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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.

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.

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.

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."

• 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.

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