(290 days)
- Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants;
- Covering of implants placed in immediate extraction sockets;
- Covering of implants placed in delayed extraction sockets;
- Covering of bone defects after root resection and removal of retained teeth; and
- Guided tissue regeneration procedures in periodontal and recession defects.
The subject device is an acellular resorbable fish dermal matrix, intended for use in periodontal surgical procedures to aid in soft tissue and bone regeneration. It is obtained from cod fish skin by a standardized controlled manufacturing process, and supplied in terminally sterile peel-pouch packaging in the following solid sizes:
- 15mm x 20mm
- 20mm x 30mm
- . 30mm x 40mm
It is biocompatible, non-cross linked, and therefore resorbable, strong, flexible, and supports fixation by sutures and pins.
This document is a 510(k) Premarket Notification from the FDA regarding the Kerecis® Oral device. It details the device's characteristics, intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence.
Based on the provided text, the device itself (Kerecis® Oral) is a biological material (acellular resorbable fish dermal matrix) used for various oral surgical procedures to aid in soft tissue and bone regeneration. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the bench testing and animal studies performed to demonstrate that the Kerecis® Oral device is substantially equivalent to existing predicate devices, thereby clearing it for market.
Here's an analysis of the provided information to answer your questions:
1. Table of acceptance criteria and the reported device performance
The document doesn't present a single, explicit "acceptance criteria" table with pass/fail thresholds for the entire device in the way a software or AI model might have. Instead, it outlines a series of tests performed on the material properties and functional characteristics of the Kerecis® Oral device and compares them to predicate devices. The "acceptance" is implied by demonstrating substantial equivalence.
Here's a table summarizing the comparison and performance points, where "acceptance" means demonstrating substantial equivalence or meeting/exceeding predicate device performance:
| Feature/Test | Acceptance Criteria (Implied: Substantial Equivalence to Predicate/Reference) | Reported Device Performance (Kerecis® Oral) |
|---|---|---|
| Technological Characteristics | ||
| Device Name | N/A (Identification) | Kerecis Oral |
| Regulation | 21 CFR 872.3930 (Bone Grafting Material) | 21 CFR 872.3930 (Same Regulation as Predicate) |
| Device Class | Class II | Class II (Same Class as Predicate) |
| Product Code | NPL | NPL (Same Product Code as Predicate) |
| Device Classification | Barrier, Animal Source, Intraoral | Barrier, Animal Source, Intraoral (Same Classification as Predicate) |
| Intended Use | Includes elements of predicate and reference devices, supported by performance testing. | Covers localized gingival augmentation, implant covering (immediate and delayed), bone defect covering, GTR. |
| Animal Origin Material | Similar origin to reference device (fish) or acceptable alternative to predicate (porcine). | Fish: skin tissue, single layer sheet (Same animal species as reference) |
| Biocompatibility | Yes (demonstrated per ISO 10993 series) | Yes (Biocompatibility testing performed per ISO 10993 series standards) |
| Non-Pyrogenic | Yes (demonstrated safe per ISO 10993 series) | Yes (Materials-mediated pyrogenicity safe per ISO 10993 series standard) |
| Tensile Strength | Comparable to predicate device (4.6 MPa for predicate) | 14.3 MPa (Meets/Exceeds tensile strength value of the predicate device per ASTM D638) |
| Resorbable | Yes | Yes (All devices are resorbable per comparative performance data) |
| Sizes | Equivalent to predicate/reference sizes (15x20mm, 20x30mm, 30x40mm) | 15x20mm, 20x30mm, 30x40mm (Equivalent sizes by dimensional analysis) |
| Sterilization | Traditional Sterilization Methods (EO or Gamma) | Ethylene Oxide (Traditional Sterilization Methods per ISO 11135 and ISO 11737-1. EO residual testing per ISO 10993-7) |
| Sterility Assurance Level (SAL) | 10^-6 | 10^-6 (Equivalent SAL per ISO 11137 and ISO 11737) |
| Shelf Life | 3 years | 3 years (Equivalent shelf life per ASTM F1980 and Q5C (R2)[ICH]) |
| Mode of Action | Fixation | Fixation (Equivalent mode of action per ANSI/AAMI/ISO 7198 and ASTM F-1839-08) |
| Performance Testing - Bench | ||
| Morphology Observation (H&E, SEM) | Rich in collagen, porous, favoring cellular infiltration, preserved collagen structure. | Rich in collagen and porous, favoring cellular infiltration. SEM shows equivalent preserved collagen structure. |
| Cellular Ingrowth Comparison (Fibroblast) | Favorable cellular infiltration after 14 days. | Favorable cellular infiltration of fibroblasts after 14 days. |
| Heavy Metal Analysis | Acceptable limits per ICH guidelines (Q3D Elemental Impurities). | Limits of Cd, Pb, As, Hg acceptable under ICH guidelines. |
