(121 days)
Mepiseal is intended to be used on periwound skin in conjunction with a wound dressing to prevent leakage and premature loosening of the dressing. It is designed to fill uneven skin surfaces and mold around wounds in challenging anatomical locations. When used under NPWT dressings, Mepiseal serves as a sealant to help create and maintain a seal, which enables delivery of effective negative pressure wound therapy.
When used under NPWT dressings to aid in seal formation, Mepiseal is compatible with the Avance Dressing Kits that include Avance Film with Safetac Technology and Avance Transparent Film.
The subject device is a soft silicone sealant intended to be used on periwound skin in conjunction with a wound dressing and is designed to fill uneven skin surfaces and mold around wounds in challenging anatomical locations. Mepiseal serves the same function as the soft silicone layer of any wound dressing, to maintain the seal of the dressing around the wound. It is considered an accessory to the wound dressing and can be used under conventional wound dressings and under Negative Pressure Wound Therapy (NPWT) dressings.
The provided text is a 510(k) summary for the Mepiseal Soft Silicone Sealant. It describes the device, its intended use, and its comparison to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of typical AI/ML device performance.
The "Performance Data" section states: "Bench testing has been performed to demonstrate that Mepiseal is capable of sealing air leaks in the Avance NPWT system and does not otherwise interfere with the system's ability to transport fluid away from the wound. Mepiseal's performance has been evaluated under both soft silicone films and acrylic films (Avance Film with Safetac Technology and Avance Transparent Film) and found to be acceptable."
This indicates functional testing of the sealing ability and compatibility with an NPWT system, not a study assessing diagnostic performance (like sensitivity, specificity, or AUC) which would be typical for an AI/ML device. Therefore, I cannot provide details for most of your requested points, as they are not applicable to the type of device described (a silicone sealant) or the type of data presented (bench testing for physical functionality).
However, I can extract the following:
1. A table of acceptance criteria and the reported device performance:
Based on the provided text, the acceptance criteria implicitly relate to the device's ability to create and maintain a seal for negative pressure wound therapy systems and not interfere with fluid transport. The "reported device performance" is a qualitative statement of meeting these criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Capable of sealing air leaks in the Avance NPWT system. | "Mepiseal is capable of sealing air leaks in the Avance NPWT system." |
| Does not interfere with the Avance NPWT system's ability to transport fluid away from the wound. | "Mepiseal... does not otherwise interfere with the system's ability to transport fluid away from the wound." |
| Performance is acceptable under both soft silicone films (Avance Film with Safetac Technology) and acrylic films (Avance Transparent Film). | "Mepiseal's performance has been evaluated under both soft silicone films and acrylic films (Avance Film with Safetac Technology and Avance Transparent Film) and found to be acceptable." |
2. Sample sized used for the test set and the data provenance: Not applicable. This was bench testing, not a clinical study or AI/ML performance evaluation test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system or diagnostic accuracy was not established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI/ML device or a diagnostic device where human reader improvement would be measured.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here would be the physical principles of sealing and fluid transport, verified through bench test measurements.
8. The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
9. How the ground truth for the training set was established: Not applicable. There is no training set for an AI/ML algorithm.
In summary, the provided document describes a medical device (a silicone sealant) and its associated bench testing results for a 510(k) submission, not an AI/ML medical device. Therefore, most of the requested information regarding AI/ML performance studies (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies) is not present and not relevant to this specific premarket notification.
§ 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.