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The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, osteotomies, and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures

The subject system is a line extension that includes clavices (superior lateral, anterior mideral, and anterior midshaft) and additional locking and non-locking screws (2.1mm, and 2.7mm diameter). The plates and screws are fabricated from either medical grade stainless steel per ASTM F138 or Titanium per ASTM F136. Plates and screws are provided non-sterile. Instruments are provided non-sterile with instructions for sterilization.

This FDA 510(k) clearance letter is for a physical medical device (The OsteoCentric Bone Plate and Screw System), not an AI/Software as a Medical Device (SaMD). Therefore, the specific information requested in your prompt regarding AI/SaMD performance criteria, such as acceptance criteria based on accuracy, sensitivity, specificity, MRMC studies, training/test sets, and ground truth establishment, is not applicable to this document.

For traditional medical devices like the OsteoCentric Bone Plate and Screw System, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically addressed through non-clinical performance testing (e.g., mechanical testing, biocompatibility, sterilization validation) and comparison to predicate devices, rather than clinical studies involving human readers or AI algorithms.

However, I can extract the relevant information regarding the non-clinical testing and conclusions provided in the document:

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

The document doesn't present a formal table of acceptance criteria with numerical targets and reported performance in the way an AI/SaMD submission would. Instead, it states:

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

• Sample Size: Not applicable. For mechanical testing of physical devices, "sample size" refers to the number of test articles (plates, screws) subjected to the engineering analyses. This specific number is not disclosed in the clearance letter but is part of the detailed test reports provided to the FDA.
• Data Provenance: Not applicable. The data comes from "Engineering analysis," which means laboratory testing and simulations performed on the device components themselves, not clinical data from patients or a specific country. This is in vitro data.

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. Ground truth for mechanical performance is established through objective, quantifiable engineering measurements against predefined standards or predicate device performance, not expert consensus interpretation.

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

Not applicable. Adjudication methods are relevant for subjective interpretations by multiple human readers, not for objective mechanical test results.

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 device is a bone plate and screw system, not an AI-powered diagnostic tool.

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

Not applicable. This is a physical medical device.

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

The "ground truth" for this type of device's performance is based on objective engineering and mechanical properties (e.g., material strength, fatigue life, torsional rigidity, bending stiffness, screw pull-out strength). These properties are measured and evaluated against established industry standards (e.g., ASTM F138 for stainless steel, ASTM F136 for titanium) and/or comparison to predicate devices, which have a known history of safe and effective use.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI algorithm.

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

Not applicable. This is a physical medical device, not an AI algorithm.

In summary, the FDA 510(k) clearance for The OsteoCentric Bone Plate and Screw System relies on non-clinical engineering analysis and comparison to predicate devices to demonstrate substantial equivalence, rather than the types of performance studies typically conducted for AI/SaMD products.

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The ARTFX Trauma Bone Plate and Screw System is indicated for fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), pelvis, and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions. The ARTFX Trauma Bone Plate and Screw System is not intended for use in the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine, nor for fixation of the sacroiliac joint. The system is intended for single use and for adult patients only.

The ARTFX 3.5 System is indicated for the fixation of upper extremity (humerus, olecranon, radius, ulna, metacarpal, phalangeal), fibula, foot (tarsal, metatarsal, phalangeal), pelvis, and clavicle fractures, fusions, osteotomies, non-unions, malunions and reconstructions.

The ARTFX 4.5 System is indicated for fixation of lower extremity (femur, tibia, fibula) and foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, non-unions and reconstructions.

The ARTFX Mini-Plate System is indicated for fixation of hand (metacarpal, phalangeal) and foot (tarsal, metatarsal, phalangeal) fractures, fusions, osteotomies, malunions and reconstructions.