| Dimensional Validation | Quality limits for capability index > 1.33. | All tested parameters met or exceeded the set goal (>1.33) on three lots. |
| Stability in Simulated Physiological Env. | Structurally stable compared to predicate, dissolves slower at neutral pH. | Structurally more stable than predicate, dissolved slower than predicate at neutral pH 7. |
| Suture Pull-Out Strength | Meets or exceeds predicate with >95% confidence. | Meets or exceeds predicate with >95% confidence (Consistent with ANSI/AAMI/ISO 7198). |
| Pin Pull-Out Strength | Exceeds predicate with >95% confidence. | Exceeds predicate with >95% confidence (Consistent with ASTM F-1839-08). |
| Compression (Peak-Load, Load-at-Break, etc.) | Meet or exceed predicate with >95% confidence. | Meet or exceed predicate with >95% confidence (Consistent with ASTM-F-1306). |
| User Evaluation (Cutting and Shaping) | Favorable usability, substantially equivalent to predicate. | Favorable usability, substantially equivalent to predicate for cutting and shaping (via questionnaire). |
| Packaging | Compliant with ISO 11607-series, ASTM F88 and ASTM F1886. | Compliant. |
| Animal Origin and Viral Inactivation | Compliant with ISO 22422 series. | Compliant. |
| Performance Testing - Animal | ||
| New Bone Formation, Xenograft Resorption, Soft Tissue Infiltration | No qualitative or significant differences compared to predicate. | No noticeable or significant differences between the two membranes at any time point (Histologic and micro-CT volumetric analysis). |
2. Sample sizes used for the test set and the data provenance
- Bench Testing: The specific sample sizes for each bench test (e.g., number of samples for tensile strength, compression, dimensional validation) are not explicitly stated in the provided text. It mentions "representative product samples" and "three lots" for dimensional validation. The provenance is implied to be laboratory testing of the manufactured Kerecis® Oral device.
- Animal Testing: The sample size for the animal study is a "canine (beagle bilateral mandibular bony defect model)." This implies multiple beagle dogs, but the exact number is not specified. The study was conducted in AAALC accredited facilities in compliance with GLP (Good Laboratory Practices) 21 CFR §58, suggesting a controlled, prospective study. The location (country) is not specified, but GLP compliance implies a rigorous study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- For the animal study, the evaluation involved "gross pathology and histological, and quantitative micro-CT volumetric analysis." This type of analysis would typically be performed by veterinary pathologists and possibly radiologists/imaging specialists. However, the number and specific qualifications of these experts are not mentioned in the text.
- For the user evaluation of cutting and shaping, it was done "using a questionnaire." This implies that "ground truth" was established by user feedback, not by experts in the context of diagnostic accuracy. The number and qualifications of these users are not stated.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None explicitly mentioned. For the animal studies, "no qualitative or significant differences was observed" suggests direct comparison by the evaluators rather than an explicit adjudication process among multiple independent reviewers, though this is not definitively stated. For the bench tests, the data itself (e.g., tensile strength, dimensional measurements) would be objective, not typically 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
- No, an MRMC comparative effectiveness study was not done. This product is a biological medical device (a tissue graft), not a diagnostic AI device that assists human readers. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm. The "performance" assessment is based on its material properties and biological interaction in an in vitro and in vivo (animal) setting, not an algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For Bench Testing: The "ground truth" is defined by objective material property measurements (e.g., tensile strength in MPa, dimensional measurements in mm, pH and conductivity values) and established international standards (e.g., ISO, ASTM, ICH).
- For Animal Testing: The "ground truth" was established through histologic and micro-CT volumetric analysis of animal tissues collected at different time points post-surgery. This involves pathological assessment (histology) and quantitative imaging analysis (micro-CT) to assess bone formation, xenograft resorption, and soft tissue infiltration. While the specific experts aren't named, this is a form of expert assessment of biological outcomes.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established
- Not applicable. As a physical device, there is no "training set" or "ground truth for the training set."
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.