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PuraSinus® is a space occupying gel stent intended to separate and prevent adhesions between mucosal surfaces, help to control minimal bleeding following surgery or nasal trauma, and act as an adjunct to aid in the natural healing process.

PuraSinus® is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate and formation of nasal adhesions during the post-operative period.

PuraSinus® is a sterile gel composed of a synthetic peptide and sterile water for injection. It is provided as a prefilled syringe (2.5% peptide content) ready for use as a wound dressing with or without the optional sterile application nozzle. PuraSinus® forms a moist wound environment that is supportive of the healing process and allows non-traumatic removal of the secondary dressing without damaging newly formed tissue.

PuraSinus® is completely non-animal and non-plant derived and contains no preservatives that might present a risk of allergic reaction or skin irritation.

Exposure to physiological fluids such as blood causes the peptide solution to quickly form a transparent gel without expansion in volume. PuraSinus® can be easily rinsed away by gently flushing the wound with sterile saline, without causing trauma to the underlying wound.

This document ("510(k) Summary for PuraSinus®") does not describe an AI/ML device, nor does it present the acceptance criteria and study proving a device meets those criteria in a format applicable to AI/ML device performance. This is a 510(k) submission for a medical device (a bioresorbable nasal dressing and sinus stent) where the key demonstration of substantial equivalence relies on comparison to a predicate device through bench testing and a small retrospective case series, rather than formal performance goals met by an AI/ML algorithm.

Therefore, many of the requested categories for defining acceptance criteria and study details for an AI/ML device cannot be extracted from the provided text. However, I can still interpret the information regarding the "performance data" that was presented to support the device.

Here's an analysis based on the provided text, interpreted as much as possible in the context of your request for device performance, but noting the relevant limitations due to the nature of the device:

Device Name: PuraSinus®

Type of Device: Bioresorbable nasal dressing and sinus stent (not an AI/ML device)

Acceptance Criteria and Reported Device Performance (as far as applicable to this non-AI device):

Study Details (as derived from the text):

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: 19 sequential patients.
   • Data Provenance: Retrospective case series. The country of origin is not explicitly stated but implied to be where the clinical institution(s) conducting the FESS procedures are located (no specific country mentioned).

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

   • Not applicable in the AI/ML sense. The "ground truth" for the clinical performance (re-bleeding, adhesion formation, adverse events) would have been established by the treating physicians/surgeons during post-operative patient follow-up. The document does not specify the number or qualifications of these clinical evaluators.

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

   • Not explicitly described. Clinical outcomes (adhesions, re-bleeding, adverse events) were reported, presumably as direct observations during patient follow-up, not through a formal adjudication process like one used for AI/ML image review.

4. 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:

   • Not applicable. This is not an AI/ML device. The "comparison" was PuraSinus® performance to literature reported performance of a predicate device (MeroGel®).
   • Comparison: PuraSinus® showed an adhesion rate of 16% compared to a literature-reported adhesion rate of 27% for MeroGel® in similar procedures. This is a comparison of device outcome, not human reader performance.

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

   • Not applicable as this is not an AI/ML device.

6. The type of ground truth used:

   • Clinical Outcomes/Observations: Directly observed post-operative clinical outcomes (adhesion formation, re-bleeding, adverse events) by treating physicians.
   • Bench Test Results: Quantitative measurements from laboratory tests (Complex Modulus, Viscosity, Injection Force).
   • Rabbit Model: In vivo animal study data for material comparison.

7. The sample size for the training set:

   • Not applicable, as this is not an AI/ML device that requires a "training set."

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

   • Not applicable, as this is not an AI/ML device.

Summary of Device Performance Evidence (based on the provided text):

The primary evidence presented to demonstrate the substantial equivalence and performance of PuraSinus® focused on:

• Bench Testing: Comparative physical and mechanical properties of PuraSinus® and the predicate device (MeroGel®).
• Animal Model: A side-by-side comparison in a rabbit model to address material differences between PuraSinus® and MeroGel®, concluding no impact on safety or effectiveness.
• Retrospective Case Series (Human Data): A small series (19 patients) showing favorable clinical outcomes (no re-bleeding, low and mild adhesion rates) compared to literature data for the predicate device.

The document emphasizes that PuraSinus® is the "identical product" to the previously cleared PuraDerm Gel (K140358), leveraging its biocompatibility and product characterization studies.

The acceptance of this device by the FDA (as indicated by the clearance letter K183015) was based on the provided data demonstrating substantial equivalence to the predicate device, not on meeting specific, pre-defined performance thresholds for an AI/ML algorithm.

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