(71 days)
TIELLE® PLUS Hydropolymer Dressing is indicated for the management of chronic and acute, moderate to heavily exuding, partial and full thickness wounds including:
- Superficial wounds .
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- Minor abrasions
- Skin Tears
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- Second Degree Burns
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TIELLE* PLUS Hydropolymer Dressing should be used under health care professional direction for the following indications:
- Pressure ulcers
Lower extremity ulcers -
- Venous
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- Arterial
Mixed etlology 3. Diabetic ulcers Donor sites
- Arterial
TIELLE* PLUS Hydropolymer Dressing is suitable for use under compression bandaging.
TIELLE* PLUS Hydropolymer Dressing is an exudate handling system intended for moderate to heavily exuding wounds. The Island dressing maintains a moist wound environment. A moist wound environment supports the wound healing process by encouraging autolytic debridement thus enabling granulation to proceed under optimum conditions. During use the absorbent island gently expands as it takes up exudate.
Here's an analysis of the provided text regarding the TIELLE® PLUS Hydropolymer Adhesive Dressing, focusing on acceptance criteria and supporting studies:
This document is a 510(k) summary for a medical device, which primarily demonstrates substantial equivalence to a predicate device rather than presenting a full clinical study with specific acceptance criteria directly tied to efficacy metrics. The "acceptance criteria" discussed here are mainly related to biocompatibility and safety, and the "study" referred to is a series of preclinical (safety/toxicity) tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility (General) | Acceptable for use as a Topical Wound Dressing (ISO 10993 Part-1) | Demonstrated as acceptable (statement of compliance) |
| Non-Woven Wicking Layer | ||
| AMES bacterial mutagenicity | Non-mutagenic | Non-mutagenic |
| Acute eye irritation | Non-irritant | Non-irritant |
| Acute dermal irritation | Non-irritant | Non-irritant |
| Skin sensitization | Non-sensitizer | Non-sensitizer |
| Cytotoxicity (Agar Overlay) | Non-toxic | Non-toxic |
| Absorbent Polyurethane Wound Contact Layer | ||
| Hemolysis (Rabbit RBCs) | Non-hemolytic | Non-hemolytic |
| Primary Skin Irritation (Rabbits) | Non-irritant | Non-irritant |
| Acute Oral Toxicity | Non-cytotoxic (from context of other tests) | Non-cytotoxic |
| Intramuscular Injection Test | Non-cytotoxic (from context of other tests) | Non-cytotoxic |
| Kligman Maximization Test | Non-sensitizer | Non-sensitizer |
| Systemic Injection (Mice) | Non-cytotoxicity (from context of other tests) | Non-cytotoxicity |
| MEM Elution Test | Non-cytotoxic | Non-cytotoxic |
| Agar Diffusion Test | Non-Cytotoxic | Non-Cytotoxic |
| Ames Assay | Non-mutagenic | Non-mutagenic |
| L5178Y TK+/- Mouse Lymphoma Mutagenesis Assay | Non-mutagenic | Non-mutagenic |
| Rat Oral LD50 | LD50 > than X g/kg (threshold for non-toxic) | LD50 > than 40g/kg |
| Rabbit Dermal LD50 | LD50 for B-15J > than X g/kg (threshold for non-toxic) | LD50 for B-15J found to be > 5g/kg |
| Rabbit Dermal Irritancy (Draize) | Non-irritating | Non-irritating |
| Rabbit Eye Irritation | Non-irritating | Non-irritating |
| Human Repeat Insult Patch Test | Non-irritating & Non-sensitising | Non-irritating & Non-sensitising |
| Cytotoxicity Test (Agar Overlay) | Non-cytotoxic using L929 mammalian cells | Non-cytotoxic using L929 mammalian cells |
Explanation of "Acceptance Criteria": For most of these preclinical tests, the "acceptance criteria" are implied by the nature of the test itself: a positive result (e.g., mutagenic, irritant, toxic, hemolytic, sensitizer) would indicate failure, while a negative or "non-" result indicates acceptance. For LD50 tests, the acceptance criterion is a sufficiently high LD50 value indicating low acute toxicity.
2. Sample Size Used for the Test Set and Data Provenance
The provided document details preclinical (safety/biocompatibility) testing, not a clinical test set on human subjects for performance evaluation in the traditional sense.
- Test Set Sample Size:
- For many tests (e.g., Ames, Cytotoxicity, Irritation, Sensitization), the sample size refers to the number of replicates or animals used per test category, which is not explicitly stated in this summary. Standard protocols for these tests typically involve a small, defined number of animals (e.g., 3-6 rabbits for irritation, multiple mice for systemic injection, specific cell cultures for cytotoxicity).
- For Rat Oral LD50, the sample size would be the number of rats used.
- For Rabbit Dermal LD50, the sample size would be the number of rabbits used.
- For Human Repeat Insult Patch Test, the sample size would be the number of human volunteers. These specific numbers are not provided in this summary.
- Data Provenance: The document does not specify the country of origin for these preclinical test results. Given the context of a US 510(k) submission, it's highly likely to be US-based testing or testing conducted by internationally recognized labs. All tests are by nature prospective preclinical studies (i.e., experiments designed and conducted to evaluate the device's safety characteristics).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the preclinical safety testing described. Establishing "ground truth" with experts, adjudication, and inter-reader variability is relevant for clinical studies, especially those involving image interpretation or diagnostic performance. For biocompatibility tests, the "truth" is determined by the objective scientific measurement outcomes of standardized tests.
4. Adjudication Method for the Test Set
This is not applicable to the preclinical safety testing described. Adjudication methods are used in clinical studies, particularly those involving human readers/interpreters, to resolve discrepancies in diagnoses or assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. This type of study evaluates the diagnostic performance or effectiveness of a device when used by multiple human readers, often comparing performance with and without an AI assistant. The presented document focuses purely on the safety and basic physical characteristics of a wound dressing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done because this device is a physical wound dressing, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the preclinical tests consisted of:
- Laboratory Assay Results: Objective measurements and observations from standardized biological and chemical tests (e.g., bacterial growth, cell viability, irritation scores in animals, presence/absence of hemolysis, lethal dose concentrations).
- Histopathology/Pathology: For certain animal tests (e.g., irritation), microscopic examination of tissues may contribute to the "truth."
- Expert Interpretation of Test Data: While not "expert consensus" in the clinical sense, the evaluation of laboratory results requires expertise in toxicology, microbiology, and biocompatibility testing. The "ground truth" is established by the accepted scientific protocols and interpretation of these tests by trained scientists.
8. The Sample Size for the Training Set
Not Applicable. This device is a physical wound dressing, not an AI or machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for this device, there is no ground truth to establish for it.
Summary Takeaway:
This 510(k) submission focuses on demonstrating the safety and biocompatibility of the TIELLE® PLUS Hydropolymer Adhesive Dressing through a series of standardized preclinical tests. It is not an AI/ML-driven device, and therefore, concepts like MRMC studies, standalone algorithm performance, training/test sets, expert adjudication, and ground truth in the context of diagnostic accuracy are not relevant to this document. The "acceptance criteria" are derived from the expected negative outcomes of these safety tests (e.g., "non-mutagenic," "non-irritant").
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