(127 days)
The BARD PERMAFIX FIXA IION SYSTEM is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.
The Bard PermaFix 1M Fixation System is disposable, single-use system designed to deliver a permanent fastener into tissue or prosthesis during general surgery procedures such as hernia repair. The fastener delivery system consists of an ergonomic handle with trigger, shaft and penetrating tip. The shaft is available in either a 36 cm length for laparoscopic use or a 20 cm length for open surgical procedures. The device is preloaded with 15 or 30 permanent fasteners. Each permanent fastener contains threads for mesh and tissue delivery.
The provided text describes a 510(k) premarket notification for a medical device and does not contain information about an AI/ML powered device, therefore, many of the requested details are not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through material characterization and mechanical performance testing.
Here's a breakdown of the information that is available and a note on what is not:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility of materials consistent with intended use. | "The biocompatibility test results show that the material used in the design and manufacture of the components of the proposed device are compatible with biological tissues consistent with its intended use." |
| Material composition similar to other implantable medical devices. | "A material characterization has been performed to demonstrate that this material is similar in composition to other implantable medical devices. This material is well characterized and has been used for several years in the medical device industry." |
| Mechanical strength of the repair in a hernia repair model comparable to the predicate device. | "The Bard PermaFix fasteners were tested in vitro in a hernia repair model to confirm the mechanical strength of the repair as compared to the predicate device." |
| Overall achievement of established specifications for consistent performance for intended use. | "All test results demonstrate that the material chosen, the manufacturing process, and the design used for the Bard PermaFix Fixation System met the established specifications necessary for consistent performance for its intended use." |
Details Not Applicable to This Device (as it is not an AI/ML device)
The document describes a Bard PermaFix Fixation System, which is a physical medical device (a stapler for hernia repair) and not an AI/ML powered device. Therefore, the following information fields are not applicable and cannot be extracted from the provided text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Adjudication method (e.g. 2+1, 3+1, none) for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.