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K Number
K190129
Device Name
AC5 Topical Gel
Manufacturer
Arch Therapeutics, Inc.
Date Cleared
2020-03-11

(408 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K182681
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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, leg ulcers, and surgical wounds.

Device Description

AC5 Topical Gel is configured as a package 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).

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification from the FDA regarding the AC5 Topical Gel. It confirms the substantial equivalence of the device to a predicate device and provides information on its intended use, composition, and some performance testing related to biocompatibility.

However, the document does not contain information about the acceptance criteria or a specific study that proves the device meets those acceptance criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or any comparative effectiveness studies as typically found in an AI/ML device submission. The performance section (11.6) discusses biocompatibility testing, which is a different type of performance evaluation.

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and performance study data as these details are not present in the provided text.

Based on the provided text, I can extract information related to biocompatibility testing, but not the specific type of performance study you are asking for (e.g., an MRMC study or standalone algorithm performance).

Here's what can be inferred from the document regarding "performance" though it pertains to biocompatibility, not clinical efficacy or AI performance:

  • Acceptance Criteria (for Biocompatibility): The implicit acceptance criterion for biocompatibility was that AC5 Topical Gel passed all tests conducted in accordance with the specified guidelines.
  • Study Proving Acceptance Criteria (for Biocompatibility): The document states:
    • Types of tests conducted: Cytotoxicity, sensitization, irritation (animal irritation with abraded skin and animal intracutaneous reactivity), acute systemic toxicity, pyrogenicity (endotoxin and material mediated), implantation, and subchronic/subacute toxicity.
    • Standards followed: Guidance for Industry and Food and Drug Administration Staff, issued on June 16, 2016, entitled "Use of International Standard ISO-10993, Biological evaluation of medical devices Part 1 Evaluation and testing within a risk management process."
    • Regulatory compliance: Conducted in full accordance with the FDA's Good Laboratory Practice regulations (21 CFR Part 58).

Missing Information:

The document does not provide any of the following details critical to your request:

  1. A table of acceptance criteria and reported device performance (for clinical or AI performance).
  2. Sample size used for a test set (clinical or AI).
  3. Data provenance (country of origin, retrospective/prospective for clinical or AI data).
  4. Number of experts used to establish ground truth or their qualifications (for clinical or AI data).
  5. Adjudication method (for clinical or AI data).
  6. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, or its effect size.
  7. If a standalone (algorithm only) performance study was done.
  8. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical or AI performance.
  9. The sample size for the training set (for AI).
  10. How the ground truth for the training set was established (for AI).

This document is a 510(k) clearance letter and summary for a topical gel, which is a traditional medical device, not an AI/ML-driven device. Therefore, the performance evaluation focuses on material safety (biocompatibility) and equivalence to a predicate device based on material composition and mechanism of action, rather than clinical efficacy metrics or AI algorithm performance.

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