Search Results

SinuBand is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing intended to separate mucosal surfaces and prevent formation of adhesions.

SinuBand is a sterile, single-use, bioresorbable two-layer film designed to be a temporary nasal dressing applied under endoscopic visualization after sinus surgery. SinuBand is composed of two layers, with one side designed to be placed against the nasal tissue and the other facing the nasal cavity.

Since the provided text describes a 510(k) premarket notification for a medical device (SinuBand) and not an AI/ML medical device, the acceptance criteria and study information requested in the prompt (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, ground truth establishment for training set) are not applicable. The provided document details the testing performed to demonstrate substantial equivalence of the SinuBand to predicate devices rather than the performance of an AI/ML algorithm against specific criteria.

However, I can extract the closest analogous information based on the content available, focusing on the device's performance against its stated indications and comparison to predicate devices, as this is the core of a 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance (Analogous to 510(k) Substantial Equivalence)

For a 510(k) submission, the "acceptance criteria" are generally demonstrating substantial equivalence to a legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate. The performance data presented below are used to support this claim.

• Maximum sustained load
• Flexibility
• Ability to absorb water
• pH
• Ease of placement and removal from tissue
• Conformability | All test results were comparable, supporting comparable functionality. |
  | In Vivo Performance (Safety & Resorbability) | Rapidly adhered to sinus mucosa.
  Remained visible after 48 hours.
  Resorbed after 9-15 days.
  No significant histologic changes when placed on intact mucosa.
  Did not alter inflammation, fibrosis, or bone remodeling at injury sites.
  No complications encountered. | Demonstrated safety, biocompatibility, and performance. Residence time of approximately 2 weeks, comparable to predicate. |
  | Intended Use | Same Indications for Use as predicate: "indicated for use in patients undergoing nasal/sinus surgery as a space-occupying dressing intended to separate mucosal surfaces and prevent formation of adhesions." | Aligns with predicate devices. |

2. Sample Size Used for the Test Set and Data Provenance

• Animal Studies (Test Set):

  • Sample Size: 16 intact or injured rabbit sinuses (for SinuBand implantation). 10 intact or injured rabbit sinuses served as controls (no implantation).
  • Data Provenance: Pre-clinical in vivo study in a New Zealand white rabbit model. This is proprietary animal data generated specifically for this submission.

• In Vitro Bench Testing: No specific sample sizes (e.g., number of devices tested) are quantified in the summary, but comparative testing was performed on SinuBand and the predicate device (MeroGel Nasal Dressing). This is proprietary in vitro bench data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the SinuBand's 510(k) submission as it focuses on physical device performance and not diagnostic algorithm accuracy requiring human expert ground truth. Histologic evaluation in the animal study would have been performed by qualified pathologists, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

This is not applicable, as the SinuBand is a physical device, not an AI/ML algorithm requiring expert adjudication of outputs.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging AI/ML devices to assess their impact on human reader performance.

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

No, a standalone performance study as described for AI/ML algorithms was not done. The SinuBand is a physical medical device.

7. The Type of Ground Truth Used

• For Animal Studies: Histologic evaluation (hemorrhage, inflammation, fibrosis, bone remodeling, presence of device) of the sinus tissue was used to assess the device's in-vivo performance and safety. This is a form of pathology/histological assessment.
• For Bench Testing: Objective measurements of physical and mechanical properties (e.g., load, flexibility, water absorption, pH) served as the "ground truth" to compare SinuBand against the predicate device.

8. The Sample Size for the Training Set

This is not applicable. The SinuBand is a manufactured physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no training set for a physical device.

Ask a specific question about this device