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To be used as an assistive device and training aid, complementing personto- 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,Parkinsons', 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 sound volume produced by an individual's voice is received by a microphone and converted into a visual display which consists of a series of multicolored light-emitting diodes arrayed on a light-bar. The number and color of the lights which are sequentially actuated represent changes in the sound volume. Each of the sixteen lights represents a logarithmic 3dB per step variation in the volume of the acoustic signals.

The device consists of a metal box, dimensioned 11.75"x 8.25" x 2.75" which weighs 9.5 lb. A hinged lid allows access to the interior. A 12V lead-acid battery and the electronics required for operation of the device are affixed to the interior of the box. A transformer/recharger, a first cable having an external microphone at one end, and a second cable having a light-bar comprising a plurality of light-emitting diodes at one end, are stored, unanchored, inside the box. The front panel of the box includes an off/on switch, a volume adjustment knob, a battery recharger connector, a light-bar connector, an internal microphone, an external microphone connector, and a battery status indicator light.

Power is supplied by the 12V battery and/or, via the battery recharger, by 120V AC current.

To operate the device, the free end of the cable having the light bar at its other end, is plugged into the designated connector at the outside of the box; the speaker is positioned so as to face the built-in microphone, and the light bar is placed within his or her line of vision. The volume is adjusted so that no light signals are displayed. Upon receiving acoustic signals from a speaker one or more lights will appear- and disappear - depending on the sound volume produced by a speaker. If it is inconvenient for a speaker to face the built-in microphone, (for instance, if he or she is bedridden or in a wheelchair) the cable with the external microphone at its free end may be plugged in. The external microphone may then be handheld or deposited in a clasp provided on the light bar, so that it faces the speaker. Substitution of the external microphone shuts off the built in microphone to prevent interference.

The provided text is a 510(k) summary for the VISIVOX device, a voice level monitor intended as a speech training aid. It states that the device provides visual feedback of a patient's voice volume. However, the document does not contain acceptance criteria or a study proving the device meets said criteria in the way typically expected for a medical device with measurable performance metrics (e.g., sensitivity, specificity, accuracy).

Instead, the submission for the VISIVOX device relies on a claim of substantial equivalence to a predicate device, the RION ELECTRO-PALATOGRAPH. The justification for this equivalence is based on the general concept of providing "visual feedback" for speech training, rather than a detailed performance study comparing the two devices against specific, measurable criteria.

Here's a breakdown of the requested information based on the provided text, highlighting where information is absent:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not applicable, no specific test set or clinical study to establish performance metrics was conducted.
• Data provenance: The "assessments" mentioned are anecdotal statements from two speech therapists in the USA (Long Beach, CA and Pomona, CA). These are not structured data from a formal study.
• Retrospective or Prospective: These assessments appear to be informal observations rather than data collected in a scientific study format.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of experts: Not applicable. No ground truth was established by experts for a performance test set. The "assessments" are provided by two speech therapists, Tracy Lloyd (Long Beach Memorial Medical Center) and Jill Wilkerson (director of Speech & Hearing, Casa Colina Centers for Rehabilitation). Specific years of experience are not mentioned.

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

• Adjudication method: Not applicable, as no formal test set with ground truth requiring adjudication was used.

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

• MRMC study: No. The device is a "Voice Level Monitor" providing visual feedback for speech training, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study and
  effect size for human readers are not relevant in this context and not mentioned.

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

• Standalone performance: The document implicitly describes the standalone function of the device: it measures voice volume and displays it. However, no quantitative standalone performance metrics (e.g., accuracy of measurement, latency tests, etc.) are provided in the way a scientific study would. The statement "The display is emitted within a fraction from the time it is received and continuously holds until the new information arrives" is a qualitative description of its performance.

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

• Ground truth: No formal ground truth was used for performance evaluation that would align with typical clinical studies (e.g., pathology, expert consensus on a diagnosis). The "assessments" are subjective statements about the device's utility in therapy. The claim of equivalence is based on the general concept of "visual feedback" for speech training, not on a detailed comparative performance study against a definitive ground truth.

8. The sample size for the training set

• Sample size for training set: Not applicable. This device is a hardware voice level monitor, not a machine learning or AI algorithm that requires a training set.

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

• Ground truth for training set: Not applicable, as no training set was used.

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