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The GyroStim is intended to assist in the treatment of balance disorders and vestibular dysfunction in adult patients, age 18 and older, up to 400lb. It is intended to be used by a trained medical professional as prescribed by physician in a clinical environment.

GyroStim is an AC powered computer-controlled multi-axial positional and rotational chair. The device consists of a patient chair mounted within a rotational frame assembly that is capable of rotating in the pitch and yaw axes. The rotational frames are automated with computer-controlled drive systems capable of executing preprogrammed positional and rotational motion profiles. The system provides clinicians with a safe and efficient means for administering a wide range of specific positional and rotational motions for inducing stimulation of the vestibular system.

GyroStim operational software runs on a pc-based desktop computer. The software can capture, monitor, and display the patient's subjective response to each run. The response data may be used by the clinician for clinical decision support (CDS) to assist with progress evaluation, for profile selection and rate of therapy advancement, for individualizing therapy sessions, and for monitoring and preventing overstimulation.

Patient data is collected and stored and may be accessed for graphing, analysis, and reports.

The software includes libraries of prewritten profiles. A library of pre-written positional profiles located on the RUN BPPV page contains a collection of profiles for executing commonly used canalith repositioning maneuvers. A library of pre-written motion profiles located on the RUN GyroStim page contains a collection of profiles for executing motion induced vestibular stimulation.

Specifically, the library of motion profiles contains 30 levels of motion induced vestibular stimulation intensity, ranging from Level 1 to Level 30. The lowest level of motion induced vestibular stimulation intensity is Level 1, which rotates at a rate of 1 revolution per minute (RPM) or 0.016667 Hz. The highest level of motion induced vestibular stimulation intensity is Level 30. which rotates at 30 RPM or 0.5Hz. The intensity of the 30 levels differs and increments linearly at a rate of 1 RPM or 0.01667Hz per level; i.e.. Level 1 rotates at 1 RPM or 0.01667 Hz, Level 2 rotates at 2 RPM or 0.03334 Hz, Level 3 rotates at 3 RPM or 0.05 Hz, and so on up to Level 30 which rotates at 30 RPM or 0.5 Hz. Additionally, each of the 30 Levels offer a selection of run durations at 15 seconds (s), 30s, 60s, and 180s.

When configured with the integrated patient transfer system, GyroStim provides accessibility to the large population of patients with moderate to severe mobility challenges, many of whom are limited or unable to engage in the existing standard of care for balance disorders and vestibular dysfunction.

The GyroStim assembly, operational software, and libraries of profiles provide clinicians with a safe, effective, and efficient medical device for assisting in the treatment of balance disorders and vestibular dvsfunction.

Here's a breakdown of the acceptance criteria and the study details for the GyroStim device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a preliminary clinical study and various non-clinical bench (performance) tests.

1. Clinical Study:

• Sample size used for the test set and the data provenance:
  • The document states that the study "utilized retrospective data from the two treatment groups: GyroStim group, and SOC Group." However, it does not specify the exact sample size (number of patients) used in either group.
  • The data provenance is retrospective. The country of origin of the data is not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
  • The assessments and treatments were performed by a "vestibular and balance medical specialist (DPT)."
  • The document does not mention a number of experts for establishing ground truth or their specific qualifications beyond "DPT." It implies one such specialist conducted the assessments and treatments.
• Adjudication method: Not described or applicable, as it was a retrospective comparison of treatment outcomes, not a diagnostic study requiring expert consensus on individual cases.
• 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, this was not an MRMC study. The GyroStim is a physical device for therapy, not an AI for image interpretation or diagnosis by human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • The document describes the performance of the device itself in both non-clinical and clinical contexts. The "algorithm" (software) of GyroStim is part of the device's control system, and its verification was done as a standalone test (software verification). However, the overall clinical study evaluated the device in use by a trained medical professional, so it's not a purely "algorithm-only" performance in the clinical sense.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
  • Outcomes data obtained from "pre and post intervention assessments" using "quantitative equipment and methods, including SOT, DHI, ABC, DVA, and mDGI." The "ground truth" for effectiveness was based on the improvement in these objective and subjective balance scores.
• The sample size for the training set: Not applicable. The clinical study was a comparison of treatment outcomes using an existing device (GyroStim) against standard of care. There is no mention of a machine learning model being trained on a separate dataset for clinical decision-making within the scope of this FDA summary. The "RUN GyroStim profiles" are pre-written profiles within the software, not learned models from a training set in the typical AI sense.
• How the ground truth for the training set was established: Not applicable, as there was no explicit training set described for an AI/ML model for clinical decision-making.

