Search Results

Ask a specific question about this device

The ARIX Cannulated Screw System is indicated for fracture fixation, fusions, osteotomies, and malunions of fragments of long bones of the pelvis, the femur, the humerus, and the foot. The system is not intended for use in the spine.

The ARIX Cannulated Screw System consists of cannulated screws and corresponding washer. The thread diameters of cannulated screws are 6.5 and 7.3 mm. They are either fully or partially threaded. Screws and a washer are made of Titanium Alloy (Ti-6Al-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. All devices in the system are provided non-sterile.

The provided document, K233912, is a 510(k) Premarket Notification for the ARIX Cannulated Screw System. This document outlines the premarket review by the FDA for a medical device, specifically a bone fixation fastener, and not an AI/ML-driven diagnostic or prognostic device.

Therefore, the information typically requested in your prompt regarding AI/ML device studies (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance, etc.) is not applicable to this submission.

The document discusses bench tests for mechanical performance to demonstrate substantial equivalence to a predicate device. Here's what can be extracted from the document regarding its performance criteria and testing:

1. Acceptance Criteria and Reported Device Performance (Mechanical Testing):

• Torsion Test
• Driving Torque Test
• Axial Pull-out Test |

2. Sample Size and Data Provenance:

• Sample Size: The document does not specify the sample size (number of screws) used for the mechanical bench tests.
• Data Provenance: Not applicable in terms of patient data. The tests were bench tests conducted on the physical device. The manufacturer is Jeil Medical Corporation in South Korea.

3. Number of Experts and Qualifications (for Ground Truth):

• Not applicable. Ground truth for mechanical performance is established through standardized engineering test methods (ASTM F543) and physical measurements, not human expert consensus.

4. Adjudication Method:

• Not applicable for mechanical bench testing.

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

• Not applicable. This is a physical medical device, not an AI/ML system requiring human reader performance evaluation. The document explicitly states: "No clinical studies were considered necessary and performed."

6. Standalone Performance:

• Not applicable. This refers to the performance of the physical device in bench tests, not an AI algorithm. The document states its performance was evaluated for each mechanical test according to ASTM F543.

7. Type of Ground Truth Used:

• Engineering Standards and Physical Measurements: For mechanical performance, the ground truth is based on the specifications and test methods outlined in ASTM F543. Measurements from the tests (e.g., torque, axial pull-out force) are compared against these established physical and material science standards.

8. Sample Size for Training Set:

• Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How Ground Truth for Training Set was Established:

• Not applicable.

In summary, the provided document relates to the FDA clearance of a conventional medical device based on mechanical bench testing and substantial equivalence to a predicate device, rather than the evaluation of an AI-powered diagnostic or prognostic tool. Therefore, many of the requested details about AI/ML study methodologies are not present in this type of FDA submission.

Ask a specific question about this device

The 4.0 mm Cannulated Screws and associated washers are indicated for arthrodesis and osteotomies of small bones and small joints, and ankle fracture.

The 5.5 mm. 6.5 mm. 7.0 mm. and 8.0 mm Cannulated Screws. Cannulated Hip Pins and associated washers are indicated for fracture fixation, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device.

The Smith & Nephew 2.5 mm, 3.0 mm Headless Compression Screws are indicated for fixation of fractures, bunionectomies and osteotomies of small bones, and arthrodesis of small joints.

The Smith & Nephew 2.0 mm QFX Screw is indicated for osteotomies of the lesser metatarsals, and osteotomies and fractures of the phalanges.

The subject Cannulated Screw System includes the 2.0 QFX Screw, 2.5mm and 3.0mm Headless Compression Screws, 4.0mm, 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated Washers (K090675, K111994, K213126).

The Smith & Nephew Cannulated Screw System consists of stainless steel (316L conforming to ASTM F139 and ISO 5832-1 or titanium (Ti-6Al-4V conforming to ASTM F1472/SO 5832-3) implantable devices of many styles for use in fracture fixation. The Smith & Nephew Cannulated Screws product family includes Large Cannulated Screws, Cannulated Hip Pins, Hip Screws, QFX Screws, and associated Washers. The components are available in various diameters, thread options, and lengths. All screws are designed with a self-drilling, self-tapping tip to facilitate easy implantion with a reverse cutting flute design to assist with implant removal. Select screws are designed with low-profile screw heads for reduced soft tissue irritation, and 3.0mm and 7.0mm screws are available headless.

