(80 days)
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No
The device description and performance studies focus solely on the mechanical properties of the fixation system components (plates, screws, washer) and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes.
The device is intended to treat bone fractures, which is a therapeutic purpose.
No
The device is described as a fixation system intended for treating fractures, not for diagnosing them. It is a surgical implant designed to stabilize bones.
No
The device description clearly outlines physical components (plates, screws, washer) and mechanical testing, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, the DePuy Motech PEAK Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to treat fractures of bones. This is a surgical intervention performed directly on the patient's body.
- Device Description: The device consists of plates, screws, and washers, which are implants used to stabilize bone fractures.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The DePuy Motech PEAK Fixation System is a surgical implant used for internal fixation of bone fractures, which falls under the category of medical devices used for treatment, not diagnosis based on in vitro testing.
N/A
Intended Use / Indications for Use
The DePuy Motech PEAK Fixation System is intended for use in treating fractures of small bones such as the metacarpals, ulna, radius, humerus and metatarsals and in treating fractures of the lateral malleolus, olecranon, and intra-articular distal tibia.
Product codes
87 HRS
Device Description
The system consists of 5 sizes of channeled reconstruction plates ranging from 26mm to 104mm in length, 13 sizes of 3.5mm cortical screws ranging from 16 to 30mm in length and a steplock washer. The reconstruction plates are 3mm thick and 9mm wide. All plates incorporate a tooth pattern, on one outer surface. The teeth are designed to interlock with the "tabs" on the steplock washer.
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
small bones such as the metacarpals, ulna, radius, humerus and metatarsals, lateral malleolus, olecranon, and intra-articular distal tibia.
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)
Mechanical testing shows that in 4 point bending the rigidity, strength and stiffness of the DePuy Motech PEAK Fixation System channeled reconstruction plates exceed those of the ACE 100° Tubular Plate and Synthes 1/3 Tubular Stainless Steel Plates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
ACE 100° Tubular Plate, Synthes (USA) LC-DCP Plate Set System, Synthes (USA) 1/3 Tubular Stainless Steel Plates
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
K96 3350
| NAME OF FIRM: | DePuy Inc.
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 | NOV 14 1996 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(K) CONTACT: | Cheryl Hastings
Manager, Clinical Affairs | |
| TRADE NAME: | DePuy Motech PEAK Fixation System | |
| COMMON NAME: | Bone Plate | |
| CLASSIFICATION: | 888.3030 Single/multiple component metallic bone fixation
appliance and accessories | |
| DEVICE PRODUCT CODE: | Product code: 87 HRS | |
| SUBSTANTIALLY
EQUIVALENT DEVICES: | > ACE 100° Tubular Plate
Synthes (USA) LC-DCP Plate Set System
Synthes (USA) 1/3 Tubular Stainless Steel Plates | |
INTENDED USE AND DEVICE DESCRIPTION:
The DePuy Motech PEAK Fixation System is intended for use in treating fractures of small bones such as the metacarpals, ulna, radius, humerus and metatarsals and in treating fractures of the lateral malleolus, olecranon, and intra-articular distal tibia. The system consists of 5 sizes of channeled reconstruction plates ranging from 26mm to 104mm in length, 13 sizes of 3.5mm cortical screws ranging from 16 to 30mm in length and a steplock washer. The reconstruction plates are 3mm thick and 9mm wide. All plates incorporate a tooth pattern, on one outer surface. The teeth are designed to interlock with the "tabs" on the steplock washer.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Motech PEAK Fixation System is similar in material, design and intended use to the ACE 100° Tubular Plate and the Synthes LC-DCP Plate Set System. All of these systems consist of CP Titanium bone plates and screws intended to treat fractures of small bones. The ACE plate has a length of 97mm, 8 holes, a width of approximately 9mm and a thickness of approximately 1.3mm and is intended to be used with cancellous screws with diameters of 4.0mm or less. The Synthes system contains plates with lengths from 25mm with 2 to 10 screw holes per plate, and is designed to be used with 3.5mm cortical bone screws. The 3.5mm screws range in length from 10mm to 50mm.
Mechanical testing shows that in 4 point bending the rigidity, strength and stiffness of the DePuy Motech PEAK Fixation System channeled reconstruction plates exceed those of the ACE 100° Tubular Plate and Synthes 1/3 Tubular Stainless Steel Plates.