(129 days)
The Applied Tissue Technologies PWD™ Platform Wound Dressing is intended to be used in conjunction with the Invia Motion Negative Pressure Wound Therapy (NPWT) system and is indicated in patients who would benefit from a suction device (NPWT) as it creates an environment that may promote wound healing by removing excess wound exudate. The Applied Tissue Technologies Platform Wound Dressing is appropriate for use on the following wounds: exudating, chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as: diabetic, pressure and venous insufficiencies), flaps and grafts.
The Applied Tissue Technologies PWD™ Platform Wound Dressing is a single use device. Its transparency permits the healthcare practitioner to observe the progress of the wound healing without removing the wound dressing. There is an access port to administer negative pressure wound therapy. The PWD is intended to be used for a maximum of 3 days. Therapy duration may be less than indicated if clinical practice or other factors require more frequent dressing changes. The PWD will be marketed in four different shapes and sizes, all having the same intended use.
The provided text describes a 510(k) premarket notification for the Applied Tissue Technologies PWD™ Platform Wound Dressing. This document asserts substantial equivalence to a predicate device, the Medela Ag Invia Foam Dressing Kit (K170088), rather than detailing an independent study to prove specific acceptance criteria for a new AI/ML device.
Therefore, many of the requested categories are not applicable to the information contained in this FDA submission. The document focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through performance data and a comparison of technological characteristics.
Here's an breakdown based on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (e.g., sensitivity, specificity, or improvement in a specific clinical outcome). Instead, it relies on demonstrating that the device's technical performance characteristics are acceptable and comparable to a predicate device.
| Performance Metric | Acceptance Criteria (Implied by Comparison) | Reported Device Performance (PWD™ Platform Wound Dressing) |
|---|---|---|
| Device Vapor Transmission | Acceptable | Acceptable test results |
| Ability to Maintain Negative Pressure | Acceptable | Acceptable test results |
| Ability to Remove Exudate | Acceptable | Acceptable test results |
| Biocompatibility | According to ISO 10993 standard series | Acceptable test results |
| Maximum Duration of a single dressing | 72 Hours (Same as predicate) | 72 Hours |
| Negative Pressure to the wound surfacerequirements in mmHg | 125 mmHg (Predicate) | 80 mmHg (nominal) +/- 20mmHG to the wound surface. Noted as a nominal recommended setting, pump settings range from -40 to -175. This difference does not raise new questions of safety. |
| Multiple Shapes for Wound Sizes up to 400cc | 240 - 2700cc (Predicate) | 400cc (within the range of the predicate device) |
| Dressing Configuration | Similar to predicate (Clear polyurethane occlusive drape dressing with foam insert) | Clear polyurethane embossed occlusive drape with tubing. (Similar materials and configuration; embossed layer allows fluid transfer instead of foam, deemed not to raise new questions of safety) |
| Access Port | Same as predicate | For attachment to the negative pressure pump; for removal of fluids. |
| Collection Pack | Same as predicate | PWD tubing connected to Medela Invia Motion canister/tubing set for fluid collection. |
| Pump | Same as predicate | To be used with the Medela Invia® Motion™ Negative Pressure Wound Therapy System. |
| How Supplied | Same as predicate | Sterile Single Use Only |
| Tissue Contact Materials | Similar to predicate | Polymers and Adhesive (Differences do not introduce new questions of safety) |
| Additives - antimicrobial, animal origin | No (Same as predicate) | No |
| Sterilization | Eto (Same as predicate) | Eto |
2. Sample size used for the test set and the data provenance
The document mentions "Bench testing" and "Biocompatibility testing" but does not provide details on the sample sizes used for these tests. The data provenance is laboratory testing, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the study involves bench testing and biocompatibility, not clinical evaluation requiring expert ground truth for patient outcomes or diagnostic accuracy.
4. Adjudication method for the test set
Not applicable as it's not a clinical study with an adjudication process.
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
Not applicable. This device is a wound dressing, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a wound dressing, not an AI/ML algorithm.
7. The type of ground truth used
For the bench tests (vapor transmission, negative pressure maintenance, exudate removal), the "ground truth" would be the measured physical properties satisfying engineering specifications. For biocompatibility, the ground truth is adherence to ISO 10993 standards and accepted biological safety profiles for the materials. This is not "expert consensus, pathology, or outcomes data."
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.