(66 days)
The Knotless AC Repair Devices are intended as adjuncts in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as adjuncts in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
The Knotless AC Repair Devices are intended to provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.
The Knotless AC Repair Devices with distal clavicle plate button are intended for use with Arthrex clavicle plates for clavicle indications and may not be used alone.
The subject devices are suture constructs configured with one or two metal buttons made of titanium or stainless steel. The nonabsorbable suture is made of UHMWPE. Some of the subject devices are compatible with the Clavicle Fracture plates cleared under K112437.
The provide FDA 510(k) summary describes the Arthrex Knotless AC Repair Devices, which are indicated as adjuncts in fracture repair and for fixation during syndesmotic trauma. The submission aims to demonstrate substantial equivalence to a predicate device, K052776: Arthrex TightRope Acromioclavicular (AC) Device, and refers to several other devices (K112437, K143139, K123341, K202581, K112990) as reference devices.
Here's an analysis of the acceptance criteria and study information provided:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Demonstrated that modifications do not negatively impact mechanical strength compared to the predicate device. This implies specific thresholds for ultimate load and cyclic displacement. Ultimate load testing and cyclic displacement were performed on the subject device and compared to the predicate device to demonstrate that the modifications do not negatively impact mechanical strength. (No specific numerical values or direct acceptance "pass/fail" stated, but the conclusion of non-negative impact implies acceptance.) Device meets pyrogen limit specifications. Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications. (Implies meeting the standard, thus acceptance.) Device is safe for use in an MR environment, specifically regarding: magnetic field induced displacement force, radiofrequency induced heating, and image artifact. (Based on standards: FDA guidance, ASTM F2052, ASTM F2119, ASTM F2182). MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, and ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging. (Implies that the testing demonstrated compliance with these standards, meaning the device met the safety criteria for MRI, thus acceptance.) Overall, the device is substantially equivalent to the predicate, with differences being minor and not raising questions concerning safety and effectiveness. "The Arthrex Knotless AC Repair Devices are substantially equivalent to the predicate in which the basic design features and intended use are the same. Any differences between the subject device and the predicate device are considered minor and do not raise questions concerning safety and effectiveness." (This is the overarching conclusion of the submission.) -
Sample size for the test set and data provenance:
- The document mentions "ultimate load testing and cyclic displacement," "bacterial endotoxin" testing, and "MRI force, torque, and image artifact testing." However, it does not specify the sample sizes (e.g., number of devices tested) for any of these tests.
- Data provenance is not explicitly stated. These are laboratory tests, so the "country of origin of the data" would likely be the location of the testing facility, which is not provided. The tests are prospective in nature, as they are conducted specifically for this submission.
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Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This document describes mechanical, biocompatibility, and MRI compatibility testing of a medical device, not a diagnostic algorithm that requires expert-established ground truth. Therefore, this information is not applicable to this type of submission.
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Adjudication method for the test set:
- Similar to point 3, this is not applicable as the studies are physical/chemical device tests, not involving human interpretation or clinical adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. The submission is for a physical medical device (suture button), not an AI-powered diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical implant, not a software algorithm.
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The type of ground truth used:
- For the mechanical tests, the "ground truth" would be the physical properties and performance characteristics of the predicate device, against which the subject device's mechanical performance is compared. Performance standards (e.g., ISO, ASTM) and established biological limits (e.g., pyrogen limits per EP/USP) serve as the "ground truth" or acceptance criteria for biocompatibility and MRI compatibility. Pathology or outcomes data are not relevant for this type of testing.
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The sample size for the training set:
- This is not applicable. There is no "training set" as this is a physical device, not an AI/machine learning model.
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How the ground truth for the training set was established:
- This is not applicable as there is no training set.
§ 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.