(101 days)
The EarPopper is indicated for the treatment of negative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing and hearing loss. The EarPopper provides a method of ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.
The EarPopper is a non-surgical, non-drug related treatment for middle ear pressure problems such as:
- . Middle ear fluid (Otitis Media with Effusion)
- Eustachian Tube Dysfunction
- . Temporary hearing loss
- Ear pain and pressure caused by air travel .
- . Ear fullness caused by colds, allergies, sinusitis
The provided 510(k) summary for the EarPopper device (K073401) is a premarket notification for substantial equivalence, not a clinical study proving performance against acceptance criteria in the typical sense of a diagnostic device.
Instead of an acceptance criteria table and device performance, the document provides a comparison of characteristics between the EarPopper and its predicate devices (Earclear, Politzer Bag, Otovent) to demonstrate substantial equivalence.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for substantial equivalence rather than a study validating specific performance metrics against pre-defined acceptance criteria, the document does not contain a "table of acceptance criteria and reported device performance" in the traditional sense for a diagnostic device.
Instead, the submission demonstrates equivalence by comparing the EarPopper's characteristics to those of its predicate devices. The "SUMMARY of EQUIVALENCE" table serves this purpose by showing that the EarPopper's intended use, patient use, principle of operation, mode of operation, major components, and air pressure output are sufficiently similar to the legally marketed predicate devices.
| Characteristic | EarPopper Performance/Description | Predicate Performance/Description (from K951596,K920840) |
|---|---|---|
| Intended use | Treatment of negative middle ear pressure, preventing fluid accumulation and hearing loss by ventilating the middle ear; momentarily increasing air pressure in the nose and eustachian tube. | Earclear (K951596): Treatment of negative middle ear pressure, preventing fluid accumulation and hearing loss by forcing air pressure through the nose and Eustachian tube into the middle ear. |
| Politzer Bag: Treatment of negative middle ear pressure. | ||
| Otovent (K920840): Treatment of negative middle ear pressure. | ||
| Patient Use | Performed at home by patient on his own, or under adult supervision. | Earclear (K951596): Performed at home by patient on his own, or under adult supervision. |
| Politzer Bag: Performed at home by patient on his own, or under adult supervision, but typically requires a second person to deliver the air pressure. | ||
| Otovent (K920840): Performed at home by patient on his own, or under adult supervision. | ||
| Principle of Operation | Ventilating the middle ear by momentarily increasing the air pressure in the nose and the eustachian tube. | Earclear (K951596): Ventilation of the middle ear by forcing air under pressure through the nose and the eustachian tube into the middle ear. |
| Politzer Bag: Ventilation of the middle ear by forcing air under pressure through the nose and the eustachian tube into the middle ear. | ||
| Otovent (K920840): Ventilation of the middle ear by forcing air under pressure through the nose and the eustachian tube into the middle ear. | ||
| Mode of Operation | Non-sterile, battery powered device held against the nostril, delivering continuous air pressure via an air pump. | Earclear (K951596): Non-sterile, battery powered device held against the nostril, delivering continuous air pressure via an air pump. |
| Politzer Bag: Non-sterile, manual device held against the nostril, delivering varying amount of air pressure via the compression of a bulb (bag). | ||
| Otovent (K920840): Non-sterile, manual device held against the nostril, delivering varying amount of air pressure via the deflation of the patient-inflated balloon. | ||
| Major Components | Plastic (ABS / Polycarbonate / Polystyrene) nosepiece mounted to a plastic case, housing an air pump, batteries and a printed circuit board. | Earclear (K951596): Plastic (PVC/ABS/PEI) nosepiece mounted to a plastic case, housing an air pump, batteries and a printed circuit board. |
| Politzer Bag: Plastic or glass nosepiece mounted to a rubber tube which is connected to a rubber bulb (bag). | ||
| Otovent (K920840): Plastic (PVC) nosepiece mounted to a latex balloon. | ||
| Air Pressure | Continuous, controlled to 3 PSI with air flow of 0.6 L/minute on low setting and 6 PSI with air flow of 1.3 L/minute on high setting. | Earclear (K951596): Continuous, controlled to 1.5 PSI on low setting and 3 PSI on high setting. |
| Politzer Bag: Varying, uncontrolled range: 1.5 to 5.9 PSI reported by Politzer, 5.2 PSI reported by Schwartz, 10 to 30 PSI*. | ||
| Otovent (K920840): Varying, uncontrolled, value not specified in the product literature. |
Outcome: The FDA determined that the EarPopper is substantially equivalent to the predicate devices, indicating that its performance and safety are comparable.
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not describe a clinical study with a test set as it pertains to diagnostic accuracy or clinical effectiveness. The submission focuses on demonstrating substantial equivalence based on technological characteristics and intended use. Therefore, no information on sample size or data provenance (country, retrospective/prospective) is provided in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since a clinical effectiveness study with a test set and ground truth establishment is not detailed in this 510(k) summary, no information is available regarding the number or qualifications of experts for establishing ground truth.
4. Adjudication Method for the Test Set
As no clinical study with a test set is described, there is no adjudication method mentioned.
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 device (EarPopper) is a non-surgical, non-drug treatment device for middle ear pressure problems, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not applicable and not mentioned in the document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Similarly, since the EarPopper is a physical, non-AI treatment device, a standalone algorithm performance study is not applicable and not described.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
As this is a 510(k) submission for substantial equivalence based on technological characteristics and intended use, and not a performance study that requires a "ground truth" to validate diagnostic accuracy, no type of ground truth is mentioned or used in this document.
8. The Sample Size for the Training Set
No training set is referenced as no machine learning algorithm development or validation is being described.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set or ground truth establishment for an algorithm is described.
N/A