The subject ARTFX Trauma Bone Plate and Screw System is submitted as a bundled submission and consists of four sub-systems: the ARTFX 3.5 System, the ARTFX 4.5 System, the ARTFX Mini-Plate System, and the ARTFX Bone Screw System. The subject system consists of bone plates and screw that are used in the treatment of fractures, fusions, osteotomies, non-unions, malunions, and reconstructive surgeries of the upper extremity (humerus, olecranon, radius, ulna, metacarpals, phalanges), lower extremity (femur, tibia, fibula, tarsals, metatarsals, phalanges), pelvis, and clavicle. After fracture reduction, these devices provide stability and maintain the alignment of bone fragments throughout the healing process. Compression is used whenever possible to increase the contact area and stability between the fragments and reduce stress on the implant. Compression is achieved by using non-locking screws that are placed in compression slots or holes of the plate, allowing for compression of the bone fragments as the screws are tightened. The locking screws do not provide compression, as they are designed to lock into the plate and stabilize the bone fragments through fixed-angle constructs. The special feature of the subject devices is the free choice of screw placement. The user is able to set any desired screw in any hole (either using a locking or non-locking screw). The free choice of screw angulation provides an advantage in fracture treatment, especially in the case of complex fractures.

Generally, the subject plates are designed to the contour of their intended anatomical location and used with cortical, cancellous, non-locking, and cancellous subject screws. The subject bone plates and bone screws are manufactured from Titanium (Ti6Al4V-ELI) per ASTM F136. The subject devices are supplied non-sterile and must be steam-sterilized prior to use.

The subject plates of the ARTFX 3.5 System consist of the clavicle shaft locking plate combi hole, clavicle distal locking plate combi hole, clavicle hook locking plate combi hole, tubular locking plate, olecranon locking plate, olecranon hook locking plate, humerus distal medial locking plate, humerus distal posterolateral locking plate, humerus distal lateral locking plate, distal ulna locking hook plate, radius distal styloid plate, radius distal dorsal L locking plate, radius distal dorsal T locking plate, proximal radius locking plate, radius distal volar locking plate, radius distal volar locking plate small, radius distal volar locking plate TP2, distal ulna locking plate, small 3.5 compression plate combi hole, small 3.5 TP2 compression plate combi hole, humerus proximal locking plate combi hole, reconstruction shaft locking plate, pelvic reconstruction curving locking plate, pelvic reconstruction straight locking plate, pelvic symphyseal plate. The plates of this system range in thickness from 1.4mm to 4.0mm and in width from 6.0mm to 13.0mm.

The subject plates of the ARTFX 4.5 System consist of the tibia distal medial locking plate, tibia distal lateral locking plate, tibia distal lateral locking plate TP2, large broad T locking plate, large broad L support locking plate, small proximal femur plate, tibia proximal medial plate, large broad T support locking plate, tibia high osteotomy plate, large narrow locking plate, tibia proximal lateral locking plate, femur distal locking plate, femur proximal locking plate, large broad locking plate, fibula locking plate, fibula distal locking plate, calcaneus locking plate. The plates of this system range in thickness from 2.0mm to 5.5mm and in width from 9.5mm to 18.0mm.

The subject plates of the ARTFX Mini-Plate System consist of the 1.5mm system, 2.5mm system, and 2.7mm system. The 1.5mm system consists of the 1.5mm hand/foot mini locking strut plate, hand/foot mini H plate, hand/foot mini locking T plate head 3 holes, hand/foot mini locking straight plate, hand/foot mini straight plate non-locking, hand/foot mini locking Y plate, hand/foot mini locking condylar plate, hand/foot mini non-locking T plate, mini non-locking mallet finger plate, and mini locking T plate head 4 holes. The 2.0mm system consists of the 2.0mm hand/foot mini locking straight plate, hand/foot mini locking T plate, hand/foot mini locking condylar plate, hand/foot mini adaptation locking straight plate, and hand/foot mini adaptation locking T plate. The 2.5mm system consists of the 2.5mm hand/foot locking H plate, hand/foot mini locking straight plate, hand/foot mini locking condylar plate, foot locking X plate, hand/foot mini locking L plate oblique, hand/foot mini locking L plate, hand/foot mini adaptation locked straight plate, and hand/foot mini locking T plate 3 holes. The 2.7mm system consists of the 2.7mm hand/foot locking H plate, hand/foot mini locked straight plate, hand/foot mini locked T plate, hand/foot mini locking condylar plate, foot locking X plate, hand/foot mini locked L plate oblique, hand/foot mini locking L plate. The plates of the ARTFX Mini-Plate System range in thickness from 0.8mm to 2.5mm.

