(54 days)
The Nextremity Solutions MSP™ System is indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone. Examples include, but not limited to, the hand, foot (shortening of the lesser metatarsal) and ankle.
The Nextremity Solutions MSP™ Metatarsal Shortening System is a set, consisting of:
- A bone plate.
- Specific length, cortical and locking screws.
- Necessary surgical site preparation and insertion instruments (as a procedure pack).
The cortical and locking screw(s) are used in conjunction with the bone plate and are individually packaged.
The plate and screws are fabricated from medical grade Titanium and the design allows for fixation of fractures, osteotomies, non-unions, malunions and fusions of small bones and small bone segments found in the foot, particularly in osteopenic bone.
This document is a 510(k) summary for a medical device called the "MSPTM Metatarsal Shortening System." It focuses on the substantial equivalence to predicate devices and presents mechanical testing data, not a clinical study involving human readers or AI. Therefore, most of the requested information regarding clinical study parameters (sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training sets) is not applicable or cannot be extracted from the provided text.
Here is the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: | Mechanical Testing: |
| 4-point bending (static and dynamic) for the MSP plate per ASTM F-382 | Testing performed per ASTM F-382 (no specific numerical performance results provided) |
| Torque to failure for the screws per ASTM F-543 | Testing performed per ASTM F-543 (no specific numerical performance results provided) |
| Axial push-out test for screws | Testing performed (no specific numerical performance results provided, but noted to properly compare to predicate) |
| Substantial Equivalence: | Substantial Equivalence: |
| Same technological characteristics as predicate devices (intended use, basic design, material, size, fundamental technology) | The device "possesses the same technological characteristics of the predicate devices" |
Study that proves the device meets the acceptance criteria:
The study performed was a mechanical testing study.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. Standard mechanical testing involves multiple samples for statistical validity, but the exact number is not provided.
- Data Provenance: Not applicable in the context of mechanical testing. The tests are conducted under laboratory conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Mechanical testing does not involve "experts" for ground truth in the way a clinical study would. The ground truth (e.g., failure load) is determined by direct physical measurement and engineering principles.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication is a process for resolving discrepancies in expert opinion in clinical studies; it is not relevant to mechanical testing.
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:
No. This document describes mechanical testing of a physical implantable device, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for mechanical testing is based on objective physical measurements of force, displacement, torque, and other material properties, as defined by relevant ASTM standards.
8. The sample size for the training set:
Not applicable. This is not a machine learning study.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.