(60 days)
The Arthrex MaxForce MTP Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the Forefoot.
The Arthrex Low Profile Screws (2.0-3.0mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist. When used with a plate, the screws may be used with the Arthrex Low Profile Plates, Small Fragment Plates and MaxForce MTP Compression Plates.
The Arthrex Low Profile Screws (3.5mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plates, Small Fragment Plates, Humeral Fracture Plates, Osteotomy Plates, and MaxForce MTP Compression Plates.
The Arthrex MaxForce MTP Compression Plates and Screws consists of a series of plates and screws of varying lengths and diameters. The plates are contoured to fit the various aspects of the metatarsals including Petite, Standard, Long, X-Long and Revision with 0° and 5° Valgus and Dorsiflex in left and right configurations. The plates are manufactured from titanium alloy conforming to ASTM F136. The plates are attached to bone with 3.0 mm cortical, 3.0 mm cortical, hybrid and 3.0 mm variable locking screws. The screws range from 3.0 mm to 3.5 mm in diameter and from 10 mm to 26 mm in length. The screws are manufactured from titanium alloy conforming to ASTM F136. The plates and screws are sold non-sterile and single-use.
The provided document describes a 510(k) premarket notification for a medical device, specifically the Arthrex MaxForce MTP Compression Plates and Screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device safety and effectiveness through clinical studies with acceptance criteria in the traditional sense (e.g., diagnostic accuracy metrics like sensitivity/specificity).
Instead, "acceptance criteria" for such a device would typically refer to meeting engineering and mechanical performance benchmarks, demonstrating that the new device is as safe and effective as its predicate. The "study" proving this largely consists of bench testing.
Here's a breakdown of the information based on the provided text, aligning it with your request where applicable, and highlighting what's not present (which is common for this type of device submission):
Acceptance Criteria and Device Performance Study for Arthrex MaxForce MTP Compression Plates and Screws
For implantable orthopedic hardware like the Arthrex MaxForce MTP Compression Plates and Screws, the "acceptance criteria" are primarily established through direct comparison to legally marketed predicate devices and by meeting engineering and mechanical performance standards outlined in relevant ASTM (American Society for Testing and Materials) standards. The "study" consists of a series of bench tests.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static Four-Point Bend (ASTM F382) | Performed. Demonstrates statistical equivalence to predicate devices (K130510, K111253, K103705). |
| Four-Point Bend Fatigue (ASTM F382) | Performed. Demonstrates statistical equivalence to predicate devices (K130510, K111253, K103705). | |
| Plate/Instrument Compression Testing (Compression Force, Compression Distance) | Performed. Demonstrates statistical equivalence to predicate devices. | |
| Screw Pull-out strength testing (ASTM F543) | Performed. Demonstrates statistical equivalence to predicate devices (K130510, K111253, K103705). | |
| Screw Torsional strength testing (ASTM F543) | Performed. Demonstrates statistical equivalence to predicate devices (K130510, K111253, K103705). | |
| Screw Insertion Torque testing | Performed. Demonstrates statistical equivalence to predicate devices. | |
| MRI Compatibility | MRI force (ASTM F2052) | Conducted in accordance with FDA guidance and ASTM standards. Supports "MR Conditional" labeling. There is no increased risk from this difference in technology compared to predicates. |
| Magnetically Induced Torque (ASTM F2213) | Conducted in accordance with FDA guidance and ASTM standards. Supports "MR Conditional" labeling. There is no increased risk from this difference in technology compared to predicates. | |
| Image Artifacts (ASTM F2119) | Conducted in accordance with FDA guidance and ASTM standards. Supports "MR Conditional" labeling. There is no increased risk from this difference in technology compared to predicates. | |
| Radio Frequency Induced Heating (ASTM F2182) | Conducted in accordance with FDA guidance and ASTM standards. Supports "MR Conditional" labeling. There is no increased risk from this difference in technology compared to predicates. | |
| Material Equivalence | Comparison of material (Titanium alloy conforming to ASTM F136 vs. stainless steel for one predicate, titanium alloy for another) | The titanium alloy used is identical to the titanium alloy cleared for a predicate (K111253), addressing the difference with the stainless steel predicate. Differences are considered minor and do not raise different questions concerning safety or effectiveness. |
| Design/Intended Use | Comparison of basic design features, intended use, fundamental scientific technology, indications for use, sterility, packaging, and shelf-life to predicate devices. Dimensions (lengths, diameters, contours) are compared to predicates where relevant. | Overall, the device is substantially equivalent to predicate devices. Minor differences in plate contours (e.g., Petite, Standard, Long, X-Long vs. Square, Linear, T-configurations or Petite, Standard, Long) and material (stainless steel in one predicate vs. titanium in the proposed device and another predicate) are noted but found not to raise different questions of safety or effectiveness. Indications for use are consistent with or encompass those of the predicates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in terms of "test set" as this refers to physical samples (e.g., plates and screws) subjected to mechanical and MRI testing. The tests are typically performed on a sufficient number of samples to ensure statistical validity for the properties being measured. The specific number of physical units tested for each mechanical or MRI compatibility test is not detailed in this summary.
- Data Provenance: The data is generated from bench testing (laboratory experiments) conducted by the manufacturer (Arthrex Inc.). This is prospective in the sense that the tests were specifically performed for this submission. Country of origin for the data generation would be the location of the manufacturing and testing facilities, implied to be in the USA (Naples, FL).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to this type of device submission. There is no "ground truth" expert review in the sense of clinical image interpretation or diagnosis. The "ground truth" for these tests is based on established engineering principles, ASTM standards, physics of materials, and comparison to the performance of predicate devices. The "experts" involved are likely engineers and scientists performing the tests and analyzing the results against these established benchmarks and predicate data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to clinical studies involving human interpretation or diagnosis where discrepancies need to be resolved. Bench tests do not involve this type of adjudication.
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
Not applicable. This device is an orthopedic implant, not an AI-based diagnostic tool. MRMC studies are used for evaluating diagnostic performance, often with AI assistance, which is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by:
- Adherence to well-defined engineering standards (e.g., ASTM F382, ASTM F543, ASTM F2052, F2119, F2182, F2213).
- Performance data from legally marketed predicate devices (K130510, K111253, K103705), which themselves have established safety and effectiveness.
- Material specifications (ASTM F136 for titanium alloy).
- Physical laws (for MRI compatibility testing).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires training data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.