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The proposed indications for use for the Integra® CAPTURE™ Screw System are as follows:
"The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.

The proposed indications for use for the Integra® Ti6® Internal Fixation System are as follows: "The Ti6@ Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.

The Integra® CAPTURETM Screw System and Integra® Ti6® Internal Fixation System consists of bone screws of various designs and sizes intended to fixate bones in cases of fractures, osteotomies, or fusions. The screws are self- drilling and self-tapping, and are manufactured from Ti-6Al-4V titanium alloy. This submission presents new cannulated (Digital Fusion) and non-cannulated (QuickSnap) screw designs that are line extensions to the current Integra® CAPTURE™ Screw System and Integra® Ti6® Internal Fixation System.

This document is a 510(k) premarket notification for the Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices. Crucially, as a 510(k) submission, it focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving novel effectiveness through clinical trials.

The document states:
"Clinical Performance Data: Clinical performance data was not necessary to demonstrate substantial equivalence."

Therefore, the specific information requested about acceptance criteria for device performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details will not be available in this document as it explicitly states clinical performance data was not required or provided.

However, I can provide the non-clinical performance data and its findings, which were used to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in the document for the non-clinical tests.
• Data Provenance: The tests were conducted "per ASTM F543," which is a standard for metallic bone screws. This indicates laboratory testing, not human patient data.

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

• Not applicable. The ground truth for mechanical testing is based on established engineering standards (ASTM F543) and physical measurements, not expert human interpretation.

4. Adjudication method for the test set:

• Not applicable as the testing involves direct physical measurements against engineering standards rather than subjective interpretations requiring adjudication.

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:

• No. A MRMC comparative effectiveness study was not done. This device is a bone fixation screw system, not an AI or imaging diagnostic device that would involve human readers or AI assistance in interpretation.

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

• No. This device is a physical medical device (screws), not an algorithm or software. Standalone performance as an algorithm is not applicable.

7. The type of ground truth used:

• Non-clinical performance data: Ground truth was established by adherence to ASTM F543 standards for mechanical properties (Torsional Strength, Driving Torque, Axial Pullout Strength) and comparison to predicate devices.

8. The sample size for the training set:

• Not applicable. This device is a physical medical implant, not an AI or machine learning model that requires a training set. The "training" for the device's design and manufacturing would come from engineering principles and standards.

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

• Not applicable. See point 8.

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The Monster BITE Screw System™ is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device

The Monster BITE Screw System™ includes snap-off, threaded bone screws offered in 2.0mm and 2.7mm diameters having overall lengths from 8 to 24mm.

Based on the provided FDA 510(k) summary, the device is the "Monster BITE Screw System™". This document is a premarket notification for a medical device and, as such, does not contain the detailed study data typically associated with clinical performance or AI algorithm validation.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than proving clinical efficacy or the device's ability to meet specific performance criteria through empirical studies with clinical endpoints like an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, study data for performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable to this document because:

• This is a traditional medical device (metallic bone fixation fastener), not an AI/ML-driven device.
• The demonstration of substantial equivalence relies on material, design, and mechanical performance comparisons to predicate devices, not clinical performance metrics or AI algorithm accuracy.

The document does mention "Performance Data" but clarifies that it refers to theoretical comparisons of torsion and pullout strength along with insertion/removal torque testing per ASTM F543, demonstrating substantial mechanical equivalence to predicate devices, not clinical outcomes in patients or diagnostic accuracy.

In summary, the provided text does not contain the information needed to answer the prompt from the perspective of an AI/ML device's acceptance criteria and performance study because it describes a mechanical bone fixation device applying for 510(k) clearance based on substantial equivalence to existing devices.

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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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