(78 days)
The Syneture™ Absorbable Tack and Applicator are intended for fixation of prosthetic material to soft tissue in various minimally invasive and open general surgical procedures, such as hernia repair.
The Syneture™ Absorbable Tack and Applicator are sterile single use devices for the fixation of prosthetic material, such as hernia mesh, onto soft tissue. The Absorbable Tack is formed from synthetic polyester derived from a lactic acid and glycolic acid copolymer. The Applicator is offered with a range of 5 to 20 tacks.
The provided text describes a 510(k) summary for the Syneture™ Absorbable Tack and Applicator. This is a medical device, not an AI/ML algorithm or software as a medical device (SaMD). Therefore, the information requested in points 1-9 (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable to this type of submission.
510(k) submissions for devices like the Syneture™ Absorbable Tack and Applicator typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance metrics against specific acceptance criteria for diagnostic or algorithmic accuracy.
- Acceptance Criteria & Device Performance: The document states "Performance testing was conducted to verify that the Syneture™ Absorbable Tack and Applicator is safe and effective and performs as intended." However, it does not provide a table of specific acceptance criteria (e.g., tensile strength, degradation rate, biocompatibility standards) or the quantitative results of these tests. This information would typically be detailed in the full 510(k) submission, but is summarized here. The summary explicitly states that the device "is identical to the predicate device in terms of intended use and mode of operation," which is the primary form of 'performance' justification in a 510(k) for substantial equivalence.
Given the nature of the device and the provided document, the requested details for AI/ML evaluation metrics are not present.
§ 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.