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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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SIMO System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of excess exudate and infectious materials.

SIMO System is suitable for use in both hospital and homecare setting and is indicated for the following wound types:

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

Anscare SIMO Negative Pressure Wound Therapy (NPWT) System including non-sterilized SIMO Pump and sterilized SIMO Dressing. Patient is able to carry the SIMO Pump easily in the pocket or a belt holder (additional accessory). Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is also called "SIMO System" in the following description.

SIMO System has 3 types of model variants including "2 SIMO Dressings and 1 SIMO Pump", "2 SIMO Dressings and 1 SIMO Pump with 1 holder" and "3 SIMO Dressings". Each type has 4 models, and each modelcontains 4 different sizes of SIMO dressing separately.

SIMO System is for single person use only. SIMO Pump could use for 30 days. The SIMO Dressing is sterilized by Ethylene Oxide and single-use.

SIMO System including non-sterilized negative pump and sterilize dressing. The negative pressure wound therapy is provided by a pump (-125±15mmHg) up to 30 days by manual and may promote wound healing via the removal of exudate. The negative pressure is provided by the SIMO Pump, and the exudates of wound bed is managed by the dressing. SIMO Dressing is applied to the wound. It should be changed in line with standard wound management guidelines, typically every 3-4 days up to 7 days. More frequent dressing changes may be required depending on the level of exudates, condition of the dressing, wound type/size, orientation of dressing, environmental considerations and/or other patient the considerations.

The provided text describes a 510(k) premarket notification for a medical device (Anscare SIMO Negative Pressure Wound Therapy (NPWT) System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance and safety testing. It does not present a study proving the device meets acceptance criteria in the format of a clinical trial or a machine learning model's performance evaluation against specific metrics.

Therefore, I cannot extract the information required to answer your request in the specified format, as the document details bench testing, biocompatibility, and sterilization, but not a study designed to evaluate performance against the kind of "acceptance criteria" you've outlined (e.g., accuracy, sensitivity, specificity, or human improvement with AI assistance).

The provided text details the following:

• Device: Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
• Intended Use: Promotes wound healing via removal of excess exudate and infectious materials. Suitable for hospital and homecare settings for various wound types (chronic, acute, traumatic, subacute/dehisced, partial-thickness burns, ulcers, flaps/grafts, closed surgical incisions).
• Predicate Device: SNaP® Wound Care System (K151710) and Reference Device: PICO Single Use Negative Pressure Wound Therapy System (K151436).
• Testing Performed:
  • Bench Testing: Tubing Tensile Strength Test, Adhesive test, Function Test after Drop Testing, Life Time for 30 Days Test (pump performance over 150 presses), Simulation Test (performance with low/moderate exudate, pressure stability, exudate management, fluid reflux rate), HFE/UE Report (Human Factors and Usability Engineering).
  • Biocompatibility Testing: In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Skin irritation, Acute Intravenous Systemic Toxicity, Acute Intraperitoneal Systemic Toxicity, Pyrogen Test, Subacute/subchronic toxicity, Implantation study, Phthalate leachables study.
  • Sterilization Testing: Verification of Ethylene Oxide (EO) sterilization process and residual testing per ISO standards.

This documentation serves to demonstrate that the device is as safe and effective as a legally marketed predecessor, not to provide statistical performance metrics typically seen in AI/ML device submissions or clinical trials.

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