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510(k) Data Aggregation
(133 days)
NewEra Small Dome Kit, NewEra Medium Dome Kit, NewEra Large Dome Kit
The NewEra Dome Kit is intended to be used with the NewEra I and II pumps. The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formations and by removing exudate and infectious material. NPWT is appropriate for use on the following wounds: Pressure Ulcers, Diabetic/neuropathic ulcers, Venous insufficiency ulcers, Chronic, Acute, Traumatic, and Subacute wounds, Post-operative and dehisced surgical wounds, Explored fistulas, Skin flaps and grafts.
The NewEra Dome Kit is a convenience kit offered in three sizes: small, medium, and large. The kit contains individually sterilized and packaged products, except PhaseOne which is not sterile. All products in the kit are 510(k) approved or exempt, except for the IHT NPWT dome (IHT dome). The kit includes an IHT dome to connect to a waste canister, PhaseOne Skin and Wound Cleanser, SkinTac, a ruler, one or more Cutimed Sorbact Compresses, and one or more transparent film IHT drapes (IHT drape), depending on the size. PhaseOne (K131542, K113820, K071056) and Cutimed Sorbact (K063059) are 510(k) approved devices. The IHT drape, SkinTac and ruler are Class I 510(k) exempt. The PhaseOne is used to cleanse the wound. Cutimed Sorbact is then fluffed and filled into the wound. SkinTac is used on the border of the wound. The IHT Drape is applied to seal the wound. A hole is cut in the drape and the IHT NPWT dome is placed over the hole to allow suction. The NewEra Dome Kit attaches to an exudate canister to carry exudate from the wound and encourage wound closure. The IHT dome and tubing are made of a medical grade thermoplastic elastomer, and the drapes and dome skirt are clear polyurethane films which are all common materials currently found in similar wound care products with established biocompatibility.
The provided text describes the NewEra Dome Kit, a Negative Pressure Wound Therapy (NPWT) system. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to serve as a conduit between NPWT Pump and NPWT dressing system for 72 hours. | Confirmed that the IHT Dome and NewEra Dome kit delivered negative pressure for 72 hours. |
| Ability to remove exudate for 72 hours. | Confirmed that the IHT Dome and NewEra Dome kit removed exudate for 72 hours. |
| No alarms contribution. | Confirmed that the IHT Dome and NewEra Dome kit contributed to no alarms. |
| Pressure delivered at the wound bed is the same as listed on the pump. | Confirmed that the pressure delivered at the wound bed was the same as listed on the pump. |
| Pressure delivered in a timely manner. | Confirmed that the pressure was delivered in a timely manner. |
| Leak alarm occurs when a leak is manually created in the dressing. | Confirmed that the leak alarm occurred when a leak was manually created in the dressing. |
| Usability requirements validated by actual potential users. | All participants successfully applied the NewEra Dome Kit to the wound model in a usability study. |
2. Sample Size Used for the Test Set and Data Provenance
- Bench top performance and pressure testing: No specific sample size is mentioned for this testing. It's implied to be conducted in a laboratory setting (benchtop). Data provenance is not specified beyond being "bench top."
- Usability study: No specific sample size is mentioned for the usability study, only "individuals who represented actual potential users." The data is prospective, generated from the usability study.
- No specific details on countries of origin are provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for the benchtop tests or the usability study in the provided text. The tests appear to be objective measurements (pressure, exudate removal, alarm function) and user performance.
4. Adjudication Method for the Test Set
No adjudication method is described for either the benchtop or usability testing. The benchtop tests likely involved direct measurement and observation. The usability study involved users applying the kit, and the "successful application" suggests a pass/fail outcome based on predefined criteria, not expert adjudication.
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
The document does not describe an MRMC comparative effectiveness study or any involvement of AI. The device is a physical NPWT kit, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the NewEra Dome Kit is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For the benchtop tests, the ground truth was based on objective physical measurements (e.g., pressure readings, observation of exudate removal, alarm activation) against predefined performance specifications.
- For the usability study, the ground truth was based on the successful completion of predefined tasks by representative users.
8. The Sample Size for the Training Set
The document does not describe a "training set" as the device is a physical product and not an AI/machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated in point 8.
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