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Rx

Management of partial and full thickness wounds including stage I - IV pressure ulcers, ulcers caused by mixed vascular etiologies, Diabetic skin ulcers, 1st and 2nd degree burns, post-surgical incisions, graft sites, lacerations, skin tears, cuts and abrasions.

OTC

Management of minor wounds including minor cuts, abrasions, lacerations and burns.

The Field Shield Wound Dressing is a spray on hydrogel wound dressing that hydrates, seals and protects dermal injuries to create and maintain a moist wound environment. A moist wound environment is known to be conducive to the wound healing process. It is a hydrophilic system containing a polyacrylate polymer matrix with silver hydrosol and lidocaine. The dressing donates moisture to a wound and maintains a moist environment. When applied to the liquid device donates moisture to the wound then sets into a thin, pliable, transparent film barrier over the surface of the wound. The film is capable of setting over intact and compromised skin surfaces. The device is intended for use for up to 30 days. with reapplication recommended every 24 to 72 hours. The device contains silver hydrosol that may inhibit the growth of microorganisms such as Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains of MRSA and VRE, as well as fungi such as Candida albicans and Candida auris within the dressing. Additionally, the dressing contains lidocaine as a topical anesthetic. Clinical evaluation showed that the Lidocaine can reduce pain within 30 minutes after application; long-term pain reduction has not been evaluated. Field Shield® Wound Dressing is intended for both Prescription and over the counter (OTC) indications for use.

The provided document describes the KeriCure Inc.'s Field Shield Wound Dressing, an unclassified device. The information focuses on demonstrating its substantial equivalence to predicate devices, particularly regarding safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds for the Field Shield Wound Dressing. Instead, the document focuses on demonstrating that the device meets safety and performance standards equivalent to predicate devices, particularly through various types of testing. The reported device performance is outlined in the "Summary of Performance Testing" table.

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Study (Pain Relief): The document states "Subjects were asked to complete an assessment prior to use of the device and within 30 minutes after application of the device." However, the sample size for this clinical study is not explicitly stated.
• Data Provenance: Not specified, but generally, clinical studies for FDA submissions are prospective. Given the medical device context, it's likely originating from a regulated clinical trial, but country of origin is not mentioned.
• Other Performance Tests (Biocompatibility, Antimicrobial, Endotoxin): These are laboratory tests typically performed on device samples. The specific number of samples for each test is not provided, but they represent a "test set" of the device material. Data provenance for these lab tests would typically be from a certified testing laboratory.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• For the Clinical Study (Pain Relief): The "ground truth" for pain reduction is based on subjects' self-assessment using a VAS pain score scale. No external experts are mentioned for establishing this ground truth, as it's a self-reported outcome.
• For other performance tests (e.g., biocompatibility, antimicrobial activity), the "ground truth" is established by the accepted standards and protocols of the respective laboratory tests. The experts involved would be the qualified laboratory personnel conducting these standardized tests. Their specific numbers and qualifications (e.g., toxicologists, microbiologists) are not detailed in this summary.

4. Adjudication Method for the Test Set

• For the Clinical Study (Pain Relief): There is no mention of an adjudication process for the VAS pain scores. Scores were directly collected from subjects. Since it's a subjective measure, individual responses constitute the data.
• For other performance tests: Adjudication is typically not applicable in the same way as expert consensus reviews. The results are determined by objective laboratory measurements against defined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed for this device. This type of study is more common for diagnostic imaging devices where different readers interpret cases. The Field Shield Wound Dressing is a therapeutic wound dressing, so a different type of clinical evaluation is more appropriate.
• The clinical study focused on the effectiveness of lidocaine for pain relief, not on reader interpretation.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• This concept is not applicable to the Field Shield Wound Dressing. This is a physical wound dressing and not a software algorithm or AI device. Therefore, there is no "algorithm only" performance to evaluate. The device's performance is intrinsically linked to its physical application and biological interaction with the wound.

7. Type of Ground Truth Used

• Clinical Study (Pain Relief): Self-reported patient outcomes (VAS pain scores).
• Other Performance Tests (Biocompatibility, Antimicrobial, Endotoxin): Established according to recognized scientific and regulatory standards (e.g., ISO, USP, FDA guidance). This includes various in vitro and in vivo laboratory test results.
• Nonclinical Wound Healing Study: Observation of device-related adverse events and comparison to standard of care in a wound healing model (likely animal model, though not specified).

8. Sample Size for the Training Set

• Not Applicable. As a physical medical device, there is no "training set" in the context of machine learning. The device itself is manufactured, and its properties are inherently defined by its composition and manufacturing process, not by a dataset it was trained on.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. Since there is no training set for this device, there is no ground truth to establish for it.

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