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Zimmer MotionLoc Screws, when used with the Periarticular Locking Plate System are indicated for temporary internal fixation and stabilization of osteotomies and fractures of long bones, including:

• Comminuted fractures
• Supracondylar fractures
• Intra-articular and extra-articular condylar fractures
• Fractures in osteopenic bone
• Nonunions
• Malunions

The Zimmer MotionLoc Screw for Periarticular Locking Plate System is used in conjunction with the Zimmer Periarticular Locking Plate (ZPLP) System. It is a member of the ZPLP Screw family and is used as an alternative for standard ZPLP Screws in applications where a surgeon desires reduced stiffness in a construct.

Zimmer MotionLoc technology has been developed to reduce the stiffness of locked plating constructs while retaining construct strength. This Zimmer MotionLoc technology relies on a screw design with a reduced diameter mid-section. These screws provide uni-cortical fixation in the far cortex of a diaphysis and are locked into the plate, without being rigidly fixed in the near cortex underlying the plate. The screw mid-section decreases the stiffness of the plating construct by acting as an elastic cantilever beam similar to a half-pin of an external fixator.

The Zimmer MotionLoc Screw for Periarticular Locking Plate System has a standard ZPLP Screw front thread section (self-tapping, single helix); an expansion section, intended to create the gap for motion in the near cortex; a mid-section thread with a reduced core-diameter and reverse cutting flutes to aid in screw removal, especially once the front thread screw section is out of the far cortex; a non-threaded collar section; and a double lead threaded head for engagement in the plate.

Here's an analysis of the provided text regarding the Zimmer MotionLoc Screw for Periarticular Locking Plate System, focusing on acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document does not explicitly state specific numerical acceptance criteria (e.g., minimum torque to failure in Nm, or fatigue cycles). Instead, it broadly states that the "results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective for their intended use and substantially equivalent to the predicate devices." This implies that the performance met internal benchmarks or demonstrated equivalence to the predicate's known performance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "physical testing" and various types of tests (torsional fatigue, axial fatigue, starting load, driving torque, torque to failure), but does not provide the number of samples or specimens tested for each.
• Data Provenance: The studies were non-clinical (lab) performance testing. The country of origin is not specified, but the sponsor is Zimmer, Inc. (USA), and the submission is to the FDA (USA). The data is prospective in the sense that the tests were conducted specifically to evaluate this device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not Applicable. This was a non-clinical (lab) performance study of a bone screw. Ground truth in this context refers to engineering specifications and material science principles, not expert medical opinion on, for example, image interpretation. There was no "test set" requiring human expert ground truth establishment in the traditional sense of medical image analysis or clinical diagnosis.

4. Adjudication Method for the Test Set

• Not Applicable. As this was a non-clinical, lab-based performance study, there was no need for adjudication of human interpretations or diagnoses. The results are objective measurements from mechanical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. An MRMC study was not conducted. This type of study involves human readers evaluating medical cases, often with and without AI assistance. The submitted device is a physical bone screw, not an AI software or a diagnostic tool that interacts with human readers in that manner.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, in spirit. The "Performance Data (Nonclinical)" section describes the standalone performance of the device itself through various mechanical tests. These tests assess the device's inherent properties and behavior without human intervention in operating or interpreting the device's output (beyond setting up the test and collecting data). The device itself (the screw) is the "algorithm" here, and its performance is measured directly.

7. Type of Ground Truth Used

• Engineering Specifications / Mechanical Properties: The "ground truth" for this study is derived from established engineering principles, material science, and the mechanical performance characteristics of the predicate devices. The implicit target is that the Zimmer MotionLoc Screw meets or exceeds the mechanical requirements for its intended use and is comparable to previously cleared predicate devices.

8. Sample Size for the Training Set

• Not Applicable. This refers to a physical medical device, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set mentioned or implied for this physical device.

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Smith & Nephew Plate and Screw Systems Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Plate and Screw Systems and their cleared Indications for Use.

PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories:
Smith & Nephew PERI-LOC Locking Bone Plates, Locking Hole Inserts and Cable Accessories Instruments are accessory devices and are intended to assist in the implantation of Smith & Nephew Periarticular Locked Plating Systems and their cleared indications for use.
The PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws, Locking Hole Inserts and Cable Accessories are indicated for:

• fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with the medial cortex instability
• proximal femur fractures combined with ipsilateral shaft fractures
• pathological fractures of the proximal femur including metastatic fractures
• proximal femur osteotomies
• fixation of fractures in osteopenic bone
• fixation of nonunions and malunions
• basi/transcervical femoral neck fractures
• subcapital femoral neck fractures
• subtrochanteric femur fractures.
  In addition, the PERI-LOC Periarticular Locked Plating System including Locking Hole Inserts and Cable Accessories can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bone plates and screws are indicated for:
• fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.

