(105 days)
The Ear Pressure Relief Device is indicated for the treative middle ear pressure. Negative middle ear pressure can lead to fluid accumulation in the middle ear, impaired hearing loss. The Ear Pressure Reliever provides a method of ventilating the middle ear by momentarily increasing the air pressure in the eustachian tube. Equalizing the pressure can prevent the accumulation of fluid and prevent hearing loss.
The Ear Pressure Relief Device is designed to blow a controlled flow of air into the nose to facilitate opening the eustachian tubes. For use, the nosepiece is fitted tightly against one nostril to make an airtight seal. While pinching the other nostril shut, the Ear Pressure Relief Device is activated by pressing and holding the adjustment button. The patient swallows while the device is running, allowing regulated air to move from the nose to the eustachian tube to help open the eustachian tube and equalize pressure in the middle ear. Ear Pressure Relief Device is provided non-sterile, and is designed for reuse with a single patient.
The provided FDA 510(k) summary for the "Ear Pressure Relief Device (ER813B)" does not contain the level of detail typically found in a study focused on establishing acceptance criteria and proving device performance for an AI/ML-driven device. This document describes a physical medical device that appears to operate without AI or complex algorithms.
However, I can extract the information relevant to what I understand you’re asking for, aligning it with the structure you provided, even if some categories are not directly applicable to this type of device.
Key takeaway: This medical device clearance is based on substantial equivalence to a predicate device, primarily demonstrated through bench testing for physical performance, electrical safety, EMC, and biocompatibility, rather than a clinical study with human readers or AI performance metrics.
Here's the analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device and not an AI/ML diagnostic tool, the "acceptance criteria" are based on engineering specifications and regulatory compliance rather than diagnostic performance metrics like sensitivity, specificity, or AUC. The reported device performance is a confirmation that these specifications were met through bench testing.
| Acceptance Criteria Category | Specific Acceptance Criteria (Target) | Reported Device Performance (Test Result) |
|---|---|---|
| Air Pressure | 31 – 41 kPa (4.5 to 6 PSI) | 31 – 41 kPa (4.5 to 6 PSI) (Confirmed, implicitly met for substantial equivalence) |
| Air Flow Rate | 1.7 – 2.1 LPM | 1.7 – 2.1 LPM (Confirmed, implicitly met for substantial equivalence) |
| Electrical Safety | Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11 | Passed electrical safety testing, complies with listed standards. |
| EMC (Electromagnetic Compatibility) | Compliance with IEC 60601-1-2, IEC 60601-1-11 | Passed EMC testing, complies with listed standards. |
| Biocompatibility | Compliance with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-23 (irritation) | Passed biocompatibility tests, complies with listed standards. |
| Dimensional Verification | (Implied: Meets design specifications of 152.335.529.7mm) | Verified (Met design specifications for dimension). |
| Pressure Value Verification | (Implied: Meets specified Air Pressure range) | Verified (Met specified Air Pressure range). |
| Flow Rate Verification | (Implied: Meets specified Air Flow Rate range) | Verified (Met specified Air Flow Rate range). |
| Drop Test Verification | (Implied: Withstands specified drop height/impact without failure affecting performance) | Verified (Met specified drop test requirements). |
| Software Verification & Validation | Not applicable (No software in device) | "This product does not include software," so no software V&V was required or performed. |
| Labeling | Meet FDA's requirement | Declared to "Meet FDA's requirement" (implicitly through review of submission documents and proposed labeling). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of a "test set" for an AI/ML algorithm or a clinical trial. The testing involved physical units of the device for bench, electrical, EMC, and biocompatibility tests. The document doesn't specify the number of physical units tested, but these are typically small numbers (e.g., 3-5 units for bench tests, relevant samples for biocompatibility).
- Data Provenance: The tests (bench, electrical, EMC, biocompatibility) were conducted on the "Ear Pressure Relief Device (ER813B)" itself. The document does not specify the origin of the samples if different from the manufacturing site (Ningbo Albert Novosino Co., Ltd., China). The tests are prospective in the sense that they are conducted on newly manufactured devices to verify performance against design specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to this type of device. There is no "ground truth" established by human experts in the context of diagnostic accuracy for this physical medical device. The "ground truth" here is adherence to engineering specifications and regulatory standards, verified by testing specialists and accredited labs.
4. Adjudication method for the test set
Not applicable. There was no "adjudication method" involving multiple experts for a diagnostic task. Testing involves objective measurements against predefined engineering specifications and regulatory standards.
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. This device is a standalone physical product, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study was not performed, nor is there any mention of human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a physical product for direct patient use to relieve ear pressure, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is adherence to engineering specifications (e.g., air pressure range, flow rate, dimensions), biocompatibility standards, electrical safety standards, and electromagnetic compatibility (EMC) standards. These are objective, measurable criteria.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for one.
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