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The 2.4mm Secure Locking Variable Angle Distal Radius Plate and Ø2.4 mm Secure Locking Screws, Self-Tapping are intended for fixation of complex intra- and extra-articular fractures arid osteotomies of the distal radius.

The 2.7mm/3.5mm Secure Locking Distal Humerus Medial Plate, 2.7mm/3.5mm Secure Locking Distal Humerus, Dorsolateral Plate, and 2.7mm/3.5mm Secure Locking Distal Humerus Plate, Dorsolateral With Lateral Support are indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, and nonunions of the distal humerus.

The 3.5mm Secure Locking Small Plate, 3.5mm Secure Locking T-Plate, Small with 3 Head Holes, and Ø3.5 mm Secure Locking Screws, Self-Tapping, are indicated for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula.

The 3.5 mm Secure Locking Superior-Anterior Clavicle Plate and 3.5 mm Secure Locking Superior-Anterior Clavice Plate With Lateral Extension is indicated for fixation of fractures, malunions, and ostectornies of the clavice in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.

The 3.5mm Secure Locking Olecranon Plate is indicated for fractures, osteotomies, malunions and non-unions of the olecranon.

The 3.5 mm Secure Locking Philos Proximal Humeral Internal Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The 4.5/5.0mm Secure Locking Narrow LC Dynamic Compression Plate is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, and fixation of nonunions or malunions in adult patients.

The 4.5mm/5.0mm Secure Locking Distal Femoral Plate is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular condylar, periprosthetic fractures, nonunions and malunions, and osteotomies of the femur.

The 4.5mm/5.0mm Secure Locking Medial Proximal Tibia Plate is intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of nonunions of the medial proximal tibia and tibia shaft.

The 4.5mm/5.0mm Secure Locking L Buttress Plate and 4.5mm/5.0mm Secure Locking T Buttress Plate are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial tibia. Also, for use in fixation of non-unions and malunions.

The 3.5mm/4.5mm/5.0mm Secure Locking Distal Tibia Plates are intended treatment of non-unions, and fractures of the distal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.

The Ø3.5mm CORTICAL SCREW and Ø4.5mm CORTICAL SCREW are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Ø2.7 mm Secure Locking Screws, Self Tapping, and Ø 2.7mm Cortical Screws are intended for fractures and osteotomies of small bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.

The Ø5.0mm Secure Locking Screws, Self-Tapping are intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or malunions.

The 6.5mm Cancellous Screw, 16mm Thread, 32 Thread, Ø4.0mm CANCELLOUS SCREW, Partial Thread, Full Thread, and Ø4.0mm SMALL CANCELLOUS CANNULATED SCREW, Partial Thread, Full Thread are indicated for use in hindfoot and midfoot fusions, subtalar fusions, calcaneal osteotomies, midfoot reconstruction, and ankle arthrodeses.

The 6.5mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, Full Thread, and 7.0mm Cancellous Cannulated Screw, 16mm Thread, 32 Thread, are indicated for fracture fixation of large bone fragments, such as tibial plateau fractures, ankle arthrodeses, intercondylar femur fractures; and subtalar arthrodeses.

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shapes and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking selftapping screws, compression and dynamic screws. The subject device system also consists of a variety of general use instruments (Class I), which include drill bits, forceps, plate benders, and drill guides.

The plates and screws are manufactured from Stainless Steel and Titanium alloy.

The system contains several models based on the size of the device and application site such as fixation/reconstruction of small fragment bones, forefoot, mid-foot, rear-foot, ankle, or other bones appropriate for the size of the device. The plate implants are in many models available, such as:, Reconstruction Plates, T-Plates, Anatomical Plates, Clavicle Plates.

These all are mainly divided into:

• . Large Fragment Plates
• Small Fragment Plates ●
• Mini Fragment Plates .

The locking screw implants are offered in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying from a minimum length of 6 mm to maximum length of 90mm.

The non-locking screw implants are offered in 2.7mm, 3.5mm and 4.5mm diameters, with lengths ranqing from 10mm to 80mm.

The cancellous screw implants are 4.0mm and 6.5mm in diameter, with lengths ranging from 10 to 120 mm. The cancellous cannulated screw implants are offered in 4.0mm. 6.5mm and 7.0mm diameters and lengths ranging from 16mm to 130 mm.

HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are provided non-sterile, the products must be sterilized prior to use. All implants are for single use only.

This document describes the 510(k) summary for the HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The information provided pertains to the substantial equivalence of a medical implant (bone plates and screws) to predicate devices, focusing on material, design, and mechanical performance rather than AI/ML algorithm performance.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device from the given text.

