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510(k) Data Aggregation
(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) | <30% w/w | <30% w/w |
| Total Sulphated GAGs' concentration of OFM (mg/g) | >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) | <2.1 mg/g | <2.1 mg/g |
| GAG foam (% total mass) | Predicate: Not applicable (0%); Subject: 20% - 45% w/w | 20% - 45% w/w |
| Permeability (Permeability Index, PI) | PI>0 | PI>0 |
| Suture Retention | ≥1.5 N | ≥1.5 N |
| Endotoxin | <20 EU/device | <20 EU/device |
| EDTA Residuals (mg/kg) | <11000 mg/kg | <11000 mg/kg |
| TX-100 Residuals (mg/kg) | <15700 mg/kg | <15700 mg/kg |
| Bioburden | <1000 CFU/device | <1000 CFU/device |
| Laminate Stability | Predicate: Hydrated device does not delaminate after 5 minutes of handling; Subject: Hydrated device maintains laminate integrity after 10 minutes hydration and continuous handling | Hydrated device maintains laminate integrity after 10 minutes hydration and continuous handling |
| Modulus of elasticity | <0.1 GPa | <0.1 GPa |
| Rehydration Time (seconds) | < 5 min (300 seconds) | < 5 min (300 seconds) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench testing conducted," "Performance and validation testing executed based on risk analysis of the design changes," and "Results of the testing confirms that the proposed device meets all product specifications." It also lists biocompatibility testing conducted "in accordance with ISO 10993-1."
No specific sample sizes for these tests are provided.
The data provenance (country of origin, retrospective/prospective) is not mentioned.
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)
This is not applicable as this document does not describe a study involving expert review for a diagnostic AI/ML device. The "ground truth" for this device's performance relies on various physical, chemical, and biological laboratory tests and measurements, comparing it against established product specifications and the predicate device's characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document describes non-clinical performance and validation testing of a medical device, not a study evaluating human reader performance or AI output 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 is a 510(k) submission for a wound dressing, not an AI/ML diagnostic or assistive device. No human reader studies are described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm. The "standalone performance" of the device itself (Symphony™ wound dressing) was assessed through the non-clinical and biocompatibility tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is defined by:
- Predicate Device Characteristics: Many parameters are compared directly to the predicate device's known characteristics.
- Established Product Specifications: The device met "all product specifications for the intended use." These specifications would be derived from regulatory requirements, industry standards, and the known performance of similar devices.
- ISO 10993-1 Standards: Biocompatibility testing followed this international standard, implying its criteria served as the ground truth for safety.
- Risk Analysis: Performance and validation testing was "executed based on risk analysis of the design changes," meaning criteria were set to mitigate identified risks.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it in this document.
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