The subject screws of the ARTFX Bone Screw System consist of the locking self tapping cortical screw, non-locking self-tapping cortical screw, non-locking self tapping cancellous screw full thread, nonlocking self tapping cancellous screw half thread, non-locking self tapping spongiose screw half thread, cannulated compression screw, locking cannulated full thread screw, locking self tapping cancellous screw, headless cannulated full thread screw, cannulated cancellous Herbert screw stamps. The screws in this system ranges in major diameter from 1.5mm. The screw stamps have a thickness of 1.5mm and range in outer diameter from 6.0mm and inner diameter from 3.0mm to 7.8mm.

This is a 510(k) premarket notification for a medical device called the ARTFX Trauma Bone Plate and Screw System. This document does not contain information on acceptance criteria for an AI/ML device or a study proving that the device meets those criteria. The ARTFX Trauma Bone Plate and Screw System is a hardware device used for orthopedic trauma fixation and is not an AI/ML powered medical device. Therefore, the requested information points, such as sample size for test set, data provenance, expert qualifications, adjudication methods, MRMC study, standalone performance, training set sample size, and ground truth establishment are not applicable.

The document describes the device, its indications for use, and establishes substantial equivalence to predicate devices based on similarities in design, dimensions, performance criteria, materials, and sterilization methods. Non-clinical performance testing was conducted according to ASTM F382-17 and ASTM F543-23, and the device met the performance criteria outlined in FDA guidance for bone screws and plates. Biocompatibility was established by demonstrating the device's identity in formulation, processing, sterilization, and geometry to a previously cleared device (K212220 – ARTFX Spinal Fixation System).

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The TopFix System is indicated for the fixation of fractures and ostectomies of the distal femur and proximal tibia related to the treatment of bone and joint deformities and / or malalignment caused by injury or disease (e.g., osteoarthritis).

The Trifix Large System is indicated for the fixation of fractures (including periprosthetic), non-unions of the femur and tibia in adult patients with normal or osteopenic bone.

The Newnecks System is indicated for the fixation of fractures of the femoral trochanteric region (e.g., simple intertrochanteric, reverse oblique trochanteric, complex multi-fragmentary, and fractures with associated medial cortex instability).

The TDM Large Bone Plate and Screw System contains the TopFix System, Trifix Large System, and the Newnecks System, which comprise a family of flat and contoured plates and screws. The plates are constructed from Titanium alloy (Ti-6AL-4V) and come in a variety of configurations. The plates are intended to be used with solid locking and non-locking screws and non-locking low profile screws. The screws are constructed from Titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, cannulated screws from 4.0mm to 6.5mm in diameter and range from 12mm to 100mm in length.

This FDA 510(k) premarket notification summary describes a orthopedic device, not an AI/ML device, therefore the requested information for acceptance criteria and study details for an AI/ML device are not applicable.

The document discusses the substantial equivalence of the TDM Large Bone Plate and Screw System to previously cleared predicate devices. The "acceptance criteria" discussed are primarily related to mechanical performance testing against established ASTM standards and biocompatibility.

Here's a breakdown based on the provided text, noting where the requested AI/ML specific information is not relevant:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set: Not explicitly stated as a "test set" in the context of an AI/ML device. The testing involved bench testing of the physical device components (plates and screws).
• Sample Size:
  • For mechanical testing, the number of samples tested per configuration is not detailed in this summary but would be specified in the full test reports.
  • Biocompatibility likely involved material testing and review, not a "sample size" in the traditional sense of patient data.
• Data Provenance: Not applicable as this is a physical device, not a data-driven AI/ML model. The "data" comes from engineered bench tests.

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

• Ground Truth Establishment: Not applicable. The "ground truth" for mechanical performance is defined by engineering standards (ASTM F382-17, ASTM F543-17) and FDA guidance documents related to orthopedic fracture fixation plates/screws. There are no clinical experts establishing "ground truth" for the mechanical properties of a bone plate.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Bench tests are assessed against objective, predefined engineering performance criteria, not 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

• MRMC Study: No. This is a physical orthopedic implant, not an AI/ML device.

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

• Standalone Performance: Not applicable. This is a physical orthopedic implant, not an AI/ML device.

