(112 days)
CollaSorb™ Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including:
- Pressure ulcers .
- Diabetic ulcers
- Ulcers caused by mixed vascular etiologies
- Venous ulcers
- Second degree burns
- Donor and graft sites
- Abrasions
- Dehisced surgical wounds
- Traumatic wounds healing by secondary intention
CollaSorb™ wound dressing is a wound care product composed of a native collagen and calcium-alginate, which comes as a sterile, non-pyrogenic product for single use in a single pouch package.
CollaSorb 10 wound dressings are pliable, absorbent dressings that absorb moisture such as wound fluid by forming a soft, conformable moist gel sheet at the wound surface and thus maintaining a moist environment. Due to its excellent wet stability and elasticity the CollaSorb 100 wound dressing can easily be applied and fitted to the wounds and is also for the management of deep wounds.
The provided text describes a 510(k) submission for the CollaSorb Collagen Wound Dressing. A 510(k) submission is a premarket notification demonstrating that a medical device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not involve explicit acceptance criteria and a detailed study proving performance against those criteria in the same way a PMA (Premarket Approval) would.
Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device. This means showing that the new device has the same intended use as a legally marketed device and the same technological characteristics, or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness, and is as safe and effective as the predicate device.
Therefore, the information I can extract will be based on the comparison of the proposed device (CollaSorb™) to its predicate device (ColActive™), rather than a study with pre-defined acceptance criteria and performance metrics.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence, there are no "acceptance criteria" presented in the traditional sense of a clinical trial or performance study with numerical targets. Instead, the "acceptance criteria" are implied by the comparison to the predicate device, where the new device must be equally safe and effective. The "reported device performance" is the demonstration that the CollaSorb™ device shares similar technical characteristics and intended uses with the predicate.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported CollaSorb™ Performance |
|---|---|---|
| Indications for Use | Must be same as predicate: Management of full and partial thickness wounds including: |
- Pressure ulcers
- Venous ulcers
- Diabetic ulcers
- Ulcers caused by mixed vascular etiologies
- Second degree burns
- Donor and graft sites
- Abrasions
- Dehisced surgical wounds
- Traumatic wounds healing by secondary intention | Meets Predicate:
- Pressure ulcers
- Venous ulcers
- Diabetic ulcers
- Ulcers caused by mixed vascular etiologies
- Second degree burns
- Donor and graft sites
- Abrasions
- Dehisced surgical wounds
- Traumatic wounds healing by secondary intention |
| Material | Collagen / Sodium-Alginate (Predicate) | Differs Slightly: Collagen / Calcium-Alginate (but deemed substantially equivalent) |
| Biodegradable | Yes | Meets Predicate: Yes |
| Biocompatibility| In accordance with ISO 10993-1 | Meets Predicate: In accordance with ISO 10993-1 |
| Sterile | Yes - gamma radiation | Meets Predicate: Yes - gamma radiation |
| Sizes | 2 in x 2 in ($25 cm^2$), 4 in x 4 in ($100 cm^2$) | Meets Predicate: 2 in x 2 in ($25 cm^2$), 4 in x 4 in ($100 cm^2$) |
| Non-Pyrogenic | (Not explicitly stated for predicate in table, but implied good manufacturing practice) | Demonstrated: Yes (rabbit pyrogen test) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail a "test set" in the context of clinical data for performance evaluation. The submission relies on a comparison of technical characteristics and intended use to a predicate device. Thus, there were no clinical studies with a specific sample size, data provenance, or study design (retrospective/prospective) presented in this 510(k) summary for the CollaSorb™ device's performance against explicit criteria. The "rabbit pyrogen test" is mentioned for non-pyrogenicity, which is a laboratory test, not a clinical study on patients.
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)
Not applicable. This is not a study involving expert readers or ground truth establishment in a diagnostic or clinical efficacy context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.
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 collagen wound dressing, not an AI or diagnostic imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The substantial equivalence is based on technical characteristics and intended use, not on clinical ground truth in a study dataset.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an algorithm-based device.
9. How the ground truth for the training set was established
Not applicable.
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