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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, metatarsals, and clavicle.

The subject of this Traditional 510k is the EVOS Straight Proximal Humerus 7-15 hole plates (137-225mm). The EVOS Straight Proximal Humerus Plate are a line extension to the existing 3 and 5 holes EVOS Straight Proximal Humerus Plates (93-114mm). The EVOS Straight Proximal Humerus Plates were previously cleared for market via premarket notification K173293. The lengths of the subject EVOS Straight Proximal Humerus Plates are being extended to include 7-15 hole plates (137-225mm). The EVOS Straight Proximal Humerus Plates are for single use only. Similar plate lengths have been cleared on EVOS Curved Proximal Humerus 6-18 hole plates (114-246mm) via premarket notification K173293.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Summary of Acceptance Criteria and Device Performance for EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm)

Based on the provided document, the device described is a bone fixation plate, not an AI or diagnostic device. Therefore, the typical "acceptance criteria" and "device performance" metrics associated with AI-powered diagnostic tools (like sensitivity, specificity, accuracy, etc.) are not applicable here. Instead, the "acceptance criteria" for this type of medical device relate to substantial equivalence to a predicate device, demonstrated through engineering analysis, material properties, and performance testing relevant to mechanical functionality and biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of an engineering analysis of a bone plate. There isn't a "test set" of patient data or images in the way an AI study would have. The "testing" refers to mechanical and material characterization of the device itself.
• Data Provenance: Not applicable. The "data" comes from engineering analysis and laboratory testing of the device, not from patient populations.

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

• Not applicable. The "ground truth" for a mechanical device is established through engineering principles, material science, and regulatory standards, not expert consensus on patient cases.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" requiring adjudication in this context.

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 for evaluating human performance, often in diagnostic tasks, with and without AI assistance. This document describes a medical implant.

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

• Not applicable. This device is a physical bone plate, not an algorithm.

7. The Type of Ground Truth Used

• For mechanical performance: The "ground truth" is based on established engineering principles, material properties, and validated computational models (finite element analysis). Compliance with validated engineering standards and comparison to a legally marketed predicate device forms the basis of performance evaluation.
• For biocompatibility: The "ground truth" is defined by established regulatory limits for endotoxins as detailed in FDA guidance and ANSI/AAMI ST72.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" for this type of medical device.

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

• Not applicable.

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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 are line additions to the EVOS Small Fragment Upper Extremity Plating System. The line additions are design modifications of existing plates cleared in K173293 and include changes to the shape and number of holes of the subject plates. When compared against the existing EVOS Small Fragment Plates already cleared for market, the subject plates use the same hole features and are designed to work with the same bone screws.

The subject EVOS Small Fragment Upper Extremity plates 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 is a 510(k) premarket notification for a medical device, specifically EVOS Small Fragment Upper Extremity Plates Line Additions. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or a specific level of performance through a clinical study with detailed acceptance criteria and expert reviews in the same way an AI/ML device might.

Therefore, the requested information regarding acceptance criteria, study details, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth for training/testing sets is not applicable to this type of submission. The FDA 510(k) process for this device relies on pre-clinical mechanical testing and comparison to a predicate device to establish substantial equivalence.

Here's how to interpret the provided document in the context of your request:

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

• Acceptance Criteria: For this type of orthopedic implant modification, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device. This typically involves showing that the new device performs at least as well as, or equivalently to, the predicate device in relevant mechanical tests, and that the modifications do not introduce new safety or effectiveness concerns. The criterion is that the "minor modifications to the shape of the plate and number of holes are not expected to impact device safety or effectiveness."
• Reported Device Performance:
  • Financial element analysis (FEA) was conducted to "evaluate the peak stress of potential design modifications to the subject plates." While no specific numerical performance metrics or thresholds are provided in this summary, the conclusion states that the "device comparisons described in this premarket notification demonstrated that the proposed devices are substantially equivalent to legally marketed predicates with respect to intended use, indications, and performance characteristics."

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

• N/A. No human or animal test subjects were used. The testing was pre-clinical (FEA on plate designs).

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)

• N/A. No expert ground truth establishment for a test set is mentioned, as this was a pre-clinical, mechanical assessment of device modifications.

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

• N/A. Not applicable, as there was no test set requiring expert 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

• N/A. This device is a passive orthopedic implant, not an AI-assisted diagnostic tool.

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

• N/A. This device is a passive orthopedic implant, not an algorithm.

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

• The "ground truth" here is implied by mechanical engineering principles and analysis (Finite Element Analysis) for stress distribution, which is compared to the expectations based on the predicate device.

8. The sample size for the training set

• N/A. There is no "training set" in the context of an orthopedic implant modification. FEA involves modeling the device, not training a machine learning algorithm.

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

• N/A. Not applicable, as there is no training set mentioned or implied.

In summary, this 510(k) submission relies on pre-clinical mechanical testing (Finite Element Analysis) to demonstrate substantial equivalence of minor design modifications to an existing orthopedic implant line. The framework for evaluating AI/ML devices with clinical studies, expert consensus, and ground truth establishment does not apply here.

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