(105 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Successful treatment of BPPV | 88% of patients successfully treated their BPPV by performing these exercise maneuvers with the assistance of the DizzyFIX device. |
| Safety | No significant side effects. |
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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