(255 days)
The OrthoPediatrics PediNail Intramedullary Platform is used for pediatric and stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; psilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
Additional indications includes simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondy|ar fractures; bone lengthening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
The OrthoPediatrics PediNail Intramedullary Platform is for single use only.
The OrthoPediatrics PediNail Intramedullary Nailing System (K083726) consists of a rigid stainless steel nail and stainless steel screws. The proposed OrthoPediatrics PediNail Intramedullary Platform seeks to broaden the reach of the PediNail brand by offering additional nail diameters, screws, nails designed specifically for child and adolescent, and improved instrumentation. The proposed device is composed of the intramedullary fixation rods (nails) with screw holes at either end for fixation to bone, screws, interlocking pegs, and end caps coupled with device-specific instruments including the Modular Necks, the Targeting Guides, the Attachment Bolts, the Derotation Dial Targeting Guide Attachment, the AP Nail Positioning Jig, the AP Position Templates, the Impactors, and the Nail Extractor Adaptor.
The OrthoPediatrics PediNail Intramedulary Platform nails have a complex 3-dimensional geometry resulting in an anatomically appropriate design. The smaller diameter of the nail allows it to be inserted in patients with a narrow medullary canal and allows for easier insertion without the need for excessive reaming.
The provided text describes the OrthoPediatrics PediNail Intramedullary Platform, a medical device, and its 510(k) premarket notification. The document focuses on demonstrating substantial equivalence to a predicate device (OrthoPediatrics PediNail Intramedullary Nailing System K083726) rather than a study validating a specific acceptance criterion for an AI/CADe system.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/CADe device is not applicable to the provided text. The submission is for a physical medical device (intramedullary fixation rod), not an AI algorithm.
However, I can extract the information that is present regarding the non-clinical performance testing of the device:
1. A table of acceptance criteria and the reported device performance:
| Test Method | Acceptance Criteria (Implied by equivalence) | Reported Device Performance |
|---|---|---|
| Static Four-Point Bend Testing | Equivalent to predicate (K083726) | Testing concluded that the proposed OrthoPediatrics PediNail Intramedullary Platform will perform equivalently to the predicate OrthoPediatrics PediNail Intramedullary Nailing System. |
| Static Torsion Testing | Equivalent to predicate (K083726) | Testing concluded that the proposed OrthoPediatrics PediNail Intramedullary Platform will perform equivalently to the predicate OrthoPediatrics PediNail Intramedullary Nailing System. |
| Torsional Yield Strength Testing | Equivalent to predicate (K083726) | Testing concluded that the proposed OrthoPediatrics PediNail Intramedullary Platform will perform equivalently to the predicate OrthoPediatrics PediNail Intramedullary Nailing System. |
| Driving Torque Testing | Equivalent to predicate (K083726) | Testing concluded that the proposed OrthoPediatrics PediNail Intramedullary Platform will perform equivalently to the predicate OrthoPediatrics PediNail Intramedullary Nailing System. |
| Full Construct Testing (Fatigue) | Survival of 150,000 cycles at 75kg (165lbs) | "Three such constructs survived 150,000 cycles at a load of 75kg (165lbs)." This demonstrates "no additional risk is conferred to the device from the presence or use of the dynamic slot." |
| MR Environment (MR Conditional) | MR Conditional Status | The OrthoPediatrics PediNail Intramedullary Platform was evaluated in an MR Environment and was determined to be MR Conditional. |
2. Sample sized used for the test set and the data provenance:
- Sample Size for Full Construct Testing: 3 constructs (described as "system worst case" with a 7mm nail locked distally and a specific fracture/osteotomy).
- Data Provenance: The tests were non-clinical, performed by the manufacturer (OrthoPediatrics). Country of origin is not specified, but the company is based in Warsaw, Indiana, USA. The data is non-retrospective as it describes custom-built test setups.
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):
- Not applicable. This is not an AI/CADe device that requires expert ground truth establishment for diagnostic performance. The ground truth for mechanical testing is based on physical scientific principles and engineering standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as this is mechanical performance testing, not diagnostic assessment.
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 is not an AI/CADe device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm. The performance described is the standalone mechanical performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is defined by the physical properties of the materials, the mechanical stress and strain limits, and the ability to withstand simulated physiological loads based on established engineering principles and standards (e.g., ASTM F138 for material). For the fatigue testing, the "ground truth" for survival was reaching 150,000 cycles at a specific load without failure.
8. The sample size for the training set:
- Not applicable. There is no training set as this is not an AI/CADe device.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set as this is not an AI/CADe device.
§ 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.