(132 days)
The device is used to anchor suture into bone . The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to obtain clearance for the Mitek Micro Anchor for the collateral ligament(s) around the (PIP) joint. The intended use is the same as the predicate device, i.e., suture, when used to approximate soft tissue to bone during a period of rehabilitation.
The Mitek Micro Anchor is 3.7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6Al 4V and uses a Nitinol arc. It is similar in design to the Mitek GII Mini Anchor. The same methods of manufacturing and assembly are used for the Micro Anchor as those used for manufacturing all other Mitek metal Anchors. The Mitek Mini Anchor design was first cleared to market by US FDA in K915089 and K930892. The Mitek Micro Anchor delivery system consists of a Mitek Micro Anchor, a drill bit, and an inserter.
The provided text is a summary of safety and effectiveness for a medical device (Mitek Micro Anchor) seeking 510(k) clearance from the FDA in 1996. It details the device's design, materials, intended use, and comparison to a predicate device (suture).
However, the document does NOT contain information regarding:
- Acceptance criteria for the device's performance in a study.
- A "study that proves the device meets the acceptance criteria" in the modern sense of a clinical trial or performance evaluation with statistical metrics.
- Sample sizes for test or training sets.
- Data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document is a regulatory submission for a medical device that predates the common expectation of detailed efficacy studies with AI elements. It focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and mechanical properties, not on performance against specific, quantifiable acceptance criteria established through a clinical study with detailed statistical analysis.
Therefore, I cannot fulfill your request for the specific information points because they are not present in the provided text. The document describes a device for physical fixation, not a diagnostic or AI-driven device that would typically involve the kind of performance metrics and study details you've requested.
The "comparison to predicate device" aspect mentions "It has greater strength than USP #4/0 suture," which is a claim of superior physical performance, but it doesn't specify how this was measured, the acceptance criteria for "greater strength," or the study details.
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SUMMARY OF SAFETY AND EFFECTIVENESS MITEK MICRO ANCHOR
SUBMITTER:
NAME: Mitek Surgical Products, Inc. ADDRESS: 60 Glacier Drive. Westwood, MA 02090 TELEPHONE: 617-461-9700 CONTACT: Edward F. Kent, Vice President, Regulatory Affairs DATE: June 28, 1996
NAME OF DEVICE
CLASSIFICATION NAME: Staple, Fixation, Bone COMMON NAME: Appliance for reconstruction of bone to soft tissue PROPRIETARY NAME: MITEK MICRO ANCHOR
PREDICATE DEVICE: SUTURE
DESCRIPTION OF DEVICE
FUNCTION
Fixation of USP #4/0 suture below bone surface.
DEVICE DESIGN
The Mitek Micro Anchor is 3.7mm in length by 1.3mm in diameter. It is manufactured from Titanium 6Al 4V and uses a Nitinol arc. It is similar in design to the Mitek GII Mini Anchor. The same methods of manufacturing and assembly are used for the Micro Anchor as those used for manufacturing all other Mitek metal Anchors. The Mitek Mini Anchor design was first cleared to market by US FDA in K915089 and K930892.
MATERIAL USED
The Mitek Micro Anchor delivery system consists of a Mitek Micro Anchor, a drill bit, and an inserter.
INTENDED USE
The device is used to anchor suture into bone . The suture is subsequently used by the surgeon to reattach the repositioned/injured soft tissue to bone. The purpose of this 510(k) submission is to obtain clearance for the Mitek Micro Anchor for the collateral ligament(s) around the (PIP) joint. The intended use is the same as the predicate device, i.e., suture, when used to approximate soft tissue to bone during a period of rehabilitation.
COMPARISON TO PREDICATE DEVICE
It has greater strength than USP #4/0 suture, and is the same "design" as the Mitek Mini Anchor.
§ 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.