(56 days)
The MINI QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Shoulder: Bankart Repair
Wrist: Scapholunate ligament reconstruction.
Hand: Thumb ulnar or radial collateral ligament.
Foot: Hallux valgus reconstruction.
Ankle: Midfoot reconstruction.
The MINILOK QuickAnchor Plus is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
Wrist: Scapholunate ligament reconstruction.
Hand: Thumb ulnar or radial collateral ligament.
Foot: Hallux valgus reconstruction.
Ankle: Midfoot reconstruction.
The MiniQuick Anchor Plus w/ Orthocord, and MINILOK QuickAnchor w/ Orthocord, are preloaded disposable anchor/inserter assemblies designed to facilitate the delivery and installation of the anchor into bone.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of performance metrics like accuracy, sensitivity, or specificity. Instead, the document is a 510(k) summary for a medical device (MINILOK QuickAnchor Plus and Mini QuickAnchor Plus with Orthocord sutures), which primarily focuses on demonstrating substantial equivalence to pre-existing legally marketed devices.
The information provided includes:
- Device Description: Explains the nature of the anchors and sutures.
- Proposed Indications for Use: Specifies the medical conditions and anatomical locations for which the devices are intended.
- Safety Information: Mentions biocompatibility studies demonstrating non-toxicity, non-irritation, non-sensitization, and non-cytotoxicity.
- Substantial Equivalence: Lists predicate devices to which the current device is deemed substantially equivalent.
There is no mention of:
- A table of acceptance criteria and reported device performance in terms of clinical or technical metrics.
- Sample sizes for test sets, data provenance, or details about training sets.
- The number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance.
- Types of ground truth used (e.g., pathology, outcomes data).
Therefore, based on the input document, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them, as this type of information is not present in the provided 510(k) summary. These summaries historically focus on demonstrating equivalence through design, materials, and intended use to predicate devices, rather than presenting detailed prospective clinical trial data with specific performance metrics and acceptance thresholds.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.