(30 days)
The NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.
The NPseal Negative Pressure Advanced System is a single-use device that includes an integrated, mechanical pump system. The NPseal maintains Negative Pressure Wound Therapy (NPWT) in the -75 mmHg to -125 mmHg nominal range. The NPseal is intended for 7 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as time to wound closure and rate of exudate, result in earlier removal or need for system change. The NPseal Small is intended to remove small amounts of exudate from surgically closed incisions up to 5 cm × 0.5 cm. The NPseal Medium is intended to remove small amounts of exudate from surgically closed incisions up to 10 cm x 0.5 cm. The NPseal Large is intended to remove small amounts of exudate from surgically closed incisions up to 15 cm x 0.5 cm.
The provided text is a 510(k) summary for a medical device called NPseal. This document does not contain information about acceptance criteria for device performance in the context of diagnostic or prognostic accuracy, nor does it describe a study that uses a test set, expert ground truth, or addresses human reader performance with or without AI.
The document describes a submission for a modification to an existing device (NPseal K212971) to allow for 7 days of wear time instead of 6, and some manufacturing-related design changes. The document explicitly states: "No clinical testing was applicable to this submission."
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study demonstrating device performance against acceptance criteria for a diagnostic/prognostic device.
The study described in this document is a non-clinical bench testing and verification/validation study to support the modified device's safety and effectiveness compared to its predicate.
Here's what information can be extracted or inferred from the provided text, related to the nature of this submission:
- Type of Study: Bench testing, verification, and validation of physical device modifications and extended wear time.
- Purpose of Study: To demonstrate substantial equivalence of the modified NPseal to the predicate device, particularly regarding the extended wear time and manufacturing changes.
- Tests Performed (Functional and Performance Testing):
- Pressure and Exudate Handling Over Time
- Benchtop Usability Testing
- Pull Testing
- Shipping Validation
- Ground Truth: For the "Pressure and Exudate Handling Over Time" test, the "ground truth" would be defined by pre-determined engineering specifications for negative pressure range (-75 to -125 mmHg nominal range) and exudate handling capabilities, both over the extended 7-day period. For "Pull Testing," it would be mechanical strength requirements. For "Usability" and "Shipping," it would be performance against established protocols and acceptance limits for functionality and integrity after use/transport.
- No Clinical Testing: The document explicitly states, "No clinical testing was applicable to this submission." This means there's no clinical trial data to evaluate device performance in patients, nor any data related to diagnostic accuracy, sensitivity, specificity, or human reader performance.
- Sample Size: The document does not specify sample sizes for the bench tests.
- Experts: Not applicable in the context of diagnostic/prognostic device evaluation. Engineering and quality control personnel would have designed, executed, and reviewed these bench tests.
In summary, the provided FDA 510(k) document is for a non-diagnostic device modification and does not contain the type of study data (clinical, AI performance, expert review, etc.) that your request targets.
§ 878.4683 Non-Powered suction apparatus device intended for negative pressure wound therapy.
(a)
Identification. A non-powered suction apparatus device intended for negative pressure wound therapy is a device that is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is further indicated for management of wounds, burns, flaps, and grafts.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).” See § 878.1(e) for the availability of this guidance document.