7. The type of ground truth used

• Ground Truth: Engineering specifications, material standards (ASTM F136, ASTM F67), and mechanical testing standards (ASTM F382-17, ASTM F543-17), along with relevant FDA guidance documents ("Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway" and "Orthopedic Non-Spinal Metallic Bone Screws and Washers -Performance Criteria for Safety and Performance Based Pathway").

8. The sample size for the training set

• Training Set: Not applicable. This is a physical orthopedic implant.

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

• Ground Truth for Training Set: Not applicable. This is a physical orthopedic implant.

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The Advanced Bone Plate (AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is internal fixation. Specific indications for the plates included in the system as follows:

The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is inticated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of adults and adolescents (age 12-21 years) in which growth plates have fused or will not be crossed by fixation.

The ITVAL Foot & Ankle VAL System is internal fixation (fractures, osteotomies, fusions, nonunions, malunions, small fragment replantations) of the foot and ankle in adults and adolescents (age 12-21 years) possessing normal or osteopenic bone where growth plates have fused or will not be crossed by fixation.

The Distal Fibular VAL Plate is indicated for internal fractures, osteotomies, nonunions, malunions, small fragment replantations) of the distal fibula of adults and adolescents (age 12-21 years) where growth plates have fused or will not be crossed by fixation.

Advanced Bone Plate is mainly used for internal fixation of hand, wrist, foot, ankle and distal fibular fractures. According to the anatomical characteristics of human bones, locking plates of different shapes and locking screws of different diameters are designed. In clinical practice, locking bone plate and locking bone screw are used in combination to play the role of temporary internal stent, providing a stable local environment for fracture ends and creating conditions for the healing of fracture ends.

Bone plates in Advanced Bone Plate are made of titanium alloy following ASTM F1472, and bone screws in Advanced Bone Plate are made of titanium alloy following ASTM F136. Advanced Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

Disclaimer: This document is a 510(k) summary for a medical device (Advanced Bone Plate) and primarily focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo efficacy or setting new acceptance criteria. Therefore, the information provided will reflect this context.

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

The provided 510(k) summary does not explicitly define quantitative "acceptance criteria" in the traditional sense of a performance study with numerical targets. Instead, it aims to demonstrate "substantial equivalence" in terms of characteristics and performance to legally marketed predicate devices. The "reported device performance" is described through the successful completion of various non-clinical tests that show the device functions similarly to the predicate devices.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each mechanical test (e.g., number of plates or screws tested). It refers to standard ASTM methods (F382-17, F543-17) which would prescribe sample sizes.
• Data Provenance: The tests are non-clinical, conducted in a laboratory setting by the manufacturer (Double Medical Technology Inc.) or a contracted lab. The data is thus prospective experimental data generated for the purpose of this submission.
  • Country of Origin: Likely China, given the submitter's address.

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

This section is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical mechanical testing is established by the specifications in the relevant ASTM standards (e.g., ASTM F382-17, ASTM F543-17) and successful execution according to those methods, rather than expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers where there's a need to resolve discrepancies in expert interpretations of data (e.g., imaging scans). For mechanical testing, the results are quantitative and objective, based on physical measurements and adherence to standard protocols.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted diagnostic tools, not for a passive internal fixation device like a bone plate. The document explicitly states: "No clinical performance data was provided to demonstrate substantially equivalence."

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

No, a standalone performance study in the context of an algorithm or AI device was not done. This device is a physical implant, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this device, within the scope of this 510(k), is established by:

• Accepted Industry Standards: Primarily ASTM F382-17 and ASTM F543-17 for mechanical properties, and ISO 10993-1, ISO 17665-1:2006, and AAMI TIR30:2003 for biocompatibility, sterilization, and reprocessing. These standards define the acceptable methods and performance benchmarks for such devices.
• Comparison to Predicate Devices: The core of a 510(k) relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device. The "ground truth" for substantial equivalence is met if the new device's characteristics and performance fall within the established safety and efficacy profile of the predicates.

8. The sample size for the training set

This section is not applicable. This device is a physical bone plate, not an AI/ML algorithm that requires a "training set."

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

This section is not applicable for the same reason as point 8.

