(43 days)
Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on wounds including: . Minor scalds and burns Superficial Wounds such as Abrasions, Laccrations, and cuts t This wound dressing may be also used under the care of a health care professional for such wound as, Pressure sores, post operative surgical wounds, donor sites, trauma wounds and dermal Icsions. And for such uses as a IV site and us a secondary fixation device for other wound care products such as alginates, gels and foams used for diabctic ulccrs.
Innovative Technologies Transparent & Intelligent Film Wound Dressings, are conformable, sterile wound dressings intended to provide a moist environment ideally suited for wound management. In particular for partial thickness wounds. Innovative Technologies Transparent Film dressings act as a semi occlusive barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing. The Innovative Technologies Intelligent wound dressings utilize an intelligent film to enhance product performance. The semi occlusive dressing acts as a barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. The film transmits water, but retains other exudate components creating the ideal environment for wound healing and extending the life of the dressing.
The provided document is a 510(k) summary for the "Innovative Technologies Transparent and Intelligent Film Wound Dressings." This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It is important to note that 510(k) summaries, especially those from 1998, typically focus on demonstrating substantial equivalence through a comparison to a predicate device, rather than presenting de novo clinical study data that would include detailed acceptance criteria and performance studies of the novel device itself. The provided text does not contain a detailed study report with acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies as requested in the prompt.
Therefore, the following information is based on the available text, and where specific details are missing (as they are not part of a 510(k) summary of this nature), it will be explicitly stated.
Acceptance Criteria and Device Performance
As this is a 510(k) submission from 1998 for wound dressings, the "device performance" and "acceptance criteria" are implied by the claim of substantial equivalence to a predicate device and the general functional description of the dressings. There are no explicit quantitative performance metrics or acceptance criteria stated in the document as would be found in a modern clinical study report for an AI/advanced medical device.
The "performance" is described in terms of its functional properties and intended use:
| Acceptance Criteria (Implied from Device Description) | Reported Device Performance (from "Description" and "Intended Use" sections) |
|---|---|
| Barrier Function: Semipermeable to moisture vapor and oxygen, barrrier to exogenous moisture and bacteria. | The film acts as a semi occlusive barrier to exogenous moisture and bacteria whilst still allowing permeability to moisture vapour and oxygen. |
| Moist Wound Environment: Creates an ideal environment for wound healing. | The film transmits water, but retains other exudate components creating the ideal environment for wound healing. |
| Extended Dressing Life: Extends the life of the dressing. | Retains other exudate components extending the life of the dressing. |
| Conformability: Conformable dressing. | "conformable, sterile wound dressings" |
| Sterility: Must be sterile. | "conformable, sterile wound dressings" |
| Applicability to Wound Types: Effective for partial thickness wounds. | Used for "partial thickness wounds," "pressure sores," "superficial wounds such as minor cuts, lacerations and abrasions, minor scalds and burns (1st & 2nd degree), donor sites, dermal lesions, trauma wounds and post operative surgical wounds." |
Specific Study Details (Based on Available Text)
1. A table of acceptance criteria and the reported device performance:
Provided above based on the functional description and intended use, as explicit quantitative criteria are not present in this 510(k) summary.
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 / Not provided. This document is a 510(k) premarket notification. It does not describe a new clinical study with a test set in the way a modern AI/diagnostic device submission would. The basis for substantial equivalence typically relies on existing data or performance of the predicate device, or non-clinical (e.g., benchtop) testing for the new device.
- The manufacturer is based in the United Kingdom.
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 / Not provided. No specific clinical test set for ground truth establishment is described for this device in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical test set is described.
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:
- Not applicable / Not provided. This device is a wound dressing, not an AI or diagnostic tool. Therefore, an MRMC study is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This device is a physical wound dressing and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. No specific ground truth for a clinical study is detailed for this 510(k) submission. The "truth" for such devices is typically established through a combination of manufacturing standards, biocompatibility testing, material science, and prior clinical use experience of similar predicate devices, demonstrating the physical and biological properties meet safety and performance expectations.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As above, no training set is relevant.
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