(125 days)
The KLS Martin Thoracic Plating System is indication and fixation of fixation of fractures in the chest wall including sternal reconstructive surgical procedures, trauma, or planned osteotomies.
The KLS Martin Thoracic Plating System includes metallic plates and screws that provide rigid fixation to fractures, planned osteotomies, and can be used for reconstructive procedures in the thoracic anatomy. The implants are available non-sterile or sterile in multiple shapes and sizes. Plates are manufactured from CP Titanium (ASTM F67:2013) and range in thickness from 1.0 - 3.0mm. Screws are manufactured from Ti-6Al-4V (ASTM F136:2013) and range in diameter from 2.3 - 3.2mm with lengths from 7 - 17mm. The system also includes the necessary instruments to facilitate placement of the implants.
This document is a 510(k) Premarket Notification for the KLS Martin Thoracic Plating System, dated April 6, 2016. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study against those criteria in the way one might for a novel AI device or a new diagnostic method.
Therefore, many of the requested categories are not applicable to this type of submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Rationale: This document describes a KLS Martin Thoracic Plating System, which is a metallic bone fixation appliance. The acceptance criteria here relate to the mechanical properties of the device and its substantial equivalence to existing predicate devices, rather than diagnostic performance metrics (e.g., sensitivity, specificity) typically associated with AI or imaging studies. Therefore, specific acceptance criteria as percentages for diagnostic accuracy are not present.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Material Composition | Plates manufactured from CP Titanium (ASTM F67:2013); Screws manufactured from Ti-6Al-4V (ASTM F136:2013). | The subject device uses the same materials (CP Titanium and Ti-6A1-4V) as the predicate devices. This indicates compliance with the material standards and similarity to predicates. |
| Mechanical Strength | Static and dynamic 4-point bending tests in accordance with ASTM F382; Strength properties of subject plates compared against predicate plates. | "Results met or exceeded the defined test conditions and demonstrate that the performance of the subject plates is substantially equivalent to the predicate devices." (No specific numerical values are provided, only a comparative statement of meeting/exceeding expectations relative to predicates). |
| Manufacturing Process | Same manufacturing process as predicate devices (e.g., KLS Martin Recon Talon - K122860, KLS-Martin Sternal Plating System - K032413 / K070169). | The subject device "undergoes identical manufacturing and sterilization processes as the KLS Martin Recon Talon - K122860 and the KLS-Martin Sternal Plating System - K032413 / K070169." |
| Sterilization Process | Same sterilization process as predicate devices. | The subject device "undergoes identical manufacturing and sterilization processes as the KLS Martin Recon Talon - K122860 and the KLS-Martin Sternal Plating System - K032413 / K070169." (Note: The subject device also offers implants in sterile packaging, whereas some predicates may not have explicitly stated sterile packaging as a distinguishing factor in this summary, but the process is stated as identical). |
| Intended Use | Stabilization and fixation of fractures in the chest wall, sternal reconstructive surgical procedures, trauma, or planned osteotomies. | The subject device has the "same intended use" as the predicate devices. |
| Principles of Operation | Rigid fixation of bone. | The subject device has "same principles of operation" as the predicate devices. |
| Technological Features | Similar technological features to predicates (e.g., metallic plates and screws, locking plate and screw characteristics). | The subject device has "similar technological features compared to the predicate devices." Differences (e.g., sterile packaging, additional plate shapes for thoracic anatomy, expanded indications for lateral/posterior chest wall fixation) were evaluated and determined "not to raise different questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "Static and dynamic 4-point bending tests" of the plates, but doesn't quantify the number of plates tested. This generally involves a small number of samples to assess mechanical properties according to ASTM standards.
- Data Provenance: Not applicable in the context of this device. The testing is laboratory-based mechanical testing, not clinical data provenance (e.g., country of origin for clinical cases).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device undergoes mechanical testing against specified material and performance standards (ASTM) and comparison to predicate devices, not evaluation against a "ground truth" established by clinical experts in the same way an AI diagnostic tool would.
4. Adjudication Method for the Test Set
- Not applicable. There is no adjudication method described as this is not a diagnostic or clinical study requiring expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. This is a medical device for surgical implantation, not an AI or diagnostic tool that involves human readers interpreting results.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Mechanical Standards and Predicate Device Performance: The "ground truth" for this device's performance is established by existing ASTM standards for material composition (ASTM F67, ASTM F136) and mechanical testing (ASTM F382) and by the established performance and safety profiles of the cited predicate devices. The device's performance is compared against these benchmarks to establish substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an algorithm, this question is not relevant.
§ 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.