The implants within this system are single-use and are Gamma sterilized.

The provided text is a 510(k) summary for a "Cannulated Screw System" and details that the submission is for labeling updates, specifically updated indications for use. The critical information here is that there are no changes to the device's design, technological characteristics, function, sterilization, or packaging.

Therefore, the submission explicitly states: "no performance testing (bench, animal, clinical) was required." This means there is no study described in this document that proves the device meets specific acceptance criteria based on performance. The clearance is based on the substantial equivalence of the device itself (which was previously cleared) and the fact that the labeling changes do not impact safety or effectiveness.

Because no performance study was conducted for this specific submission, I cannot fill in the requested table and information points.

Here's a breakdown of why based on the input:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. No performance study was conducted.
• 2. Sample size used for the test set and the data provenance: Not applicable. No performance study was conducted.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No performance study was conducted.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No performance study was conducted.
• 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 screw system, not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a screw system, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No performance study was conducted.
• 8. The sample size for the training set: Not applicable. No machine learning training was performed.
• 9. How the ground truth for the training set was established: Not applicable. No machine learning training was performed.

The core of this 510(k) submission is to update the indications for use based on existing, cleared devices, implying that the safety and effectiveness have already been established through prior submissions for functionally identical devices. The changes are specifically for "user clarification" of the indications.

Ask a specific question about this device

The RESPONSE 4.5/5.0 and 5.5/6.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of dicogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), turnor, pseudarthrosis, and/or failed previous fusion. When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RESPONSE 4.5/6.0 Spine System and the RESPONSE 5.5/6.0 Cannulated Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, neuromuscular scoliosis, and congental scoliosis. The RESPONSE 4.5/5.0 Spine Systems and the RESPONSE 5.5/6.0 Cannulated Screw System are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The RESPONSE 5.5/6.0 Cannulated Screw System is a cannulated screw spinal implant system consisting of anchors (screws) that attach to the longitudinal members (rods) and interconnection components (connectors) previously cleared in the RESPONSE 5.5/6.0 Spine System see K193100. Pedicle screws are placed in the spine that attach to rods that allow immobilization and stabilization of the spine. The RESPONSE 5.5/6.0 Cannulated Screws are cannulated screws that are passed over a guidewire to achieve insertion. The RESPONSE 5.5/6.0 Cannulated Screws are available in a 6mm to 9mm diameter range by 40mm to 100mm lengths. All implant components are manufactured from titanium alloy, cobalt chrome, and commercially pure titanium. All components are supplied non-sterile. The screws, which have a Ø1.750 mm cannulation, are available in the following diameters and lengths: Ø6.0 - 40-80mm Ø6.5 - 40-90mm Ø7.0 - 40-100mm Ø8.0 - 40-100mm Ø9.0 - 40-100mm. All screws are double lead with a 2.750 mm thread pitch which is identical to the predicate screws. For the subject screws, the minor diameter, neck diameter and thread runout length were increased and the hexalobe feature and root radius were modified from the predicate pedicle screw design to accommodate the cannulation. The subject drivers are cannulated with features to interface with the screw hexalobe.

The provided text is a 510(k) summary for the OrthoPediatrics RESPONSE 5.5/6.0 Cannulated Screw System, a medical device for spinal fixation. This document primarily focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing. It does not describe a study involving human readers or AI performance in diagnostic or clinical tasks.

Therefore, the requested information regarding AI performance, human reader studies, ground truth establishment for AI, and related metrics cannot be extracted from this document, as it is not relevant to the type of device review described.

Below is the information that can be extracted, primarily related to the mechanical performance testing of the device for its substantial equivalence determination.

Acceptance Criteria and Reported Device Performance

The document describes various performance tests conducted to support substantial equivalence. The acceptance criteria themselves are not explicitly detailed as numerical thresholds in this summary, but rather implied as meeting the standards set by the predicate device and relevant ASTM standards. The "reported device performance" is that the device "supports the differences between the subject and predicate devices" and "is substantially equivalent."