2. Non-Clinical Bench (Performance) Testing:

• Sample size used for the test set and the data provenance: This refers to physical units of the device (V4-GYROSTIM III-04A, V4-GYROSTIM III-04, GyroStim software). The sample size implicitly refers to the device units tested to ensure compliance with the specified standards. The data provenance is from internal engineering analysis and testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: These tests rely on established engineering standards and test methods (e.g., IEC, ANSI/AAMI). The "ground truth" is compliance with these standards, verified by qualified engineers or test facilities. The specific number or qualifications are not detailed beyond adherence to the standards.
• Adjudication method: Not applicable for bench testing. Pass/fail criteria are defined by the standards.
• MRMC study: Not applicable.
• Standalone performance: Yes, these are standalone performance tests of the device and its software components against engineering and safety standards.
• Type of ground truth: Defined engineering and safety standards (e.g., ANSI/AAMI/ES 60601-1, IEC 60601-1-2, IEC 62304, IBC 2018).
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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The Orion rotary chair is an optional accessory for VisualEyes 515 eye movement recording systems.

The VisualEyes™ system provides information to assist in the nystagmographic evaluation, diagnosis and documentation of vestibular disorders. VNG testing evaluates nystagmus using goggles mounted with cameras. These images are measured, recorded, displayed and stored in the software. This information can then be used by a trained medical professional to assist in diagnosing vestibular disorders. The target population for videonystagmography is five years of age and above.

The Orion is a rotary chair designed to assess the Vestibular Ocula Reflex (VOR).

Orion rotary chair includes these three variants

• Orion Reclining
• Orion Auto Traverse
• Orion Comprehensive .

The Orion is considered an accessory to vestibular examination system software designated VisualEyes 525 and VisualEyes 515 manufactured by Interacoustics (FDA 510(k) K200534).

The Orion is an update of the System 2000 by Micromedical ((FDA 510(k) ID K922037).

The provided text is a 510(k) summary for a medical device (Orion Rotary Chair). It does not contain details about acceptance criteria or a study proving the device meets those criteria in a quantitative sense.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (System 2000 by Micromedical). The "performance tests" mentioned are primarily comparative, asserting that the new device performs "as specified" and is "safe and effective" based on these comparisons, rather than against predefined, quantitative acceptance criteria. There are no clinical tests performed.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is a summary of what can be extracted and what cannot:

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

The document does not explicitly state quantitative acceptance criteria or a formal table comparing them against reported performance. Instead, it offers a "Comparison table" between the Orion device and its predicate (System 2000) for various descriptive and technical characteristics, aiming to show equivalence rather than adherence to specific numeric performance thresholds.

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

Not applicable. No formal test set or clinical study is described. The "performance tests" involved comparisons of the physical device features and operational parameters against the predicate device.

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)

Not applicable. No ground truth was established by experts for a test set, as no clinical study or diagnostic performance assessment involving human interpretation is described.

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

Not applicable. No test set requiring adjudication is described.

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

Not applicable. This is a rotary chair for vestibular testing, not an AI-assisted diagnostic imaging device that would typically undergo an MRMC study. No AI component is mentioned.

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

Not applicable. This is a physical medical device (rotary chair) that requires operation by a trained medical professional; it is not a standalone algorithm.

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

Not applicable. The basis for safety and effectiveness is substantial equivalence to a predicate device, demonstrated through comparative technical specifications and internal performance testing, not against a clinical ground truth.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not a machine learning model; therefore, there is no "training set."

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

Not applicable, as there is no training set.

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The TRV is intended to assist in the diagnosis and treatment of balance disorders and vertigo, including benign paroxysmal positional vertigo.

The TRV is a multi-axial chair that can rotate 360° around both the horizontal and vertical axes. With the patient secured by a four-point harness, a head mount, a leg strap, and shoulder pads, an examiner is able to rotate the patient around the plane of each of the 6 semicircular canals and hold the patient in any position for detailed examination of the semicircular canals. The TRV chair is manually handled by the healthcare professional. The axes of rotation are lockable in preset positions. The primary axis has a battery-powered electromagnetic lock controlled by a footswitch and the secondary axis is manually locked with a mechanical lever. A mechanical system with an adjustable counterweight ensures that the weight of the chair and the patient are balanced during the maneuvers.

