(294 days)
The V.A.C. DERMATACTM Drape is an accessory to the:
· ACTIV.A.C.™, INFOV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings.
· V.A.C.ULTA™ and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.
When used on open wounds, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudates via the application of negative pressure wound therapy.
The V.A.C. DERMATAC Drape is a semi-occlusive wound drape that is used as an accessory to the V.A.C. Therapy System. The V.A.C. DERMATAC Drape is single-use and it is provided sterile. The V.A.C DERMATAC Drape provides a sealed environment which allows for a moist wound environment and it allows for the delivery and maintenance of negative pressure at the wound site.
The drape consists of a polyurethane film with acrylic adhesive with a perforated silicone layer. The perforations in the silicone layer expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the drape to the periwound and the silicone layer primarily provides a seal for negative pressure.
The V.A.C. Therapy System is comprised of the following:
- . Software controlled neqative pressure therapy unit
- . Disposable canister which collects wound exudate
- . Polyurethane foam dressing
- Semi-occlusive wound drape
The provided text describes the V.A.C. DERMATAC Drape, an accessory for Negative Pressure Wound Therapy (NPWT) Systems, and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the format requested (e.g., performance metrics like sensitivity, specificity, AUC, or comparative effectiveness with human readers).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and a human factors assessment. The "study" mentioned is a set of engineering and biocompatibility tests, not a clinical trial or an AI performance study with ground truth established by experts.
Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, or training set details as that information is not present in the provided text.
Here's what I can extract based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated Requirements) | Reported Device Performance |
| Biocompatibility | Met requirements according to ISO 10993 series testing (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Genotoxicity, Chemical Characterization, Leachable Substances). |
| Shelf Life (Packaging Integrity) | Met all requirements after 3 cycles of EtO sterilization and simulated shipping, for an accelerated aged equivalent of 2 years real time (shelf life stated as 1 year). |
| Adhesive Peel Test (Force required to remove drape) | Met specification requirements. |
| Moisture Vapor Transmission Rate (MVTR) | Met minimum requirements when using ASTM E96/E96M (Upright Cup Method at 38°C and 10%RH). |
| Negative Pressure Maintenance System Test (Maintain negative pressure with simulated wound exudate, maximum air leak, worst-case dressing, max use life, re-application cycling) | Capable of maintaining negative pressure within specification, including after re-application cycling. |
| Peel Adhesion with Re-Application Cycling Testing (Peel force after multiple re-applications) | Capable of meeting specification for peel adhesion after multiple re-applications and removals. |
| Human Factors (Safe and effective use by representative users) | 30 representative users found the new user interface could be safely and effectively used. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Biocompatibility: Not specified, but involved testing according to ISO standards.
- Shelf Life: Not specified for unit count.
- Adhesive Peel Test: Not specified for unit count.
- Moisture Vapor Transmission Rate Test: Not specified for unit count.
- Negative Pressure Maintenance System Test: Not specified for unit count.
- Peel Adhesion with Re-Application Cycling Testing: Not specified for unit count.
- Human Factors: 30 representative users.
- Data Provenance: The tests described are laboratory/engineering tests conducted to assess physical and biological properties. A "country of origin for data" is not applicable in the context of these non-clinical tests. These are considered prospective tests performed on the device to prove its characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the evaluations were non-clinical engineering and biocompatibility tests, not studies requiring expert-adjudicated ground truth. The human factors study involved "representative users" but didn't establish ground truth for a diagnostic task.
4. Adjudication method for the test set:
- This information is not applicable as the evaluations were non-clinical engineering and biocompatibility tests.
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:
- No, an MRMC comparative effectiveness study was not done. The device is a wound drape, not an AI diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable as the device is a wound drape, not an algorithm or AI system.
7. The type of ground truth used:
- Not applicable in the context of diagnostic ground truth. The "ground truth" for these tests was established by meeting engineering specifications and ISO standards (e.g., passing a biocompatibility test means no cytotoxic effect, maintaining negative pressure within a specified range).
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.