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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.

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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.

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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.

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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.

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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, non-unions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.

CREEDTM Cannulated Screws consists of subject components that will be available in thread diameters ranging from Ø2.5mm to Ø7.4 mm and lengths ranging from 14-120mm. They are either headed or headless compression. All screws are self-drilling and self-tapping. The screws are offered in configurations that include a Titanium alloy Ti-6AL-4V ELI (ASTM F136) screw and a Titanium alloy Ti-6AL-4V ELI (ASTM F136) screw with an outer layer of Zeniva ZA-600 PEEK (ASTM F2026). 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 for the CREED™ Cannulated Screws, a medical device for bone fixation. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, but does not describe acceptance criteria for an AI/ML device or a study proving its performance.

Therefore, I cannot provide the requested information about acceptance criteria or a study related to AI/ML device performance from the provided text. The document is for a traditional medical device (cannulated screws) and does not involve AI/ML.

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The Cannulated Screws Neoortho are generally intended for fracture fixation of various bones and bone fragments, such as femoral neck, intercondylar femoral, malleolus, pilon tibial, calcaneus, talus, tibial plateau, tarsal, metatarsal, wrist, metacarpal, carpal, scaphoid and radius fracture. The Cannulated Screws Neoortho are also intended for fixation arthrodesis, iliosacral dislocations, and hallux valgus corrections. Accessories implants: The washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.

The Neoortho Cannulated Screws include nine cannulated screw specifications and associated washers, which are manufactured from stainless steel and titanium alloy. The cannulated screw is a self-tapping screw with a cancellous or cortical thread that can be guided into a position via a guided wire. They are used to aid in the alignment and stabilization of fractures to the skeletal system.

The technological characteristic of the Neoortho Cannulated Screws are similar to the predicate devices including design, dimensions, and materials. The Neoortho cannulated screws and washers are fabricated from stainless steel per ASTM F138 and Ti-6Al-4V alloy per ASTM F136. The stainless steel and Ti-6Al-4V are commonly used material in orthopedic implants.

The provided text describes a 510(k) premarket notification for "Cannulated Screws Neoortho" and details the non-clinical tests performed to demonstrate substantial equivalence to predicate devices. It does not contain information about an AI device or details relating to acceptance criteria and studies typically associated with AI/ML medical devices. The document focuses on mechanical and sterilization properties for an orthopedic implant.

Therefore, I cannot provide an answer based on the prompt's request for AI device acceptance criteria, performance, and study details like sample size for test/training sets, expert qualifications, or MRMC studies.

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The SMV Scientific 2.4mm and 3.0mm Cannulated Screws are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies. The SMV Scientific 3.5mm Cannulated Screws are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation. The SMV Scientific 4.5mm Cannulated Screws is intended for fracture fixation of long bones and long bone fragments. The SMV Scientific 6.5mm and 7.3mm Cannulated Screws are intended for fracture fixation of large bones and large bone fragments, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to DHS in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, pediatric femoral neck fractures, intercondylar femur fractures, and subtalar arthrodesis.

The SMV Scientific Cannulated Bone Screws consist of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided non-sterile. Screws are manufactured from Stainless Steel per ASTM F138 or Titanium per ASTM F136 or F1295.

I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or any study that proves the device meets those criteria. The document is a 510(k) premarket notification letter from the FDA, a summary of the device, and a comparison to predicate devices, focusing on substantial equivalence for a medical device (SMV Scientific Cannulated Screws).

The information you are requesting, such as performance metrics, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance, is not present in this document.

The document primarily states that the SMV Scientific Cannulated Screws are substantially equivalent to legally marketed predicate devices based on:

• Identical indications for use
• Identical materials of manufacture
• Identical principles of operation
• Engineering analysis and dimensional comparison
• Mechanical performance data (though no specific data or acceptance criteria are detailed).

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The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions 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 DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula, and the bones of the foot and hand 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 DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non-unions, and malunions of various long bones, such as the humerus, femur and tibia; the pelvis, and the bones of the foot and hand 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 DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of 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 DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments; and the bones of the hand and foot, 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 DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot 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. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.

The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bone fragments, pelvis, sacrum, and the bones of the foot 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. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis.

