Search Results

TRIGEN MAX Tibial Nail System:

The TRIGEN MAX Tibial Nail is indicated for stable and unstable fractures that occur in and between the proximal and distal third of the tibia, including the shaft.

INTERTAN MAX Hip Fracture Nail System:

The INTERTAN MAX Nails are indicated for fractures of the femur including:

· Fractures of the femur including simple shaft fractures, comminuted shaft fractures, spiral shaft fractures, and segmental shaft fracture; subtrochanteric fractures; intertrochanteric fractures;

ipsilateral femoral shaft/neck fractures; and intracapsular fractures

• · Polytrauma and multiple fractures
• · Prophylactic nailing of impending pathologic fractures
• · Reconstruction following tumor resection and grafting.

The Smith & Nephew TRIGEN MAX Tibial Nail and INTERTAN MAX Hip Fracture Nail systems consist of implant intramedullary nails, screws, nail caps, buttress plate, washers and their corresponding US Class II instrumentation. The TRIGEN MAX Tibial Nail system is designed to address fractures of the tibia and the INTERTAN MAX Hip Fracture Nail system is designed to address fractures of the proximal femur.

The provided text is an FDA 510(k) clearance letter and associated summary for the TRIGEN MAX Tibial Nail System and INTERTAN MAX Hip Fracture Nail System. This document does not describe a study involving an AI/software device that requires specific acceptance criteria for performance metrics like sensitivity, specificity, or AUC.

Instead, this clearance is for mechanical bone fixation appliances and accessories, which are physical medical devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical (benchtop) performance evaluations and biocompatibility testing to demonstrate substantial equivalence to predicate devices, not AI algorithm performance.

Therefore, I cannot provide a response with the requested information template (table of acceptance criteria with reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set sample size, and ground truth establishment for training set) because those metrics and study types are relevant for AI/software medical devices, which this submission is not for.

The document explicitly states: "No clinical tests were performed to support safety and efficacy of the subject devices. The performance bench evaluations and tests were used as a basis for the determination of substantial equivalence. The results of each evaluation or test show that when compared to the predicate devices have demonstrated substantially equivalent performance."

The types of "acceptance criteria" for these devices are related to mechanical properties and material compatibility, derived from standards like ASTM and ISO. These are not presented in a quantitative performance table like for an AI device.

To summarize, based on the provided document:

• This submission is for physical metallic bone fixation appliances, not an AI/software device.
• Therefore, the requested information template for AI device performance and validation studies is not applicable.
• The "studies" performed were non-clinical benchtop tests (e.g., Finite Element Analysis, Insertion/Removal Torque, Fatigue Testing, Biocompatibility).
• The "acceptance criteria" are implied by meeting the requirements of the referenced ASTM and ISO standards for substantial equivalence to predicate devices.

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The EVOS Wrist Plating System is indicated for adult and pediatric patients with osteopenic bone. It is indicated for fixation of fractures, malunions, and osteotomies involving the radius and ulna.

Subject of this premarket notification is the EVOS Wrist Fragment Plating System. The proposed devices incorporate design features that are currently incorporated on previously cleared Smith & Nephew bone plate and screw systems. Like their previously cleared counterparts, the proposed plates feature a screw-to-plate locking feature that permits their use with the proposed and compatibility designed locking and non-locking cortex screws described in this premarket notification. Each screw hole contains five separate tabs that engage with the threads of the locking screw. The locking screws can be angled and locked up to fifteen degrees in any direction, allowing for custom, multi-directional locked plating constructs. The subject plates can be used with screws previously cleared via K161665, K132296, K993106, K162078, K140814 and K132886 and pegs subject of this premarket notification.

This document describes the submission for the EVOS Wrist Fracture Plating System and does not contain information related to software or AI/ML acceptance criteria or studies. Instead, it focuses on the substantial equivalence of a medical device (bone plating system) to previously cleared predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria and studies proving the device meets those criteria, as it pertains to AI/ML devices. The document details mechanical testing, packaging verification, bacterial endotoxin testing, and biocompatibility testing for a physical implantable device, not a software algorithm.

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The EVOS Small Fragment Plating System is indicated for adult and pediatric 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, metatarsals, and clavicle.

