(211 days)
The GrappLR™ and GrappLR™ Extender are intended to provide suspension fixation for soft tissue to bone in the repair of the natural ligament of tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.
The GrappLR™ suspension fixation device is a single-use, titanium implant used for fixation of soft tissue to bone. The GrappLR™ has two configurations: One has a Continuous Loop, made of ultra high molecular weight polyethylene, offered in several sizes to accommodate various bone tunnel lengths. The second configuration does not have a loop, and enables custom loop lengths to be tied using an appropriate material (not included). Both of these configurations have a Lead Suture. The GrappLR Extender™ is a single-use, titanium implant used for providing additional button width and length to the GrappLR™
The provided text is a 510(k) summary for the GrappLR™ and GrappLR™ Extender, which are metallic bone fixation fasteners. It focuses on demonstrating substantial equivalence to predicate devices. As such, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically expected for an AI/algorithm-based medical device.
Therefore, I cannot provide the requested information in the table format or answer specific questions related to AI/algorithm performance.
However, I can extract the relevant information about the device and its regulatory submission:
Device Information:
- Device Name: GrappLR™ and GrappLR™ Extender
- Regulatory Class: Class II
- Product Code: MBI (Smooth or threaded metallic bone fixation fastener), HWC
- Intended Use: To provide suspension fixation for soft tissue to bone in the repair of the natural ligament or tendon disruption or assist in reconstruction surgeries and to assist in the management of reconstructive surgeries.
- Description: Single-use, titanium implants for fixation of soft tissue to bone. Available in two configurations: one with a Continuous Loop (ultra-high molecular weight polyethylene) and one without a loop, allowing for custom loop lengths. Both have a Lead Suture. The Extender provides additional button width and length.
- Predicate Devices:
Regulatory Basis for Substantial Equivalence:
The manufacturer, T.A.G. Medical Products Corporation, Ltd., claims substantial equivalence based on:
- Same Indication for Use: The GrappLR™ and GrappLR™ Extender are intended for the same clinical purpose as the predicate devices.
- Similar Technology: "the design is similar as confirmed by comparison."
- Same Performance (Verified by Validation): "the performance is the same as verified by validation."
Key Missing Information for AI/Algorithm Studies:
The document does not describe the following:
- Acceptance criteria for an algorithm's performance (e.g., sensitivity, specificity, AUC).
- Any studies involving a test set, data provenance, ground truth establishment, or sample sizes related to an AI/algorithm.
- Multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- Training set details for an algorithm.
This is expected as the document describes a mechanical bone fixation device, not an AI/software device.
§ 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.