(85 days)
KLS-Martin Rigid Fixation - Sterile is intended to provide, in sterile packaging, osteosynthesis products with the following indications for use.
K051236: The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
K032442: The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstruction.
K971297: The KLS Martin Centre-Drive Drill-Free screws are intended for use in rigid i internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device reference.
K944565: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillocranio-facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.
K944561: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio facial surgery to stabilize fractured bone structures. The bone segments are attached to the plate with screws to prevent movement of the segments.
The KLS Martin Rigid Fixation - Sterile includes titanium plates of various shapes and thickness, titanium screws of various length and diameter, stainless steel twist drills of various length and diameter and stainless steel sonotrode tips that are provided in sterile packaging.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the KLS Martin Rigid Fixation - Sterile device:
This submission is for a medical device (bone plate, screws, drills, and sonotrode tips) provided in sterile packaging, not a software or AI/ML-based device. Therefore, many of the requested categories related to algorithm performance, training sets, and expert adjudication are not applicable.
The primary "study" in this context is the demonstration of substantial equivalence to predicate devices, focusing on the new aspect of sterile packaging and sterilization method.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Sterilization Method (Gamma Radiation) | Identical to cleared Resorb-X Resorbable Plating System (K011590). | This demonstrates the sterile packaging and sterilization method meets the standard set by a previously cleared device. |
| Manufacturing and Design | Identical to KLS-Martin Mandibular/Reconstruction System II (K032442), Centre-Drive Drill-Free Screw (K971297), Micro Osteosynthesis System (1.0) (K944561), and KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565). | This indicates that the core mechanical components are unchanged from previously cleared devices, thus their performance characteristics are presumed to be the same. |
| Intended Use | Provides KLS Martin's osteosynthesis products in sterile packaging. Does not change the already cleared intended use of the component parts. | The sterilization process is not intended to alter the therapeutic or diagnostic function of the device but merely to deliver it in a sterile state. |
| Packaging (to identify sterile product) | Different stock numbers from originally cleared stock numbers to identify the product as sterile. | This is an administrative control to ensure proper identification of the sterile version. No performance criteria are associated with this beyond clear labeling. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a medical device (hardware) submission, not a software or AI/ML device requiring a test set of data. The "test" here refers to demonstrating manufacturing and sterilization equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. Ground truth as typically understood for AI/ML models is not relevant here. The "ground truth" for the device's functionality and safety is established through the previous clearance of the predicate devices and the validation of the sterilization process.
4. Adjudication Method for the Test Set
This is not applicable. There's no "test set" in the context of adjudication for AI/ML performance.
5. 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. This is a hardware medical device; it does not involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a hardware medical device and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Previous FDA clearances: The KLS Martin Rigid Fixation - Sterile components (plates, screws, drills) have established safety and effectiveness through prior FDA clearances (K032442, K971297, K944561, K944565).
- Validated Sterilization Process: The sterilization method (gamma radiation) is considered "substantially equivalent" to one previously cleared (Resorb-X Resorbable Plating System K011590), implying its effectiveness in achieving sterility is already established.
8. The Sample Size for the Training Set
This is not applicable as this is not an AI/ML or software device.
9. How the Ground Truth for the Training Set was Established
This is not applicable as this is not an AI/ML or software device.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.