Subject of this premarket notification is an extension to the EVOS family of plates and screws, the EVOS Small Fragment Plating System. This system features similarities to existing Smith & Nephew small fragment plates (TC-100 Small Bone Plating System, PERI-LOC Plating System) and also shares some instruments and implants from the existing EVOS MINI Plating System. It is comprised of a variety of locking and non-locking 2.7mm and 3.5mm straight plates as well as 3.5mm locking and non-locking screws and 4.7mm non-locking osteopenia screws.

The provided document is a 510(k) premarket notification for a medical device (EVOS Small Fragment Plating System), not a study analyzing AI performance. Therefore, I cannot extract information related to AI acceptance criteria, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance.

However, I can extract the acceptance criteria and study descriptions for the mechanical performance of the physical EVOS Small Fragment Plating System, as detailed in the document.

Here's the information based on the provided text, focusing on the mechanical testing of the device itself:

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

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

• Sample Size: Not explicitly stated for each mechanical test. The document mentions "worst-case designs" for FEA and fatigue testing, and specific sizes of screws (3.5mm, 4.7mm) for others. Typically, mechanical testing involves a limited number of samples (e.g., 5-10 per test condition) to satisfy a statistical confidence level or regulatory requirement, but the exact numbers are not provided here.
• Data Provenance: Not applicable as these are pre-clinical (benchtop) tests of the device's physical properties, not clinical data from patients. The testing was conducted by Smith & Nephew, Inc.

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. These are engineering and mechanical tests, not analyses requiring expert human interpretation or ground truth establishment in a clinical sense. The "ground truth" is defined by the objective measurement of mechanical properties against predetermined performance standards, often based on existing predicate devices or industry standards like ASTM.

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

Not applicable. This is not a study involving human interpretation or adjudication. The results are quantitative measurements against objective criteria.

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 document describes the mechanical testing of a medical implant, not an AI or diagnostic imaging device.

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

Not applicable. This document describes the mechanical testing of a medical implant, not an AI algorithm.

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

The "ground truth" for the mechanical testing is based on:

• Performance of legally marketed predicate devices. The acceptance criteria consistently refer to being "similar or superior" to predicates.
• Adherence to industry standards (e.g., ASTM F543 for screw testing).
• Compliance with FDA Guidance documents for sterility and endotoxin testing.

8. The sample size for the training set

Not applicable. This is not an AI study requiring a training set.

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

Not applicable. This is not an AI study requiring a training set or its associated ground truth establishment.

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The Alians Elbow Locking Plating System is intended for the fixation of fractures and ostectornies of the distal humerus and proximal ulna in adults.

The Alians Elbow Locking Plating system consists of plates and screws, designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
The plates and screws are manufactured from titanium alloy and are color anodized.

The Alians Elbow Locking Plating system will be provided non-sterile for sterilization by health care professionals prior to use. A sterile version of the Alians Elbow Locking Plating System is provided in single use sterile kits, called Initial O kits, including one plate, screws and single use instrumentation necessary for the implantation.

I am sorry, but based on the provided text, there is no information about an AI/ML-driven device or study parameters that would allow me to populate the requested table and describe the study proving the device meets acceptance criteria.

The document is a 510(k) premarket notification for a medical device called the "Alians Elbow Locking Plating System," which is a metallic bone fixation appliance. It discusses the regulatory review process, device description, indications for use, and a comparison to predicate devices, including mechanical testing (non-clinical tests).

There is no mention of:

• Acceptance criteria for an AI/ML device
• Device performance reported for an AI/ML device
• Test set sample sizes, data provenance, or the number/qualifications of experts involved in establishing ground truth for AI/ML
• Adjudication methods, MRMC studies, standalone AI performance, or types of ground truth for an AI/ML system
• Training set sample size or how ground truth for a training set was established for an AI/ML system

Therefore, I cannot fulfill your request for this specific document.

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

The D-RAD SMART PACK is a cost-effective sterile procedural kit that contains an anatomically contoured volar distal radius plate and single-use instruments to treat extra-articular and intra-articular distal radius fractures. The Kit consists of an anatomically shaped distal radius fixation plate, associated locking and non-locking screws and pegs, and instrumentation to assist in implantation of the fixation construct.

The provided document, K132296, for the Smith & Nephew D-RAD SMART PACK is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information (like acceptance criteria, specific device performance metrics beyond mechanical testing, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment) is not typically found or required in a 510(k) submission for this type of device.

