(279 days)
PELNAC™ Bilayer Wound Matrix is indicated for the management of wounds including:
- · partial and full-thickness wounds,
- · pressure ulcers,
- · venous ulcers,
- · diabetic ulcers,
- · chronic vascular ulcers,
- · 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.
PELNAC™ Bilayer Wound Matrix is a collagen-based wound matrix that consists of two layers: a porcine collagen sponge layer and a silicone film layer and is offered in two versions: 1. Meshed Type (i.e., fenestrated) and 2. Non-Meshed Type (i.e., non-fenestrated). The collagen sponge layer should be applied to the wound surface. Both versions of the device also contain a synthetic gauze material to add strength to the silicone film layer. When applied to full-thickness skin defects, PELNAC™ Bilayer Wound Matrix provides a scaffold for cellular invasion and capillary growth. PELNAC™ Bilayer Wound Matrix is offered in sheet form of various sizes and is provided terminally sterilized by ethylene oxide, is for single patient use, and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.
This document is a 510(k) premarket notification for the PELNAC™ Bilayer Wound Matrix. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving that an AI/software device meets specific performance acceptance criteria for diagnostic tasks.
Therefore, most of the requested information regarding acceptance criteria for AI/software, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable to this document. This submission is for a material device (wound matrix) and the "study" mentioned is a human repeat insult patch test (HRIPT) and a clinical follow-up for a tissue-based medical device.
However, I can extract information related to the device's safety and performance testing as presented in the document, which serves a similar role to "acceptance criteria" for a physical medical device.
Acceptance Criteria and Study for PELNAC™ Bilayer Wound Matrix
The "acceptance criteria" for this device are established through demonstrating its substantial equivalence to a legally marketed predicate device (AVAGEN Wound Dressing) and conformity to recognized standards and guidance. The "study" refers to non-clinical and clinical testing performed to support this claim.
1. Table of "Acceptance Criteria" and Reported Device Performance
Since this is a physical medical device and not an AI/software, the "acceptance criteria" are not reported as diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are related to biocompatibility, sterility, physical/chemical properties, and clinical safety/tolerance. The "reported device performance" indicates whether the device met these established safety and performance benchmarks.
| Acceptance Criteria Category (Derived from Testing Standards/Guidance) | Reported Device Performance / Evaluation Outcome |
|---|---|
| Material Safety (Biocompatibility) | |
| - Cytotoxicity (ISO 10993-5) | Performed; Results confirm design inputs met. |
| - Skin Sensitization (ISO 10993-10) | Performed; Results confirm design inputs met. |
| - Intracutaneous Reactivity (ISO 10993-10) | Performed; Results confirm design inputs met. |
| - Implantation (ISO 10993-6) | Performed; Results confirm design inputs met. |
| - Material-mediated Pyrogenicity (USP ) | Performed; Results confirm design inputs met. This is not explicitly listed under ISO 10993-1 in the table, but USP is listed separately under Sterilization, Packaging and Shelf Life. It is inferred to be part of the biological evaluation. |
| - Chemical Characterization (ISO 10993-18) | Performed; Results confirm design inputs met. |
| - Toxicological Risk Assessment (ISO 10993-17) | Performed; Results confirm design inputs met. |
| Viral Inactivation (for animal-derived materials) | Performed; Results confirm design inputs met. |
| Physical and Chemical Properties | Performed; Results confirm design inputs met. |
| Sterility (ISO 11135) | Performed; Results confirm design inputs met. |
| Packaging Integrity (ISO 11607-1, ASTM F1886) | Performed; Results confirm design inputs met. |
| Shelf Life (Stability over time) | 36 months; Deemed "Similar" to predicate (24 months). This difference was likely supported by stability data. |
| Usability (IEC 62366-1) | Performed; Results confirm design inputs met. |
| Risk Analysis (ISO 14971) | Performed; Results confirm design inputs met. |
| Immunogenicity/Irritation (Clinical) | None of 56 subjects developed irritation or sensitization; No adverse events related to the product demonstrated irritant or sensitizer activity. |
| Local Inflammatory Tissue Response (Clinical) | No reports of expanding erythema, edema, pain, vesicles, or other immune response, signaling removal of the dressing in 18 subjects with finger degloving injuries. Biopsy samples and histological analysis at 12 months showed no immune response. |
2. Sample Size Used for the Test Set and Data Provenance:
- Non-Clinical (In vitro/Bench/Animal Studies): The document states "final finished samples of PELNAC™ Bilayer Wound Matrix" were tested, but specific sample sizes for these tests (biocompatibility, physical/chemical, sterility, packaging) are not provided.
- Clinical Data:
- Human Repeat Insult Patch Test (HRIPT): 56 subjects.
- Finger Degloving Injuries Pilot Study: 18 subjects.
- Data Provenance: Not explicitly stated for all non-clinical tests. For the clinical studies:
- The HRIPT and the finger degloving study were likely conducted by or sponsored by the manufacturer (Gunze Limited), which is based in Japan. The document does not specify the country of origin for the clinical data points, nor whether they were retrospective or prospective studies, though the nature of HRIPT and follow-up studies typically implies a prospective design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This device is a material device, not an AI/software. There is no "ground truth" to be established by experts in the context of image interpretation or diagnostic accuracy. The "ground truth" for the clinical study would be observed physiological responses to the device (irritation, sensitization, healing, lack of adverse immune response), assessed by qualified medical professionals involved in the study (e.g., dermatologists for HRIPT, surgeons for the finger injury study). The number and qualifications of these medical professionals are not specified in the provided text.
4. Adjudication Method for the Test Set:
- Not applicable for this type of medical device submission. Adjudication methods are typically relevant for human reader studies or expert consensus for ground truth establishment in AI/software evaluations. Clinical observations for this device would be direct assessments by the treating/evaluating clinicians.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:
- No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging AI, not for a wound matrix medical device. The "clinical studies" described (HRIPT, finger degloving) are safety and performance studies for a material device, not diagnostic effectiveness studies comparing human readers with and without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used:
- For Biocompatibility and Physical/Chemical Testing: The "ground truth" is adherence to established international standards (e.g., ISO 10993 series) and internal specifications, derived from scientific understanding of material safety and performance.
- For Clinical Studies (HRIPT, Finger Degloving): The "ground truth" is direct clinical observation and objective measurement of patient responses (e.g., absence of skin irritation/sensitization, absence of specific immune responses, healing progression, histological analysis reports). This is based on outcomes data and clinical assessment by medical professionals.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth establishment for it.
N/A