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The Biodesign® ENT Repair Graft is intended to separate tissue or structures compromised by surgical trauma, help control minimal bleeding, and act as an adjunct to aid in the natural healing process. The device is indicated for use where an open wound dressing material is required in the nasal and/or sinus cavities following nasal and/or sinus surgery where separation of tissues or structures is desired. The device is supplied sterile and is intended for one-time use.

The Biodesign ENT Repair Graft is composed of a bioabsorbable, extracellular collagen membrane matrix (Small Intestinal Submucosa, SIS). The Biodesign ENT Repair Graft is similar to its predicate MeroGel™ Control Gel ENT Surgical Dressing (K002972) which is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of extracellular matrix. The device is available in multilayered sheets with sizes from 1 cm by 2 cm to 20 cm x 40 cm. The Biodesign ENT Repair Graft is a scaffold which becomes infiltrated by the host cells during the body's natural repair process. The Biodesign ENT Repair Graft can be shaped by the physician to the appropriate size for the desired indication. The Biodesign ENT Repair Graft is similar to its MeroGel predicate in its technology in that it has the ability to be incorporated into the body. The device is packaged in a lyophilized (dried) state and supplied sterile in a sealed double pouch system.

Here's an analysis of the provided text regarding the Biodesign ENT Repair Graft, focusing on acceptance criteria and supporting studies:

This submission is for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving efficacy against a set of predefined performance endpoints. Therefore, the "acceptance criteria" here are primarily about demonstrating that the new device is as safe and effective as the predicate, based on similar intended use, materials, and technological characteristics. There isn't a conventional "device performance" described in terms of specific metrics like sensitivity or accuracy in the way it would be for a diagnostic AI device.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Direct numerical "device performance" metrics (e.g., specific tensile strength values, degradation rates, quantitative clinical outcomes) are not provided in this summary. The focus is on qualitative equivalence ("adequate," "substantially similar," "evidence that...").

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

• Biocompatibility Testing: The text states "sterilized SIS devices (which have already been cleared in multiple applications)" were used. The specific number of devices tested for each biocompatibility test is not mentioned.
• Mechanical Testing: Specific sample sizes for suture retention strength and ultimate tensile strength tests are not mentioned.
• Preclinical Testing (Mouse Study): The number of mice used in the subcutaneous study is not mentioned.
• Clinical Testing: The number of patients included in the clinical study for nasal septal perforation repair is not mentioned. The provenance (e.g., country of origin, retrospective/prospective) of the clinical data is not mentioned, though the study was performed using SIS material (Surgisis), implying it could have been a previously conducted study.

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

This type of information is not applicable to this 510(k) submission. For this medical device (a surgical graft), "ground truth" is not established by expert consensus on interpretations as it would be for an AI diagnostic device. Instead, the "truth" is determined by established scientific/engineering test methods (e.g., ISO standards for biocompatibility) and clinical observation of outcomes, which are assessed by medical professionals in the context of a clinical study. The document does not specify the number or qualifications of experts who interpreted the results of the biocompatibility, mechanical, or preclinical tests. For the clinical study, the results would typically be analyzed by clinical researchers and physicians, but their specific roles or number establishing "ground truth" (e.g., pathology confirmation of repair) are not detailed.

4. Adjudication Method for the Test Set

This is not applicable in the context of this device and testing. Adjudication methods (like 2+1 or 3+1) are typically used in studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved to establish a robust ground truth. Here, the "test sets" involve physical, chemical, and biological measurements or clinical outcomes, not interpretations requiring adjudication.

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

This is not applicable. This submission is for a surgical graft, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

This is not applicable. This device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for demonstrating substantial equivalence for this device is based on a combination of:

• Standardized Biocompatibility Test Results: Adherence to ISO 10993-1 standards for various biological responses, with results indicating "meets biocompatibility requirements."
• Mechanical Testing Results: Measurements of physical properties like suture retention and tensile strength, deemed "adequate."
• Preclinical (Animal) Observations: Post-implant observations in a mouse model regarding tissue separation, cellular ingrowth, and degradation.
• Clinical Outcomes Data: The clinical study on nasal septal perforation repair using SIS material implies evaluation of patient outcomes such as healing, complication rates, and efficacy in achieving the intended purpose. The specific endpoints or type of data forming this "ground truth" are not detailed (e.g., surgical success rate, re-perforation rate, symptomatic improvement).

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no training set for this device.

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