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Innovative Technologies' Transparent Film and Intelligent Film Dressings are indicated for use on partial thickness wounds including:

• Pressure sores
• . Superficial burns
• Abrasions
• . Lacerations
• . Post-operative surgical wounds
• . Donor Sites
• . Trauma Wounds
• Dermal Lesions
• IV Sites .
• Fixation device ●

Innovative Technologies' Transparent Film & Intelligent Film Dressings are conformable, sterile wound dressings intended to provide a moist healing environment for partial thickness wounds, eg. pressure sores, abrasions, lacerations, donor sites and superficial burns. The dressings may also be used for IV sites or as secondary fixation devices for products such as alginates, gels and foams used for venous stasis and diabetic ulcers. Dressings are supplied sterile in single use blister packs.

This submission, K973312, is for Transparent Film and Intelligent Film Dressings. The submission does not contain information about acceptance criteria or a study to prove the device meets these criteria. Instead, it describes a substantial equivalence comparison to a predicate device (Hydroderm, K935796).

Here's a breakdown of the provided information, noting the absence of the requested points:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the submission. The document lists comparative features between the applicant's devices and the predicate device, but these are characteristics, not pre-defined acceptance criteria with performance targets.

Regarding the study proving the device meets acceptance criteria:

The submission highlights several aspects related to safety and effectiveness, but it uses an equivalence approach rather than presenting a standalone study with pre-defined acceptance criteria.

• Sterilization: The devices are gamma irradiated according to ANSI/AAMI/ISO11137-1995 and AAMI TIR8-1991, achieving a sterility assurance level (SAL) of 10^-6. This ensures the product is sterile.
• Biocompatibility: Biocompatibility testing, including cytotoxicity, acute systemic toxicity, skin irritation, and sensitization, was successfully completed per ISO/Tripartite guidelines. This addresses the biological safety of the materials.
• Performance Comparison: The submission primarily relies on a comparison of features and intended use with a legally marketed predicate device (Hydroderm K935796) to establish substantial equivalence.

The 510(k) summary explicitly states: "The Innovative Technologies' Film & Intelligent Film Dressings are similar in design, composition and function to Hydroderm Breathable Simmar in actigh, Complex #K935796." This indicates that the predicate device serves as the benchmark against which the new devices are deemed "substantially equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided. The submission details manufacturing, sterilization, and biocompatibility testing, but it does not describe a clinical "test set" with a specified sample size or data provenance in the context of device performance against specific criteria. The comparison is based on device characteristics, not clinical study data for a "test set."

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):

This information is not provided. As there's no mention of a clinical "test set" requiring ground truth establishment by experts, this detail is absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided. Without a clinical "test set" requiring adjudication, there is no mention of such a method.

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 is not applicable to this submission. The device is a wound dressing, not an AI-powered diagnostic tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable to this submission. The device is a wound dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided in the context of device performance or comparison. For biocompatibility, the "ground truth" is compliance with ISO/Tripartite guidelines. For sterility, it's achieving an SAL of 10^-6 through validated gamma irradiation processes. For the overall device, the "ground truth" for market clearance is its substantial equivalence to the predicate device K935796, as determined by the FDA.

8. The sample size for the training set:

This information is not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

This information is not provided. As there is no "training set," this detail is absent.

In summary, this 510(k) submission primarily demonstrates substantial equivalence to a predicate device (Hydroderm K935796) based on comparative features, intended use, manufacturing processes (sterilization), and biocompatibility testing against established standards, rather than a clinical study with specific acceptance criteria and detailed performance metrics as might be seen for novel diagnostic or therapeutic devices.

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