(286 days)
Collagen Dental Wound Dressings are indicated for the management of oral wounds and sores, including:
- Denture sores
- Oral ulcers (non-infected or viral)
- Periodontal surgical wounds
- Suture sites
- Burns
- Extraction sites
- Surgical wounds
- Traumatic wounds
Collagen Dental Wound Dressings are absorbent, porous, collagen matrices engineered from purified collagen derived from bovine dermis tissue. The Collagen Dental Wound Dressings are applied directly to the wound and protect the wound and delicate new tissue. Collagen Dental Wound Dressings can be removed, replaced or left in situ. If left in situ the dressings will be essentially resorbed in 30 days. Collagen Dental Wound Dressings are available in tape, sponge and plug form, and are supplied sterile, non-pyrogenic and for single use only.
The provided text describes a 510(k) premarket notification for "Collagen Dental Wound Dressings" (K152600). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a comparative effectiveness study or a comprehensive study with human readers.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Strict "acceptance criteria" as would be set for a clinical trial with specific performance metrics (e.g., sensitivity, specificity for diagnostic devices, or specific clinical outcomes for therapeutic devices) are not explicitly stated in this 510(k) summary. Instead, the focus is on demonstrating "substantial equivalence" of the Collagen Dental Wound Dressings to its predicate devices by comparing technical characteristics and showing similar in vitro and in vivo performance in non-clinical tests.
The criteria for demonstrating substantial equivalence are implicitly that the new device performs comparably to the predicate devices in various tests.
| Parameter | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (Collagen Dental Wound Dressings) |
|---|---|---|
| Material | Purified Collagen (similar to predicate) | Purified Collagen |
| Collagen Source | Bovine Dermis (similar to K142712 predicate) / Porcine Tendon (K122115) | Bovine Dermis |
| Form | Porous Collagen Matrix (similar to predicate) | Porous Collagen Matrix |
| Color | White to off-white (similar to predicate) | White to off-white |
| Shapes | Rectangular and Cylindrical (similar to predicate) | Rectangular and Cylindrical |
| Sizes | Specific sizes (25x75x1mm, 20x40x3mm, 10mm(ID) x 20mm(L)) (similar) | Specific sizes (25x75x1mm, 20x40x3mm, 10mm(ID) x 20mm(L)) |
| Absorbency | Absorbs local wound fluids upon application (similar) | Absorbs local wound fluids upon application |
| Biocompatibility | Biocompatible (similar to predicate) | Biocompatible |
| Pyrogenicity | Non-pyrogenic (similar to K122115 predicate) | Non-pyrogenic |
| Cytotoxicity | Non-cytotoxic (similar to predicate expectations) | Non-cytotoxic |
| Sensitization | No evidence of causing delayed dermal contact sensitization | No evidence of causing delayed dermal contact sensitization |
| Intracutaneous Reactivity | No erythema or edema from the extract injected intracutaneously | No erythema or edema from the extract injected intracutaneously |
| Residues | Within acceptable limits (similar to predicate expectations) | Within acceptable limits |
| pH | pH similar to predicate device | pH similar to predicate device |
| Hydrothermal Transition Temp. | Hydrothermal transition temperature similar to predicate device | Hydrothermal transition temperature similar to predicate device |
| Viral Inactivation | Viral inactivation demonstrated (similar to predicate expectations) | Viral inactivation study performed |
| Resorption | Resorption profile comparable to predicate device (in animal model) | Resorption study conducted in rat model |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" in this context refers to the samples used in the non-clinical tests (e.g., materials for in vitro characterization, animals for biocompatibility and resorption studies). The document does not specify exact sample sizes for each test. For example:
- In vitro characterization: The number of samples for each test (Composition, Dimensions, Thickness, Density, Weight, Absorbency, pH, Hydrothermal transition temperature) is not specified.
- Biocompatibility:
- Cytotoxicity: Not specified.
- Sensitization: "Guinea Pig Maximization" – typically involves a group of guinea pigs, but the exact number is not stated.
- Intracutaneous Reactivity: "Intracutaneous Study in Rabbits" – typically involves a group of rabbits, but the exact number is not stated.
- Pyrogenicity: "USP (151) Rabbit Pyrogen Study" – typically involves a few rabbits (e.g., 3-8), but the exact number is not stated.
- Resorption study: "rat subcutaneous model" – typically involves a group of rats, but the exact number is not stated.
- Viral inactivation study: Not specified how many samples/batches were tested.
Data Provenance: The data comes from non-clinical laboratory studies (in vitro and in vivo animal models). The document does not mention any human data (retrospective or prospective) for these tests. The country of origin for these specific tests is not stated but implied to be part of the manufacturer's R&D process, likely within the USA given the submission to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical testing. "Ground truth" established by human experts (e.g., radiologists, pathologists) is relevant for studies involving human data or diagnostic imaging. The "results" of these non-clinical tests are determined by standard laboratory methods and validated interpretations of those methods.
4. Adjudication Method for the Test Set
This information is not applicable for non-clinical laboratory testing. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies or studies evaluating diagnostic performance where independent reviewers assess cases, and discrepancies are resolved. The tests described here have objective outputs determined by the experimental protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the performance of human readers, sometimes with and without AI assistance, on a set of cases. The document describes a medical device (wound dressing) and its non-clinical characteristics, not a diagnostic or AI-enabled device requiring such a study.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this refers to a medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by the results of the standardized scientific tests themselves (e.g., an in vitro lab test concludes "Non-cytotoxic," an animal study shows "No evidence of causing delayed dermal contact sensitization"). These are objective measurements and observations determined by established methodologies rather than expert consensus, pathology reports (from human patients), or clinical outcomes data.
8. The Sample Size for the Training Set
This refers to a training set for machine learning models. Since this document is for a physical medical device (collagen wound dressings) and not an AI/ML product, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML model, this question is not applicable.
N/A