The provided text describes the TRV device and its substantial equivalence to a predicate device, the Epley Omniax™. However, it does not contain information related to a study that establishes acceptance criteria and then proves the device meets those criteria, especially in the context of an AI-powered device or for clinical accuracy.

Instead, the document details a 510(k) submission for a physical medical device (a multi-axial chair) used in the diagnosis and treatment of balance disorders. The performance data presented focuses on electrical safety, electromagnetic compatibility, and mechanical testing, not on predictive performance, accuracy, or diagnostic effectiveness in the way an AI/software device would be evaluated.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in an AI/software context are not present in the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Not Applicable / Not Provided: The document does not describe a "test set" in the context of data for an algorithm. The "testing" refers to physical device safety and mechanical performance. There is no data provenance for a diagnostic or predictive model.

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)

• Not Applicable / Not Provided: No "ground truth" establishment for a diagnostic output is described, as this is a physical chair, not an AI diagnostic tool.

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

• Not Applicable / Not Provided: No adjudication method for a data test set is described.

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) study was not done. The device is a physical chair, not an AI assistant.

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

• No: This is not an algorithm. The device is a physical chair, and human healthcare professionals manually operate it. Its function is to assist professionals in performing maneuvers, not to make a standalone diagnosis or treatment decision without human input.

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

• Not Applicable / Not Provided: See point 3. The "ground truth" in this context pertains to compliance with safety regulations and functional equivalence to a predicate device, not diagnostic accuracy.

8. The sample size for the training set

• Not Applicable / Not Provided: No training set is described, as this is a physical device and not an AI model.

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

• Not Applicable / Not Provided: No training set or ground truth establishment for it is described.

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The ClearEdge® Balance System is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers, physical therapists, chiropractors, nurses and physicians. The ClearEdge® Balance System can be used wherever compatible Android mobile operating devices can be used.

The ClearEdge® Balance System is a mobile software system that analyzes balance through measurements of postural sway. The System is comprised of application software, and accompanying hardware consisting of a mobile computing device, proprietary sensor, balance pad, and friction pad. The test data is collected, uploaded to a HIPAA compliant server, analyzed by Motion Intelligence developed algorithms and presented in report form for clinician's review. The reports indicate how a subject's balance score may have changed between testing sessions, and whether the measured change is likely due to measurement error and normal human variation in performance of the selected balance stance or a real change in performance caused by an external factor.

Using proprietary software on an Android tablet and the Edge Sensor, the ClearEdge Balance System tests balance by administering eight select balance stances.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the ClearEdge Balance System:

This document focuses on demonstrating substantial equivalence to a predicate device (Sway™ Balance System) rather than absolute performance against pre-defined, numerical acceptance criteria for a novel device. Therefore, the "acceptance criteria" presented are implicitly derived from the comparison to the predicate and statistical demonstrations of equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for demonstrating substantial equivalence are based on demonstrating that the ClearEdge Balance System's performance is equivalent enough to the predicate device (Sway™ Balance System) to not raise new questions of safety or effectiveness. This is shown through a combination of laboratory testing and human performance testing.

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EQ Balance is intended to assess body tilt as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses and physicians. Interpretation of EQ Balance results should only be made by a healthcare professional, as part of a multifaceted assessment of balance. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. EO Balance should be used in an indoor setting free from obstructions and free from excessive noise or visual distractions. EQ Balance should be only be used as directed by your healthcare practitioner. EQ Balance may be used on mobile devices running iOS or Android operating systems.

EQ Balance is a mobile balance test to be used on mobile phone and tablet devices with iOS version 10.3 or later, or Android OS version 6 or later. EQ Balance measures balance using the accelerometer within the device.

EQ Balance utilizes an algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer. Balance is measured during a series of stances with the mobile device held to the chest by the user. Users follow the step-by-step voice guidance that runs after launching the app during the entirety of the test to ensure consistency in obtaining balance measures. EQ Balance does not function as a diagnostic test, and EQ Balance results should be interpreted by qualified individuals only.

The provided text details the 510(k) summary for the EQ Balance device, which is intended to assess body tilt as an indicator of balance. The study's primary goal was to demonstrate substantial equivalence to the predicate device, Sway Balance.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the performance testing verified that "EQ Balance and the Sway™ Balance System (Sway) are in statistical agreement." The agreement was primarily assessed using Spearman's analysis and Deming Regression Model.

