(19 days)
The device is intended for fixation of prosthetic material to soft tissue in various minimally invasive and open surgical procedures such as hernia repair.
AbsorbaTack™ Absorbable Fixation Devices are sterile single use devices for the fixation of prosthetic material such as hernia mesh to soft tissue. The Tack is constructed of an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C violet #2. The device is offered with 5, 10, 15, 20, or 30 tacks. AbsorbaTack™ Absorbable Fixation device is similar to the predicate device except for the revised shaft design. The design modifications include adding a flex cable in the inner drive tube of the shaft to allow for continuous rotation if the outer tube is bent to ensure tack deployment, shortening an existing stiffener to reinforce the interface between the outer shaft tube and the body halves, and extending the spring up the entire length of the outer shaft tube that is outside of the body halves.
The provided text does not contain information about acceptance criteria or a study proving that the AbsorbaTack™ Absorbable Fixation Device meets acceptance criteria in the manner typically associated with AI/ML device evaluations.
Instead, the document is a 510(k) premarket notification for a design change to an existing medical device. The key points from the document regarding performance are:
- Reason for 510(k) submission: To obtain premarket clearance for a change in the design of the AbsorbaTack™ Absorbable Fixation Device with no changes in the indications or intended use of the device.
- Technological characteristics: The device is similar to the predicate device except for a revised shaft design. The modifications include adding a flex cable, shortening an existing stiffener, and extending a spring.
- Performance data: "There has been no change to the performance specifications of the AbsorbaTack™ Absorbable Fixation Device. The modified design does not change the performance of the device for its intended use."
This indicates that the submission is based on the premise that the design changes do not alter performance specifications, thus no new performance study demonstrating "acceptance criteria" compliance was required or conducted for this specific 510(k). The FDA's letter confirms substantial equivalence without requiring new performance data beyond biological evaluation (ISO 10993-1).
Therefore, most of the requested information (sample size, experts, adjudication, MRMC study, standalone performance, ground truth, training set) is not applicable to this 510(k) submission as described.
§ 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.