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The Relieva Sinus Balloon Dilation Catheter is intended to provide a means to dilate ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

The Relieva Sinus Balloon Dilation Catheter will be provided in the following balloon sizes:

• 3 mm Sinus Balloon Catheter .
• 5 mm Sinus Balloon Catheter .
• 7 mm Sinus Balloon Catheter .
  The family of Relieva Sinus Balloon Dilation Catheters allows for the enlargement of sinus ostia and paranasal spaces with a minimally invasive method. The Relieva Sinus Balloon Dilation Catheters are placed in the narrow opening over a guidewire. Once positioned the balloons are inflated with a high pressure inflation device that provides feedback as to the internal pressure of the balloon. After a few seconds at the desired balloon inflation pressure, the balloon can be deflated and removed or repositioned.

The provided text describes a medical device, the Relieva Sinus Balloon Dilation Catheter, and its substantial equivalence to predicate devices, but does not contain information regarding traditional acceptance criteria or a study proving the device meets those criteria, as one would expect for an AI-based device. Instead, it focuses on demonstrating conformance to product specifications and comparing it to existing, cleared devices.

This is a Class I medical device, which typically has lower regulatory hurdles compared to Class II or Class III devices, especially if it's considered substantially equivalent to pre-amendment devices or existing predicate devices. The validation relies on demonstrating that the device is safe and effective for its intended use through comparison and product testing, rather than a clinical study with acceptance criteria often seen for novel AI systems.

Here's an analysis based on the provided text, highlighting the absence of the requested information for an AI-based device:

1. A table of acceptance criteria and the reported device performance:

Explanation: The document lists various tests performed ("Testing included: Visual Inspection, Dimensional Analysis, Surface Finish, Catheter Hub Leak, Shaft to Hub Separation, Balloon Inflation Cycle Fatigue, Balloon Burst Pressure") and states that "Products were tested to ensure conformance to product specification." However, it does not explicitly state the quantitative acceptance criteria for each of these tests (e.g., "burst pressure must be >X psi" or "leakage <Y ml/min") nor does it provide the specific numerical results obtained from these tests. It generally states that the device "conforms to product specification," which is the overarching acceptance criterion in this context for mechanical device validation.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document only mentions "Products were tested," but does not indicate how many units of each product size were tested for each criterion.
• Data Provenance: Not applicable in the context of clinical data. These are engineering design verification and validation tests, not a clinical study involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is a mechanical surgical instrument. The "ground truth" for its performance is established through physical and mechanical testing against engineering specifications, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This refers to a method for resolving discrepancies among expert opinions in clinical studies, which is not relevant for the engineering tests described.

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 is not an AI-assisted device. The document describes a standalone manual surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a manual surgical instrument and does not involve an algorithm. Its performance is entirely dependent on its physical properties and how it's used by a human surgeon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Engineering Specifications / Industry Standards. The "ground truth" for this device's performance is its adherence to predefined engineering specifications and possibly relevant industry standards for medical devices of this type. For example, balloon burst pressure would be measured against a specified minimum pressure.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the ground truth for the training set was established:

• Not applicable. As there is no training set, this question is irrelevant.

In summary: The provided 510(k) summary for the Relieva Sinus Balloon Dilation Catheter demonstrates that the device's acceptance relied on internal "conformance to product specification" via engineering tests and a comparison of its "Intended Use" and "Technological Characteristics" to "marketed predicate devices" to establish substantial equivalence. It is a Class I manual surgical instrument, and its regulatory pathway does not involve the types of acceptance criteria and studies (like MRMC or standalone AI performance) typically associated with AI-driven medical devices.

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