Information Not Applicable to this Device/Study:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is a mechanical device, and the "tests" refer to laboratory-based mechanical and material performance evaluations, not diagnostic image analysis or clinical data.
• 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 defined by engineering specifications and material properties, assessed in a lab, not by expert human interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept is relevant for clinical or diagnostic studies involving human assessment, not for mechanical testing.
• 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. There is no AI component in this device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no AI component.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical tests, the ground truth is based on physical scientific principles, engineering standards (ASTM), and direct measurement of material and structural performance, not expert consensus or clinical pathology.
• The sample size for the training set: Not applicable. Pertains to AI model development.
• How the ground truth for the training set was established: Not applicable. Pertains to AI model development.

Ask a specific question about this device

CREED™ Cannulated Screws are intended to maintain alignment and fixation of bone fractures in the presence of appropriate additional immobilization such as rigid fixation implants, cast or brace, nonunions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.

CREED™ Cannulated Screws Subject device consists of components that will be available in Ø2.5mm thread diameter and lengths ranging from 20-44 mm. They areheadless compression screws. All screws are self-drilling and self-tapping. The screws are Titanium alloy Ti-6AL-4V ELI (ASTM F136) screws. A variety of instrumentation is offered as part of the kit to facilitate delivery of the screws. The screws are provided sterile via Gamma irradiation.

This document is a 510(k) Premarket Notification from the FDA regarding the "CREED™ Cannulated Screws." It is a premarket submission for a medical device and, as such, does not contain information about clinical studies with human participants, AI algorithms, or the evaluation of diagnostic performance.

The document primarily focuses on demonstrating substantial equivalence of a new medical device (CREED™ Cannulated Screws) to a legally marketed predicate device (also CREED™ Cannulated Screws, K200291) based on mechanical performance and material characteristics, not on clinical outcomes or diagnostic accuracy.

Therefore, I cannot provide the requested information regarding:

• Acceptance criteria for diagnostic performance
• Study proving device meets acceptance criteria (in the context of diagnostic performance)
• Sample size for test set or data provenance
• Number of experts or their qualifications for ground truth
• Adjudication method
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for training set
• How ground truth for training set was established

The "Performance Data" section explicitly states: "Static bending (ASTM F1264) test results were presented along with engineering rationale for other relevant measures." This indicates that the performance evaluation was based on mechanical testing, not clinical or diagnostic studies.

Ask a specific question about this device

Metal Cannulated Screw is indicated for internal fixation of fracture, fusion and correction of limb bone and metaphysis, hand and foot:
1)The 2.3mm No Profile Cannulated Screw is indicated for the fixing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
2)The 3.0mm No Profile Cannulated Screw is indicated for internal fixation of bone fractures of ulna, and small bones (metacarpals, metatarsals, and phalanges).
3)The 4.0mm No Profile Cannulated Screw and 4.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of small bones and small bone fragments.
4)The 5.0mm No Profile Cannulated Screw and 5.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, and the bones of the hand and foot.
5)The 7.0mm No Profile Cannulated Screw and 7.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capiplysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
6)The Headless Cannulated Screw (2.5-4.5mm)/Headless Compression Screw (2.5-4.5mm) are indicated for fixation of fractures in large bones of humerus, ulna, radius, tibia and fibula, and small bones of the foot. These screws are also indicated for intra-articular fractures of knee and ankle joint.
7)The Headless Cannulated Screw (5.0-7.0mm)/ Headless Compression Screw (5.2-7.0mm) are indicated for fixation of fractures of femur, tibia and calcaneus, and intra-articular fractures of knee joint.
8)The 3.5mm/4.0mm Headless Compression Screw, Oblique are indicated for fixation of bone fractures or for bone reconstruction of the foot and hand, including calcaneus, talar, navicular, metacarpals, metatarsals and phalanges.
9)The 6.5mm Cannulated Screw are intended for fixation of fractures, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capital femoral epiphysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
10)The 7.3mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum and the bones of the foot. These screws are also indicated for slipped capital femoral epiphysis, ankle arthrodesis and subtalar arthrodesis.

Metal Cannulated Screw consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, Metal Cannulated Screw is used alone, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Metal Cannulated Screw are made of Ti-6Al-4V ELI following ASTM F 136. Metal Cannulated Screw is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

The provided text (K221090) describes a premarket notification for a medical device called "Metal Cannulated Screw." It details the device's indications for use, comparison to predicate devices, and non-clinical performance data.

However, the provided document does not contain any information about an AI/ML-based medical device, nor does it mention any studies involving acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment by experts, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance.

