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The Cook® Biodesign® Otologic Repair Graft is intended for use as an implant material to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.

The Cook® Biodesign® Otologic Repair Graft is a porous, absorbable, multi-layer biomaterial composed of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). SIS is obtained from the intestine using a process that retains the natural composition of matrix molecules such as collagen (Types I, III, VI), glycosaminoglycans (hyaluronic acid, chondroitin sulfate A and B, heparin, and heparin sulfate), proteoglycans, and fibronectin. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.

This document describes a 510(k) premarket notification for the Biodesign Otologic Repair Graft (K161000). The key information revolves around a packaging change and the demonstration of substantial equivalence to a predicate device (K150594).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state specific sample sizes for the "sterilization adoption," "package performance testing," or "cytotoxicity testing." It only mentions that these tests were "performed to demonstrate substantial equivalence."

• Data Provenance: The studies were conducted by Cook Biotech Incorporated, as part of their 510(k) submission. The data is retrospective in the sense that these tests were performed on the device and its new packaging configuration to demonstrate equivalence, rather than being part of a prospective clinical trial. The country of origin of the data is implied to be the USA, where Cook Biotech Incorporated is located.

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

This document does not pertain to studies requiring expert adjudication for ground truth (e.g., medical image interpretation). The testing described here is related to device engineering, materials science, and packaging performance. The "ground truth" for these tests would be established through defined scientific methodologies and standards (e.g., ISO standards for biocompatibility or ASTM standards for package testing), rather than expert consensus on a clinical outcome or image.

4. Adjudication Method for the Test Set

Not applicable as this is not a study involving human reader interpretation or clinical outcomes that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a material and packaging change, not an AI or diagnostic device that would involve human readers.

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

No, a standalone algorithm performance study was not done. This device is a surgical graft, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests would be based on:

• Scientific Standards: For sterilization adoption, it would be demonstration of sterility in accordance with established standards (e.g., ISO 11135 for ethylene oxide sterilization).
• Engineering Standards: For package performance, it would be meeting pre-defined physical and barrier property requirements based on industry standards (e.g., ASTM F1980 for accelerated aging, various ASTM standards for package integrity like peel strength, burst tests, etc.).
• Biological Standards: For cytotoxicity, it would be meeting the requirements of recognized biocompatibility standards (e.g., ISO 10993-5 for in vitro cytotoxicity).

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable for the same reason as above.

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The Biodesign Otologic Repair Graft is intended for use as an implant to aid in surgical repairs and as an adjunct to aid in the natural healing process in various otologic procedures, including but not limited to myringoplasty and tympanoplasty. The device is supplied sterile and is intended for one-time use.

The Biodesign Otologic Repair Graft is an absorbable multi-layer biomaterial composed of four layers of laminated extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). The SIS material is lyophilized and then punched into the desired shape. The device is available in 4 mm, 6 mm and 9 mm diameter discs, as well as 2.5 x 2.5 cm and 5 x 5 cm square sheets. Upon implantation, the Biodesign Otologic Repair Graft is infiltrated by the host cells and acts as a scaffold for these cells during the body's natural repair process.

Additionally, the circular configurations of the device are packaged in a dried state and supplied sterile in a tray inside a sealed Tyvek® pouch. The square configurations of the device are also packaged sterile in a dried state inside a sealed Tyvek® pouch.

The provided text describes the Biodesign Otologic Repair Graft and its substantial equivalence to predicate devices, but it does not contain the specific information required to complete the detailed table about acceptance criteria and study design for a device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing devices rather than defining and proving acceptance criteria with specific performance metrics and a detailed study design as might be seen for a novel device or PMA.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information/Cannot be extracted:

The document focuses on substantial equivalence based on material properties, biocompatibility, and clinical outcomes, rather than specific, quantified acceptance criteria for novel performance claims. For example, while mechanical strength was tested, the acceptance criterion (e.g., "burst strength must exceed X MPa") is not provided, only the qualitative statement that it was "adequate." Similarly, for efficacy, there's no explicitly stated acceptance criteria (e.g., "myringoplasty success rate must be >90%") before the study results are presented.

2. Sample Size for the Test Set and Data Provenance

• Biocompatibility Tests: The exact number of samples used for each test (genotoxicity, cytotoxicity, etc.) is not specified. The tests were performed on "sterilized SIS devices," which are identical in composition to the Biodesign Otologic Repair Graft.
• Mechanical Testing (Burst Strength): The sample size is not specified.
• Animal Testing:
  • Efficacy study: Chinchilla model (number of animals not specified).
  • Implant study: Mouse model (number of animals not specified).
• Clinical Testing (Prospective Data):
  • Primary Study: 404 patients (217 SIS repairs, 215 temporalis fascia (PTF) repairs).
  • Data Provenance: The study was conducted by D'Eredita, but the country of origin is not explicitly stated. The material was labeled as "Surgisis." The comparison was made against "temporalis fascia (PTF) repairs performed by the same surgeon," implying a clinical setting. The follow-up was 2-11 years (average 7.7 years).
  • Additional Unpublished Data:
    • a) 18 patients (Hsu, DuPage Medical Group, 2015)
    • b) 19 patients (Toh C. et al., Birmingham Heartland Hospital, UK, 2003) - UK origin.
    • c) 32 patients (Ofo E. et al., North West London Hospital, UK, 2009) - UK origin.
    • d) 8 patients (Lalwani A. San Francisco, CA, COSM 2003) - USA origin.
  • Retrospective/Prospective: The 404-patient study is explicitly called "Prospective data." The additional data are referred to as "unpublished data" but their specific prospective/retrospective nature is not detailed.

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

• This information is not provided. Clinical outcomes (e.g., stable tympanic membrane closures, adverse events) would have been assessed by treating physicians, but the document does not detail a specific expert panel/adjudication process for establishing ground truth for the clinical studies mentioned.

4. Adjudication Method for the Test Set

• This information is not provided. For clinical outcomes, the treating surgeon or independent clinicians would typically assess post-operative results, but no specific adjudication method (like 2+1 consensus) is outlined.

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

• No, an MRMC comparative effectiveness study was not done. The clinical studies reported involved a comparison of the device material (SIS) with autologous tissue repair (temporalis fascia) or comparison to a predicate in an animal model, and observations of patient outcomes. These are not MRMC studies as typically understood for AI device assessments involving multiple readers evaluating cases with and without AI assistance to measure reader improvement.

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

• This is not applicable. The Biodesign Otologic Repair Graft is a physical medical device (implantable biomaterial), not an AI algorithm or software device. Therefore, a "standalone algorithm performance" study is not relevant to this product.

7. The Type of Ground Truth Used

• Biocompatibility: In vitro and in vivo test results against ISO 10993-1 standards.
• Mechanical Testing: Measured burst strength.
• Animal Testing: Histological assessment of cellular response and device degradation (observations by researchers), and efficacy observations in chinchilla tympanic membrane repair.
• Clinical Testing: Clinical outcomes data (e.g., stable tympanic membrane closures, occurrence/absence of adverse reactions/events) observed post-operatively by treating physicians or study investigators. This would be considered outcomes data or clinical expert observation.

8. The Sample Size for the Training Set

• This is not applicable. The Biodesign Otologic Repair Graft is a physical medical device (biomaterial), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device itself is manufactured using a specific process and its properties are inherently defined by its material and design, not by being "trained" on data.

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

• This is not applicable for the reasons stated in point 8.

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