(59 days)
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No
The description focuses solely on the mechanical properties and design of a traditional intramedullary nail for fracture fixation. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device is an intramedullary fixation rod used for internal fixation of tibial fractures, which is a structural support device rather than one that treats or cures a disease or condition.
No
This device, the DePuy ACE AIM® Titanium Tibial Nail, is indicated for "internal fixation of tibial fractures" and is described as an "intramedullary fixation rod." These are therapeutic or treatment functions, not diagnostic ones. Diagnostic devices are used to identify or detect medical conditions.
No
The device description clearly states it is an "intramedullary fixation rod" made of "Titanium 6Al-4V ELI," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "internal fixation of tibial fractures." This describes a surgical implant used within the body to stabilize bones.
- Device Description: The description details a physical implant (an intramedullary rod) made of titanium, designed to be inserted into the tibia.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory tests.
Therefore, the DePuy ACE AIM® Titanium Tibial Nail is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DePuy ACE AIM® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique and spiral fractures, comminuted fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions metaphyseal fractures and epiphyseal fractures.
Product codes
87 HSB
Device Description
The DePuy ACE AIM® Titanium Tibial Nail is an intramedullary fixation rod for the fixation of tibial fractures. The nail has a distal bend of 2º for the nails of 10mm, 12mm and 13mm diameters. The distal bend in the nails of 8mm and 9mm diameters is 5°. The DePuy ACE AIM® Titanium Tibial Nail has diameters from 8.0mm to 13.0mm and lengths from 25.5 cm to 43.5cm. The proximal end of the 10mm, 11mm, 12mm and 13mm nails is 13mm in diameter while the proximal end of the 8mm and 9mm nails is I Imm in diameter. The proximal end of the nail contains two 6mm cross locking screw holes which accept 5.5mm solid cortical bone screws. The distal end of the nail contains two 5.0mm holes which accept 4.5mm solid cortical bone screws. The 8mm and 9mm nails are solid while the 10mm to 13mm nails are cannulated.
The DePuy ACE AIM® Titanium Tibial Nail is manufactured from Titanium 6Al-4V ELI (ASTM standard F-136)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Tibial shaft, metaphyseal fractures, epiphyseal fractures
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative testing between the versions of the tibial nails was conducted on cadavers which showed that the insertion and extraction forces are decreased by reducing the distal bend for a 13mm nail. Under clinical usage, it is believed that a distal bend is necessary during insertion to reduce the likelihood of fracturing or perforating the posterior cortex. Therefore, the distal bend of the large tibial nails will be reduced to 2°.
The 8mm and 9mm nails are used in unreamed applications. Due to their small diameter, difficulty during insertion and extraction has not been encountered. Therefore, the small nails will keep the a 5° distal bend.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
DePuy ACE AIM® Titanium Tibial Nail
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
K97 0202
510(k) SUMMARY
MAR 2 1 1997
NAME OF FIRM:
510(k) CONTACT PERSON
TRADE NAME
COMMON NAME
CLASSIFICATION
DEVICE PRODUCT CODE
SUBSTANTIALLY EQUIVALENT DEVICE DePuy ACE Medical Company 2260 East El Segundo Blvd. El Segundo, CA 90245
Paul Doner Director, Regulatory and Clinical Affairs DePuy ACE Medical Company
DePuy ACE AIM® Titanium Tibial Nail
Intramedullary Bone Fixation Rod
888.3020 Intramedullary Fixation Rod
87 HSB - class2
DePuy ACE AIM® Titanium Tibial Nail
INTENDED USE:
The DePuy ACE AIM® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique and spiral fractures, comminuted fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions metaphyseal fractures and epiphyseal fractures.
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The DePuy ACE AIM® Titanium Tibial Nail is an intramedullary fixation rod for the fixation of tibial fractures. The nail has a distal bend of 2º for the nails of 10mm, 12mm and 13mm diameters. The distal bend in the nails of 8mm and 9mm diameters is 5°. The DePuy ACE AIM® Titanium Tibial Nail has diameters from 8.0mm to 13.0mm and lengths from 25.5 cm to 43.5cm. The proximal end of the 10mm, 11mm, 12mm and 13mm nails is 13mm in diameter while the proximal end of the 8mm and 9mm nails is I Imm in diameter. The proximal end of the nail contains two 6mm cross locking screw holes which accept 5.5mm solid cortical bone screws. The distal end of the nail contains two 5.0mm holes which accept 4.5mm solid cortical bone screws. The 8mm and 9mm nails are solid while the 10mm to 13mm nails are cannulated.
The DePuy ACE AIM® Titanium Tibial Nail is manufactured from Titanium 6Al-4V ELI (ASTM standard F-136)
Comparative testing between the versions of the tibial nails was conducted on cadavers which showed that the insertion and extraction forces are decreased by reducing the distal bend for a 13mm nail. Under clinical usage, it is believed that a distal bend is necessary during insertion to reduce the likelihood of fracturing or perforating the posterior cortex. Therefore, the distal bend of the large tibial nails will be reduced to 2°.
The 8mm and 9mm nails are used in unreamed applications. Due to their small diameter, difficulty during insertion and extraction has not been encountered. Therefore, the small nails will keep the a 5° distal bend.
Based on this information, DePuy Ace believes that the modified DePuy ACE AIM® Titanium Tibial Nails are substantially equivalent to the DePuy ACE AIM® Titanium Tibial Nail previously cleared for tibial fractures.