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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, 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, 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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