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Cork Medical Products NPWT Wound Dressing Kit is intended to be used in conjunction with the Genadyne XLR8 Pump to deliver negative pressure wound therapy to the wound.

When used in conjunction with a NPWT pump system, Cork Medical Products NPWT Wound Dressing Kit is indicated for patients who would benefit from a suction device particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

Cork Medical Products NPWT Wound Dressing Kit is comprised of components necessary to dress a wound for negative pressure wound therapy. The kit includes reticulated, 30 pores per inch (PPI), polyether, polyurethane foam; transparent polyurethane film drape with adhesive backing; and port pad assembly comprised of silicone port pad, drainage tubing, luer connector, pinch clamp, and transparent polyurethane film drape with adhesive backing.

The kits are available in two (2) sizes: medium and large based on the size of the foam. The medium foam is: 0.75″ x 5″ x 8″. The large foam is 0.75″ x 6″ x 10″. Each kit is single-use and housed in a Tyvek peel pouch, which is sterilized using ethylene oxide.

The provided 510(k) summary describes the Cork Medical Products NPWT Wound Dressing Kit and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device in terms of performance, biocompatibility, and intended use. The study conducted was primarily a series of nonclinical performance tests and biocompatibility assessments.

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify a numerical sample size for the performance tests. It states "Performance tests used simulated wound exudate. Pressure measurements were taken using a wound test bed fixture." This suggests a laboratory-based testing approach.
   • Data Provenance: The data is from laboratory testing of the Cork Medical Products NPWT Wound Dressing Kit, compared against the predicate device. It is prospective in the sense that the tests were designed and conducted to evaluate the device. The data is generated in-house or through contract labs (e.g., Nelson Laboratories for biocompatibility) with no explicit country of origin specified beyond the company's US address.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable in this context. The study did not involve human experts establishing ground truth for the device's performance in a diagnostic or clinical setting. Instead, the "ground truth" for the performance tests was defined by the expected operational parameters and alarm functions of a negative pressure wound therapy (NPWT) system, which were quantitatively measured using a test bed fixture. For biocompatibility, the ground truth was defined by passing pre-defined acceptance criteria for standard ISO 10993 tests.

3. Adjudication method for the test set:

   • This is not applicable. There was no need for adjudication as the tests were objective, quantitative measurements (e.g., pressure readings, alarm activation) and standard biological assays (e.g., cytotoxicity, sensitization) with pre-defined pass/fail criteria.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This device is a medical dressing kit for negative pressure wound therapy, not an AI-powered diagnostic tool requiring human interpretation.

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

   • Yes, in essence, standalone performance testing was done. The nonclinical tests evaluated the physical and functional performance of the device components (foam, drape, port pad assembly) in conjunction with a pump system against established parameters and the predicate device's expected performance, without direct human intervention in the measurement of performance. The biocompatibility tests were also standalone evaluations of the materials.

6. The type of ground truth used:

   • Objective performance criteria and ISO 10993 standards.
     • For performance tests: The ground truth was based on the functional requirements of a NPWT wound dressing kit and the established performance characteristics of the predicate device (e.g., maintaining specific negative pressure levels, triggering alarms correctly). Measurements were taken using a "wound test bed fixture."
     • For biocompatibility: The ground truth was defined by the pre-defined acceptance criteria set by ISO 10993 biological evaluation standards. All tests had to be "negative" and "passed the pre-defined test acceptance criteria."

7. The sample size for the training set:

   • This concept is not applicable to this type of device submission. This is a 510(k) for a physical medical device (wound dressing kit), not a machine learning or AI-driven algorithm. Therefore, there is no "training set" in the computational sense.

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

   • This question is not applicable as there was no training set for an AI/ML model.

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