(47 days)
The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System is intended for use in stabilization and fixation of the 1st MTP joint in the foot for fusion, osteotomy, nonunion, malunion or revision surgery.
The CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System consists of anatomically contoured bone plates and screws which are intended to be used for surgical fusion (arthrodesis) of the 1st MTP joint. The plate is available in both left and right configurations. Locking, non-locking and interfragmentary screws are included as part of the system.
This document is a 510(k) summary for the CheckMate™ Metatarso-Phalangeal (MTP) Arthrodesis System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove device performance as typically understood in a clinical trial context. This device is a bone fixation appliance, and its acceptance is based on mechanical performance and comparison to existing, cleared devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Material Equivalence: Materials used are comparable to predicate devices. | Stated that "materials" of the proposed device are substantially equivalent to predicate devices. Specific material properties or tests are not detailed in this summary. |
| Design Equivalence: Design features are comparable to predicate devices. | Stated that "design features" of the proposed device are substantially equivalent to predicate devices. Specific design parameters or comparisons are not detailed in this summary. |
| Functional Equivalence (Mechanical Strength/Stability): The device performs mechanically at least as well as predicate devices for its intended use. | Comparative static and dynamic four-point bending test results were used to support equivalence to predicate devices. No specific numerical thresholds (acceptance criteria) or quantitative results (reported performance) from these tests are provided in this summary. |
| Dimensional Equivalence: Dimensions are comparable, ensuring proper fit and function similar to predicate devices. | Comparative dimensional analyses were used to support equivalence to predicate devices. No specific numerical thresholds (acceptance criteria) or quantitative results (reported performance) from these analyses are provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: This document does not specify a "sample size for the test set" in the context of human subjects or clinical data. The tests performed were mechanical (static and dynamic four-point bending, dimensional analyses) on the device itself. The number of devices tested is not provided.
- Data Provenance: The data provenance is from in-vitro mechanical testing and dimensional analyses of the proposed device and specified predicate devices. This is not clinical data, so country of origin or retrospective/prospective classification is not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this 510(k) submission. The ground truth for device performance in this context is established through engineering and biomechanical testing, not through expert clinical consensus on patient data. Experts involved would be engineering and materials science professionals performing the tests and interpreting the results, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method for the Test Set
This information is not applicable to this 510(k) submission. Adjudication methods like 2+1 or 3+1 typically refer to agreement among human readers/experts for clinical ground truth establishment. For mechanical testing, the "adjudication" is based on established engineering standards and comparison methods.
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 information is not applicable. This 510(k) is for a mechanical orthopedic implant, not an AI-assisted diagnostic or therapeutic device. No MRMC studies or AI components are mentioned.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
This information is not applicable. This is not an algorithm-based device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this device's performance is established through comparative in-vitro mechanical testing against predicate devices and adherence to relevant engineering standards (though specific standards are not cited in this summary). The implicit ground truth is that if the proposed device performs mechanically equivalent or superior to the predicate devices, it is safe and effective for its indicated use.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this 510(k) submission for a mechanical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device submission.
§ 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.