(219 days)
The Augustine Medical Wound Care System is intended to be used for the local management of wounds by maintaining moisture and body temperature in the wound bed and is indicated for partial and full thickness wounds, such as, Stage I through IV venous, arterial, diabetic, and pressure ulcers.
The wound care system is comprised of a power supply/battery charger, heater control unit, heater card, and a sterile dressing/bandage called a Wound Cover which supports the heater card and holds it away from the wound and skin.
The Wound Cover is a disposable, single-use, sterile, non wound-contact dressing. The Wound Cover may be used either as a stand-alone wound dressing or as part of the Augustine Medical Wound Care System. The Wound Cover incorporates a clear or opaque window. The clear window allows the caregiver to view and assess the tissue. The Wound Cover surrounds and protects the wound, absorbs wound exudate and allows active warming of the periwound area by the application of radiant heat.
The warming components of the system include a thin heater card, a control unit, and a power supply/battery charger. The system operates on standard wall outlet electricity or the self-contained batteries. The heater card is sized appropriately to the Wound Cover and attaches easily over the clear window of the Wound Cover. The heater card does not contact the wound and is intended for single patient use. The control unit incorporates temperature safety limits.
Below is an analysis of the provided text regarding the Augustine Medical Wound Care System, focusing on acceptance criteria and supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance is based on the device being "substantially equivalent" to predicate devices, rather than meeting specific numerical performance criteria in the way a diagnostic device might. The core acceptance criteria revolve around safety and effectiveness comparable to existing devices for the same intended use.
| Acceptance Criterion (Implicit from SE Determination) | Reported Device Performance |
|---|---|
| Similar Intended Use: Local management of wounds by maintaining moisture and body temperature in the wound bed for partial and full thickness wounds (Stage I-IV venous, arterial, diabetic, and pressure ulcers). | The device's "Intended Use" statement explicitly matches this criterion. Clinical data indicated wound healing with the device was "at least as well as 'standard of care'" for these ulcer types. (pages 14, 16) |
| No New Questions of Safety or Effectiveness (including heating of periwound area): The additional feature of heating the periwound area should not introduce new safety or effectiveness concerns. | The FDA reviewer determined that heating the periwound area "does not raise new questions of safety and effectiveness because the device only raises the temperature of the wound bed above 'normal' body temperature" and a predicate device (Lyofoam) also claimed to "maintain wound temperature to optimize wound healing." Safety limits for heater cards and prescription-only use by healthcare professionals were also noted. (page 16) |
| Biocompatibility: Materials used in construction should be biocompatible. | "Biocompatibility testing was performed on the materials used in the construction of the sterile dressing. All materials passed biocompatibility testing and are suitable for this application." (page 20) |
| Physical Testing: Dimensional inspection, functional performance, electrical safety, electromagnetic compatibility, pressure switch activation, overtemperature safety shut-off, and performance under clinical conditions. | "All testing of the product yielded acceptable results." (page 20) |
| Similar Materials, Sizes, Configurations, Packaging, and Sterilization | "The Augustine Wound Care System components are constructed of the same or substantially equivalent materials as the predicate products. The sizes and configurations available along with the packaging and sterilization methods are also equivalent." (page 21) |
| Healing Rates: Wound healing should not be slower with the device compared to standard care. | Clinical data showed "Healing rates were not slower when this device was applied." For Diabetic Ulcers, median percentage reduction in wound area per day was 1.86% for standard care vs. 2.30% for the device. For Venous Stasis Ulcers, values were 3.11% vs. 3.36%. For Pressure Ulcers, values were 1.40% vs. 2.38% (in one study). For Chronic Leg Ulcers, values were 4.85% for the device (no direct comparison value given for standard care in text, but generally implied to be comparable or better). (page 15) |
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions several clinical studies were conducted:
- Number of Studies: Seven studies (completed or in progress) involving different wound types. (page 15)
- Sample Size for Test Set: Specific sample sizes for each study are not provided. The text only gives median percentage reduction values.
- Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the studies were likely conducted within the United States, given the context of FDA submission by a US-based company. The data is retrospective in the sense that results were submitted after the studies were, at least partially, completed to address FDA's request for additional information. It's not a prospective, pre-planned IDE study, but rather data gathered from existing or ongoing clinical work.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not specify the number or qualifications of experts who established the "ground truth" for the clinical studies. The data presented are wound healing rates (median percentage reduction in wound area per day), which would typically be measured objectively (e.g., planimetry, digital imaging) rather than relying on expert consensus for each individual wound. The "ground truth" here is the measured healing rate itself. The "experts" would be the investigators running the studies.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the data collected in the clinical studies.
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
This device, the Augustine Medical Wound Care System, is a wound care treatment system (physical device with heating capability and wound cover) and not an AI/Software as a Medical Device (SaMD) that typically undergoes MRMC studies involving human readers and AI assistance for interpretation. Therefore, no such study was performed or is relevant in this context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Again, this is a physical medical device, not an algorithm or AI. Standalone performance as typically described for AI/SaMD devices is not applicable. The device's performance is inherently linked to its physical application and interaction with the wound and human users (healthcare professionals).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
The ground truth for evaluating the device's effectiveness appears to be primarily outcomes data, specifically:
- Wound Healing Rates: "median percentage reduction of the wound area per day" (page 15).
- Absence of Adverse Effects: "no reports of any adverse effects or extended healing times" (page 15).
- Biocompatibility Test Results: "All materials passed biocompatibility testing" (page 20).
- Physical Test Results: "All testing of the product yielded acceptable results" (page 20).
8. The Sample Size for the Training Set
The concept of a "training set" is fundamentally tied to machine learning algorithms. Since the Augustine Medical Wound Care System is a physical medical device, there is no "training set" in the context of an AI algorithm. Its development would have involved engineering design, material selection, and iterative physical testing/prototyping, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no algorithm or "training set" for this physical device. The "ground truth" for its development would be engineering specifications, material properties, and the intended physiological effects, established through standard biomedical engineering and clinical research practices.
§ 878.4020 Occlusive wound dressing.
(a)
Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.