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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 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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PERI-LOC* Periarticular Locked Plating System VLP Plates and Screws can be used for adult and pediatric 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 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.

Components in the PERI-LOC® Periarticular Locked Plating System are for single use only.

PERI-LOC™ Periarticular Locked Plating System - VLP Plates and Screws are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K062216. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC™ VLP locking bone plates and locking/non-locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

The provided text is a 510(k) summary for the PERI-LOC™ Periarticular Locked Plating System. This type of submission is for medical devices and does not contain acceptance criteria or a study that evaluates the performance of an AI/ML powered device.

Instead, a 510(k) submission demonstrates substantial equivalence to a legally marketed predicate device. This typically involves:

• Comparison of technological characteristics: Showing the new device has similar design features, materials, and technological properties to the predicate.
• Comparison of indications for use: Demonstrating that the new device is intended for the same population and conditions as the predicate.
• Performance testing (mechanical/biocompatibility): This usually involves non-clinical bench testing to ensure the device meets specified engineering and safety standards, but these are not the same as clinical studies evaluating AI model performance.

Therefore, I cannot extract the requested information from the provided text because it describes a traditional medical device (bone plates and screws), not an AI/ML powered device. The questions you've asked are relevant for AI/ML device submissions, which typically require different types of studies and acceptance criteria.

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