(304 days)
TorrentX Wound Wash is indicated for use in cleansing and removal of debris, including microorganisms from wounds.
TorrentX Wound Wash is a non-sterile, clear, colorless, aqueous solution that is used to remove debris, including microorganisms from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign material such as debris and bacteria via hydrodynamic shear.
TorrentX Wound Wash will be provided in a 20mL low density polyethylene ampoule with a twist-off seal. Ten (10) ampoules and applicator tips will be provided together in a shelf carton.
The formulation for TorrentX Wound Wash is composed of ethanol, water, sodium citrate, citric acid and benzalkonium chloride.
The provided text is a 510(k) summary for a medical device called "TorrentX Wound Wash." It describes the device, its indications for use, and a summary of nonclinical studies performed to demonstrate its substantial equivalence to a predicate device.
Regarding your request for acceptance criteria and study details, it's important to understand that a 510(k) submission primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving a device meets specific, quantitative "acceptance criteria" in the way a novel therapeutic might.
For the TorrentX Wound Wash, the "acceptance criteria" are implied by demonstrating that it is "as safe, as effective, and performs as well as the legally marketed device Next Science® Irrigation Solution (K161165)." The studies listed are designed to show that the new device does not raise new questions of safety or effectiveness compared to the predicate.
Given this context, I will provide the information based on the available text, understanding that it's framed within a 510(k) submission for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit, quantitative "acceptance criteria" for performance metrics are not typically presented in a 510(k) summary for a wound wash in the same way they would be for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are demonstrating similarity or equivalence to the predicate device in terms of safety and effectiveness, across various nonclinical tests.
| Acceptance Criterion (Implied by Substantial Equivalence Goal) | Reported Device Performance (Summary from Text) |
|---|---|
| Mechanical Action / Cleansing Efficacy equivalence (hydrodynamic shear, debris removal) | Both TorrentX Wound Wash and the predicate (Next Science® Irrigation Solution) share the same mechanism of action: mechanical removal of debris via hydrodynamic shear, aiding in the removal of foreign material such as microorganisms, dirt, and debris. |
Performance Bench Testing:
- Application Pressure Test: Performed to support safety, effectiveness, and substantial equivalence. (Specific results not detailed, but implied to be acceptable/comparable). |
| Antimicrobial/Preservation Effectiveness | Performance Bench Testing: - Antimicrobial Effectiveness Test (Preservation) (USP ): Performed. (Specific results not detailed, but implied to be acceptable/comparable for the preservation properties of the formulation). |
| Biocompatibility / Safety (no new safety concerns) | Biocompatibility Testing: - Sensitization: Performed.
- Material-mediated Pyrogenicity: Performed.
- Toxicological Risk Assessment: Performed.
Endotoxin Test:
- Endotoxin LAL Test: Performed.
Animal Testing:
- Porcine Wound Healing Study: Performed to support safety, effectiveness, and substantial equivalence. (Specific results not detailed, but implied to show no adverse effects or comparable healing to expectation).
Conclusion: "The difference in ingredients do not raise different questions of safety or effectiveness." and "The conclusions drawn from the performance tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device Next Science® Irrigation Solution (K161165)." |
| Chemical Composition Compatibility | "All the components of TorrentX Wound Wash are consistent with known ingredients for cleared wound dressings under the FRO product code."
"The proposed and predicate devices contain the same surfactant to assist in the solubilization of debris and the same vehicle to carry away any debris..." |
Detailed Information on Studies:
The text describes nonclinical studies, not clinical trials with human subjects or AI performance evaluations, therefore, many of your specific questions (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this type of submission or the information provided.
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document describes nonclinical studies (bench, animal, biocompatibility) rather than a test set for an algorithm with human data. Details are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of expert consensus, is not relevant for the nonclinical studies summarized here.
4. Adjudication method for the test set:
- Not Applicable. No test set requiring expert adjudication is described.
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 device is a wound wash, not an AI diagnostic or assistance tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical wound wash product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Bench Testing: Likely based on established physical/chemical standards (e.g., USP for Antimicrobial Effectiveness Test, standard test methods for pressure, LAL test for endotoxin).
- For Animal Testing (Porcine Wound Healing Study): Ground truth would be based on macroscopic and/or microscopic assessment of wound healing parameters, typically by veterinary pathologists or trained researchers against controls, following established protocols.
- For Biocompatibility Testing: Ground truth is against established ISO standards for biocompatibility (e.g., for sensitization, pyrogenicity, toxicology).
8. The sample size for the training set:
- Not Applicable. This is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established:
- Not Applicable. (See #8)
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