The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intra-articular fractures, avulsions, non-unions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints 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 DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, non-unions, and malunions of small bones and small bone arthrodesis 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 DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra-articular fractures, non-unions, malunions, and osteotomies of small bone fragments, as well as arthrodesis of small joints 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 DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of various bone fragments including bones of the foot, humerus, femur and tibia 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 DePuy Synthes Cortex, Cannulated, and Headless Compression Screws are metallic bone screws manufactured from Stainless Steel (ASTM F138), Commercially Pure Titanium (ASTM F67), and/or Titanium Alloy (ASTM F1295). 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 DePuy Synthes Cannulated and Headless Compression screws are cannulated for use with guidewires for precise placement in bone with the exception of the 1.5 mm Headless Compression Screw, which is a solid screw and therefore does not allow for instrumentation with a guide wire. The Headless Compression Screws feature threaded heads that allow for purchase in the near cortex of bone during and after implantation, potentially reducing complications associated with countersinking of traditional cortex or cannulated screws.

This document is a 510(k) Pre-market Notification to the FDA for various bone fixation screws manufactured by DePuy Synthes. It aims to demonstrate substantial equivalence to previously cleared devices.

Based on the provided text, there is no acceptance criteria or study data related to an AI/ML powered medical device. This document pertains entirely to traditional medical devices (bone screws) and their mechanical properties, indications for use, and comparison to predicate devices. The "performance data" section explicitly states "There is no bench testing included in this submission," "There is no animal data included in this submission," and the "Clinical" section refers to "published clinical literature to support the safety and efficacy of the modifications to the Indications for Use" rather than a clinical study conducted by the manufacturer specifically for this submission.

Therefore, I cannot provide the requested information for an AI/ML powered medical device based on this document. The questions about test sets, data provenance, expert consensus, MRMC studies, standalone performance, and training sets are not applicable here.

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The CANNULATED SCREW Internal Fixation System is intended to be used for alignment and stabilization of small bone fractures. Specifically:

· Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, non-unions, or mal-unions

· Ligament reconstruction

• Osteochondritis dissecans
  · Arthrodesis of the foot, ankle, wrist, elbow and hand

· Small bone osteotomies, including first metatarsal head osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies

These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

The Cannulated Screw Internal Fixation System is comprised of Cannulated Headed and Headless Screws and Hook Plates intended to align and stabilize small bone fragments around articular regions. It is fabricated and manufactured from titanium alloy (6AI-4V-ELI per ASTM F 136). Screws and hook plates offer a variety of sizes of non-sterile, single use implantable components. Longer pitched threads on the distal tip of the screw penetrates bone at a faster rate than the shorter trailing threads for headless screws, allowing interfragmentary compression as the screw is advanced and countersunk. The non-threaded portion facilitates compression of the joint surfaces through a lag technique. The low profile hook plate can provide interfragmentary compression and is well suited for areas of limited soft tissue coverage.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Cannulated Screw Internal Fixation System components with components from any other system or manufacturer. The Cannulated Screw Internal Fixation System components should never be reused under any circumstances.

The provided text describes a 510(k) premarket notification for the Life Spine Cannulated Screws. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with established acceptance criteria and detailed study results. Therefore, the information requested in your prompt related to acceptance criteria, specific study designs, sample sizes, expert ground truth, adjudication methods, and AI performance is not present in this document.

However, I can extract the information that is available regarding the device performance and comparison to predicate devices:

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

Since this is a 510(k) submission, there are no explicit "acceptance criteria" in the traditional sense of a clinical study with predefined statistical targets. Instead, the performance data presented aims to demonstrate equivalence to predicate devices.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No clinical test set or sample size is mentioned. The performance data consists of "Benchtop Testing" and "Finite Element Analysis." These are laboratory and computational studies, not human or animal studies. Therefore, data provenance related to country of origin or retrospective/prospective is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no human-involved "test set" or ground truth establishment by experts for this type of mechanical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as there is no human-involved "test set" 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:

Not applicable. This device is a surgical screw, not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable. This device is a surgical screw, not an algorithm.

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

For the mechanical performance data, the "ground truth" is defined by established engineering principles and standards (ASTM F543) for material and device properties.

8. The sample size for the training set:

Not applicable. There is no "training set" for an AI algorithm or a clinical study in this context. The performance data is from mechanical testing.