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K-D Balance is an objective balance assessment tool and is intended to be used for individuals for whom a balance measurement is a desired outcome. K-D Balance is intended for use to assess balance performance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified or licensed in their state to prescribe and use balance devices including but not limited to athletic trainers and coaches, physical therapists, nurses, physicians, and other health care providers. Patients with could affect balance include, but are not limited to, vestibular dysfunction, nausea, headaches, orthopedic injury, inner ear infection or dysfunction, neurological conditions, head injury, medication side effects, dehydration and fatigue. K-D Balance can be used wherever an iOS mobile operating device is available. K-D Balance may only be used by health care professionals.

K-D Balance is a mobile balance test to be used on the 6th generation iPhone or iPod touch with iOS versions 9.0 or later. K-D Balance measures balance using motion sensors already built-in to the iPhone or iPod touch devices. K-D Balance utilizes a proprietary algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer. Balance is measured during a series of stances with the mobile device secured to the subject with a device holder. Health care professionals follow the step-by-step voice guidance that runs after launching the app during the entirety of the test to ensure consistency in obtaining balance measures. K-D Balance does not function as a diagnostic test, and K-D Balance results should be interpreted by healthcare professionals only.

Here's a breakdown of the acceptance criteria and the study details for the K-D Balance device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for performance metrics. Instead, the primary acceptance criterion appears to be statistical agreement with the predicate device (Sway Balance™) for balance outcomes in both normal and balance deficit groups, across various stances.

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

• Sample Size for Test Set: 79 subjects (25 males, 54 females; mean age: 38.63 ± 12.88, range: 18-65).
  • 34 subjects had brain injury or other neurological conditions (balance deficits).
  • 45 subjects were non-injured (normal group).
• Data Provenance: The study was conducted by the University of Texas, Southwestern Medical Center, Neurology and Sports Medicine Department. The data is prospective as testing was performed for the purpose of this device evaluation. The country of origin is the USA.

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

This study does not appear to use human experts to establish "ground truth" in the traditional sense of diagnostic interpretation. Instead, the "ground truth" for balance performance is based on the objective measurements derived from the predicate device (Sway Balance™) and the clinical categorization of subjects (injured vs. non-injured).

The document mentions that the study was conducted by the University of Texas, Southwestern Medical Center, Neurology and Sports Medicine Department, implying medical professionals at that institution were involved in classifying subjects (e.g., identifying those with brain injury or neurological conditions). However, specific numbers or qualifications of individual experts for this categorization are not provided.

4. Adjudication Method for the Test Set

Not applicable. This was a comparative performance study against a predicate device and clinical categories, not an expert-driven adjudication of AI output. The "ground truth" for comparison was the predicate device's output and the subject's clinical status (injured/non-injured).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not explicitly described. This study focused on the performance of the K-D Balance device itself in comparison to a predicate device, not on how the K-D Balance assists human readers.

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

Yes, a standalone performance study was done. The performance testing directly evaluated the K-D Balance application's ability to measure balance and its statistical agreement with the predicate device (Sway Balance™). The balance assessment is performed by the application's algorithm, and the output is a score. Human involvement is in administering the test and securing the device, but the balance measurement itself is algorithmic.

7. The Type of Ground Truth Used

The ground truth for this comparison study was:

• Objective measurements from a legally marketed predicate device: The balance scores generated by the Sway Balance™ application.
• Clinical categorization: Subjects were categorized as "normal" or "balance deficit" (which included those with brain injury or other neurological conditions). Poorer balance scores were expected and observed in the deficit group, confirming the clinical relevance of the measurements.

8. The Sample Size for the Training Set

The document does not provide information regarding a specific training set size or how the K-D Balance algorithm was developed (i.e., whether it used a training set in machine learning terms). The description focuses on its proprietary algorithm and its use of motion sensors.

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

As no training set is described, the method for establishing ground truth for a training set is not available in the provided text. The evaluation is focused on the device's performance against a predicate and clinical categories rather than a machine learning model's training process.

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The Sway™ Balance System is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses and physicians. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. The Sway™ Balance System can be used wherever an iOS mobile operating device is available.

The Sway Balance™ System is a mobile measurement system that analyzes balance through thoracic sway, using the built in accelerometer of a mobile device. The Sway Balance™ System is a stand-alone mobile operating system software application that does not include any peripheral hardware add-ons.

