(143 days)
The ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices are indicated for soft tissue to bone or bone-tendon to bone fixation for: ACL/PCL Repair/Reconstruction and soft tissue to bone fixation for Extracapsular Repair: MCL, LCL.
The Smith & Nephew ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices consist of an ultra-high molecular weight polyethylene graft suspension loop and a titanium cortical button. The devices facilitate knee ligament repair/reconstruction through placement and retention of soft tissue or bone-tendon within bone.
The ULTRABUTTON QUAD Adjustable Fixation Device and the ULTRABUTTON BB Adjustable Fixation Device is available in one size. The UTLRABUTTON TIB Adjustable Fixation Device is available in a small, medium, or large size.
The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of an AI/ML-based medical device. Instead, it is an FDA 510(k) clearance letter and summary for a physical medical device: the ULTRABUTTON QUAD, BB, and TIB Adjustable Fixation Devices.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance (for an AI/ML device)
- Sample size used for the test set and data provenance
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The available text describes the device, its intended use, indications for use, and a summary of performance data for non-clinical testing to demonstrate substantial equivalence to a predicate device. This performance data relates to mechanical and material characteristics of the physical device, not an AI algorithm.
Specifically, the "Summary of Performance Data" section states:
- "Device cyclic displacement, device repair strength, and construct stiffness met the acceptance criteria established by the predicate device (K153186)."
- "Biocompatibility testing per ISO 10993-1:2018 demonstrated passing results."
- "Bacterial endotoxin testing was completed and met acceptable limits per ANSI/AAMI ST72:2019."
- "The devices have a three (3) year shelf-life. Storage and stability is based on completed packaging material storage stability testing, device storage stability testing, and distribution testing. Packaging testing per ISO 11607-1:2019 demonstrated passing results."
- "Sterile adoption was completed per ISO 11135:2014+A1:2018."
These are typical performance tests for surgical fixation devices to ensure mechanical integrity, biocompatibility, sterility, and shelf-life, not for assessing the diagnostic or predictive performance of an AI algorithm.
§ 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.