The document states: "No clinical performance data was provided to demonstrate substantially equivalence." This further indicates that the submission relies on non-clinical (mechanical and biocompatibility) testing to demonstrate equivalence to a traditional medical device (bone screws), not a software-based AI device requiring performance metrics.

Therefore, I cannot answer your request based on the provided text, as it does not contain the necessary information regarding acceptance criteria and a study proving an AI device meets these criteria.

Ask a specific question about this device

The Avanti Orthopaedics 2.2mm Cannulated Compression Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of small bones in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Avanti Orthopaedics 3.2mm, and 4.0mm Cannulated Compression Screws are intended for fixatures, fusions, osteotomies, non-unions of small bones and small bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Avanti Orthopaedics Cannulated Compression Screw System are metallic bone screws manufactured from Stainless Steel (ASTM F138). The screws are available in multiple lengths and diameters, and are intended to be used as stand-alone bone screws for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation. The Avanti Orthopaedics Cannulated screws are cannulated for use with guidewires for precise placement in bone.

The provided text describes a 510(k) premarket notification for Avanti Orthopaedics 2.2mm, 2.7mm, 3.2mm, and 4.0mm Cannulated Screws. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing of the device hardware itself, rather than the performance of an AI/ML powered medical device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device (referring to aspects like sample size, ground truth, expert consensus, MRMC studies, etc.) is not present in the provided document.

The document entirely pertains to the physical characteristics and performance of orthopedic screws.

Here's what can be extracted about the non-clinical performance testing of these orthopedic screws:

Summary of Acceptance Criteria and Device Performance for Orthopedic Screws

The provided document describes the acceptance criteria and performance for physical orthopedic devices, specifically Avanti Orthopaedics 2.2mm, 2.7mm, 3.2mm, and 4.0mm Cannulated Screws. The testing is focused on the mechanical properties and safety of the screws, not on an AI/ML algorithm's performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document states that "Testing was performed per ASTM F543-17."
• Sample Size: Not explicitly stated in the document. ASTM F543-17 (Standard Specification and Test Method for Metallic Bone Screws) would specify the required number of samples for each mechanical test (e.g., torsion, bending, dynamic fatigue).
• Data Provenance: Not applicable in the context of clinical data/images. This testing pertains to the physical device. The testing was non-clinical (laboratory testing).

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

• Not applicable. Ground truth in this context refers to the physical properties and performance of the screw under specific test conditions, as defined by engineering standards (ASTM F543-17) and FDA guidance. No human expert interpretation of data is involved in establishing "ground truth" for mechanical testing.

4. Adjudication Method for the Test Set:

• Not applicable. This is mechanical testing against defined specifications, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a physical medical device (orthopedic screw), not an AI/ML software device. MRMC studies are used for evaluating diagnostic or treatment planning software performance with human readers.

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

• Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used:

• Engineering Standards and Specifications: The "ground truth" for the device's performance is established by the specified mechanical properties and performance requirements outlined in ASTM F543-17 and the FDA guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway". This is objective, measurable data.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set was Established:

• Not applicable.

In summary, the provided FDA document is a 510(k) submission for conventional orthopedic screws, not an AI/ML device. Therefore, the detailed questions about AI/ML device performance (like training sets, ground truth establishment by experts, MRMC studies, etc.) are outside the scope of this document.

Ask a specific question about this device

The EVOS MINI Plating System is indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The EVOS MINI Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation of small bones and small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The EVOS Small Fragment Plating System is indicated for adult and adolescent (greater than 12-21 years of age) patients, as well as patients with osteopenic bone. It is indicated for fixation of small and long bone fractures, including, but not limited to, those of the tibia, fibula, femur, humerus, ulna, radius, pelvis, acetabulum, metacarpals, and clavicle. The EVOS Partial Articular and Anti-Glide Plates are indicated for the treatment of partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula. The EVOS Wrist Fracture Plating System is indicated for adult and pediatic patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna. The EVOS Large Fragment Plating System is indicated for adult patients. It is indicated for fixation of long bone fractures.

