(161 days)
Symphony™ is indicated for use in the management of the following wounds:
- · partial and full-thickness wounds
- · pressure ulcers
- venous ulcers
- · diabetic ulcers
- chronic vascular ulcers
- · tunnelled / 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)
- draining wounds
Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular collagen matrix. The 4-ply rectangular devices are available in sizes up to 200 cm².
The provided text is a 510(k) summary for the device "Symphony™," a wound dressing. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on material, manufacturing, and performance characteristics, rather than evaluating an AI/ML medical device. Therefore, much of the requested information about acceptance criteria, ground truth, expert adjudication, MRMC studies, and training/test set details for AI/ML models is not present in this document.
However, I can extract the information related to the device's performance and the non-clinical testing performed to establish its substantial equivalence.
Here's an analysis of the provided text, addressing the points where information is available and noting where it is not:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table between the Symphony™ device (Subject Device) and the predicate device (Endoform® Topical Matrix). This table implicitly shows the acceptance criteria by listing the parameters and the expected range/value for both the subject and predicate devices.
| Parameter | Acceptance Criteria (Predicate / Subject Device) | Reported Device Performance (Symphony™ - Subject Device) |
|---|---|---|
| Indications for Use | Same as predicate | Same as predicate |
| Animal Origin | Ovine | Ovine |
| Tissue Type | Forestomach | Forestomach |
| Presentation - ply's | Predicate: 2-, 3-, 4-, 5-layers of OFM; Subject: 4 layers (OFM, OFM, GAG Foam, OFM) | Device are lugged and comprised of 4 layers as follows: OFM, OFM, GAG Foam, OFM |
| Presentation - sizes | Predicate: 1 cm² to 400 cm²; Subject: 2.5x2.5, 5x5, 10x10, 10x20 cm² | 2.5 cm x 2.5 cm, 5 cm x 5 cm, 10 cm x 10 cm, 10 cm x 20 cm |
| Thickness | Predicate: 1-ply ≥ 0.05mm, 2-ply ≥ 0.20mm, 3-ply ≥ 0.35mm, 4-ply ≥ 0.50mm, 5-ply ≥ 0.65mm; Subject: ≥ 0.35 mm | ≥ 0.35 mm |
| OFM Content (% total mass) | Predicate: 100% w/w; Subject: 55% - 80% w/w | 55% - 80% w/w |
| Final device moisture content (%w/w) | ≤30% w/w total mass | ≤30% w/w total mass |
| Collagen concentration of OFM (% total mass) | ≥70% w/w | ≥70% w/w |
| Onset Melt Temperature of OFM (°C) | 55-70 °C | 55-70 °C |
| Moisture content of OFM (% total mass) | 0.05 mg/g | >0.05 mg/g |
| OFM Basement membrane remnants (laminin) | Present | Present |
| OFM Fibronectin | Present | Present |
| DNA concentration of OFM (mg/g) | 0 | PI>0 |
| Suture Retention | ≥1.5 N | ≥1.5 N |
| Endotoxin |
N/A