(87 days)
The PRECICE® Plate System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions and non-unions of long bones in pediatrics and small stature adult patients.
The PRECICE Plating System includes the PRECICE plate, cortical screws, surgical instruments, and is compatible with an external remote controller (ERC). The PRECICE plate is supplied sterile by gamma radiation while the cortical screws and instruments are supplied non-sterile and must be sterilized prior to use. The system is designed to achieve limb correction through gradual lengthening or compression and providing internal fixation for fractures of long bones. The telescopic PRECICE plate is implanted using cortical screws and reusable surgical instruments. The PRECICE plate contains an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing which allows the length of the plate to be adjusted non-invasively by the External Remote Controller (ERC). The PRECICE Plate is available in various sizes, lengths and screw hole configurations to accommodate a variety of patient anatomies and implantation methods. The cortical screws are also available in a variety of lengths and thread styles. The ERC is available in several compatible models.
The provided text is a 510(k) summary for the PRECICE Plating System, a medical device for orthopedic indications. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical performance data.
However, the document does not contain information regarding acceptance criteria for device performance in the context of clinical studies, sample sizes for test sets or training sets, ground truth establishment methods (expert consensus, pathology, etc.), details about human expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
The provided text details non-clinical performance verification, establishing substantial equivalence to existing predicate devices through mechanical testing and engineering analysis. It lacks the elements typically associated with proving device performance against specific acceptance criteria in a clinical setting, particularly for AI/machine learning devices where the requested information is highly relevant.
Therefore, many of the requested fields cannot be filled from the given document.
Here's a breakdown of what information can and cannot be extracted based on your request:
| # | Information Requested | Details from the Document |
|---|---|---|
| 1 | A table of acceptance criteria and the reported device performance | Not available. The document details non-clinical testing for substantial equivalence against predicate devices rather than specific acceptance criteria thresholds for clinical performance. It states that the subject device performs substantially equivalent to the predicate devices under various loading conditions. |
| 2 | Sample sizes used for the test set and the data provenance | Not available. This document describes non-clinical performance verification (mechanical testing and engineering analysis). There are no test sets or training sets in the context of clinical data for algorithmic performance. |
| 3 | Number of experts used to establish the ground truth for the test set and the qualifications of those experts | Not applicable. No test set with ground truth established by experts is mentioned, as this is a mechanical device, not typically evaluated by human expert consensus on diagnostic images or other clinical data. |
| 4 | Adjudication method (e.g., 2+1, 3+1, none) for the test set | Not applicable. No test set requiring expert adjudication is mentioned. |
| 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 orthopedic implant, not an AI/ML diagnostic or assistive tool for human readers. Therefore, MRMC studies comparing human performance with/without AI assistance are not relevant to this submission. |
| 6 | If a standalone (i.e., algorithm only without human-in-the-loop performance) was done | Not applicable. This device is a mechanical orthopedic implant. "Standalone" performance as an algorithm is not relevant. The document refers to the "PRECICE Plate" as containing an enclosed rare earth magnet, telescoping distraction rod, and planetary gearing and being adjusted by an External Remote Controller (ERC), implying a physical device with a control mechanism, not a software algorithm. |
| 7 | The type of ground truth used (expert consensus, pathology, outcomes data, etc.) | Not applicable. For the non-clinical performance verification, the "ground truth" is defined by the standards of mechanical testing (e.g., ASTM F384, ASTM F543) and engineering analysis, comparing the device's physical properties and performance against those of predicate devices. |
| 8 | The sample size for the training set | Not available. No training sets are mentioned, as this is not an AI/ML device. |
| 9 | How the ground truth for the training set was established | Not applicable. No training sets are mentioned, as this is not an AI/ML device. |
Summary of Device Performance (Based on "Performance Data" section):
The "Performance Data" section describes non-clinical testing performed to demonstrate substantial equivalence. The device's performance is reported in terms of its ability to perform "substantially equivalent" to predicate devices under various mechanical tests.
Table of Performance (Based on H. Performance Data section):
| Testing Description | Comparison to Predicate Devices (Reported Performance) |
|---|---|
| Static Compression Bending Strength per ASTM F384 | Bending load on construct of subject device performs substantially equivalent under the same loading conditions as predicate devices (Orthofix Modulsystem K955848 and Orthopediatrics Fracture and Osteotomy Bone Plate System K111086). |
| Dynamic Compression Bending strength per ASTM F384 | (Continuation of above - "substantially equivalent" implied). |
| Engineering Analysis of Bending Construct | Characterization of an offset bending load of the subject device was demonstrated to perform substantially equivalent to the predicate device (Orthofix Modulsystem K955848). |
| Torque Resistance per ASTM F543 | Characterization of torque resistance of subject device is substantially equivalent to the predicate devices (Orthofix Modulsystem K955848 and Orthopediatrics Fracture and Osteotomy Bone Plate System K111086). |
| Axial Pullout per ASTM F543 | Characterization of screw pullout force is substantially equivalent to the predicate devices (Orthofix Modulsystem K955848 and Orthopediatrics Fracture and Osteotomy Bone Plate System K111086). |
| Torsion | Characterization of torsional strength of subject device is substantially equivalent to the predicate devices (Orthofix Modulsystem K955848 and PRECICE STRYDE K180503). |
| Tensile and Collapse Strength | Subject device resists tensile loads substantially equivalent to the predicate devices (Inter-Os Limb Lengthener K031875 and Orthofix Modulsystem K955848). |
| Distraction Force | Distraction force is substantially equivalent to the predicate device (PRECICE STRYDE K180503) and clinical literature. (Note: "clinical literature" suggests external evidence rather than direct device testing within this submission for distraction force comparison). |
Conclusion from document: The results demonstrate that the subject PRECICE Plating System is substantially equivalent to the predicates.
§ 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.