(28 days)
Passing Needle with PANACRYL, ETHIBOND, or ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.
Mitek Passing Needle with ETHIBOND Loop is indicated for use in general soft tissue approximation and/or ligation in orthopedic procedures. Specifically Arthroscopic Bankart and Rotator Cuff Procedures encompassing tendon and ligament reconstruction.
Mitek Passing Needle with ETHIBOND, PANACRYL or ORTHOCORD suture is a suture and needle assembly to be used in vivo for suture passage through soft tissue during the surgical procedure. It is packaged with two colored clips and is designed to be used with the Mitek Suture Passer. The Passing Needle with PANACRYL, ETHIBOND or ORTHOCORD suture may also be used with other Mitek anchor products.
Mitek Passing Needle with ETHIBOND Loop is a utility suture and needle assembly that is used in vivo for suture passage of operative suture through soft tissue during the surgical procedure. It is packaged with a colored clip and is designed to be used with the Mitek Suture Passer.
The provided text is a 510(k) summary for a medical device (Passing Needle with various sutures) that seeks to demonstrate substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through testing.
Instead, the document primarily focuses on:
- Device Classification and Description: Details about the sutures used and the intended use of the passing needle assemblies.
- Substantial Equivalence: Listing predicate devices (previously cleared sutures) to which the current device is deemed substantially equivalent.
- Indications for Use: What orthopaedic procedures the device is intended for.
- Safety Reference: Stating that safety data for the sutures can be referenced in the clearance documents of the predicate devices.
Therefore, I cannot provide the requested information, which typically pertains to performance studies with specific metrics, acceptance criteria, sample sizes, and ground truth establishment. This type of information is usually found in detailed performance study reports, not in a 510(k) summary that relies on substantial equivalence.
To answer your request, if this were a document that did contain such a study (e.g., a clinical trial report or a comprehensive bench testing report), the table and other details would look something like this (hypothetical example, as the provided text doesn't support it):
(Hypothetical Example Based on a Fictional Performance Study)
1. A table of acceptance criteria and the reported device performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength (Suture A) | Mean tensile strength ≥ X Newtons | Mean tensile strength = X+Y Newtons (Pass) |
| Knot Security (Suture B) | No slippage or breakage at Z Newtons of force | No slippage or breakage observed up to Z+W Newtons (Pass) |
| Needle Bend/Breakage (Needle Type 1) |
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.