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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.

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 Classification Type B), and for fracture fixation of the fibula.

Subject of this premarket notification is an extension of the EVOS Small Fragment Plating System, the EVOS Small Fragment Lower Extremity Plates. The subject plates feature similarities to existing Smith & Nephew small fragment plates (TC-100 Small Bone Plating System, PERI-LOC and PERI-LOC VLP Plating Systems, EVOS Small Fragment Plating System Straight Plates) and also share some instruments and compatible implants from the existing EVOS MINI Plating System and EVOS Small Fragment Plating System. EVOS Small Fragment Lower Extremity Plates are available in a variety of plate designs for specific anatomical areas. These plate designs include plates with 2.7mm holes or 3.5mm holes only, or with a combination of 2.7mm and 3.5mm holes. Plate designs may include threaded holes, nonthreaded holes, and variable-angle locking holes. The subject plates are offered in "thick" and "thin" varieties. The "thin" plates are the partial articular/antiglide plates.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EVOS Small Fragment Lower Extremity Plates, presented in the requested format:

It's important to note that the provided document is a 510(k) clearance letter and an associated summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance acceptance criteria through a clinical study in the way an AI/ML device would. Therefore, much of the requested information for AI/ML device studies (like sample sizes for test/training sets, ground truth establishment, MRMC studies, etc.) is not applicable to this traditional medical device clearance.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a traditional medical device (bone plates) seeking 510(k) clearance by demonstrating substantial equivalence, the "acceptance criteria" are not based on clinical performance metrics like sensitivity/specificity but rather on engineering and material performance compared to predicate devices.

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

• Sample Size for Test Set: Not applicable. For traditional medical device clearances based on substantial equivalence, mechanical and materials testing are typically performed on a subset of product configurations or representative samples, not on a "test set" in the context of clinical data. The document mentions "worst case plates" identified by FEA for mechanical testing. The specific number of plates or trials is not provided within this summary.
• Data Provenance: Not applicable in the sense of patient data. The provenance for the testing data would be Smith & Nephew's internal labs or authorized testing facilities performing controlled laboratory experiments.

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

• Not applicable. This device is cleared based on engineering and performance testing, not on interpretation of clinical images or data by experts to establish a "ground truth."

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" in the sense of data requiring expert adjudication.

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

• Not applicable. This is not an AI/ML device, and thus MRMC studies are not performed for its clearance.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Not applicable. This is a physical medical device (bone plates), not a software algorithm.

7. Type of Ground Truth Used

• Not applicable in the context of clinical "ground truth." The "ground truth" for this device's clearance would be established engineering principles, material science standards (e.g., ASTM standards for mechanical testing), and regulatory guidance regarding sterility and biocompatibility.

8. Sample Size for the Training Set

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

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

• Not applicable. This is not an AI/ML device, and therefore no training set or its ground truth establishment is relevant.

Summary Conclusion from the Document:

The EVOS Small Fragment Lower Extremity Plates received 510(k) clearance (K170457) based on demonstrating substantial equivalence to legally marketed predicate devices (Smith & Nephew Bone Plate System K993106, K033669, K062216, K071563, and K162078). This was achieved through:

• Technological Characteristics: Showing similarities to predicate devices in design, materials, and hole configurations (locking and non-locking).
• Pre-Clinical Testing:
  • Finite Element Analysis (FEA) to identify worst-case configurations.
  • Mechanical bending tests proving performance "similar or superior" to predicates.
  • Packaging verification to ensure sterility and prevent damage.
  • Bacterial endotoxin testing meeting established standards.
• Intended Use and Indications: The indications for use are consistent with those of predicate devices, covering adult and pediatric patients with osteopenic bone for fixation of various small and long bone fractures, including partial articular and anti-glide plates for specific tibia and fibula fractures.

The regulatory conclusion is that, "Based on similarities to the predicate plating systems and a review of the mechanical testing performed, the subject devices are substantially equivalent to the predicate devices."

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The OIC Variable Angle Small Fragment Locking Plate System is indicated for the fixation of fractures, mal-unions, nonunions or osteolomies for the clavicle, humerus, radius, ulna, metacarpal, tibia, fibula, malleolus and metatarsal.

The OIC Variable Ande Small Fragment Locking Plate System consists of titanium plates for the Distal Radius. Clavice. Proximal Humerus, Tibia and Distal Fibula, bone screws and instruments for implantation. The platety of sizes and are pre-contoured to match the anatomy of the patient and 3.5mm bone screws. The bone screws are available in two diameters (2.5mm) and range in length from 6mm to 130mm. The bone screws are available with both threaded (locking) and non-threaded (non-locking) heads.

The OIC Variable Angle Small Fragment Locking Plate System implants are made of titanium alloy or cp titanium in compliance with ASTM F136 or ASTM F67.

The provided text describes a medical device submission (K140357) for the OIC Variable Angle Small Fragment Locking Plate System. However, it does not contain information regarding traditional acceptance criteria or a study proving the device meets said criteria in the context of clinical performance or diagnostic accuracy.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through engineering and material testing, rather than clinical trials with patient outcomes or AI-driven performance studies.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here's an attempt to answer based on the available information, with clear indications where the information is not present:

Acceptance Criteria and Device Performance Study for K140357: OIC Variable Angle Small Fragment Locking Plate System

The provided 510(k) summary for the OIC Variable Angle Small Fragment Locking Plate System does not detail specific acceptance criteria or clinical performance studies related to diagnostic accuracy or human-in-the-loop improvements for an AI device. Instead, the document focuses on demonstrating substantial equivalence through mechanical testing and material compliance.

The "acceptance criteria" can be inferred from the standards the device conforms to and the evaluation methods used to demonstrate substantial equivalence, which are primarily related to mechanical properties and materials.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable/not provided. The evaluation was primarily based on engineering analyses (FEA) and literature review, not a test set of data in the context of AI or clinical outcomes.
• Data Provenance: Not applicable/not provided. The document refers to "literature review" for comparative mechanical performance, but does not specify the origin of this literature.

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

• Not applicable. The ground truth for mechanical performance was established via engineering analyses and comparisons to published standards and literature, not expert consensus on a test set of cases.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring expert adjudication is described.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI-assisted interpretation, which is not the nature of this orthopedic implant submission.

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

• No, a standalone algorithm performance study was not done. This device is a physical orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

• The 'ground truth' for this 510(k) submission relates to engineering standards, material specifications, and documented mechanical performance characteristics established through finite element analysis and literature review. It is not clinical pathology, outcomes data, or expert consensus on patient cases.

8. The Sample Size for the Training Set

• Not applicable. This device is an orthopedic implant, not an AI algorithm requiring a training set. The "training" for its design and evaluation would come from established engineering principles, material science, and the design of predicate devices.

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

• Not applicable, as there is no "training set" in the context of this orthopedic implant. The benchmarks for performance (comparable mechanical properties, material compliance, etc.) were established through recognized ASTM standards, the performance of predicate devices, and engineering analyses (FEA).

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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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