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Innomed NPWT Silicone Foam Dressing is intended to be used along with VCare 1000- 300S pump for wound management via the application of negative pressure to the wound, in order for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.

When used along with VCare 1000-300S pump, Innomed NPWT Silicone Foam Dressing is intended for patients with the following wound types:

• Chronic
• Acute
• · Traumatic
• Subacute and dehisced wounds
• · Partial-thickness burns,
• · Ulcers (such as diabetic or pressure)
• · Flaps and grafts

The device is for use in professional healthcare facilities only.

Innomed NPWT Silicone foam dressing is a single-use device, as an accessory to VCare-1000-300S pump, manufactured by VR Medical Technology Co., Ltd. The NPWT Silicone foam dressing consists of silicone adhesive coated foam dressing attached with a suction bell and fixation film strips.

The silicone foam dressing is comprised of PU film, absorbent pad consisting of polyurethane (PU) foam, absorbent fibre and polyester fabric, a layer silicone adhesive is coated onto the entire surface.

The suction bell is comprised of a polyvinyl chloride drainage tubing with a polypropylene pinch clamp, a polypropylene luer taper, a bell shape dome made of polyvinyl chloride, a transparent poly urethane film coated with acrylic adhesive. The suction bell is attached on the silicone foam dressing surface.

Fixations film strips is composed of PU film coated with acrylic adhesive.

Machnism of Action: The silicone adhesive coated foam dressing is used to pack the wound bed and cover periwound area, and the fixation film strips are applied over the outside edges of the dressing to facilitate hold the silicone foam dressing in place and seal the wound bed area. The other end of the attached suction bell is connected to a canister attached to the negative pressure pump, VCare 1000-300S pump, and served as a conduit to transfer the wound exudate to the canister under negative pressure when the pump is turned on.

Innomed NPWT Silicone Foam Dressing is available in 10 sizes: SNPWT-1010 ( 10cm X 10cm ), SNPWT-1020 (10cm X 20cm ), SNPWT-1030 (10cm X 30cm ), SNPWT-1040( 10cm X 40cm ), SNPWT-1515(15cm X 15cm ), SNPWT-1520 (15cm X 20cm ), SNPWT-1530 (15cm X 30cm ), SNPWT-2020 (20cm X 20cm ), SNPWT-2025(20cm X 25cm ), SNPWT-2525(25cm X 25cm )

The provided text describes the "Innomed NPWT Silicone Foam Dressing," an accessory for negative pressure wound therapy (NPWT). This device is cleared for marketing based on a 510(k) submission, meaning it was found substantially equivalent to existing predicate devices rather than requiring de novo approval or a PMA that would necessitate extensive clinical trials.

Therefore, the study design and acceptance criteria are evaluated against the substantial equivalence paradigm, not a traditional clinical trial proving efficacy against specific numerical thresholds in a clinical population. The performance is assessed by demonstrating similarity to predicate devices through non-clinical testing.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, "acceptance criteria" are generally understood as demonstrating functional equivalence or similarity to predicate devices through a series of bench tests and biocompatibility assessments. The "reported device performance" refers to the results of these non-clinical tests for the subject device and the predicates.

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

The document does not specify a "test set" in the context of a clinical study with human subjects. The testing performed was non-clinical (bench and biocompatibility). Therefore, there is no information on human sample size or data provenance in terms of country of origin or retrospective/prospective nature. The tests involved material samples and simulated environments.

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

Not applicable. As this was a non-clinical study, there was no "ground truth" established by human experts in the context of diagnostic interpretation or clinical outcomes. The "ground truth" for non-clinical tests comes from standardized testing methods and specifications (e.g., ISO standards for biocompatibility).

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring human expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A MRMC study is a clinical study involving human readers interpreting medical cases. This submission is for a medical device (dressing) and relies on non-clinical testing.

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

Not applicable. This device is a physical dressing used in conjunction with a pump, not an AI algorithm.

7. The type of ground truth used

For biocompatibility testing, the "ground truth" is derived from the established standards (e.g., ISO 10993 series) which define acceptable ranges or outcomes for various biological responses. For bench testing, the "ground truth" is typically defined by engineering specifications, performance requirements, and comparison to the predicate devices. There is no pathology or patient outcomes data directly determining "ground truth" for the device's performance in this 510(k) submission.

8. The sample size for the training set

Not applicable. The description is for a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable.

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