted visualfeedback.	speech tasks. The hardwaredevice in the legallymarketed device issubstituted by a computer, agraphical user interface andother software components.
Where Used	Inside and outside of aclinical setting	Inside and outside of aclinical setting
Performance Data:	Two practicing speechlanguage pathologists reportthe utility of using thevisual feedback instrumentto improve vocal loudnessin speech disordered andother individuals.	The LSVT Companion inPDA form was the subjectof a preliminaryinvestigation to exploredevice efficacy and usersatisfaction. Sixteenindividuals with PD wereable to independently usethe LSVT Companion andshowed therapeutic gainssimilar to those followingclassically/traditionallyadministered LSVTtherapy. These gains weresignificant from pre to postand pre to follow-up andthere were absolutely noadverse effects of using theassistive technology toimprove vocal loudness.Individuals were highlyenthusiastic about the use ofthe assistive technology.

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and the state of the state of the states and the states of the states and

and the control control of the control of the control of

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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Image /page/11/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, creating a sense of protection and care. The logo is rendered in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

LSVT Global, LLC c/o David H. McFarland 6890 E. Sunrise Drive Suite 120, #241 Tucson, AZ 85750

AUG 2009

Re: K091682

Trade/Device Name: LSVT C or LSVT COMPANION, MODE Regulation Number: Unclassified Regulation Name: Regulatory Class: Unclassified Product Code: LEZ Dated: 5/26/2009 Received: 6/10/2009

Dear Mr. McFarland:

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.

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

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

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Indications for Use

510(k) Number (if known): _

Device Name: LSVT C or LSVT Companion

Indications for Use

The LSVT Companion Device is designed:

To be used as a technical aid complementing person speech therapy to improve the vocal loudness of persons with Parkinson's disease.

K091682

To be used for voice/speech impaired adults, 18 years of age and older, who are able to follow the directions of a Speech-Language Pathologist.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

Sir Nanofon

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K091682

Regulation Number and Section

N/A