(58 days)
The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
The Arthrex DynaNite Nitinol Staples are indicated for:
• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy.
• Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
• Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
• When used with Arthrex FiberTape Cerclage System, the Arthrex DynaNite Nitinol Staple (sizes 13x10 and 15x12 only) is intended for sternotomy indications including the "rewiring" of osteotomized sternums.
The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation devices intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomy.
This document is a 510(k) Summary for the Arthrex DynaNite Nitinol Staples, which is a medical device. It describes the device's indications for use and states that the submission is to expand these indications. The document mainly focuses on proving substantial equivalence to a predicate device rather than presenting a study to meet specific performance acceptance criteria for a new device.
Therefore, the information provided does not directly describe a study that sets acceptance criteria for device performance in the sense of accuracy or efficacy (as would be typical for an AI/CADe device). Instead, it describes performance testing conducted to demonstrate safety and substantial equivalence for an implantable medical device.
Based on the provided text, here’s an extraction of the requested information, adapted for a medical device rather than an AI/CADe system:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics in the way one would for an AI model (e.g., sensitivity, specificity thresholds). Instead, it describes types of performance tests and implies the acceptance criterion is "perform substantially equivalent" or "meets specifications" for safety parameters.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cyclic/Fatigue Testing (with Arthrex Cerclage Sutures) | Perform substantially equivalent to the Arthrex Cerclage Suture construct for sternal closure. | "Cyclic/Fatigue construct testing was conducted to demonstrate that when used with the Arthrex Cerclage Sutures, the Arthrex DynaNite Nitinol Staples perform substantially equivalent to the Arthrex Cerclage Suture construct for sternal closure." |
| MRI Compatibility (Force, Torque, Image Artifact) | Meets safety standards as per FDA guidance and ASTM standards for MR Environment. | "MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance [specific guidance documents listed]... and ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213." (Implied: met the standards.) |
| Bacterial Endotoxin | Meets pyrogen limit specifications per EP 2.6.14/USP . | "Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes or data provenance for the performance tests conducted. These tests are typically biomechanical or material tests performed in a lab setting, not clinical studies with human data.
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 is not applicable as the studies described are laboratory performance tests for a physical implant, not diagnostic assessments requiring expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the types of engineering and material performance tests described.
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, as the device is a physical bone fixation staple, not an AI/CADe system for diagnostic imaging.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable, as the device is a physical bone fixation staple, not an algorithm. Performance tests are inherently "standalone" in this context, evaluating the physical properties of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests described:
- Cyclic/Fatigue Testing: The "ground truth" or reference is the performance of the predicate device/construct (Arthrex Cerclage Suture construct).
- MRI Compatibility: The "ground truth" is established by relevant national and international standards (FDA guidance, ASTM standards).
- Bacterial Endotoxin: The "ground truth" is established by pharmacopeial standards (EP 2.6.14/USP pyrogen limit specifications).
8. The sample size for the training set
This is not applicable, as the device is a physical bone fixation staple and does not involve AI model training.
9. How the ground truth for the training set was established
This is not applicable for the reasons mentioned above.
§ 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.