(49 days)
Collatek Sheet may be used in the management of:
- Partial and full thickness wounds
- Pressure (stage 1-1V) and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Venous stasis and diabetic ulcers
- 1st and 2nd degree burns
- Cuts, abrasions and surgical wounds
Collatek® Shect is a stcrile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Collatek® Sheet is packaged as a sclfadhering island dressing which is able to conform to most wound sites. Collatek® Sheet consist of a hydrocolloid sheet with a clear adherent medical tape backing on one side and a peel-off silica-coated paper on the other. It is to be used manage full and partial thickness wounds with light exudate.
The provided 510(k) summary for the "Collatek® Sheet" wound dressing primarily focuses on establishing substantial equivalence to predicate devices through comparisons of design, function, materials, and intended use. It does not describe a study that involves acceptance criteria and device performance in the way typically expected for a detailed clinical or performance study report.
Instead, the submission states:
"Bench testing was performed to verify that the performance characteristics of Collatek® Sheet are comparable to the currently marketed predicate device. Collatek® Sheet is designed to absorb light amounts of exudates while forming a protective gelatinous barrier. The collagen helps to protects the wound bed and newly formed granulation tissue by formation of an occlusive gelatinous barrier that is conducive to wound healing."
And regarding safety:
"Biocompatibility texting has confirmed that Collatek(s) Sheet meets requirement as stated in the FDA Blue Book Memorandum G95-J and in ISO10993. Biocompatibility tests were performed by North American Science Associates, Inc. (NAmSA) in accordance with GLP. Biocompatibility data has shown that Collatek® Sheet is safe for use as a medical device for wound care management and is substantially equivalent to the commercially available predicate devices (Cutinova® hydro and DuoDerm® CGF)."
Given the information provided, I cannot populate the table or answer most of your specific questions related to acceptance criteria and a study proving its performance against those criteria, as the document details a substantial equivalence claim based on comparison to existing devices and bench testing/biocompatibility rather than a direct performance study with defined acceptance criteria and clinical outcomes.
Here's what can be inferred or explicitly stated based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Performance | Comparability to predicate device performance characteristics | "Bench testing was performed to verify that the performance characteristics of Collatek® Sheet are comparable to the currently marketed predicate device." |
| Design to absorb light amounts of exudates | "Collatek® Sheet is designed to absorb light amounts of exudates..." | |
| Design to form a protective gelatinous barrier | "...while forming a protective gelatinous barrier." | |
| Collagen to protect wound bed and granulation tissue | "The collagen helps to protects the wound bed and newly formed granulation tissue by formation of an occlusive gelatinous barrier that is conducive to wound healing." | |
| Biocompatibility | Meets requirements of FDA Blue Book Memorandum G95-J and ISO10993 | "Biocompatibility texting has confirmed that Collatek(s) Sheet meets requirement as stated in the FDA Blue Book Memorandum G95-J and in ISO10993." |
| Sterility | Sterilized to an SAL value of 10-6 | "Collatek®Sheet will be stcrilized to an SAL value of 10-6" |
| Sterilization process validated per ANSI/AAMI/ISO1137 | "The sterilization process will be validated using ANSI/AAMI/ISO1137 guidelines." | |
| Substantial Equivalence | Equivalence in design, function, materials, and intended use to predicate devices. | "Collatek® Sheet is equivalent in design, function, materials and intended use and is therefore substantially equivalent to the commercially available predicate devices: (Cutinova® hydro and DuoDcrm® CGF)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Provided: The document mentions "bench testing" and "Biocompatibility tests" but does not specify sample sizes for these tests or the data provenance.
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)
- Information Not Applicable/Provided: This type of information is typically relevant for studies involving human judgment (e.g., image interpretation, clinical assessment). The described "bench testing" and "biocompatibility testing" are laboratory evaluations, not dependent on expert ground truth in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information Not Applicable/Provided: Adjudication methods are typically used in clinical trials or studies where human assessment is involved. This is not described for the bench or biocompatibility testing mentioned.
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 type of study is not mentioned or implied in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information Not Applicable/Provided: The device is a wound dressing, not an algorithm or AI. Standalone performance as an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For bench testing: The "ground truth" would be established by validated test methods and physical/chemical properties, measured against established standards or predicate device performance.
- For biocompatibility testing: The "ground truth" is adherence to specific ISO standards (ISO10993) and FDA guidelines (FDA Blue Book Memorandum G95-J), assessed through specific laboratory assays (e.g., cytotoxicity, sensitization, irritation).
- No clinical ground truth (expert consensus, pathology, outcomes data) derived from patient studies is described in this 510(k) summary.
8. The sample size for the training set
- Information Not Applicable/Provided: The device is a physical wound dressing, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Information Not Applicable/Provided: As above, this is not relevant for this type of device.
N/A