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The subject device is fish skin medical device indicated gingiva augmentation.
The subject device is obtained from cod fish skin by a standardized controlled manufacturing process and supplied in a peel-pouch terminally sterile packaging in the following rectangular sizes:

15mm x 20mm
20mm x 30mm
30mm x 40mm
The subject device becomes completely integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The physical properties of the subject device allow cellular ingrowth for augmentation of keratinized tissue.
The subject device is biocompatible, non-crosslinked, bioresorbable, strong, pliable and supports fixation by sutures.

AI/ML Overview

The provided text describes the Kerecis Gingiva Graft device, a collagen membrane intended for localized gingival augmentation. This is a 510(k) submission, meaning the device seeks clearance based on its substantial equivalence to a legally marketed predicate device, not necessarily on meeting quantitative acceptance criteria established by the FDA for novel devices.

Therefore, the information typically requested in questions 1 through 9 (acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets) is not applicable in the context of this 510(k) summary, as it describes a different type of regulatory submission process. The study presented here aims to demonstrate equivalence, not to quantify the device's performance against pre-defined thresholds.

However, I can extract information related to the "study that proves the device meets the acceptance criteria" in the context of proving substantial equivalence to the predicate device.

Here's the relevant information based on the provided text, reinterpreting "acceptance criteria" as "criteria for demonstrating substantial equivalence" for this 510(k) submission:

1. A table of (Substantial Equivalence) Criteria and the Reported Device Performance:

The document establishes substantial equivalence by comparing the Kerecis Gingiva Graft (subject device) to the MUCOGRAFT® Collagen Matrix (predicate device) and other reference devices across various characteristics and performance tests. Rather than explicit "acceptance criteria" with numerical thresholds, the "performance" is the demonstration of comparability or superiority to the predicate device.

Characteristic / Performance Element	Substantial Equivalence Criterion (Implicit)	Reported Device Performance
Intended Use	Same as, or subset of, predicate device.	"Subset of the intended use of the predicate device." (Kerecis: "a biocompatible, sterile collagen membrane intended for augmentation and regeneration of soft tissue in oral surgical settings." Predicate: includes broader indications like "guided tissue regeneration and multiple oral tissue defect regeneration in oral surgical settings.")
Indications for Use	Same as, or subset of, predicate device.	"Subset of the indications of the predicate device." (Kerecis: "Localized gingival augmentation to increase Keratinized tissue (KT) around teeth and implants." Predicate: includes this, plus "Covering of implants placed in immediate extraction sockets," "Alveolar ridge reconstruction for prosthetic treatment," and other GTR procedures.)
Regulation, Product Code, Class	Same as predicate.	"Same as predicate." (21 CFR 872.3930, NPL, Class II)
Biocompatibility	Meets ISO 10993 series standards. Comparable to predicate.	"Yes" (Same as predicate). Leveraged testing from applicant's own predicate devices (K190528 and K153364) for Cytotoxicity, Sensitization, Irritation, Acute/Subacute/Sub-chronic/Chronic Toxicity, Genotoxicity, Implantation, Materials-Mediated Pyrogenicity, Carcinogenicity.
NON-Pyrogenic	Yes.	"Yes" (Same as predicate). Endotoxin validation (<20 EU/device) per LAL turbidimetric kinetic method following ISO 10993-11.
Resorbable	Yes.	"Yes" (Same as predicate).
Sterilization & SAL	Validated sterilization method, SAL 10-6.	Ethylene Oxide sterilization with SAL 10-6. "Traditional Sterilization Method." Ethylene Oxide residual test following ISO 10993-7.
Shelf Life	Validated, comparable to predicate.	"3 years" (Same as predicate). Validated per ASTM F1980 and Q5C (R2)[ICH] using accelerated and real-time aged samples. Packaging per ISO 11607-series, ASTM F88 and ASTM F1886.
Animal Origin Material	Safe and suitable (via viral inactivation, etc.).	North Atlantic Cod fish: skin tissue, single layer sheet. Predicate is Porcine skin and connective tissue, double layer sheet. "Different animal source, same anatomical tissue." Viral inactivation per ISO 22422 series.
Morphology (H&E, SEM)	Rich in collagen, porous, favoring cellular infiltration, preserved collagen structure.	Both subject and predicate "rich in collagen and porous, therefore favoring cellular infiltration." SEM "shows equivalent preserved collagen structure." Cross section shows porous surfaces allowing tissue adherence and promoting cellular ingrowth.
Cellular Ingrowth	Favorable cellular infiltration in vitro.	Both materials "showed favorable cellular infiltration of fibroblasts after 14 days which is a key component for tissue augmentation and re-epithelization of defected keratinized tissue."
Tensile Strength	Comparable to predicate.	"Determined to be comparable to the predicate device measured by ultimate tensile strength."
Heavy Metal Analysis	Within ICH guidelines: Q3D Elemental Impurities.	Limits of cadmium (Cd), lead (Pb), arsenic (As), and mercury (Hg) were "acceptable under the ICH guidelines."
Stability (Simulated Physiological)	Stable in artificial saliva buffer, comparable to predicate's effect on pH/conductivity.	Buffer incubated with both products was "stable over time." Subject device "raises the pH slightly," predicate "decreases it slightly." Subject device "is structurally more stable than the predicate device since it dissolved slower than the predicate device at neutral pH 7."
Suture Pull-Out Strength	Meets or exceeds predicate with 95% confidence.	"Meets or exceeds that of the predicate with a confidence of greater than 95%." Deemed equivalent for oral surgery and gingival augmentation.
Pin Pull-Out Strength	Exceeds predicate with 95% confidence.	"Exceeds that of the predicate at a confidence level of greater than 95%." Deemed equivalent for oral surgery and gingival augmentation.
Compression	Compressive Peak-Load, Load-at-Break, Probe Penetration-at-Break, Energy-to-Break meet or exceed predicate with 95% confidence.	"Meet or exceed those of the predicate device, with a confidence of greater than 95%." Deemed equivalent for oral surgery and gingival augmentation.
User Evaluation (Cutting/Shaping)	Favorable usability, substantially equivalent to predicate.	Evaluated by four dental clinicians using questionnaire. "Showed a favorable usability that was substantially equivalent to the predicate for cutting and shaping the device for use as a dental barrier membrane." Assessed ease of placement, stability, robustness, handling satisfaction.
Animal (Canine) Study - Safety	Acceptable safety profile for the subject device.	"All animals remained in good general health throughout the duration of the study and gross pathological findings suggest an acceptable safety profile for the subject device."
Animal (Canine) Study - Efficacy	No statistically significant difference from predicate in key outcomes.	For all parameters (KT thickness, KT length, root coverage, inflammation, membrane degradation), "no statistically significant difference was detected between the subject and predicate devices after 90 days of healing." Both devices "were able to increase keratinized tissue around teeth."
Clinical Study - Safety	No adverse effects or complications.	"There were no adverse effects or complications during the duration of the clinical study."
Clinical Study - Efficacy	Increased KT, similar to predicate's published results, long-term stability.	"An increased in the in the width of the KT was noticed for all treated sites. This average gain has been reported as adequate to maintain long-term periodontal health." "The device showed stability as the KT slowly replaced the piscine xenograft." Results "similar to published results reported for the predicate device."

