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510(k) Data Aggregation
(419 days)
The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System comprised of the; PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump, and the PWD™ Wound Exudate Canister is indicated in patients who would benefit from a suction device (Negative Pressure Wound Therapy) 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, sub-acute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure and venous insufficiencies), flaps, grafts and closed surgical incisions.
PWD Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.
The Applied Tissue Technologies PWD™ Platform Wound Dressing Negative Pressure System consists of the PWD™ Dressing, PWD™ Negative Pressure Wound Therapy Pump and the Wound exudate canister. The system provides a negative pressure wound dressing therapy in a moist environment to facilitate the wound healing process. The dressing has an access port through which fluids can be drawn from the wound site. The same port can also be utilized to administer negative pressure wound therapy using the negative pressure pump if required. The negative pressure pump is used with a collection cannister to collect the exudate. The PWD Platform Wound Dressing is supplied in five different shapes and sizes, all having the same intended use.
The provided document describes the PWD™ Platform Wound Dressing Negative Pressure System and its substantial equivalence to predicate devices, focusing on performance data from bench testing.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Description | Reference Standards | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| Water Vapor Transmission Rate | Measures the passage of water vapor through the membrane/adhesive barrier | ASTM 1249 | Must be at least equivalent to commercially available NPWT dressing | Pass |
| Exudate Throughput Properties Under Negative Pressure | Simulated Use testing using various exudate types to confirm acceptable fluid flow when connected to the Pump and Canister system | N/A | System must demonstrate the ability to remove exudates of various types from the wound bed | Pass |
| Maintenance of Negative Pressure | Simulated use testing from under moist conditions to demonstrate maintenance of negative pressure | NA | The PWD must maintain negative pressure at the wound bed for the test duration | Pass |
| Usability | Usability testing for both healthcare and home use environments | NA | Users must demonstrate the ability to correctly use the device | Pass |
| Electrical Safety | Complies with applicable safety standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 | Requirements for electrical safety per the applicable safety standards is met | Pass |
| Electro-magnetic Compatibility | Complies with applicable safety standards | Complies with IEC 60601-2-3 | Requirements for electromagnetic compatibility per the applicable safety standards is met | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states that the performance data was generated through "Bench testing" for various characteristics. This type of testing typically uses laboratory samples of the device components or simulated systems rather than human subjects or a clinical test set.
- Sample Size for Test Set: Not specified, but implied to be laboratory samples of device components.
- Data Provenance: Not applicable in the context of clinical data. The data is from laboratory bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. For bench testing, ground truth is typically established by engineering specifications, validated test methods, and compliance with industry standards, rather than expert clinicians.
4. Adjudication Method for the Test Set:
- This information is not applicable as the described tests are bench tests, not clinical studies requiring adjudication of output from human readers or an algorithm.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The document describes a 510(k) premarket notification process based on substantial equivalence to predicate devices and bench testing. There is no mention of a clinical trial involving human readers or a comparison of human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical medical device (Negative Pressure Wound Therapy System), not an AI algorithm. The performance evaluation focuses on the physical and functional aspects of the system.
7. The Type of Ground Truth Used:
- The ground truth for the bench tests appears to be based on engineering specifications, established industry standards (e.g., ASTM, IEC), and the functional requirements for a negative pressure wound therapy system. For instance, "ability to remove exudates of various types from the wound bed" and "maintain negative pressure at the wound bed for the test duration" serve as the functional ground truths.
8. The Sample Size for the Training Set:
- Not applicable. This document describes the testing of a physical medical device. There is no mention of an AI component requiring a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there is no AI component or training set mentioned, this information is not relevant to the provided document.
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