(150 days)
ologen™ Collagen Matrix is intended for the management of wounds including: surgical wounds, trauma wounds, second degree burns, partial and full-thickness wounds, pressure ulcers, venous ulcers, vascular ulcers, diabetic ulcers, oral wounds and sores.
ologen™ Collagen Matrix (K173223) proposed device has 9 models which differ in sizes and shapes but with the same composition. Different specifications are all intended for wound dressing. Which specification should be applied is determined by the physician according to the size, depth, location, type of wound and his/hers preference. The lists the specifications and shapes of all 9 models refer to Instruction for Use.
single-use sterile
Environment of Use: healthcare facility/hospital
ologen™ Collagen Matrix is a biodegradable material composed of collagen. It is indicated for the management of wounds. ologen™ Collagen Matrix is obtained from porcine hide and the matrix structure has a porous configuration made of ≥90% cross-linked lyophilized porcine collagen and
The provided text describes the 510(k) premarket notification for the "ologen™ Collagen Matrix" device. This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to existing predicate devices.
However, the provided text does not describe a study involving a device that uses artificial intelligence or machine learning. The "ologen™ Collagen Matrix" is a medical device for wound management, consisting of a collagen matrix. The performance data section describes standard biological and material characteristic tests rather than performance metrics for an AI/ML algorithm.
Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the device described in the input.
The document details performance data related to material characteristics and biocompatibility of the collagen matrix. Here's a summary of that information:
Summary of Performance Data for ologen™ Collagen Matrix (Non-AI/ML Device):
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Product Characteristics Tests: | |
| Hydroxyproline assay (Collagen concentration) | Met acceptance criterion of total protein concentration >90% collagen, same as predicate device. |
| pH value test (Semi-product) | Met acceptance criterion of pH value 7.0 ± 0.5. |
| Stability test (Microstructure) | No significant difference between samples stored under 40 ± 2°C at 0, 6, and 36 months. |
| Stability test (Optical) | No significant difference between samples stored under 40 ± 2°C at 0, 6, and 36 months. |
| Stability test (pH value) | No significant difference between samples stored under 40 ± 2°C at 0, 6, and 36 months. |
| Stability test (Water absorption ratio) | No significant difference between samples stored under 40 ± 2°C at 0, 6, and 36 months. |
| Stability test (Sterility) | No significant difference between samples stored under 40 ± 2°C at 0, 6, and 36 months. |
| Biocompatibility Tests: | |
| Pyrogen Test | Concluded that the proposed device was non-pyrogenic. |
| Implantation Study (Rabbits - Muscle, 12 wks) | After 12-week implantation, the device degraded, and histopathological evaluation showed no irritation reaction at the implantation site. |
| Hemolytic Properties Study | ologen™ Collagen Matrix extract had non-hemolytic potential in rabbit blood in vitro. |
| Cytotoxicity Study | ologen™ Collagen Matrix had no cytotoxic effect on L929 cells under the testing conditions employed. |
| Acute Systemic Toxicity Study (Mice) | ologen™ Collagen Matrix had no significant evidence of systemic toxicity from the test article extracts into ICR mice. |
| Skin Sensitization Study (Guinea Pig) | Classified as a non-sensitizer. |
| Skin Irritation (Intradermal reaction) | Classified as non-irritative. |
| Subchronic Systemic Toxicity | Test sample exhibited no subchronic systemic toxicity. |
Regarding the other requested points (AI/ML specific):
- Sample size used for the test set and data provenance: Not applicable to this device. The 'test set' here refers to samples of the collagen matrix itself for material and biological testing, not a dataset for an AI model.
- Number of experts used to establish the ground truth and qualifications: Not applicable. Ground truth for an AI model is not relevant here. The 'ground truth' for this device's performance comes from standardized biological and material science testing protocols.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an interpretive/diagnostic device.
- Standalone (algorithm only) performance: Not applicable, as there is no algorithm.
- Type of ground truth used: For this device, the "ground truth" refers to established scientific and regulatory standards for biocompatibility, material composition, and stability, as defined by international standards (e.g., ISO 10993) and pharmacopeial monographs (e.g., USP).
- Sample size for the training set: Not applicable, as there is no AI model to train.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the provided text describes a traditional medical device (collagen matrix wound dressing) and its regulatory submission, which focuses on demonstrating substantial equivalence to a predicate device through material characterization and biocompatibility testing, not AI/ML performance.
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