The provided text is a 510(k) summary for the Sway Balance™ System, a mobile application designed to assess balance. Based on this document, here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

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The Nydiag 200 rotary chair is an optional accessory for the Interacoustics eye movement recording systems. The rotary chair is used to elicit Vestibulo-Ocular Reflexes in patients aged 2 years or older who weigh less than 135 kg / 300 lbs who are being tested for bilateral or unilateral lesions in the peripheral vestibular organs.

The Nydiag 200 is a rotation chair, including a chair unit and a motor pedestal unit. The Nydiag 200 is controlled by software. The rotating chair is an optional accessory and is used for stimulation of the patients balance organs. The chair is supplied from the mains and controlled from a computer through an USB connection. The chair unit includes the chair itself attached to a frame assembly, seat belts and other restraints, patient discomfort signal device and goggle connections (Firewire and USB). The pedestal includes a power unit and motor and gearing units.

The Nydiag 200 Rotary Chair is a medical device, and the provided document is a 510(k) premarket notification summary. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria in the same way a new drug or novel high-risk device might.

Therefore, many of the typical performance study details (like sample size, ground truth establishment, expert qualifications, and MRMC studies) are not present in this type of submission for this particular device. The "acceptance criteria" here are primarily about meeting safety standards and demonstrating equivalence to the predicate device in terms of technological characteristics and intended use.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The VertiGONE goggle is indicated for the treatment of Benign Paroxysmal Positional Vertigo (BPPV). The VertiGONE goggle guides the practitioner to move the patient's head accurately through the Epley, or canalith repositioning maneuver.

The VertiGONE BPPV Goggle is a head mounted medical device worn by the patient. The VertiGONE Goggle is designed as a non-intrusive device with nonsubstantial risk to the subjects. The subject device consists of a molded plastic goggle, an elastic strap to secure the goggle to the head, and a visual reference platform including two visual reference mechanisms. The VertiGONE Goggle provides a visual reference platform for the practitioner to guide the patient to accurately conduct the Epley, or canalith repositioning, maneuver. When using the device, the patient and/or the practitioner are each provided with visual references. Thus, the practitioner can help the patient to complete the Epley maneuver more accurately.

Here's an analysis of the acceptance criteria and the study conducted for the VertiGONE BPPV Goggle based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state quantifiable acceptance criteria (e.g., "rotary nystagmus scores must improve by X%"). The acceptance criteria are implicitly derived from the discussion of the study's purpose and its findings.

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

The document does not specify the exact sample size used for the clinical study (test set). It is referred to as "patients" in the context of the Epley maneuver.

• Sample Size: Not explicitly stated.
• Data Provenance: The study was conducted in a "controlled practitioner office environment." The country of origin is not specified but given the submitter and contact information are in the U.S., it is highly probable the data is from the U.S. The study was prospective.

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

The document does not provide details on the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study design was a "prospective, single-blind crossover study" which compared performing the Epley maneuver with the VertiGONE Goggle versus a "less accurate Epley maneuver performed." This indicates a comparison of a procedure aided by the device versus a non-aided procedure, not a comparison of multiple readers' interpretations of cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

This device is not an algorithm-only device. It is a physical goggle that aids a human practitioner. Therefore, a standalone (algorithm only) performance study was not applicable and not performed. The performance is inherently tied to human use.

7. Type of Ground Truth Used

The ground truth implicitly used for the study was the improvement in rotary nystagmus scores and BPPV outcomes. This is a clinical outcome observed by the practitioner. It's an objective physical manifestation of the condition.

8. Sample Size for the Training Set

The document does not mention any "training set." This device is a physical medical device, not an AI/ML algorithm that requires a training set in the conventional sense.

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

As no training set is discussed for this physical device, this question is not applicable.

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The DizzyFIX is indicated for the treatment of vertigo where a physician has diagnosed posterior canal BPPV and recommended one of the exercise variations which are used to treat this type of vertigo. The DizzyFIX should be used as a component to assist in correct performance of therapeutic exercises for the treatment of vertigo.