2. Sample sizes used for the test set and the data provenance:

Bench Testing: "representative products" used for various tests. Specific numbers for each test are not provided, only statements like "with a confidence of greater than 95%" (implying statistical analysis on a certain sample size).
Animal Study: 10 canines (3 terminated at 30 days, 3 at 60 days, 4 at 90 days). Data provenance: Preclinical testing in canines (implied prospective). No country of origin specified.
Clinical Study: 6 human individuals. Data provenance: Open label, noncomparative study (prospective). No country of origin specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Bench Testing (User Evaluation): Four "dental clinicians" evaluated the device for cutting and shaping. Their specific qualifications (e.g., years of experience, specialization) are not detailed.
Animal Study: Outcomes included "Histomorphometric measurements" and "Histological analysis." This implies expert pathologists/histologists reviewed the samples, but the number and qualifications are not specified.
Clinical Study: Ground truth was the observation of clinical outcomes (KT increase) by clinicians. The number and qualifications of the clinicians performing assessments in the clinical study are not specified beyond the study being "clinical."

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

No specific adjudication method is mentioned for any of the studies (bench, animal, or clinical). For a 510(k) submission focused on equivalence, such detailed adjudication methods are less commonly emphasized compared to novel device approvals.

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:

Not applicable. This device is a physical gingival graft, not an AI or imaging diagnostic device. Therefore, MRMC studies and the concept of human readers improving with AI assistance are not relevant to this product.

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

Not applicable. This device is a physical gingival graft. There is no "algorithm" or standalone software component. Its performance is inherent to its physical properties and biological interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Bench Testing: Laboratory measurements (tensile strength, compression, etc.), and subjective "user evaluation" feedback from dental clinicians.
Animal Study: Histomorphometric measurements (objective), histological analysis (pathology, expert interpretation), in vivo and postmortem measurements by periodontal probe.
Clinical Study: Clinical observations of "increased in the width of the KT" and overall "stability" reported by the study investigators/clinicians as outcomes data.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set" in the traditional sense for algorithm development. The "training" here would be the manufacturing process and quality control methods to ensure consistent device properties.

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

Not applicable for the same reason as point 8.

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