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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, acctabulum, metacarpals, metatarsals, and clavicle.

The subject of this special premarket notification are minor modifications to the 3.5mm nonlocking cortex screws and 4.7mm non-locking osteopenia screws (fully and partially threaded) previously cleared for market via Traditional 510(k), K162078. Design modifications described in this submission include minor updates to the tip of the cortex screw design and an increase in the screw head diameter for both the cortex and osteopenia screws.

The subject EVOS Small Fragment non-locking screws are intended to be used with existing Smith & Nephew implants and instruments that have been previously cleared for market for use with the EVOS Small Fragment Plating System.

The provided text is a 510(k) premarket notification for a medical device, the EVOS Small Fragment Plating System, specifically concerning minor modifications to existing non-locking screws. This document outlines the regulatory submission process and the justification for substantial equivalence to a predicate device.

It's important to understand that a 510(k) notification for a Class II medical device like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing a clinical study to prove the device meets specific acceptance criteria in a patient population. The "acceptance criteria" here refer to mechanical performance tests to show that the minor design changes do not negatively impact the device's safety and effectiveness compared to the predicate.

Therefore, the requested information elements related to clinical study design, such as sample size for test sets, data provenance, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this type of submission. This document describes a pre-clinical mechanical testing study.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Device: EVOS Small Fragment Plating System (modified 3.5mm non-locking cortex screws and 4.7mm non-locking osteopenia screws)

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

• Sample Size: The document does not specify the exact number of screws or test replicates used for the screw insertion and maximum stripping torque tests. This level of detail is typically found in the full test reports, which are not included in this summary.
• Data Provenance: The studies were pre-clinical mechanical tests performed by the manufacturer (Smith & Nephew, Inc.). The data would be internally generated from laboratory testing. It is not patient or human subject data, so concepts like "country of origin" or "retrospective/prospective" in a clinical sense do not apply.

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

• Not Applicable. This was a pre-clinical mechanical testing study, not a study involving human interpretation of data where "ground truth" would be established by medical experts (e.g., radiologists). The "ground truth" is derived from direct physical measurements and engineering standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this was a pre-clinical mechanical testing study, there was no need for adjudication by multiple experts. The results are quantitative measurements from lab equipment.

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

• No. An MRMC study is a type of clinical study evaluating diagnostic accuracy (e.g., of an imaging algorithm) with multiple readers and cases. This submission is for a bone fixation system and involves pre-clinical mechanical testing, not a diagnostic or clinical comparative effectiveness study of human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

• Not Applicable. This device is a physical medical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• For the mechanical tests (screw insertion, stripping torque), the "ground truth" is based on engineering measurements and material science principles. The performance is compared against established benchmarks or the performance of the predicate device to ensure equivalence or improvement.
• For pyrogenicity, the "ground truth" is based on established testing methodologies and safety standards for medical device biocompatibility.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of this pre-clinical mechanical testing for a physical implant. The concept of a training set applies to AI/ML algorithms.

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

• Not Applicable. (See #8)

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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, acctabulum, metacarpals, metatarsals, and clavicle.

The subject of this special premarket notification is a modification in the manufacturing process for select EVOS Small Fragment Straight Plates that were previously cleared via K162078. Also subject to this special premarket notification is the addition of EVOS 3.5mm Locking Hole Inserts and EVOS 3.5mm Washers and Double Washers. The subject devices are intended to be used with existing Smith & Nephew implants and instruments that have been previously cleared for market for use with the EVOS Small Fragment Plating System.

This document is a 510(k) premarket notification for the EVOS Small Fragment Plating System. The focus of the changes discussed in this submission is on manufacturing process modifications and the addition of new components (locking hole inserts and washers), rather than providing a detailed study that proves the device meets specific performance acceptance criteria in a clinical setting.

Therefore, the requested information cannot be fully provided as the document does not contain details about:

• A specific clinical study proving device performance against acceptance criteria.
• Sample sizes for test sets, data provenance, number of experts, adjudication methods, or MRMC studies.
• Standalone algorithm performance.
• Specific ground truth types or training set details.

However, based on the provided text, here is what can be inferred about the pre-clinical engineering testing and its acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance (Pre-clinical Engineering Testing)

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for each test, but referred to as "worst-case designs" for plate fatigue testing.
• Data Provenance: This is pre-clinical engineering testing, not clinical data from patients or a specific country. It's a lab-based study to assess mechanical properties and biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as this is pre-clinical mechanical and biological testing, not a study involving human expert interpretation of data like images.

4. Adjudication method for the test set

• Not applicable for pre-clinical mechanical and biological testing.

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 is not an AI/imaging device.

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

• Not applicable. This is not an AI/imaging device.

7. The type of ground truth used

• For the plate and locking hole insert bending fatigue tests, the "ground truth" would be established by the physical testing methods themselves (e.g., measuring force, displacement, cycles to failure) against predefined engineering specifications derived from predicate devices and industry standards.
• For bacterial endotoxin levels, the ground truth is established by the LAL (Limulus Amebocyte Lysate) method, which is a standard assay for endotoxin detection.

8. The sample size for the training set

• Not applicable. This is pre-clinical testing, not a machine learning model.

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

• Not applicable. This is pre-clinical testing, not a machine learning model.

In summary: The provided document is a 510(k) submission focusing on demonstrating substantial equivalence through engineering rationales and pre-clinical mechanical and biological testing. It does not include information about clinical studies with human subjects or AI performance, which are the typical contexts for many of the questions asked. The "acceptance criteria" here refer to engineering performance benchmarks.

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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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