The PERI-LOC Plate and Screw System can be used for adult and pediativ patients with osteopenic bone. PERI-LOC bone plates and bone screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, humerus, ulna, radius, calcaneus, and clavicle. PERI-LOC Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatic patients, as well as patients with osteopenic bone. PERI-LOC contoured VLP Plates and Screws are indicated for partial articular fractures (AO/OTA Fracture Classification Type B) of the distal and for fracture fixation of the firstion of the firstilula. PERI-LOC VLP One-Third Tubular Locking Plates are indicated for, but not limited to, fixation of fractures, non-unions and osteotomies of the medial malleolus, fibula, distal ulna, olecranon, calcaneus and metatarsals. PERI-LOC Periarticular Locked Plating System Proximal Femur Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC Proximal Femur Bone Plates, Bone Screws 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 medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures of the proximal femur including metastatic fractures: proximal fenur osteotonies: fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures. The Smith & Nephew VLP FOOT Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP FOOT Plating System is indicated for fixation, reconstruction or arthrodeses of small bones, including those in the forefoot, midfoot and hindfoot. The Smith & Nephew PERI-LOC Ankle Fusion Plating System can be used in adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The PERI-LOC Ankle Fusion Plating System is indicated for ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus. The VLP MINI-MOD Small Bone Plating System and VLP MINI-MOD Talus Plates are indicated for adolescent (12-18 years) and transitional adolescent (18-21 years) subpopulations and adults, as well as patients with osteopenic bone. The VLP MINI-MOD Small Bone Plating System is indicated for fracture fixation, arthrodesis, reconstruction, replantation or reduction of small bone fragments. This system is also indicated for non-load bearing stabilization and reduction of bone fragments in long bones. The VLP MINI-MOD Talus Plates are indicated for fracture fixation, reconstruction or arthrodesis of small bones, including those in the forefoot, midfoot and hindfoot. The VLP Wrist Fracture System Radial Plates are indicated for fixation of fractures, malunions, and osteotomies involving the radius.

The D-RAD SMART PACK System is intended for the fixation of fractures involving the distal radius.

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

1. Intracapsular fractures of the femoral neck. (For high subcapsular fractures it may be more prosthesis in lieu of internal fixation to reduce the risk of a nonunion or avascular necrosis of the femoral head.) 2. Trochanteric or subtrochanteric fractures with appropriate additional precautions about weight bearing and more than sedentary activity. 3. Osteotomies for patients with diseases or deformities of the hip. 4. Hip arthrodesis. 5. Supracondylar fractures and distal femoral fractures using a supracondylar plate. 6. Ipsilateral femoral shaft/neck fractures.

CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

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, metatarsals, patella, ultar 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 bone fragments appropriate for the size of the device including joint fusions (arthrodesis) in the foot and ankle. The Smith & Nephew 2.5mm, 3.0mm Cannulated and 3.0mm Headless Compression Screws are intended for fixation of intraarticular and extra-articular fractures and non-unions of small bone fragments; arthrodeses of small ioints; bunionectomies and osteotomies; scaphoid and other carpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The Smith & Nephew 2.0mm OFX Screw is indicated for osteotomies of the lesser metatarsals, such as Well osteotomies. Osteotomies, fusions and fractures of the phalanges, metacarpals and carpals of the hand.

The purpose of this Traditional 510(k) is to update the MR safety information for the Smith & Nephew Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws. The technological characteristics, function of the devices, packaging and sterilization remain unchanged. No modification has been made to the device design, material, sterilization and the manufacturing processes of the previously cleared devices.

The provided document is a 510(k) premarket notification for various orthopedic plates and screws systems from Smith & Nephew. The purpose of this submission is solely to update the MR safety information for these devices. The document explicitly states that no modifications have been made to the device design, material, sterilization, and manufacturing processes.

Therefore, this document does not contain information about acceptance criteria for device performance, nor does it describe a study proving the device meets such criteria. The performance data mentioned (Magnetically induced displacement force, Magnetically induced torque, Radiofrequency (RF) induced heating, MR image artifact) relates to MRI compatibility testing, not the primary clinical performance of the orthopedic fixation devices themselves.

Given this, the requested information about acceptance criteria and a study demonstrating device performance cannot be extracted from this document. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices based on unchanged technological characteristics and updated MR safety information.

Ask a specific question about this device

Cannulated Screw and Double Compression Cannulated Screw are intended for the treatment of fractures, and arthrodesis of bones with the appropriate screw size.

The Cannulated Compression Taper Screw (2.5-3.0 mm cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, and wrist.

