(28 days)
The Pegasus Biologics Unite™ Biomatrix is a collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including:
- Partial and full thickness wounds, .
- Draining wounds, .
- Pressure sores/ulcers, ◆
- Venous ulcers, .
- . Chronic vascular ulcers,
- Diabetic ulcers, .
- Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), ●
- Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, . podiatric wounds, dehisced surgical incisions)
The Pegasus Biologics Unite™ Biomatrix is decellularized, equine pericardium. The Unite™ Biomatrix has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use.
Please note that the provided text describes a medical device called "Unite™ Biomatrix," which is a collagen-based wound dressing. It is not an AI/ML device, and therefore, many of the typical acceptance criteria and study details relevant to AI/ML device performance (like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training set details, etc.) are not applicable or present in this type of submission.
The document primarily focuses on establishing substantial equivalence to a predicate device for a wound dressing,
not on evaluating the performance of an algorithm.
Here's an analysis of the provided text based on your request, highlighting what is (and isn't) present:
Device Name: Unite™ Biomatrix
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a wound dressing that establishes substantial equivalence to a predicate device, the "acceptance criteria" are not reported in terms of specific performance metrics (like accuracy, sensitivity, specificity) for an AI/ML algorithm. Instead, the acceptance criteria are implicitly met by demonstrating equivalence in design, materials, manufacturing controls, and intended use. The "device performance" in this context refers to its
similarity to the predicate device.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as stated for "Unite™ Biomatrix") |
|---|---|
| Material Composition: Equivalence in base material and processing. | Decellularized, equine pericardium; crosslinked and exposed to liquid chemical sterilant. |
| Sterility: Meets standards for sterility. | Passed the USP sterility test. |
| Endotoxin Limit: Satisfies endotoxin limits for a medical device. | Satisfies FDA requirements for LAL endotoxin limit for a medical device. |
| Intended Use/Indications for Use: Equivalent to the predicate device. | "A collagen-based wound dressing for the local management of moderately to heavy exuding wounds, including: Partial and full thickness wounds, Draining wounds, Pressure sores/ulcers, Venous ulcers, Chronic vascular ulcers, Diabetic ulcers, Trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs' surgery, podiatric wounds, dehisced surgical incisions)" (Identical to predicate's indications). |
| Manufacturing Processes/Controls: Supplier qualification, receiving controls, and design verification demonstrate equivalence. | "Supplier qualification activities, receiving controls, and design verification testing demonstrate that the Unite™ Biomatrix device is equivalent to the predicate device in terms of design, performance and intended use." (K071425) |
| Safety and Effectiveness: No new questions of safety or effectiveness. | Implied by substantial equivalence to a legally marketed predicate (DermADAPT™ Wound Dressing, K061494). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable/not provided in the context of this 510(k) submission for a wound dressing. There is no "test set" in the sense of a dataset for an AI/ML algorithm. The equivalence is based on physical and chemical characterization, and comparison of design, materials, and intended use to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable/not provided as there is no "test set" or "ground truth" establishment in the context of an AI/ML algorithm. The evaluation is chemical and physical testing, and comparison to regulatory standards and a predicate device.
4. Adjudication Method for the Test Set
This information is not applicable/not provided for the same reasons as above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance for diagnostic tasks, which is not the nature of this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone performance study was not done. This concept is only applicable to AI/ML algorithms, which the Unite™ Biomatrix is not.
7. The Type of Ground Truth Used
Not applicable in the AI/ML sense. The "ground truth" for this device's acceptance would be defined by:
- Standardized chemical and physical testing results (e.g., USP sterility test, LAL endotoxin limit).
- Demonstration of material properties and design characteristics matching the predicate device.
- Compliance with general controls for medical devices.
8. The Sample Size for the Training Set
This information is not applicable/not provided as the device is not an AI/ML algorithm and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as above.
Summary of the Study:
The "study" described in the 510(k) submission for the Unite™ Biomatrix is not a clinical trial or an AI/ML performance study. Instead, it is a design verification and substantial equivalence demonstration study.
- Objective: To demonstrate that the Unite™ Biomatrix is substantially equivalent to the predicate device, DermADAPT™ Wound Dressing (K061494).
- Methodology: The submission focuses on comparing the new device to the predicate in terms of:
- Device Description: Both are decellularized equatorial pericardium, crosslinked, and liquid chemical sterilized.
- Material Composition: Equine pericardium.
- Performance Characteristics: Meeting USP sterility, satisfying FDA LAL endotoxin limits. The document states, "Supplier qualification activities, receiving controls, and design verification testing demonstrate that the Unite™ Biomatrix device is equivalent to the predicate device in terms of design, performance and intended use."
- Intended Use/Indications for Use: The indications for use listed are identical to those of the predicate device.
- Conclusion: The FDA reviewed the submission and determined the device to be substantially equivalent to the legally marketed predicate device for the stated indications for use. This determination allows the device to be marketed.
N/A