Search Results

Relieva Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Relieva Acella Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

The Relieva Sinus Balloon Catheter is a catheter designed to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.

The Relieva Acella Sinus Balloon Catheter is a catheter designed to access and to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.

The provided FDA 510(k) summary for the Acclarent Relieva™ Sinus Balloon Catheter and Relieva Acella™ Sinus Balloon Catheter indicates that the devices met all performance acceptance criteria. However, due to the nature of this submission (a traditional 510(k) for a medical device that does not involve AI/software for diagnostic purposes), the detailed information typically associated with AI/software performance studies is not present.

Here's an analysis of what can and cannot be extracted from the document based on your request:

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

Reasoning: The document states, "The Relieva Sinus Balloon Catheter met all performance acceptance criteria. The Relieva Acella Sinus Balloon Catheter met all performance criteria." However, it does not elaborate on what those specific criteria were. This is typical for a 510(k) summary for a physical medical device. The criteria would likely involve physical performance metrics like burst pressure, inflation/deflation times, material biocompatibility, and sterilization effectiveness, rather than diagnostic accuracy metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document focuses on the physical device and its equivalence to predicates, not on clinical data in the way an AI diagnostic device would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Number of Experts: Not applicable/Not specified. This device is a physical surgical instrument for dilation, not an AI device that requires expert ground truth for interpretation of medical images or data. Performance testing would likely involve engineering and clinical performance in a procedural context, not expert interpretation of outputs.
• Qualifications of Experts: Not applicable/Not specified.

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

• Adjudication Method: Not applicable/Not specified. This concept is relevant for AI image analysis where disagreements between readers need to be resolved to establish ground truth. For a physical device, performance is evaluated against engineering specifications and clinical outcomes in usability/safety studies.

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

• MRMC Study: No. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for this physical balloon catheter device.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical instrument, not an algorithm.

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

• Type of Ground Truth: For a physical medical device like this, "ground truth" would relate to engineering specifications, material properties, and clinical outcomes (e.g., successful dilation, lack of tissue trauma, safety data) from usability/performance studies. The document does not specify the exact nature of the performance data (e.g., in-vitro bench testing, animal studies, or specific human clinical data beyond general statements of equivalence) or how "ground truth" for those outcomes was established, although it would inherently be based on direct measurement and observation rather than expert interpretation of a model's output.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. This is a physical medical device, not an AI model that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (balloon catheter) under Class I (Low Risk). It confirms that the device met all specified performance criteria, but the detail expected for an AI performance study (e.g., sample sizes for test/training, expert qualifications, adjudication, MRMC studies) is not present because those concepts are not relevant to this type of device submission. The submission is focused on demonstrating substantial equivalence to predicate physical devices.

Ask a specific question about this device