(248 days)
The KLS Martin Resorb-X G is intended for use in non-load bearing fracture repair and reconstructive procedures in adolescent and adult populations. In addition, resorbable meshes, plates and pins may be used in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in oral and maxillofacial reconstruction.
KLS Martin Resorb-X G is a resorbable fixation system similar to the SonicWeld-RX (Resorb-X) (K080862). The system consists of plates, meshes and pins manufactured in a variety of diameters and geometrical configurations that provide fixation and aid in the alignment and stabilization of fractures and reconstructive procedures. Resorb-X G is implanted utilizing ultrasonic force generated by an ultrasonic unit that causes a phase transition in the pin, allowing the pin to adapt to the previously drilled pilot hole in the surgical site and utilize the micro undercuts of the bone for retention.
The provided document, K112064, is a 510(k) summary for the KLS Martin Resorb-X G, a resorbable fixation system. The summary focuses on demonstrating substantial equivalence to predicate devices, primarily through material changes and performance verification. However, it does not present a typical "acceptance criteria" table or a full "study" report in the way one might expect for a diagnostic AI device or a comparative clinical trial.
Instead, the "acceptance criteria" can be inferred from the regulatory pathway for substantial equivalence, and the "study" is the performance testing conducted to support that equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a medical device (resorbable fixation system) and not a diagnostic algorithm or AI, typical "accuracy," "sensitivity," or "specificity" metrics are not applicable. The acceptance criteria and performance are tied to material properties and mechanical functionality, demonstrating that the new device (Resorb-X G with PLLA/PGA) is as safe and effective as the predicate devices.
| Acceptance Criteria (Inferred from regulatory pathway and predicate comparison) | Reported Device Performance (from "Performance Testing") |
|---|---|
| Biocompatibility and Material Safety (similar to predicate) | Chemical analysis to ISO 10993-12, -18 submitted |
| Mechanical Degradation Profile (comparable to predicate) | Mechanical degradation comparison testing for PDLLA vs. PLLA/PGA submitted |
| Overall Safety and Effectiveness (no new issues) | Performance testing results demonstrate that Resorb-X G (PLLA/PGA) is substantially equivalent to Resorb-X (PDLLA) and does not raise new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
This is not a study involving a "test set" of patient data in the typical sense of a diagnostic or AI device. The "test set" would refer to the samples of the medical device material that underwent analytical and mechanical testing. The document does not specify the sample sizes used for the chemical analysis or mechanical degradation comparison tests (e.g., number of material samples, number of replicates).
The data provenance is not explicitly stated beyond "submitted to demonstrate product safety and effectiveness." It is assumed these tests were conducted internally or by a contracted lab. This is not patient data from a specific country, nor is it retrospective or prospective in the clinical trial sense.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable for this type of submission. There is no concept of "ground truth" established by experts for a test set of patient data, as this is a device material and mechanical property evaluation.
4. Adjudication Method
Not applicable. There is no expert adjudication for a test set of patient data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a study involving human readers or AI assistance.
6. Standalone Performance Study
Yes, a "standalone" performance evaluation of the device's material properties was conducted. This refers to the chemical analysis and mechanical degradation testing of the Resorb-X G (PLLA/PGA) material itself, independent of human interaction or a clinical setting for initial submission purposes. The goal was to compare it directly to the predicate device's material properties.
7. Type of Ground Truth Used
The "ground truth" here is established by validated laboratory methods and engineering standards (e.g., ISO 10993-12, -18 for chemical analysis, and unspecified mechanical testing protocols). The "truth" is whether the material meets predefined specifications and performs comparably to the predicate device under these controlled conditions.
8. Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
§ 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.