Patients with a diagnosis of Posterior Canal Benign Paroxysmal Positional Vertigo (BPPV) who exhibit:
a. Momentary spinning dizziness,
b. Which lasts seconds to minutes,
c. Which is associated with position change

The DizzyFIX is a small, non powered, non-sterile head worn device which can assist in the performance of the treatment exercises for vertigo. The DizzyFIX is a device which assists in the performance of a correct "Particle Repositioning Maneuver". Whether being used by a patient at home, a doctor or other health professional, this device helps to treat BPPV by encouraging the correct angles and duration for conducting both diagnostic and treatment exercise maneuvers. With the DizzyFIX, persons who suffer from BPPV can repeat the repositioning exercises at home as often as needed to achieve resolution of symptoms.

The DizzyFIX consists of a specially curved acrylic tube containing a non-toxic viscous fluid and a bead. The entire device is about the size of a person's fist and weighs only a few hundred grams. Factors such as fluid viscosity and tube shape were carefully designed so that motion of the bead within the tube guides the patient accurately through the series of vestibular exercises.

The device clips onto the mid-brim of any hat such that it is visible to the wearer. Beginning with the bead at one end of the tube, the patient tilts his or her head at appropriate angles and time intervals to slowly move the bead to the other end of the tube. Thus, there is real-time feedback to the patient. If the bead arrives at the other end of the tube, the exercise maneuvers have been performed correctly. The exercise maneuver can be repeated as often as needed.

The DizzyFIX device consists of a transparent tube filled with mineral oil. The device contains a bead that freely travels within the mineral oil. The tube is permanently sealed at both ends. The device has a clip which facilitates its attachment to the included hat such that it is visible to the user. The hat has a strap such that it is affixed snugly to the users head. The device, tube and bead have characteristics such that only by performing a correct vestibular exercise might the bead move from one end of the tube to the other.

Here's an analysis of the DizzyFIX 510(k) submission, extracting the requested information:

The document (K081602) describes the DizzyFIX, a device intended to assist in the performance of the particle repositioning maneuver for Benign Paroxysmal Positional Vertigo (BPPV).

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on the clinical effectiveness of the device in assisting BPPV treatment, rather than discrete, quantifiable technical acceptance criteria with pre-defined thresholds. The key "acceptance criteria" is implied by the clinical trial outcome: successful treatment of BPPV.

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

The document states:

• Sample Size (Test Set): Not explicitly stated numbers for individual studies. It mentions "Three clinical trials were performed." The reported performance of "88% of patients successfully treated" implies a test set was used across these trials.
• Data Provenance:
  • Country of Origin: Canada (specifically, University of Western Ontario, London, Ontario, Canada).
  • Retrospective or Prospective: Not explicitly stated, but the description of "clinical trials were performed" typically implies a prospective study design.

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

This information is not provided in the supplied text. The document refers to "physicians for the treatment of BPPV" and mentions "specialist physicians," but it does not specify how many experts established ground truth or their exact qualifications for the clinical trials.

4. Adjudication Method for the Test Set

This information is not provided in the supplied text.

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

This is not applicable. The DizzyFIX is a non-powered, head-worn mechanical guidance device, not an AI-powered diagnostic or assistive tool. There is no mention of human readers or AI assistance in the context of an MRMC study.

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

This is not applicable. The DizzyFIX is a physical device that assists a human user in performing a maneuver. The device itself "does not treat BPPV," but rather "assists in the exercise while the user performs the standard exercise maneuver." Therefore, its performance is inherently human-in-the-loop.

7. The Type of Ground Truth Used

The ground truth used to determine "successful treatment" in the clinical trials was based on the resolution of BPPV symptoms after performing the Particle Repositioning Maneuver with the DizzyFIX's assistance. This typically involves assessing the patient's subjective experience of dizziness and objective clinical tests used to diagnose and confirm BPPV (though specific tests aren't detailed here).

8. The Sample Size for the Training Set

This information is not applicable (or not provided in the context of "training set"). The DizzyFIX is a mechanical device, not a machine learning model, so it doesn't have a "training set" in the conventional sense of AI/ML. Its design (fluid viscosity, tube shape) was likely developed through iterative engineering and biomechanical modeling, not data-driven machine learning training.

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

This is not applicable as there is no mention of a "training set" for an AI/ML model for this device. The design principles were established using:

• Known anatomical and physical properties of the human balance organ (vestibular apparatus).
• Previously published mathematical and biomechanical models of the vestibular apparatus.
• Clinical aspects like latency of vertigo onset, patient anxiety, and safety.
  The device's design was engineered so that "only by performing a maneuver essentially similar to Epley's maneuver... would it register success" (i.e., the bead moving correctly).

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