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The Anatomic Bone Plates are intended for the internal fixation of fractures (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral, Distal Ulnar Locking, Distal Radial Locking, VAL Proximal Tibia, VAL Distal Tibia, VAL Distal Lateral Fibular, VAL Distal Femoral, Pelvic Bone Plate), fracture dislocations (VAL Proximal Humeral), osteotomies, and mal/non-unions (VAL Distal Clavicle, VAL Proximal Humeral, VAL Distal Humeral) of the clavicle, pelvis, and the upper (i.e., humerus, ulna and radius) and lower (i.e., femur, tibia, and fibula) extremities. Additional plates included in the system with specific indications as follows:

• A VAL (Variable Angle Locking) Distal Clavicle Plate is indicated for fractures of the shaft and lateral clavicle, malunions and non-unions ;

• VAL Distal Humeral Plate is indicated for fractures (including supracondylar), and nonunions :

• A VAL Distal Femoral Plate is indicated for distal femoral fractures (diaphyseal, supracondylar, and intra-articular);

• Pelvic Bone Plate is indicated for pelvic fractures (e.g., acetabular , iliac wing, and symphysis pubis).

Anatomic Bone Plate is mainly used for internal fixation of fracture. According to the anatomical characteristics of human bones, locking plates of different shapes and locking screws of different diameters are designed. In clinical practice, locking bone plate and locking bone screw are used in combination to play the role of temporary internal stent, providing a stable local environment for fracture ends and creating conditions for the healing of fracture ends. Anatomic Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

Anatomic Bone Plate are made of titanium alloy following ASTM F1472 or unalloyed titanium following ASTM F67.

This document is a 510(k) premarket notification for a medical device called "Anatomic Bone Plate." It does not include information about acceptance criteria or a study proving that an AI/software device meets those criteria. The submission is for a traditional medical device (an orthopedic implant), not a software device, and therefore the types of studies and acceptance criteria you are asking for (related to AI performance, ground truth, expert consensus, MRMC studies, etc.) are not applicable here.

The document discusses:

• Device Description: Anatomic Bone Plate, made of titanium alloy, for internal fixation of fractures.
• Indications for Use: Internal fixation of fractures, fracture dislocations, osteotomies, and mal/non-unions in various bones (clavicle, pelvis, upper and lower extremities).
• Comparison to Predicate Device: States substantial equivalence in regulatory classification, indications for use, materials, and design features to a predicate device (K130108).
• Non-Clinical Performance Data:
  • Biocompatibility testing: Performed according to FDA Guidance "Use of International Standard ISO 10993-1".
  • Mechanical testing: Performed per ASTM F382-17 (Standard Specification and Test Methods for Metallic bone plate) and a three-point bending test method to determine bending stiffness, strength, and structural stiffness. This is to demonstrate substantial equivalence in safety and efficacy.
• Clinical Data: States that "Clinical literature was provided to demonstrate substantially equivalence."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/software device meets acceptance criteria, as this document pertains to a physical orthopedic implant and not a software device.

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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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NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are indicated for treating fractures of various bones including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, phalanges).

The system is indicated for use in adult patients only. All implants are for single use only.

The NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System is submitted as a bundled submission. Throughout the submission there is a mention of NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System that represents the range of products covered under this 510(k) submission. The NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System are subdivided into the following categories:

Generally, there are the following types of bone plates used with cortical (cortex), cancellous, and Locking Screws. These bone plates are generally designed on the basis of the bone contour and anatomy.

NEBULA BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, NEBULA BRAND of DHS Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking selftapping screws, compression and dynamic screws.

The plates and screws are fabricated from Stainless Steel and Titanium. The implants are supplied non-sterile and should be steam-sterilized prior to use.

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, and the ankle. The plate implants are available in models such as Reconstruction Plates, T- Plates, , Anatomical Plates, and Clavicle Plates.

These all are mainly divided into the following:

• . Large Fragment Plates
• Small Fragment Plates
• Hip Plates (DHS Plate)

The thickness of the plates varies from 1.3mm to 6mm; and the nomber of the holes varies from 2 to 20. The Locking screw implants are in corresponding diameter ranges from 2.7mm, and 4.9 mm diameters with lengths varying as per the requirements and lengths of 10mm to 90 mm

The Non-locking cortical screw implants are in 3.5mm diameter and length range from 10mm to 80mm.

