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Axis Charcot Fixation System:
The Axis Charcot Fixation System in diameters of 5.5, 6.5 and 7.5mm is indicated for reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthopathy (Charcot).
4.5 to 8.5 Screw System:
The 4.5 to 8.5mm Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints.

Axis Charcot Fixation System
The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy fixation beams and accessories used for midfoot reconstruction.
4.5 to 8.5 Screw System
The 4.5 to 8.5 diameter screws consists of cannulated, titanium alloy fixation screws for use in bone reconstruction, osteotomy, arthrodesis and fracture repair and fixation in the foot.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is a 510(k) premarket notification for the "Axis Charcot Fixation System, 4.5 to 8.5mm Screw System." It's important to note that 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than de novo approval requiring extensive clinical efficacy studies. Therefore, the "acceptance criteria" here are framed around demonstrating comparable performance to existing, legally marketed devices.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document explicitly states: "No clinical testing was performed." Therefore, there is no "test set" in the sense of patient data.

• Sample Size for Mechanical Testing: Not explicitly stated in the summary, but typical for bench testing, multiple samples of each device configuration would be tested.
• Data Provenance: Not applicable as no clinical data was collected. The bench testing would have been conducted by Extremity Medical, LLC or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical testing was performed, there was no ground truth to establish from patient data using expert review. The "ground truth" for the mechanical testing would be the raw data collected from the testing equipment, and the comparison point would be the performance of the predicate device (likely from published data or internal testing).

4. Adjudication method for the test set

Not applicable. No expert adjudication of clinical data was performed.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a bone fixation system (screws), not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance in image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical testing:

• Ground Truth: The physical properties and performance measurements (e.g., pull-out force, bending stiffness, fatigue life) derived directly from the bench tests.
• Comparison Basis: The performance characteristics of the identified predicate devices, likely obtained through literature, publicly available predicate device information, or internal testing for comparison purposes.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. The design and manufacturing processes are informed by engineering principles, material science, and the performance characteristics of existing devices, rather than a "training set" in the context of data-driven models.

9. How the ground truth for the training set was established

Not applicable. See point 8.

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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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Bone plates and screws from the Smith and Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include, fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation.

The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid.

The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle.

The subject of this Traditional 510(k) premarket notification is to expand the indications of the already existing, cleared Smith & Nephew Cannulated Screws and Washers by adding osteotomies and arthrodesis. The subject devices are part of the Smith and Nephew Bone Plate System cleared under 510(k) number K993106 and K060736 with the same original indications but the subject 4.0mm, 5.5mm, 6.5mm, 7.0mm and 8.0mm cannulated screws and associated washers have additional indications independent of the Bone Plate System.

The screws vary in diameter, length and thread length; have fluted screw tips for self-tapping and self-drilling and have a hexagonal screw heads. The screws may be used with bone washers to extend the surface area of the head if needed. These screws are cannulated to allow the screws to be accurately positioned with the use of a guidewire instrument. The device offering consist of diameters of 4.0mm, 5.5mm, 7.0mm and 8.0mm in titlanium allov and stainless steel.

This is a 510(k) premarket notification for a medical device (Smith & Nephew Cannulated Screws and Washers), not an AI/ML medical device. Therefore, much of the requested information regarding acceptance criteria and study design for AI/ML performance is not applicable to this document.

However, I can extract information related to the device's functional performance and how its safety and effectiveness were demonstrated through bench testing and comparison to predicate devices.

Here's a summary of the information relevant to the device's acceptance criteria and the study that demonstrates it meets those criteria, rephrased to align with the spirit of your request where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

Since this is a submission for a traditional medical device (cannulated screws and washers), the "study" demonstrating performance is primarily bench testing and comparison to predicate devices to establish substantial equivalence.

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size in terms of "cases" or "patients" as would be for an AI/ML study. Instead, the "test set" consists of physical samples of the Smith & Nephew Cannulated Screws (4.0mm and 5.5mm in both Ti and SS) used for mechanical bench testing.
• Data Provenance: The mechanical testing was conducted by Smith & Nephew, Inc. at their facilities, using their manufactured devices and predicate devices. No patient or human data is involved in this type of testing for substantial equivalence.

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

• Not Applicable. For a traditional mechanical device, the "ground truth" for performance is established through objective physical measurements and engineering standards in bench testing. There are no "experts" establishing ground truth in the context of interpreting medical images or diagnoses. The interpretation of test results would be done by qualified engineers.

4. Adjudication Method for the Test Set

• Not Applicable. Mechanical bench testing results are quantitative and objective. There is no subjective interpretation requiring adjudication among multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is not an AI/ML device, so an MRMC study is not relevant or performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Bench Test Results / Engineering Standards: The "ground truth" for showing the device meets its performance criteria is based on direct measurements of mechanical properties (fatigue, torsion, pullout strength) against established engineering standards and comparisons to the performance of legally marketed predicate devices. The goal is to demonstrate that the new device performs "equal or better" than existing similar devices, suggesting it is safe and effective for its intended use.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device; there is no "training set."

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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