(84 days)
The device is intended for the management of minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.
CoMatryx OTC Collagen Wound Dressing is a native bovine Type I Collagen which, when applied to a wound surface in powder or pad form, absorbs wound fluid and maintains a moist wound environment. The CoMatryx OTC powder and pads are provided sterile in the following configurations:
- . 1 gram powder in 1 pouch
- 2"x2," 3"x4," and 8"x12" pad in pouch
The provided text describes a 510(k) premarket notification for a medical device called "CoMatryx OTC Collagen Wound Dressing." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable (N/A) in the context of this 510(k) submission.
Here's why and what information is provided:
- 510(k) Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is "substantially equivalent" to a predicate device already on the market. This often means demonstrating similar technological characteristics, intended use, and performance, with little to no new safety or effectiveness concerns. It does not typically involve the rigorous performance studies, human-in-the-loop assessments, or detailed ground truth establishment associated with AI/ML device approvals or PMAs.
- Focus on Bench Testing and Biocompatibility: For devices like wound dressings, the evidence typically relies on bench testing (e.g., sterilization, shelf life, physical properties) and biocompatibility testing, rather than studies involving human readers or complex algorithms.
Based on the provided document, here's what can be extracted and why the requested information is N/A:
1. A table of acceptance criteria and the reported device performance
| Parameter / Acceptance Criteria | Reported Device Performance | Rationale for N/A |
|---|---|---|
| Acceptance Criteria for Clinical Performance | N/A - Not Applicable | The submission is for substantial equivalence to a predicate device, not for proving clinical efficacy against specific performance metrics directly. The performance is assessed by comparison to the predicate. |
| Device Performance (Clinical/Algorithmic) | N/A - Not Applicable | No clinical performance data (e.g., accuracy, sensitivity, specificity for a diagnostic device, or wound healing rates) is provided or required for this type of submission beyond demonstrating equivalence to the predicate. |
Instead, the document highlights parameters compared to the predicate device:
| Parameters | Subject Device CoMatryx OTC Collagen Wound Dressings | Predicate Device Cellufil and Cellusheet Wound Dressings K213092 |
|---|---|---|
| Manufacturer | Strukmyer Medical LLC | Human Biosciences Inc. |
| Intended Use | Management of wounds | Management of wounds |
| Indications for Use | Management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns | Management of minor cuts, minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns. |
| Product Code | KGN | KGN |
| Device Class | Unclassified | Unclassified |
| Rx or OTC | OTC | OTC |
| Physical Shape | Powder and Pads | Powder and Pads |
| Usage | Single patient use only | Single patient patient use only |
| Package Sizes | 1 gram in 1 pouch, 2"x2", 3"x4", 8"x12" pads | 1 gram in 1 pouch, 2"x2", 3"x4", 8"x12" pads |
| Product Description | Type I Bovine Collagen | Type I Bovine Collagen |
| Animal Tissue | Dermis | Dermis |
| Sterilization Method | E-Beam. Product supplied sterile. | E-Beam. Product supplied sterile. |
| Storage Condition | Store in a cool and dry space | Store in a cool and dry space |
| Shelf Life | Powder - 36 months, Pads - 48 months | 60 months |
The conclusion states: "Comatryx OTC Collagen Wound Dressings are identical to the predicate device except for the indications for use; therefore, testing from K171645 applies to this device." This implies that prior testing for the predicate device (K171645) supported its safety and effectiveness, and since the current device is "identical except for indications," that prior testing is considered sufficient.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: N/A - No clinical "test set" in the context of an AI/ML or comparative clinical performance study is described. The relevant data for a wound dressing is likely bench testing (sterilization, physical properties, biocompatibility).
- Data Provenance: N/A - Not applicable for this type of submission.
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)
- N/A - Not applicable. This type of ground truth establishment by experts is relevant for diagnostic devices, particularly those involving image interpretation (e.g., radiology AI). This wound dressing device does not involve such an assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A - Not applicable. No expert adjudication process is described or required for this type of device submission.
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
- N/A - Not applicable. This device is a collagen wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A - Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A - Not applicable. The "ground truth" for a wound dressing focuses on its material properties, biological compatibility, and ability to maintain a moist wound environment, typically demonstrated through in vitro and in vivo (animal, not human clinical trials unless specifically deemed necessary for a novel claim) testing, rather than clinical outcomes data or expert consensus on interpretations. The submission relies on "comparison of the composition, technological characteristics, intended use and biocompatibility test results" to a predicate.
8. The sample size for the training set
- N/A - Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- N/A - Not applicable. As above, this device is not an AI/ML algorithm.
N/A