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510(k) Data Aggregation
(22 days)
MSA
The Augustine Medical Wound Care System is intended for the local management of wounds by maintaining moisture and body temperature in the wound bed. It is indicated for partial- and full-thickness wounds, such as venous, arterial and diabetic ulcers, and Stage II through Stage IV pressure ulcers.
The Augustine Medical wound cover is part of the Wound Care System, which includes a power supply/battery charger, temperature control unit, warming card, and a clean dressing called a wound cover that supports the warming card and holds it away from the wound and skin.
The wound cover is a disposable, single-patient-use wound dressing. It is comprised of a thin shell, a window, and a foam frame. The shell has an adhesive border to hold the wound cover in place. It is water-resistant and can be easily cleaned. A clear window in the center of the wound cover allows the caregiver to view and assess the wound, and a pocket on top of the window holds the warming card used during warming therapy. The foam frame absorbs wound fluid (exudate), and keeps the pocket above the wound surface so neither the window nor the warming card contact the wound.
The provided document is a 510(k) premarket notification for a medical device called the "Augustine Medical Wound Care System, Model 68XXX". It describes a device that maintains moisture and body temperature in wound beds. However, the document explicitly states that "No additional testing was performed" for this specific 510(k) submission (K020077) because it's a "Special 510(k) Modified Device" and "does not differ in design, technology, materials, or size relative to the cleared device, nor its intended use" (page 5).
Therefore, this document does not contain information about acceptance criteria or a study proving that this specific modified device meets acceptance criteria. It refers to a previously cleared device (Augustine Medical Wound Cover, Model 68XXX, K963293) as its equivalent marketed device. To answer your questions, one would need to access the documentation for K963293.
Based solely on the provided text for K020077, I cannot complete the table or answer most of your detailed questions regarding acceptance criteria and a study that proves the device meets those criteria.
However, I can provide limited information based on the explicitly stated lack of new testing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in this document for K020077.
- Reported Device Performance: Not reported in this document for K020077 as no new testing was performed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for K020077, as no new test set was used. The document states "No additional testing was performed".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable for K020077, as no new test set was used and thus no new ground truth was established by experts for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for K020077, as no new test set was used.
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
- No MRMC study was done for K020077. This device is a wound dressing system, not an AI-assisted diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical wound care system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified for K020077, as no new testing was performed. For the predicate device, it would likely involve clinical outcomes, efficacy in maintaining moisture and temperature, and safety data.
8. The sample size for the training set
- Not applicable for K020077, as this is a physical device and not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable for K020077, as this is a physical device and not an AI/machine learning algorithm.
In summary, the provided K020077 document is a "Special 510(k) Modified Device" submission, indicating that the device is substantially equivalent to a previously cleared device (K963293) and no new performance testing was conducted for this specific submission.
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(219 days)
MSA
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.
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