The document explicitly states: "Mechanical testing and analysis has been conducted on the devices to ensure that they meet or exceed predicate standards in terms of fatigue, material strength, and biocompatibility." This indicates that mechanical testing was the primary method used to demonstrate that the device performs equivalently to the predicate devices.

Here's an attempt to answer the questions based on the available information, noting where information is not present in the document:

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 for Test Set: Not applicable or not specified for a clinical study. The "test set" here refers to the actual device components undergoing mechanical testing. The exact number of samples tested is not provided in this summary.
• Data Provenance: Not applicable for a clinical study. Data would be generated from laboratory mechanical testing. The country of origin for this testing is not specified. It is laboratory data, not patient data (retrospective or prospective).

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. Ground truth as typically understood in AI/imaging studies (e.g., expert consensus on diagnoses) is not relevant for this type of medical device submission. The "ground truth" for mechanical performance is established by standardized material and mechanical testing protocols, interpreted by engineers and regulatory experts.

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

• Not applicable. This is not a study involving human interpretation or adjudication of cases. Mechanical testing results are typically evaluated against pre-defined engineering specifications.

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. This device is a bone plate and screw system, not an AI-assisted diagnostic or therapeutic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance was not conducted.

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

• No. This device is a physical implant and surgical instrumentation, not an algorithm.

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

• For mechanical performance: Compliance with established industry standards and engineering specifications for fatigue, material strength, and biocompatibility. These standards themselves are developed from extensive research and clinical experience.
• For substantial equivalence: Comparison against the design, materials, and mechanical properties of the predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. No training set for an algorithm was used.

Summary of the Study (Mechanical Testing for Substantial Equivalence):

The "study" referenced in this 510(k) submission is primarily a series of mechanical tests and analyses designed to demonstrate that the D-RAD SMART PACK meets or exceeds the performance standards of its predicate devices in terms of fatigue, material strength, and biocompatibility. This type of testing is standard for orthopedic implants. The document indicates that the device's functional characteristics, intended use, and materials were also compared directly to three predicate devices previously cleared by the FDA (K993106, K051735, K083032). The conclusion is based on this direct comparison and mechanical data rather than a clinical trial or AI performance study.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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The OrthoPediatrics PediPlate™ system is used for adult and pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include fractures of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius; middle hand and middle foot bones, treatment of the calcaneal; hip arthrodesis, and provisional hole fixation; as well as for redirecting the angle of growth of long bones. This is useful for gradually correcting angular deformities in growing children.

Specific pediatric conditions/diseases for which the devices will be indicated include:

• Valgus, varus, or flexion, extension deformities of the knee (femur and/or tibia) .
• Valgus, varus, or plantar flexion deformities of the ankle
• Valgus or varus deformities of the elbow (humerus)
• Radial or ulnar deviation, flexion or extension deformities of the wrist (radius)

The two and four-hole plates feature a contoured mid-section and low profile for pediatric use. There is an alignment mark or small provisional fixation hole in the center of the O. H and I-Plates to aid accurate placement of the device relative to the growth plate that is localized radiographically. The plates are available in various sizes to accommodate variations in bone size and geometry. The plate is transfixed to bone using two to four screws, depending on which plate is selected.

• Materials: The devices are manufactured from 316L stainless steel, which meet ASTM F138 or ASTM F139.
• Function: The system functions to provide immediate stability and temporary . fixation during the natural healing process.
  The OrthoPediatrics PediPlate TM System is intended for use in the treatment of pelvic, small and long bone fractures, as well as deformity corrections of pediatric patients' long bones, which includes osteotomies, and redirecting the angle of growth of children's long bones. The system includes cortical and cannulated screws, and specialty plates, referred to as O, 1, and H-Plates.

Based on the provided document, I cannot fulfill the request because the document is a 510(k) summary for the OrthoPediatrics PediPlates™ System, which is a medical device for bone fixation. This type of document establishes substantial equivalence to predicate devices and outlines the device description, indications for use, and materials.

However, it does not contain the information required to describe acceptance criteria and a study proving device performance against those criteria. Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study proving performance, sample sizes (test set, training set), data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

The document focuses on:

• Establishing substantial equivalence to predicate devices (K081407, K073344, K031493, K020221, K993106, K000684, K013248, K080522).
• Describing the device's design, materials (316L stainless steel), and function (immediate stability and temporary fixation during healing).
• Listing the indications for use for adult and pediatric patients for various bone fracture fixations and deformity corrections.