The Non-locking cancellous screws are in 6.5mm diameter and length range from 30mm to 120mm The Non-locking cannulated cancellous screws are in 4.0mm diameter and length range from 10mm to 72mm

The Lag Screw is of 12.5mm Diameter and length from 50mm to 120mm

This document is a 510(k) summary for the Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System and Nebula Brand of DHS Plating System. It focuses on demonstrating substantial equivalence to predicate devices, rather than proving the device meets acceptance criteria through a clinical study.

Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as it is not a clinical study report for device performance.

The non-clinical performance testing section briefly mentions:

• Non-Clinical Performance Testing: Performance was demonstrated through test parameters outlined in ASTM F-382 (Static and Dynamic Four Point Bend Testing) and ASTM F-384 (Static and Dynamic Four Point Bend Testing). Torsional and Axial pullout testing was conducted on the screws per ASTM F-543. These are standard test methods for mechanical properties of bone plates and screws. The document states that the performance is "similar" to predicate devices, implying that the results of these tests met a level comparable to the predicate devices, which is the basis for proving substantial equivalence.

Here's a breakdown of why many of your questions cannot be answered by this document:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on demonstrating similarities to predicate devices based on design, materials, and non-clinical performance testing (mechanical properties). It doesn't present specific acceptance criteria in terms of clinical outcomes or diagnostic accuracy (which would be relevant for an AI/diagnostic device, not a bone fixation system).
2. Sample sizes used for the test set and the data provenance: Not applicable. This document refers to mechanical testing of physical devices, not a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant to this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of clinical performance. The "ground truth" for this device's performance would be its mechanical properties meeting established standards (ASTM).
8. The sample size for the training set: Not applicable. There is no "training set" for this type of device.
9. How the ground truth for the training set was established: Not applicable.

In summary: This FDA 510(k) clearance letter and its associated summary are for a bone fixation system (plates and screws). The regulatory pathway for such devices typically relies on demonstrating substantial equivalence to existing legally marketed predicate devices through material characterization, mechanical testing, and sometimes benchtop or animal studies. It does not involve clinical studies with patient data, AI, or human reader performance, which are common for diagnostic or AI/ML-based medical devices.

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The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures

The OsteoCentric Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths.

The provided text is a 510(k) summary for the OsteoCentric Bone Plate and Screw System. It details the device's characteristics, indications for use, and a comparison to predicate devices, but it does not contain information about an AI/ML-based medical device or any study proving a device meets acceptance criteria related to AI/ML performance.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these concepts are not discussed in this document. The document describes a traditional medical device (bone plates and screws) and relies on substantial equivalence to previously cleared predicate devices, primarily through engineering analysis and existing performance testing of those predicates (ASTM F543 and ASTM F382).

The 510(k) clearance process for this type of device does not involve the kind of performance studies (e.g., clinical trials, AI algorithm validation) that would generate the data you're asking about.

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The MLP Special Locking Bone Plate System is indicated for use in internal fixation for bone fractures, fusions, osteotomies, pseudoarthroses, and non-unions of the humerus, radius, ulna, tibia, scapula, clavicle, fibula, tarsal, metatarsal and metatarsophalangeal in pediatrics and adult populations.

The MLP Special Locking Bone Plate System consists of Bone Plates and locking screw components that are intended to be used in various bone fixation procedures. The MLP Special Locking Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from titanium (Ti-6Al-4V) in conformance with ASTM F136. Plates and screws are provided non-sterile.

This is a 510(k) premarket notification for the MLP Special Locking Bone Plate System. This type of submission rarely contains the kind of detailed performance data and study information you're asking for, as the primary goal is to demonstrate "substantial equivalence" to a predicate device.

Based on the provided document, here's what can and cannot be answered regarding acceptance criteria and a study proving those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document states that the MLP Special Locking Plate System is equivalent to the predicate devices based on these tests, but it does not provide specific numerical acceptance criteria or detailed numerical results for any of these tests. For instance, it doesn't say "bending strength must be > X MPa" and then report "our device achieved Y MPa." It only states that the results "indicate equivalence."

