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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 ACTIVE TM Screw Bone Screw is intended for implantation into prepared bone during orthopaedic surgery when the surgeon determines the need for additional fixation: bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ACTIVE™ Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ACTIVE ™ Screw Bone Screws subjected to this premarket notification are 4.5 mm diameter screws available in 5 mm length increments from 20 to 50 mm. The screws are manufactured from titanium alloy and have an expandable thread crest. The implants are single use only devices.

The ACTIVE ™ Screw Bone Screw consists of a screw shank in conjunction with a spiral helical thread crest component. With the spiral helical thread component, the screw has the ability to expand an additional 1 mm after implantation.

The ACTIVE TM Screw Bone Screw is made of wrought titanium 6AI-4V ELI (ASTM F136) and is available in a 4.5 mm diameter size from 20 mm to 50 mm and will be provided non-sterile, and is to be steam sterilized by the end user. Resterilization of screws upon contamination is not recommended.

The provided document describes a 510(k) premarket notification for the "ACTIVE™ Screw Bone Screw" and contains information about its performance testing. However, it does not present acceptance criteria in a quantitative, pass/fail manner with specific numerical targets. Instead, it describes general compliance with existing standards and acceptable results.

Here's a breakdown of the information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria are not explicitly stated in the document, I will infer them from the reported testing methods and positive outcomes.

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

• Sample Size for Test Set: The document does not explicitly state the specific number of screws or tests conducted for each performance evaluation (torsion, pullout, torque in/out, bone interaction). It refers to "testing" as a general activity.
• Data Provenance: The studies were pre-clinical bench tests. The data is generated from laboratory testing of the device itself, not from human subjects or retrospective/prospective clinical data. Therefore, notions of "country of origin of the data" or "retrospective/prospective" do not apply in the typical sense; the tests were conducted by the manufacturer, Intelligent Implant Systems, LLC.

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

This question is not applicable to the type of safety and effectiveness testing described in the document. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F543-07) and objective physical measurements rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where subjective assessments (e.g., image interpretation) require reconciliation; this document describes objective mechanical performance 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

This question is not applicable. The device described is a bone screw, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of AI assistance for human readers is irrelevant to this device.

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

This question is not applicable. The device is a physical bone screw, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on:

• Engineering Standards: Specifically, ASTM F543-07 for bone screw testing methods.
• Physical Measurements: Objective measurements of torsional strength, breaking angle, axial pullout strength, and force exerted.
• Comparative Performance to Predicate Devices: Damage from removal was compared directly to that of "traditional (predicate) bone screw[s]."

8. The Sample Size for the Training Set

This question is not applicable. As a physical medical device (bone screw), there is no "training set" in the context of machine learning or AI models. Performance is evaluated through physical testing.

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

This question is not applicable, as there is no training set for this device.

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