Therefore, since the document discusses a physical medical device (bone plates for fixation) and not an AI/software device, and lacks any clinical study data or performance metrics against specific acceptance criteria, I cannot extract the information requested related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device evaluation.

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The PERI-LOC™ Bone Plating and Screw System 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.

The PERI-LOC™ Bone Plating and Screw System represents titanium versions of stainless steel PERI-LOC™ Periarticular Locked Plating System bone plates and bone screws previously cleared under K082516, K061352, K051735, and K033669. Like the predicate devices, the PERI-LOC™ Bone Plating and Screw System devices feature various lengths of straight and contoured locking bone plates: locking and non-locking bone screws, washers, plus a screw adapter accessory. Bone plates in the PER/-LOC™ Bone Plating and Screw System feature a screw to-plate locking feature, which forms a locked, fixed-angle construct to aid in maintaining fracture reduction.

The provided text is a 510(k) summary for the PERI-LOC™ Bone Plating and Screw System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) pathway is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove performance against specific acceptance criteria like those outlined in your request. While the device's technological characteristics are mentioned as being similar to predicate devices, there's no discussion of quantitative performance metrics, study designs, sample sizes, or ground truth establishment.

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document focuses on regulatory approval through substantial equivalence, not on a detailed performance study with defined acceptance criteria.

Here's what I can infer or explicitly state based on the provided text:

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

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

• Sample size for test set: Not applicable and not mentioned in the document. The 510(k) submission does not describe a performance test set.
• Data provenance: Not applicable. No performance data is presented.

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. The document does not describe a study involving ground truth establishment by experts.

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

• Not applicable. No test set or adjudication process is described.

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

• Not applicable. This device is a bone plating and screw system, not an AI-based diagnostic tool for which MRMC studies are typically performed.

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

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

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

• Not applicable. The document does not reference performance studies that would require ground truth. The substantial equivalence argument relies on the established safety and effectiveness of predicate devices.

8. The sample size for the training set

• Not applicable. This submission doesn't describe an algorithm or a training set.

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

• Not applicable. This submission doesn't describe an algorithm or a training set.

Summary of what the document does communicate regarding evidence for substantial equivalence:

The "study" referenced in a 510(k) context is often the comparison to legally marketed predicate devices. The device's safety and effectiveness are supported by demonstrating that it has:

• Similar intended use.
• Similar technological characteristics (e.g., made of titanium like some predicate devices, screw-to-plate locking feature).
• No new questions of safety or effectiveness compared to those predicates.

The acceptance criteria for a 510(k) largely revolve around demonstrating this substantial equivalence, which is typically shown through engineering comparisons, material biocompatibility, and sometimes mechanical testing (though specific results of such tests are not detailed in this summary). The document lists several predicate devices (K082516, K072818, K061352, K051735, K033669, K993106, K000682, K000684, K011815) to which the PERI-LOC™ Bone Plating and Screw System is compared. The "study" proving it meets acceptance criteria is the regulatory review finding of substantial equivalence based on the submitted documentation comparing the device to these predicates.

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The OrthoPediatrics Plating System is intended for use in the treatment of pelvic, small and long bone fractures.

The OrthoPediatrics Pediatric Plating system is a system of bone plates and screws to provide the pediatric and general orthopedic surgeon with necessary devices to achieve optimal bone fixation when treating fractures, osteotomies, mal-unions, and mal-alignments.

• Materials: The devices are manufactured from 316L stainless steel, which . meet ASTM F138 and F139, and ISO-5832 standards.
• Eunction: The system functions to provide immediate stability and . temporary fixation during the natural healing process.
  The system includes cortical and cannulated screws, and specialty plates. The specialty plates will include three distinct shapes and each shape will be offered in multiple sizes to accommodate the individual requirements of the patient anatomy to aid the surgeon in achieving optimal fixation. The three specialty plates' shapes resemble the letters H and I, and the infinity symbol (similar to the number 8, lying on its side).

The provided text is related to a 510(k) premarket notification for a medical device (OrthoPediatrics Plating System). It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and indications for use.

Crucially, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC or standalone AI performance tests). These types of studies and their results are typically required for AI/ML-driven devices to demonstrate their clinical validity and utility.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

The document is a standard 510(k) clearance letter for a traditional medical device (bone plates and screws), where substantial equivalence is typically established through comparisons of material properties, design specifications, and intended use with already marketed devices, rather than through performance metrics of an AI algorithm.

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