(86 days)
The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft: subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.
OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel.
The OrthoPediatrics PediNail™ system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft: subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting, supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated. The OrthoPediatrics' PediNail™ is for single use only.
- Materials: The devices are manufactured from 316L stainless steel which meets the ASTM-F138 standard.
- Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.
Here's an analysis of the acceptance criteria and study information based on the provided document:
Analysis of Acceptance Criteria and Study for OrthoPediatrics PediNail™ Intramedullary Nailing System (K083726)
This 510(k) submission for the OrthoPediatrics PediNail™ Intramedullary Nailing System primarily relies on substantial equivalence to legally marketed predicate devices. The evidence provided is focused on non-clinical laboratory testing to demonstrate the device's functional equivalence rather than clinical performance (e.g., patient outcomes, diagnostic accuracy).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (like accuracy, sensitivity, specificity, or success rates in a clinical context) with corresponding numerical targets. Instead, the "acceptance criteria" for this type of device, relying on substantial equivalence, are met by demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The reported device performance is primarily based on non-clinical laboratory testing.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance and Evidence |
|---|---|
| Design Similarity: The device's design (e.g., rod shape, screw holes, insertion method) is comparable to predicate devices. | "OrthoPediatrics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design..." |
| Material Equivalence: The materials used are equivalent to those in predicate devices and meet established standards. | "Materials: The devices are manufactured from 316L stainless steel which meets the ASTM-F138 standard." (This implies equivalence to predicate devices using similar medical-grade stainless steel that also meet relevant ASTM standards). "...similarities in... materials..." |
| Functional Equivalence: The device performs its intended function (fixation, stability during healing) comparably to predicate devices. | "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." "Function: The system functions to provide immediate stability and temporary fixation during the natural healing process." This functional claim is supported by the non-clinical testing. |
| Indications for Use Equivalence: The intended uses of the device are substantially the same as those of legally marketed predicate devices. | The document lists comprehensive indications for use (stabilizing femoral shaft fractures, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing, nonunions, malunions, osteotomy correction, simple long bone fractures, comminuted/spiral/oblique/segmental fractures, polytrauma, multiple fractures, reconstruction after tumor resection, grafting, supracondylar fractures, bone lengthening/shortening, fixation of fractures in proximal/distal third of long bones). This broad list implicitly aligns with the indications of the cited predicate devices. |
| Biocompatibility/Safety Data: The materials and design do not pose new or different safety concerns compared to predicate devices. (Implicit in substantial equivalence) | The use of 316L stainless steel (ASTM-F138 standard) implies biocompatibility and safety consistent with established medical device materials. Non-clinical testing would also cover mechanical safety aspects. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" in the context of clinical data (e.g., patient images or patient outcomes). The evaluation was primarily based on non-clinical laboratory testing. Therefore, the sample size would refer to the number of devices or components tested in the lab, which is not stated.
- Data Provenance: Not applicable in the context of clinical data for this submission. The "data" originated from non-clinical laboratory testing conducted by the manufacturer, OrthoPediatrics, Corp. The geographic origin of this laboratory testing is not specified, but the firm is located in Warsaw, Indiana, USA. The testing is inherently prospective as it was conducted specifically to support this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relies on non-clinical testing and substantial equivalence, not expert-adjudicated clinical ground truth.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication in the context of the provided documentation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for evaluating diagnostic or interpretive aids (e.g., AI systems in radiology), not for an intramedullary nailing system which is a physical implant. The submission is based on substantial equivalence through design and material comparisons, and non-clinical functional testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical implant (intramedullary nail), not an algorithm or an AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device, in the context of substantial equivalence, is established by the performance characteristics and safety profile of the legally marketed predicate devices for their intended use. The non-clinical laboratory testing aims to demonstrate that the new device meets this established "ground truth" of performance and safety as demonstrated by the predicates.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" in this 510(k) submission as it is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no concept of a "training set" in this 510(k) submission.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.