Regarding "the study that proves the device meets the acceptance criteria":

The document describes non-clinical mechanical testing as the study that supports the substantial equivalence claim.

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

• Sample Size for Test Set: Not specified in the document. The tests performed are ASTM F382-17 and ASTM F543-17, but the number of devices or components tested is not mentioned.
• Data Provenance: The document does not specify the country of origin of the data. It's an in-vitro non-clinical test conducted by the manufacturer or a contracted lab. It is a retrospective analysis in the sense that the tests were performed to support the 510(k) submission, not as part of an ongoing clinical trial.

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

• This question is not applicable to this submission. The "ground truth" here is established by standardized mechanical testing protocols (ASTM). It's not a diagnostic device where expert interpretation of data generates a ground truth.

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

• This question is not applicable to this submission. Mechanical tests don't involve adjudication in this manner.

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

• No, an MRMC comparative effectiveness study was not done. This is a bone plate system, not an AI-powered diagnostic device.

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

• No, a standalone (algorithm only) performance study was not done. This is a mechanical device, not an algorithm.

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

• The "ground truth" for the non-clinical tests is the specified performance requirements and methods defined by the ASTM standards (ASTM F382-17 and ASTM F543-17). These standards define how the mechanical properties should be measured and likely include performance benchmarks (though the specific benchmarks are not reported in this document). The comparative aspect is against the performance of the predicate device(s).

8. The sample size for the training set

• This question is not applicable to this submission. There is no "training set" as this is not an AI/machine learning device. The design and validation of the device rely on engineering principles, material science, and mechanical 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 type of device.

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The DARCO™ Locking Bone Plate System is intended for use in stabilization of fresh fractures, joint fusion, and reconstruction of small bones of the feet, and toes. The system can be used in both adult and pediatric patients.

The DARCO ™ Locking Bone Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, ankles and toes. The system can be used in both adult and pediatric patients.

The DARCO™ Locking Bone Plate system is comprised of a variety of titanium plates and screws designed for internal fixation of bone fragments. The plates are designed with rhombus (parallelogram) plates with an assortment of width, lengths, and configurations to address varying patient anatomy. The system includes locking and non-locking 2.7 mm and 3.5 mm diameter screws of various lengths.

This document is a 510(k) Summary of Safety and Effectiveness for the DARCO™ Locking Bone Plate System, essentially a premarket notification for a medical device. As such, it does not contain a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study with defined performance metrics and acceptance thresholds like those seen for AI/ML devices.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K061808 DARCO™ Locking Bone Plate System) through non-clinical testing and comparison of characteristics. The "acceptance criteria" here is met by demonstrating that the modified device performs at least as well as the predicate device in relevant non-clinical tests.

Here's an analysis based on the provided text, addressing your points where applicable:

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

Since this is a substantial equivalence submission for a mechanical device, the "acceptance criteria" are implied by successful completion of mechanical and performance tests, demonstrating equivalence to the predicate. Specific numerical acceptance criteria are not explicitly stated in the summary, but rather the conclusion that the testing supports substantial equivalence.

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

• Sample Size: Not specified in the provided summary. The summary refers to "testing" but does not give specific numbers of components tested.
• Data Provenance: The testing is "non-clinical" and likely conducted in a controlled lab environment by Wright Medical Technology, Inc. The country of origin and whether it's retrospective or prospective are not relevant for this type of non-clinical mechanical testing.

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. This is a submission for a physical medical device (bone plate system), not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is mechanical performance as measured in lab tests.

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

Not applicable. This is not an AI/ML device undergoing a clinical study with human readers/interpreters. The "adjudication" is based on comparing test results against established engineering standards or the predicate device's performance.

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 a physical medical device, not an AI system. No MRMC study was performed.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device, in the context of demonstrating substantial equivalence, is primarily mechanical and material properties as measured through standardized engineering tests (e.g., measuring pullout strength, torque, yield strength). The comparison is made against the performance of the legally marketed predicate device (K061808 DARCO™ Locking Bone Plate System) to demonstrate "at least as good as" performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, 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 a physical medical device, not an AI/ML device that requires a training set.

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