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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.

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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The REUSABLE BLOOD PRESSURE CUFF is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in infant, pediatric and adult sizes. The DISPOSABLE BLOOD PRESSURE CUFF is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes.

The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, pediatric and adult sizes. The proposed device includes disposable blood pressure cuff and reusable blood pressure, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics &PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 26 models with different size for different population with different arm size, and the 13 models of 26 are use single tube of air hose and other 13 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff) and PVC (Air Hose), thereinto, the 210D Nylon TPU (Cuff) is the material used to contacting with the patient. The reusable blood pressure cuff has 16 models with different size for different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.

This is a 510(k) premarket notification for Reusable Blood Pressure Cuffs and Disposable Blood Pressure Cuffs. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by compliance with specific international standards. The performance is reported as meeting these standards.

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