(110 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 mmHq to -125 mmHq nominal range. The NPseal is intended for 3 days of use. Therapy duration of the system may be less than indicated if clinical practice or other factors such as wound size, rate or volume of exudate, or orientation of the dressing results in earlier removal or need for system change. The NPseal can be replaced only one time for a total maximum wear time of 6 days. The NPseal is intended for surgically closed incisions up to 5 cm x 0.5 cm.
(1) A table of acceptance criteria and the reported device performance:
The provided text does not contain explicit acceptance criteria in a table format with corresponding reported device performance, as one might find in a detailed study report. Instead, it lists the types of performance data submitted for FDA's substantial equivalence determination.
Summary of Performance Data Submitted:
| Test Category | Specific Tests Performed |
|---|---|
| Biocompatibility Testing | Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Subacute Systemic Toxicity, Subchronic Systemic Toxicity, Implantation |
| Bench Testing | Pressure and exudate handling over time test, Curved surface pressure over time, Foam characterization test, Pump body adhesion test, Dressing peel test, Exudate handling without negative pressure test, Moisture vapor transmission rate (MVTR) test, Shelf Life test, Benchtop Usability Verification, Set Negative Pressure test |
| Human Factors Testing | User validation study |
The "Conclusions" section states: "The test data support the safety of the device and the hardware verification and validation demonstrate that the NPseal shall perform as intended in the specified use conditions." This implies that the device met the internal acceptance criteria for each of these tests, although the specific numerical or qualitative targets for these criteria are not detailed in this summary.
(2) Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The provided document is a 510(k) summary for a medical device (NPseal). It summarizes the performance data used to support substantial equivalence. It does not provide details on the sample sizes, data provenance (e.g., country of origin), or whether the studies were retrospective or prospective for the various tests mentioned (Biocompatibility, Bench, and Human Factors). These details would typically be found in the full study reports, which are not part of this summary document.
(3) Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided in the document. The NPseal is a physical device (non-powered suction apparatus for negative pressure wound therapy), not an AI/imaging diagnostic device that would typically rely on expert ground truth for a "test set" in the way an AI algorithm for image analysis does. The studies mentioned (biocompatibility, bench testing, human factors) involve laboratory or user-based assessments, not an expert panel reviewing diagnostic outcomes for ground truth establishment.
(4) Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies involving expert interpretation of data (e.g., medical images) where discrepancies need to be resolved to establish ground truth. As the NPseal is a physical medical device for wound therapy and the studies mentioned are largely laboratory or performance-based, such adjudication would not be relevant.
(5) 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:
This information is not applicable and therefore not provided. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices or AI algorithms where multiple human readers interpret cases. The NPseal is a non-powered suction apparatus for negative pressure wound therapy, not a diagnostic imaging device or an AI assistance tool for human readers.
(6) If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and therefore not provided. The NPseal is a physical medical device, not a standalone algorithm. The performance data provided relate to the physical and functional aspects of the device, as well as its interaction with users (human factors).
(7) The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" in the context of an AI or diagnostic study does not directly apply to the testing of the NPseal device as described. The testing (biocompatibility, bench testing, human factors) would have established expected performance parameters and safety profiles against predetermined engineering specifications, international standards (e.g., ISO 10993-1), and user requirements. For example:
- Biocompatibility: Ground truth would be the established safety limits and biological responses as defined by ISO standards.
- Bench Testing: Ground truth would be the engineering specifications for pressure, exudate handling, material strength, etc.
- Human Factors Testing: Ground truth would be the user performance against predefined usability objectives and safety critical tasks.
(8) The sample size for the training set:
This information is not applicable and therefore not provided. The NPseal is a physical medical device, not an AI algorithm that requires a training set. The various tests performed (biocompatibility, bench, human factors) are part of the verification and validation process for a hardware device, not model training.
(9) How the ground truth for the training set was established:
This information is not applicable and therefore not provided, as there is no "training set" for this physical medical device.
§ 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.