(262 days)
SynePure™ Wound Cleanser is intended for the cleansing and rinsing of dermal wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor irritations of the skin.
SynePure is a biocompatible, cleansing solution that is intended for rinsing and cleansing dermal wounds through irrigation. The solution is preserved and provided in flexible low density polyethylene (LDPE) bottles with a nozzle spray top to allow for easy delivery of a stream of liquid to remove dirt, debris and contamination from a wound. A screw cap is used to secure the device when not in use. The cap/bottle assembly is sealed with a strip to indicate tampering.
The wound cleanser is supplied as 125mL single-use or 250mL multiple-use bottle. The mechanical action of fluid moving across the wound provides for the mechanism of action to aid in the removal of foreign objects, such as dirt and debris, from the wound.
This document is a 510(k) premarket notification for a medical device (SynePure Wound Cleanser). It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria and results typical for a completely novel device or an AI/software as a medical device (SaMD).
Therefore, much of the requested information regarding acceptance criteria, study design for ground truth establishment, expert adjudication, MRMC studies, standalone performance, and training set details for AI/SaMD is not applicable to this document. This document describes a relatively simple wound cleanser, not an AI-powered diagnostic or predictive tool.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
Based on the document, two performance data points are mentioned, which could be interpreted as meeting certain criteria. However, explicit numerical acceptance criteria are not stated.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Minimum duration of fluid spray from the bottle | "exceeds a minimum duration of delivery" |
| Percentage of solution delivered from the bottle (e.g., >X%) | "greater than 90% of the solution is delivered from the bottle" |
| Biocompatibility: Cytotoxicity | "device is not cytotoxicity" |
| Biocompatibility: Sensitization (delayed-type hypersensitivity) | "show no sensitization" (not sensitizing) |
| Biocompatibility: Acute systemic toxicity | "no abnormalities in all animals" (no acute systemic toxicity) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Performance Data (Spray Duration, Solution Delivered): Not specified.
- Sample Size for Biocompatibility Testing: Not specified for individual tests. For acute systemic toxicity, it mentions "all animals," implying a group of animals, but the exact number is not given.
- Data Provenance: Not specified. The testing was done by Synedgen, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical wound cleanser, not an AI or diagnostic tool that relies on expert interpretation for ground truth. Biocompatibility testing follows established protocols and laboratory readouts rather than expert consensus on interpretations of images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the physical performance tests (spray duration, solution delivery), the ground truth is likely direct measurement and observation against a defined threshold.
- For biocompatibility, the ground truth is established through standardized laboratory assays (e.g., cell cultures for cytotoxicity, animal models for sensitization and systemic toxicity) which yield objective results based on predefined biological endpoints.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
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