(9 days)
The Osteo 9mm IC Tibial Nail is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
- Static and compression locking
- Transverse and short oblique fractures
- Pseudarthrosis
- Correction osteotomies
The Osteo 9mm IC Tibial Nail is a cylindrical, cannulated stainless steel tube. Tibial Nails provide for the alignment and stabilization of long bone fractures while maintaining limb length and resisting rotation of the fracture segments. The Osteo 9mm IC Tibial Nail is implanted in association with proximal and distal locking screws with the aid of several associated Class I manual surgical instruments. The Tibial Nails are stainless steel tubes gun-drilled from a solid Stainless Steel bar. Three external longitudinal grooves are pressed into the tube and are intended to provide greater resistance to bending and increased torsional stability. The Osteo 9mm IC Tibial Nail is available in lengths from 240mm to 420mm in 15mm increments, and has a distal shaft diameter of 9mm. A compression screw and locking screw may be used with the Tibial Nail. An end cap is also available for use with the Tibial Nail. An end cap is used if a compression screw has not been used.
The following changes have been made to the modified Tibial Nail.
- The wall thickness of the Tibial Nail has been increased by 0.2mm, resulting in a reduction in the distal cannulation diameter from 6.4mm to 6.0mm. The 9mm outer diameter of the distal end of the nail remains the same.
- The length of the ø11mm proximal portion of the Tibial Nail was increased from 33mm to 60mm, and the proximal portion of the nail is tapered at a 2° angle from o1 1mm to 09mm.
- In order to reduce irritation of the patella tendon, the proximal anterior end of the modified Tibial Nail features a small 10° chamfer 5.7mm in length.
The provided 510(k) K984353 is for a special premarket notification for a modified Osteo 9mm IC Tibial Nail and does not contain a clinical study with acceptance criteria and device performance as typically expected for software-as-a-medical-device (SaMD) or AI-based devices.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device based on design and material modifications and mechanical testing, which is common for implantable orthopedic devices.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of submission.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of acceptance criteria and device performance in the way one would for a diagnostic or AI device (e.g., sensitivity, specificity, AUC).
Instead, the "acceptance criteria" are implied by demonstrating that the modified device maintains its mechanical integrity and functionality despite changes, thus remaining substantially equivalent to the predicate device. The "performance" is implicitly demonstrated through the modifications described, which suggest improved characteristics while maintaining the core function.
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Acceptance Criteria (Implied):
- Maintain overall mechanical integrity and strength for long bone fracture fixation.
- Continue to provide for alignment and stabilization of long bone fractures.
- Resist bending and provide increased torsional stability.
- Be compatible with associated Class I manual surgical instruments.
- Maintain the same indications for use as the predicate device.
- Reduce irritation of the patella tendon (new improvement).
- Wall thickness increase, cannulation diameter reduction, proximal length increase, and taper angle are within acceptable engineering parameters for the intended function.
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Reported Device Performance (Implicit through modifications):
- Increased wall thickness (by 0.2mm): This generally implies greater strength and resistance to deformation.
- Reduction in distal cannulation diameter (from 6.4mm to 6.0mm): A consequence of increased wall thickness, still allowing for guide wire usage.
- Increased length of ø11mm proximal portion (from 33mm to 60mm) and 2° taper: These changes likely improve fit, stability, or surgical technique.
- Small 10° chamfer (5.7mm in length) on proximal anterior end: Specifically designed to "reduce irritation of the patella tendon," indicating an improvement in patient comfort/safety.
- The modifications are described to "provide greater resistance to bending and increased torsional stability" (though the pre-modification nail also claimed this, the increased wall thickness would support this for the modified nail).
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable for this type of submission. This submission relies on engineering design changes and mechanical performance evaluations, not clinical data from a "test set" in the context of diagnostic accuracy. The testing would involve physical samples of the device.
- Data Provenance: Not specified as it's a device modification, relying on in-house engineering and potentially biomechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. "Ground truth" in this context would refer to the physical and mechanical properties of the device, established through engineering specifications and testing. It doesn't involve clinical expert consensus on an interpretation.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication process as it's not a diagnostic study.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not a diagnostic device or an AI-assisted interpretation tool. It's an orthopedic implant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used:
- Engineering specifications and biomechanical testing (implied). The "ground truth" for this device's performance relies on its physical and mechanical properties as designed and confirmed through standard engineering tests, ensuring it meets the requirements for load-bearing and fracture fixation.
8. The Sample Size for the Training Set:
- Not applicable. No "training set" in the context of an algorithm. Design iterations and materials research would be more analogous to "training," but not in the AI sense.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. See point 8.
§ 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.