The document discusses the following:

• Device Name: HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System
• Intended Use: Fixation of various bone fractures and osteotomies.
• Predicate Devices: A list of Synthes Locking Compression Plate Systems and Screws.
• Non-Clinical Testing:
  • Material Standards: ASTM F136, ASTM F138, ASTM F139 (for Stainless Steel and Titanium alloy).
  • Performance Standards: ASTM F382 (Metallic Bone Plates), ASTM F384 (Metallic Angled Orthopedic Fracture Fixation Devices), ASTM F543 (Metallic Medical Bone Screws), and FDA guidance documents for orthopedic screws and fracture fixation plates.
  • Performance Results: Conforms to Static Four Point Bend Test, Dynamic Four Point Bend Test (for plates), Torsional Properties, Driving Torque, and Pull-out Test (for screws).
• Clinical Evaluation: Not necessary to demonstrate substantial equivalence, as the device is similar in design, pattern, and intended use to predicate devices.

In summary, the provided text does not describe an AI/ML device or its performance evaluation. It details the regulatory clearance process for a traditional medical implant based on substantial equivalence.

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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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The 2.4mm Variable Angle LCP Volar Rim Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.

The 2.4mm Variable Angle LCP Distal Radius Plates are used with a range of 2.4 mm variable angle locking screws, 2.4 mm cortex screws, and 2.7 mm cortex screws. These new plates incorporated variable angle locking technology. The Variable Angle LCP Volar Rim Distal Radius Plates are designed as low profile plates, designed to minimize soft tissue irritation by featuring a low contoured plate profile with countersunk screws, rounded edges, and polished surfaces. The plates feature both variable angle locking screw holes in the head and shaft and elongated variable angle combination holes along the shaft only. The plates are offered in 6- and 7-hole head configurations each with two additional contourable wing tabs with screws holes to provide even greater variability in screw placement for additional fragment capture and fracture reduction.

The provided document is a 510(k) summary for the Synthes 2.4mm Variable Angle LCP Volar Rim Distal Radius System. This type of submission is for medical devices that are substantially equivalent to a predicate device and, as such, does not contain acceptance criteria and studies demonstrating device performance in the same way a de novo or PMA submission would.

Instead, the documentation focuses on demonstrating substantial equivalence through:

1. Comparison of intended use and design features to predicate devices.
2. Mechanical testing to show comparable performance in terms of mechanical strength and fatigue to predicate devices.

Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies are not typically included or required for a 510(k) submission based on substantial equivalence to existing devices. Such detailed studies are usually reserved for novel devices or those with higher risk classifications where clinical efficacy and safety need to be established independently.

However, I can extract the information related to the device description and the type of testing performed to support substantial equivalence.

Here's a breakdown of what can be extracted from the provided text, addressing the closest relevant points:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics. The general implied acceptance criterion is "comparable mechanical strength and fatigue" to predicate devices.
• Reported Device Performance: The document states that "Mechanical testing demonstrates substantial equivalence of the subject components to the predicate device in regards to mechanical strength" and "Testing conducted to support the substantial equivalence for the 2.4mm VA-LCP Volar Rim Distal Radius Plates was aimed to assess the fatigue strength of the subject device." It also mentions "Functional & mechanical testing demonstrates the comparable mechanical and functional properties of the 2.4mm Variable Angle LCP Volar Rim Radius System to the predicate devices."

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

• Sample Size: Not specified. Mechanical testing typically involves a set number of specimens, but this detail is not provided in a 510(k) summary.
• Data Provenance: The testing was conducted by Synthes (USA), the sponsor of the device. The data would be internal to the company, performing the tests to demonstrate equivalence. It is not patient data, but rather mechanical test data.

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

• Ground Truth/Experts: This question is not applicable. The "ground truth" for mechanical testing is established by engineering standards and test methods, not by expert consensus on clinical data. No human experts are involved in establishing a "ground truth" for mechanical properties in this context.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Mechanical test results are objective measurements against defined engineering parameters, not subjective interpretations requiring 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

• MRMC Study: No. This is a medical implant (bone plate) used for fixation of fractures, not an image-based diagnostic or AI-powered device. Therefore, MRMC studies are irrelevant.

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

• Standalone Performance: No. This is not an algorithmic device. The performance is physical and mechanical.

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

• Ground Truth: For this type of device and study, the "ground truth" refers to established engineering standards for mechanical properties (e.g., strength, fatigue limits) and the mechanical properties of the predicate devices. It is based on objective physical measurements and engineering analysis.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. There is no "training set" as this is not a machine learning/AI device. Finite element analysis (FEA) was used, which involves computational models, not a data training set.

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

• Ground Truth for Training Set: Not applicable for the same reason as above. FEA relies on material properties and geometric models, not a "ground truth" for a training set. The FEA was used to "determine the worst case construct" for further dynamic loading testing.

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