The Cannulated Compression Taper Screw (3.5 mm and larger, cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, ostectomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, femur, and fibula.

Cannulated Screws are implantable medical devices developed for application in osteosynthesis, with the purpose of reducing, compressing, aligning, stabilizing, and fixing different types of fractures, in small, medium, and large bones, of lower and upper limbs, and can be used in isolated form or associated with washers. This submission also includes the corresponding washers for Cannulated Screws.

The screws have a hexagonal connection for a wrench and can be found in three different models: Cannulated Screw, Double Compression Cannulated Screw and Cannulated Compression Taper Screw. These devices are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, being provided in non-sterile condition.

The provided text is a 510(k) Premarket Notification from the FDA regarding "Cannulated Screws." It details the device's indications for use, technological characteristics, and performance data. However, this document does not contain information about an AI/ML-driven medical device, a study involving human readers or expert ground truth, or an AI algorithm's performance.

The "Performance Data" section discusses mechanical properties testing of the physical screws (torsional properties, driving torque, axial pullout strength, chemical and mechanical properties) against ASTM standards. It concludes that the device presents safety and efficacy in terms of its mechanical properties, but this pertains to the physical product, not a diagnostic or AI-assisted system.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-driven device, as the provided document does not pertain to such a device.

Ask a specific question about this device

The Asnis III 4.0 and 5.0 mm Cannulated Screws are intended for fixations, osteotomies, non-unions, and malunions of fragments of small and long bones, the pelvis and bones of the foot.

The Asnis III 6.5 and 8.0 mm Cannulated Screws are intended for:

· fracture fixation, fusions, osteotomies, and malunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot

· sacroiliac joint fusion for conditions including sacroiliac joint disruptions

The Asnis PRO 6.5 and 8.0 mm Cannulated Screws are intended for:

· fracture fixation, fusions, osteotomies, nonunions of fragments of small and long bones, the pelvis, sacrum, and bones of the foot

· sacroiliac joint fusion for conditions including sacroiliac joint disruptions

The Asnis® III Cannulated Screw System, previously cleared in K213199, consists of self-tapping cannulated screws and the corresponding washers. All devices in the system are provided sterile and non-sterile. The thread diameters are 4.0, 5.0. 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. There are corresponding washers to the 4.0 and 5.0 mm screws respectively and one washer fitting for both diameters, 6.5 and 8.0 mm. Screws and washers are made of stainless steel and titanium alloy.

The Asnis® PRO Cannulated Screw System consists of self-tapping cannulated screws. All devices in the system are provided sterile and non-sterile. The thread diameters are 6.5, and 8.0 mm. They are either fully or partially threaded. All screws are self-drilling and self-tapping. There are corresponding washers to the 4.0 and 5.0 mm screws respectively and one washer fitting for both diameters, 6.5 and 8.0 mm. Screws and washers are made of stainless steel and titanium alloy.

The subject of this bundled traditional submission is to clarify the indications to the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System, cleared in K213199 and to introduce a new washer to the Asnis® PRO Cannulated Screw System cleared in K213199.

The provided document is an FDA 510(k) clearance letter for the Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System. This document focuses on the substantial equivalence of a medical device to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical or AI-based studies.

Therefore, the information required to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training data details) is not present in this type of regulatory submission.

The document explicitly states under "Performance Data (Nonclinical)":

• "No mechanical testing was deemed necessary as the new washers does not create a new worst case."
• "All bench tests performed in accordance with ASTM F543 and previously presented in Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System (K213199), remain true and accurate. Static Cantilever Bending Test was performed according to ASTM F2193."
• "Tests performed to establish compatibility with a magnetic resonance environment...Magnetically Induced Displacement per ASTM F2052 Magnetically Induced Torque per ASTM F2213 RF Heating per ASTM F2182 Image Artifacts per ASTM F 2119"
• "Clinical data and conclusions were not needed for this device."

This indicates that the assessment for this device clearance relied on bench testing and comparison to existing data from a predicate device (K213199), rather than a clinical study evaluating diagnostic accuracy, reader performance, or AI algorithm performance as you've outlined in your request.

In summary, none of the specific details you requested regarding acceptance criteria based on a clinical study, sample sizes, expert adjudication, MRMC studies, or AI algorithm performance can be extracted from this 510(k) document because such a study was not conducted or required for this particular type of device clearance.

Ask a specific question about this device