(209 days)
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
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Effectiveness | Improvement in rotary nystagmus scores. | "The results of the clinical trial suggest moderate improvement in BPPV outcomes in patients when the Epley maneuver was performed correctly using VertiGONE verse outcomes when a less accurate Epley maneuver was performed." |
| Safety | No new questions of safety raised compared to predicate devices. | "Although there are differences in the technological characteristics... those differences do not raise new questions of safety." |
| Intended Use | Device accurately guides the practitioner to perform the Epley maneuver. | "The controlled clinical design was a prospective, single-blind crossover study... to confirm that VertiGONE goggles improve rotary nystagmus scores, and thus BPPV, by aiding the physician in accurately performing the Classical Epley, or canalith repositioning, maneuver." |
| Substantial Equivalence | Device is substantially equivalent to legally marketed predicate devices. | "VertiGONE, Inc. believes that, based on the results of clinical performance data, the VertiGONE BPPV Goggle is substantially equivalent to other legally marketed devices for the treatment of benign paroxysmal positional vertigo (BPPV)." |
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.
N/A