(137 days)
The ACell UBM Hydrated Wound Dressing is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.
The ACell UBM Hydrated Wound Dressing is primarily composed of porcine collagen and is supplied sterile in single sheet sizes ranging from 2 x 4 cm to 14 x 20 cm
This 510(k) summary for the ACell UBM Hydrated Wound Dressing does not contain detailed acceptance criteria or a specific study proving the device meets those criteria in the traditional sense of a clinical trial with statistical endpoints. Instead, it relies on demonstrating substantial equivalence to predicate devices through biocompatibility and performance testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, no explicit table of acceptance criteria or quantified performance metrics are provided in the document. The statement "It passed the requirements of all tests and was shown to be safe and effective as a wound dressing" is the only indication of performance and acceptance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for performance evaluation. It only mentions "a number of tests" were conducted for biocompatibility and performance. There is no information about the sample sizes for these tests, the type of data (e.g., in vitro, animal, human), or its provenance (country of origin, retrospective/prospective). This is typical for 510(k) submissions that rely on substantial equivalence to predicate devices rather than new clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There is no mention of a "test set" requiring expert ground truth establishment for this type of device submission. The evaluation appears to be based on laboratory testing.
4. Adjudication Method for the Test Set
Not applicable. There is no information to suggest any adjudication method was used for a clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through material characteristics and performance tests, not through comparative effectiveness with human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical wound dressing, not an algorithm or AI-based device. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this device appears to be established through:
- Biocompatibility testing: Conformance to established standards for biological safety, likely using in vitro and/or in vivo animal models.
- Performance testing: Evaluation of material properties and characteristics relevant to its function as a wound dressing (e.g., absorption, porosity, strength, sterility).
- Substantial equivalence to predicate devices: The primary "ground truth" for regulatory approval here is that the device is as safe and effective as legally marketed predicate devices (K993948, Cook Biotech, Inc., SIS Wound Dressing II and K943781, AcryMed, Inc., AcryDerm® Advanced Wound Dressing).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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