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

Not applicable, as there is no "training set."

Summary of available information:

The document primarily focuses on demonstrating that the Life Spine Cannulated Screw System is substantially equivalent to existing legally marketed predicate devices (Biomet BioDrive Micro Screw, Synthes Cannulated Screw, ACE Medical Cortical Screw).

• Performance Data: The device underwent Static and Dynamic Compression and Torsion testing in accordance with ASTM F543, as well as Benchtop Testing and Finite Element Analysis. This data was presented to demonstrate the substantial equivalence of the mechanical properties.
• Materials: Manufactured from implantable grade titanium (Ti 6Al-4V ELI) per ASTM F136, matching the material of predicate devices.
• Conclusion: The manufacturer concluded that the device is substantially equivalent in indications for use, design, function, and materials.

In essence, this document is a regulatory submission for a physical medical device (a screw) and does not involve AI, clinical efficacy studies with predefined acceptance criteria, or expert-adjudicated ground truth as would be relevant for a diagnostic or AI-driven device.

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The Tiger Headless Cannulated Screws are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.

Tiger Headless Cannulated Screws are headless, cannulated, self-drilling, self-tapping screws for the management of small bone orthopedic osteotomies and trauma. The system consists of multiple screw lengths and diameters and the necessary instruments to facilitate the placement of these implants.

Here's an analysis of the provided text regarding the Tiger Headless Cannulated Screws, focusing on acceptance criteria and supporting studies:

It is important to note that the provided 510(k) summary is for a medical device (bone screw), not an AI/ML powered device. As such, many of the typical questions for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) do not apply to this type of device submission. The acceptance criteria and "studies" are based on non-clinical (mechanical) testing rather than clinical performance or AI/ML algorithm evaluation.

Here's a breakdown based on the provided input:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the document. For mechanical testing of medical devices, sample sizes are typically determined by engineering standards (e.g., ASTM, ISO) to achieve statistical significance for material properties and performance claims.
• Data Provenance: Not applicable. The "data" comes from laboratory-based mechanical testing, not human clinical data or patient records.
• Retrospective/Prospective: Not applicable. This refers to the nature of clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. For mechanical testing, "ground truth" is established by direct measurement against engineering standards and specifications. There are no human experts establishing a clinical ground truth for these tests. The tests themselves are the "truth." Engineers and lab technicians conduct the tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are used for resolving disagreements in human interpretation of data, typically in clinical studies or AI/ML evaluations. Mechanical testing results are quantitative and do not require 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. An MRMC comparative effectiveness study is used to evaluate the performance of AI-assisted systems in diagnostic or interpretative tasks involving human readers. This device is a bone screw and does not involve AI or human interpretation in its function or evaluation in this 510(k) submission.

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

• Not applicable. This device is a bone screw, not an algorithm, so the concept of standalone algorithm performance does not apply.

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

• Mechanical Engineering Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is established by ensuring the device's mechanical properties (pull-out strength, torque, etc.) meet or exceed recognized standards for bone fixation devices and are comparable to the legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This device does not use a training set as it is not an AI/ML algorithm.

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

• Not applicable. As there is no training set, there is no ground truth for a training set.

Summary of the Study Proving Acceptance Criteria:

The study conducted to prove the Tiger Headless Cannulated Screws meet acceptance criteria was a non-clinical mechanical testing program. This involved subjecting the screws to a series of tests:

• Static Axial Pull Out Test: Measures the force required to pull the screw out of a material designed to simulate bone.
• Static Axial Pull Through Test: Measures the force required to pull the screw head through a material.
• Driving Torque Test: Measures the torque required to drive the screw into a material.
• Failure Torque Test: Measures the torque at which the screw (or its interface) fails.

The results of these tests were then compared to the performance of legally marketed predicate devices (Tiger Cannulated screws K081510, and 2.4 and 3.0mm Headless Compression Screws K050636/K021556). The acceptance criterion was that the Tiger Headless Cannulated Screws demonstrate equivalent mechanical performance to these predicate devices, thereby establishing "substantial equivalence" in terms of mechanical safety and performance.

No human clinical studies were performed for this 510(k) submission, as stated in the document: "No clinical studies were performed." The substantial equivalence claim is based solely on the non-clinical mechanical testing and comparison to the predicate devices.

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