(29 days)
The Bone Mulch Screw System is indicated for use in anterior cruciate ligament (ACL) reconstruction using semigracilis/semitendinosus or fascia lata (hamstring tendons) graft. It is intended for use in fixing the graft within the femoral graft tunnel.
The Bone Mulch Screw System consists of three different Bone Mulch Screws made of Titanium alloy, available in different lengths as well as cannulated and non-cannulated configurations, a titanium screw plug and an UHMWPE plug. The blunt nose of the screw transverses the femoral tunnel allowing for femoral fixation of the ACL graft. With the graft wrapped over the blunt nose of the screw, the larger portion of the cannulated screw is packed with bone graft material. The bone graft material is pushed into the tunnel by a graft insertion rod and secured in place with either the titanium screw plug or the UHMWPE plug. The non-cannulated screw is used in the same manner but does not require the addition of bone graft to fill the screw.
The Bone Mulch Screw and titanium screw plug is made of titanium alloy Ti-6Al-4V per ASTM F136 and the poly plug is made of UHMWPE. These materials have been successfully used as implantable materials for the past several decades. The biocompatibility and wear properties have been established by many years of usage in medical devices.
Mechanical testing of this device demonstrated more than adequate strength for this ACL reconstruction indication. In summary, the device is made of biocompatible materials and is able to withstand loads greater than those expected in an intact ACL.
This document describes the marketing authorization for the Bone Mulch Screw System, not a study evaluating its performance against specific acceptance criteria. The FDA letter states that the device is "substantially equivalent" to a legally marketed predicate device (K991298), which is a regulatory pathway for medical devices rather than a performance study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert roles, and MRMC study results cannot be extracted from this document, as it does not contain such a study or performance evaluation.
The provided text only includes a "Summary of Safety and Effectiveness" which focuses on:
- Intended Use: ACL reconstruction.
- Device Description: Materials (Titanium alloy, UHMWPE), configurations (cannulated/non-cannulated), and how it works.
- Mechanical Testing: A general statement about "more than adequate strength" and ability to "withstand loads greater than those expected in an intact ACL." This is not a detailed account of acceptance criteria or performance metrics.
- Possible Adverse Effects: A list of potential complications.
- Substantial Equivalence: To K991298.
In summary, this document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.