(71 days)
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures, prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
In addition to the indications for interlocking intramedullary nails, devices that contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability (i.e. Femoral/Recon Antegrade Nail) are indicated for the following: subtrochanteric fractures with lesser trochanteric involvement; ipsilateral femoral shaft/neck fractures; and intertrochanteric fractures.
In addition to the indications for interlocking intramedullary nails, devices that utilize a retrograde femoral surgical approach (i.e. Retrograde/Tibial and Supracondylar Nails) are indicated for the following: severely comminuted supracondylar fractures with or without difficult intra-articular extension; fractures that require opening the knee joint to stabilize the femoral condylar segment; fractures above total knee implants.
The Titanium Nail System is intended to be removed upon fracture healing.
The Titanium Nail System includes femoral and tibial nails and screws. All components are manufactured from titanium alloy.
This document describes the Titanium Nail System, a device for fixing long bone fractures. However, it does not contain information about acceptance criteria or a study proving device performance using the requested metrics.
Instead, the document details a 510(k) premarket notification to the FDA, asserting that the Titanium Nail System is substantially equivalent to existing, legally marketed devices. The FDA's letter (K981529) confirms this substantial equivalence.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a performance study, as this information is not present in the provided text.
The "study" cited for the device's safety and effectiveness is its "long history of use" of the predicate devices it is compared to, rather than a specific performance study of the Titanium Nail System itself.
Here's what can be inferred from the provided text regarding the closest equivalent to "acceptance criteria" and how "performance" is "proven":
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Criterion: Substantial Equivalence to Predicate Devices | Performance: The Titanium Nail System is found to be substantially equivalent to the following predicate devices: |
- TriMax Antegrade and Retrograde Nails (Smith & Nephew Orthopaedics)
- Kuntscher Nail (Smith & Nephew Orthopaedics)
- Aim Antegrade Femoral, Retrograde Femoral and Tibial Nails (Ace)
- Unreamed Femoral (URFN) and Tibial Nails (Synthes)
- Retrograde Femoral Nail (Biomet)
- Ace ART Femoral Nail (DePuy Ace) |
| Criterion: Indications for Use Alignment with Predicate Devices | Performance: The Titanium Nail System's indications for use (fractures of long bones, specific femoral fractures, etc.) are consistent with those of the predicate devices. |
| Criterion: Material Composition (Titanium Alloy) | Performance: All components are manufactured from titanium alloy, consistent with materials used in similar predicate devices. |
| Criterion: Design Similarity to Predicate Devices | Performance: "All of the devices listed above are similar in design to the Titanium Nail System." |
2. Sample Size for the Test Set and Data Provenance:
* N/A. No performance study with a test set is described. The "proof" is based on the long history of use of predicate devices, not a test set for the Titanium Nail System itself.
3. Number of Experts and Qualifications for Ground Truth:
* N/A. No experts were used to establish ground truth for a performance test set, as no such test set or study is detailed. The "ground truth" for substantial equivalence is based on regulatory assessment by the FDA, considering existing market data for predicate devices.
4. Adjudication Method:
* N/A. No adjudication method is described as there is no performance study where ground truth was independently established and adjudicated.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
* No. No MRMC study was performed or described. This document is focused on regulatory clearance based on substantial equivalence, not comparative effectiveness.
6. Standalone Performance Study:
* No. No standalone performance study (i.e., algorithm only without human-in-the-loop performance) was performed or described. The device is a surgical implant, not an AI algorithm.
7. Type of Ground Truth:
* The "ground truth" for the device's safety and effectiveness is fundamentally based on the "long history of use" and established clinical outcomes of the predicate devices (other intramedullary nail systems). This is a form of historical outcomes data relating to the class of devices.
8. Sample Size for the Training Set:
* N/A. This device is a physical implant, not an AI/ML model that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set was Established:
* N/A. Not applicable for a physical medical device.
§ 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.