Smith & Nephew VLP FOOT Plating System, Screw System and Accessories:
Smith & Nephew VLP FOOT Plating System, Screw System and Accessories Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew VLP FOOT Plating System and Screw Systems and their cleared indications for use.
The Smith & Nephew VLP FOOT Plating System is indicated for:

• the treatment of fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot.
  The Smith & Nephew Screw Systems, containing 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws, are indicated for:
• fixation of interarticular and extra-articular fractures and non-unions of small bones and small bone fragments;
• arthrodesis of small joints;
• bunionectomies and osteotomies;
• scraphold and other carpal bones;
• metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.
  The Smith & Nephew 2.0mm QFX Screw is indicated for:
• osteotomies of the lesser metatarsals, such as Weil osteotomies, osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.
  Smith & Nephew Accessories, such as pins and wires, are indicated for:
• pelvic, small and long bone fracture fixation.

Smith & Nephew InterTAN CHS Limited Collapse Set Screw:
Smith & Nephew InterTAN CHS Limited Collapse Set Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew InterTAN CHS Limited Collapse Set Screw Systems and their cleared indications for use.
InterTAN CHS Limited Collapse Set Screw is indicated for:

• Intracapsular fractures of the proximal femur (For certain high subcapsular fractures, it may be more prudent to select a prosthesis in lieu of internal fixation to reduce the risk of nonunion or AVN of the femoral head).
• Intertrochanteric fractures.
• Stable and unstable fractuers of the proximal femur in which medial cortex stability can be restored.
• Hip osteotomy

PERI-LOC Periarticular Locked Plating System- VLP Locking Bone Plates and Locking/Non-Locking Bone Screws:
Smith & Nephew VLP Locking Bone Plates and Locking/Non-Locking Bone Screws Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew PERI-LOC Periarticular Locked Plating Systems and their cleared indications for use.
PERI-LOC contoured VLP Plates and Screws are indicated for:

• partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and proximal tibia and for fracture fixation of the fibula
  PERI-LOC VLP One-Third Tubular Locking Plates are indicated for:
• fixation of fractures, non-unions, and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals.

Smith & Nephew 6.5mm and 8.0mm Cannulated Screws:
Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew 6.5mm and 8.0mm Cannulated Screw Systems and their cleared indications for use.
Smith & Nephew 6.5mm and 8.0mm Cannulated Screws are indicated for:

• fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones;
• treatment of the calcaneal
• hip arthrodesis
• provisional bone fixation.

Smith & Nephew Bone Plate System:
Smith & Nephew Bone Plate System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Bone Plate Systems and their cleared indications for use.
Smith & Nephew Bone Plates, Bone Screws, and Accessories are indicated for:

• pelvic fracture fixation
• small bone fracture fixation
• long bone fracture fixation.

Titanium Classic Compression Hip Screw System:
Smith & Nephew Titanium Classic Compression Hip Screw System Instruments are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Titanium Classic Compression Hip Screw Systems and their cleared indications for use.
The Titanium Classic Compression Hip Screw System is indicated for:

• Pelvic Radius Plate- general fractures of the pelvis and acetabulum
• Tibial Plateau Plate- fractures of the proximal tibia with or without diaphyseal involvement
• One Third Tubular Plate- fractures of the fibula, lateral malleolus, metacarpals, metatarsals, olecranon, and distal ulna
• Small Auto-Compression Plate- fracture fixation of metatarsals, metacarpals, radius, and ulna
• Titanium Cortical Bone Screw- small and long bone fracture fixation

Subject of this Traditional 510(k) Premarket Notification are the Smith & Nephew, Inc. Plate and Screw Systems Instruments. The subject devices are accessory devices and are intended to be used to assist in the implantation of Smith & Nephew Plates and Screws and their cleared Indications for Use. Smith & Nephew Plate and Screw Systems Instruments can be organized into instrument families which are categorized as follows: Templates, Reamers, Handles, Bases, Pins, Taps, Drill Guides, Insertion or Removal, and Other Guides.

This document describes a 510(k) premarket notification for "Plate and Screw Instruments" by Smith & Nephew, Inc. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/ML medical device.

The document pertains to orthopedic surgical instrumentation, which are physical tools (templates, reamers, handles, pins, taps, drill guides, etc.) used to assist in the implantation of bone plates and screws. These are accessory devices to existing cleared bone fixation systems.

The submission is for substantial equivalence to previously cleared predicate devices, not for a novel device requiring performance studies or clinical trials to establish new safety and effectiveness claims based on specific acceptance criteria. The basis for substantial equivalence is listed as:

• Sharing the same raw materials
• Manufactured through the same processes
• Utilizing the same sterilization procedures
• Having a similar nature of body contact
• Similar in design and function to competing surgical instrumentation on the market.

Therefore, the requested information points, which are typically relevant for AI/ML device submissions involving performance benchmarks and clinical studies, are not applicable to this document. There are no acceptance criteria related to a model's performance, no data sets (training or test), no ground truth establishment, and no mention of human-in-the-loop studies or standalone algorithm performance.

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