(191 days)
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
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1 standards | Biodesign Otologic Repair Graft met biocompatibility requirements for genotoxicity, direct contact in vitro hemolysis, cytotoxicity, muscle implantation, acute intracutaneous reactivity, ISO sensitization, acute systemic toxicity, pyrogenicity, LAL endotoxins, and subchronic systemic toxicity. |
| Mechanical Strength (Burst Strength) | Adequate mechanical strength for application (Specific threshold not provided) | Biodesign Otologic Repair Graft "has adequate mechanical strength for its application" (specific values and comparison not detailed). |
| Efficacy (Myringoplasty & Tympanoplasty) | Effectiveness comparable to predicate device/autologous tissue repair for myringoplasty. | In a 404-patient study for myringoplasty, stable tympanic membrane closures were seen in 212/217 (97.2%) of SIS repairs (Biodesign material) compared to 204/215 (94.8%) of temporalis fascia (PTF) procedures. This difference was not statistically significant regarding procedural times. |
| Safety (Adverse Reactions) | No significant adverse reactions | No adverse reactions observed with SIS or PTF repairs in the 404-patient study. |
| "No significant adverse events were reported" in additional unpublished clinical data sets (18, 19, 32, and 8 patients). | ||
| Device Degradation/Host Response | Similar to predicate device MeroGel Otologic Pack | Mouse implant study showed Biodesign Otologic Repair Graft performed similarly to MeroGel Otologic Pack in terms of device degradation and non-inflammatory host responses. |
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.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.