(79 days)
Under the supervision of a health care professional, AC5 Topical dressing used for the management of partial and full-thickness wounds, such as pressure sores, diabetic ulcers, and surgical wounds.
AC5 Topical Gel is configured as a kit containing one vial of synthetic self-assembling peptide, one vial of diluent (Sterile Water for Injection, USP), one syringe, one needle, two blunt fill needle applicators and two Alcohol Prep pads. AC5 is biocompatible. The diluent (Sterile Water for Injection, USP) is sterile and non-pyrogenic. AC5 is to be prepared by reconstitution of the lyophilized peptide in Sterile Water for Injection, USP. The reconstituted peptide solution is acidic (pH 2.3 ± 0.7).
This is a 510(k) summary for AC5 Topical Gel, which is a wound dressing. The document describes the device, its intended use, and claims substantial equivalence to predicate devices (PuraDermTM Gel and DuoDERM® Hydroactive Gel).
The 510(k) summary does not contain the specific acceptance criteria or a detailed study report that proves the device meets specific acceptance criteria in a quantitative manner as would typically be presented for a device reliant on algorithmic performance. Instead, the performance evaluation for this topical gel focuses on biocompatibility and non-clinical performance (in vivo and bench-top studies).
Here's an analysis of the provided text based on your request, keeping in mind that the nature of this submission (a topical gel, not an AI/algorithm-driven device) means some of your requested points are not directly applicable or are interpreted differently.
1. A table of acceptance criteria and the reported device performance
Since this is not an AI/algorithmic device, there are no specific numerical acceptance criteria like sensitivity, specificity, or AUC. The "acceptance criteria" for this type of device revolve around safety and demonstrating comparable performance to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (Safety) | AC5 passed all recommended biocompatibility tests from ISO-10993, including cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity (endotoxin and material mediated), implantation, and subchronic/subacute toxicity. |
| Non-Irritating & Non-Sensitizing in Humans | In the Human Repeat Insult Patch Testing (HRIPT), AC5 was found to be non-irritating and non-sensitizing. |
| Wound Hydration Performance (Effectiveness - Comparative) | The performance of AC5 Topical Gel for hydration of wounds was found equivalent to that of DuoDERM Hydroactive Gel in a bench-top study. This is a key comparative effectiveness claim for this type of device. |
| Similar Indications for Use | AC5 Topical Gel's indications for use (management of partial and full-thickness wounds: pressure sores, leg ulcers, diabetic ulcers, surgical wounds) are substantially equivalent to the predicate devices. |
| Similar Safety Profile | Risks addressed through materials, processing controls, quality assurance, and compliance with GMP. |
2. Sample size used for the test set and the data provenance
- Biocompatibility tests: These tests are typically conducted on standardized laboratory models (in vitro and animal models). The document doesn't specify the exact "sample size" in terms of number of animals or repeat tests but mentions it was done "in full accordance with the Food and Drug Administration's Good Laboratory Practice regulations."
- Human Repeat Insult Patch Testing (HRIPT): This is a human clinical study. The sample size is not specified in this document, nor is the country of origin. HRIPTs are typically prospective studies.
- Porcine Excisional Wound Model: This is an animal study. The sample size (number of pigs, number of wounds) is not specified. This is a prospective animal study.
- Bench-top study (Wound Hydration): This is an in vitro study. The sample size (e.g., number of test samples, replicates) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable for this type of device. There is no "ground truth" established by experts in the context of image interpretation or diagnostic accuracy for this topical gel. The evaluations are based on direct biological and physical measurements and observations in laboratory, animal, and human patch tests.
4. Adjudication method for the test set
Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for expert consensus in cases like radiological image reading or clinical event classification, which don't apply to the performance studies of a topical gel.
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, and no human "readers" or AI assistance studies were conducted. The comparative effectiveness stated is about the wound hydration performance of the gel itself versus a predicate gel, not about clinician performance with or without the device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a topical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in the context of this device's performance studies relies on:
- Standardized endpoints for biocompatibility: Measured biological reactions (e.g., cell viability for cytotoxicity, skin reaction for sensitization, pyrogen levels).
- Observed outcomes in animal models: Healing progression in the porcine excisional wound model.
- Direct physical/chemical measurements in bench-top studies: Measurement of hydration properties.
- Clinical observations in human patch tests: Skin reactions (irritation, sensitization) assessed by trained professionals.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device, so there is no training set in that sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an algorithm.
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