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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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