(58 days)
The ParaLock Bone Plates and TUFFNEK™ Bone Screws of the ParaLock Plating System™ are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi- fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients. In addition, the TUFFNEK™ non-locking, titanium alloy (Ti6Al4V ELI) screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
The ParaLock Plating System™ and TUFFNEK™ screws are lower extremity fixation systems. ParaLock Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. TUFFNEK™ screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the TUFFNEK™ screws when the latter are used for fixation without the plates.
The provided text is a 510(k) Summary for a medical device (ParaLock Plating System™). It describes the device, its intended use, materials, and how it demonstrates substantial equivalence to predicate devices. However, this document describes a traditional medical device (bone plates and screws) and not a software/AI-driven device.
Therefore, most of the requested information regarding acceptance criteria and studies for AI/software performance is not applicable to this document. The concepts of "test set," "training set," "ground truth," "expert consensus," "MRMC studies," "human-in-the-loop performance," or "algorithm-only performance" are specific to the validation of AI/Software as a Medical Device (SaMD) and are not relevant to the mechanical testing of orthopedic implants described here.
The document does provide information relevant to the device's mechanical performance, which serves as its "acceptance criteria" for demonstrating substantial equivalence.
Here's the relevant information that can be extracted, framed within the context of traditional device acceptance:
Device Type: ParaLock Plating System™ (bone plates and screws, mechanical fixation)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Standards Investigated) | Reported Device Performance |
|---|---|
| ParaLock Plates: | ParaLock Plates: |
| Static bending (according to ASTM F382) | Mechanical test results demonstrated performance that is substantially equivalent to predicate devices. |
| Dynamic bending (according to ASTM F382) | Mechanical test results demonstrated performance that is substantially equivalent to predicate devices. |
| TUFFNEK™ Screws: | TUFFNEK™ Screws: |
| Torsion (according to ASTM F543) | Mechanical test results demonstrated performance that is substantially equivalent to predicate devices. |
| Insertion/removal (according to ASTM F543) | Mechanical test results demonstrated performance that is substantially equivalent to predicate devices. |
| Pullout (according to ASTM F543) | Mechanical test results demonstrated performance that is substantially equivalent to predicate devices. |
| Technological Characteristics Comparison: | Technological Characteristics Comparison: |
| Performance (as described above) | Same as predicate devices |
| Basic design (screws and plates in various shapes) | Same as predicate devices |
| Material (titanium and/or titanium alloys) | Same as predicate devices |
| Sizes (dimensions comparable to predicate systems) | Comparable to predicate devices |
Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria was a mechanical testing study of "worst-case" configurations of the ParaLock Plates and TUFFNEK™ screws.
2. Sample sizes used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated in terms of number of samples, but refers to "worst-case ParaLock Plates" and "worst-case TUFFNEK™ screws." For mechanical testing, this typically refers to a statistically significant number of test articles per configuration to demonstrate compliance with standards.
- Data Provenance: Not explicitly stated, but typically generated in a laboratory setting for medical device testing. No indication of country of origin of data or retrospective/prospective clinical data as it's a mechanical test report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For mechanical testing, "ground truth" is established by adherence to recognized testing standards (ASTM F382, ASTM F543) and the physical properties of the materials and designs, not by human expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically for subjective assessments or AI model disagreements, not for objective mechanical test results.
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 a mechanical implant, not an AI/software device that would involve human "readers" or be used with AI assistance for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For this type of device, the "ground truth" is defined by established mechanical testing standards (ASTM F382, ASTM F543) and the corresponding performance characteristics of predicate devices. The goal is to demonstrate that the new device's mechanical performance is equivalent to these benchmarks.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for this type of device.
In summary, the provided document details the regulatory filing for a mechanical orthopedic implant, not an AI/software medical device. Therefore, the questions related to AI/software validation methodologies (e.g., test/training sets, ground truth establishment by experts, MRMC studies) are not pertinent to this specific 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.