(48 days)
The PatchAssist device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).
The PatchAssist device is a single use device that will be provided sterile.
This document is a 510(k) summary for the PatchAssist device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone performance study with specific acceptance criteria and detailed quantitative results. Therefore, many of the requested items are not explicitly available in the provided text.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria or provide specific numerical performance metrics in a table format. Instead, it describes general performance demonstrations.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe and effective performance in delivering, deploying, and placing hernia mesh | Underwent a full battery of bench tests and animal studies demonstrating safe and effective performance. |
| Facilitates the attachment of the mesh to the abdominal wall | Usability testing concluded that the device facilitates mesh attachment. |
| Easily withdrawn from the abdominal cavity | Usability testing concluded that the device is easily withdrawn. |
| Does not raise new safety or effectiveness issues | Testing demonstrated the device is safe and effective without raising new issues. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document mentions "a full battery of bench tests and animal studies" and "usability testing" but does not detail the number of units tested, animals used, or participants in usability testing.
- Data Provenance: The document implies the tests were conducted by PolyTouch Medical Ltd. or its partners. The country of origin of the data is not explicitly stated. The nature of the studies (bench and animal) suggests they are prospective, designed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided. The testing described (bench, animal, usability) would typically involve engineers, veterinarians, and possibly surgeons/medical professionals for usability, but their specific number or qualifications are not detailed.
4. Adjudication Method for the Test Set
- This information is not provided. Since the studies described are primarily technical performance and usability, a formal adjudication process as seen in clinical trials with expert consensus is less likely to be detailed in this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No. This is a medical device for facilitating surgical procedures, not an AI diagnostic or interpretive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. The PatchAssist device is a physical surgical tool that is used by a human surgeon. It's not an algorithm, and therefore standalone performance (without human interaction) is not relevant or applicable.
7. The Type of Ground Truth Used
-
For the bench tests: Engineering specifications, physical measurements, and possibly simulated anatomical models.
-
For the animal studies: Surgical outcomes, tissue integrity, absence of adverse events, proper mesh deployment.
-
For usability testing: User feedback, successful task completion, absence of reported difficulties.
The document broadly states that testing demonstrated "safe and effective performance," implying that the outcomes of these tests served as the "ground truth" for the device's function.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This device is a physical surgical tool, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As this is not a machine learning device, there is no training set or associated ground truth establishment process in that context.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.