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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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GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/ Dynamic Condylar Plates Plating System are provided non-sterile.

GREENS BRAND Locking Bone Plates and Screws Osteosynthesis 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).

GREENS Brand of DHS/ Dynamic Condylar Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, intertrochanteric fractures.

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

GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/ Dynamic Condylar Plates Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws.

The plates and screws are fabricated from Stainless Steel And Titanium.

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: like, Reconstruction Plates, T- Plates, , Anatomical Plates, Clavicle Hook Plates.

These all are mainly divided into

• Large Fragment Plates
• Small Fragment Plates ●
• Mini Fragment Plates
• Hip Plates (DHS and Dynamic Condylar Plate)

The thickness of the plates varies from 1.0mm to 6mm; and the number of the holes varies from 2 to 22.

The Locking screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm

The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm.

These implants are supplied non-sterile, the products have to be sterilized prior to use.

The provided document is a 510(k) premarket notification for a medical device: "GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS Brand of DHS/Dynamic Condylar Plates Plating System." This document aims to demonstrate substantial equivalence to legally marketed predicate devices, not to prove the device's efficacy through clinical trials. Therefore, much of the requested information (like sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, training set details) is not applicable or present in this type of submission.

The acceptance criteria provided are related to the mechanical and material properties of the bone plates and screws, demonstrating that the device conforms to established industry standards for such implants.

Here's a breakdown of the available information:

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

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

The document does not specify the exact sample sizes for the non-clinical tests (e.g., how many plates or screws were tested for each standard). The data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission, confirming compliance with material and performance standards. It doesn't involve patient data (prospective or retrospective) or country of origin in the context of clinical studies.

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)

This is not applicable as this is a submission for a hardware medical device based on mechanical and material testing, not an AI or diagnostic device that requires expert-established ground truth from clinical data.

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

Not applicable for a non-clinical, mechanical/material testing submission.

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. No MRMC study was performed as this is a hardware device for bone fixation, not a diagnostic or AI-assisted system.

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

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

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

The "ground truth" in this context refers to the established requirements and specifications within the referenced ASTM (American Society for Testing and Materials) standards. The device's materials and performance metrics are compared against these predetermined, scientifically validated engineering and material specifications.

8. The sample size for the training set

Not applicable. There is no "training set" of data as this is a hardware device for bone fixation, not a machine learning model.

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

Not applicable, as there is no training set. The "ground truth" for the device's conformance is established by adherence to recognized ASTM standards, which are developed and validated through extensive engineering principles and consensus.

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CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS 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).

CARE Brand of DHS/DCS Plating System is used to provide fixation of fractures to the proximal femur shaft and generally indicated for use in trochanteric, intertrochanteric fractures.

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

CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of DHS/DCS Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws, compression and dynamic screws.

The plates and screws are fabricated from Stainless Steel and Titanium.

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: like, Reconstruction Plates, T- Plates, Anatomical Plates, Clavicle Hook Plates.

These all are mainly divided into

• DHS/DCS Plates.
• Large Fragment Plates
• Small Fragment Plates
• Mini Fragment Plates

The number of the holes varies from 2 to 22.

The Locking screw implants are in corresponding diameter ranges from 2.4mm, 2.7mm, 3.5mm, 5.0mm diameters with lengths varying as per the requirements and minimum length: 6 mm to maximum length 90mm.

The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 74mm.

CARE Brand of DHS/DCS Plating System consist of DHS/DCS Plates, lag Screw, compression screw, and 4.5 Cortex screw (Standard and Self Tapping). The DHS plates are available with barrel length 25mm (short barrel) and 38mm (Standard barrel angels varies from 130° to 150°. The DHS/DCS Screw is available in total length from 50 to 120 mm. thread length 22mm. shaft diameter of 12.5. The thread of DHS/DCS Screw has a buttress type. The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 36mm and outer diameter 3.8 mm.

These devices are not indicated for use in spine.

These implants are supplied non-sterile, the products have to be sterilized prior to use.

This document is a 510(k) premarket notification for a medical device, the CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System. The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes the device's performance in terms of conformance to specific ASTM standards. This is a common way to establish acceptance criteria for mechanical devices like bone plates and screws.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Conforms": For a 510(k), 'Conforms' indicates that the device met or exceeded the performance requirements specified in the referenced ASTM standards, demonstrating mechanical equivalence to the predicate devices which are also expected to meet these standards.

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

The document does not explicitly state the sample sizes used for the non-clinical tests (e.g., how many plates were static bend tested, how many screws were pull-out tested). The provenance of the data is also not explicitly stated in terms of country of origin for the testing, nor whether it was retrospective or prospective. However, it mentions that "copies of the relevant test results were provided in the submission," implying that the testing was performed, likely by the manufacturer or a contracted lab, to generate this data.

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

This type of information (number and qualifications of experts) is typically relevant for studies involving human interpretation or clinical data, such as image analysis for disease detection. For a mechanical device like bone plates and screws, "ground truth" is established by adherence to engineering specifications and performance standards through laboratory testing. Therefore, this section is not applicable in the traditional sense for this submission. The "experts" would be the engineers and technicians who conducted the specified ASTM tests, ensuring adherence to the methodology and interpretation of the results according to the standards.

4. Adjudication Method for the Test Set

As explained above, an adjudication method (like 2+1 or 3+1) is relevant for studies where subjective expert opinion is used to establish ground truth from clinical data. For this submission, which relies on objective mechanical performance testing against established standards, an adjudication method is not applicable. The results of the tests are binary (conforms/does not conform to the standard's requirements).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

An MRMC study is designed to evaluate the performance of human readers, often aided by AI, in tasks like medical image interpretation. This type of study is not applicable to the submission of a mechanical orthopedic device. The focus here is on the physical and mechanical properties of the implants themselves.

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

This refers to the performance of an AI algorithm without human involvement. Since the device is a physical bone plating and screwing system and not an AI algorithm, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

For this device, the "ground truth" is based on accepted engineering standards and material specifications (ASTM standards). The device's performance is compared directly against the predefined requirements within these standards. This is a form of objective, empirical data.

8. The Sample Size for the Training Set

A "training set" typically refers to data used to train a machine learning algorithm. As this submission is for a physical medical device and not an AI/ML algorithm, the concept of a training set is not applicable. The device's design, materials, and manufacturing processes are developed based on established engineering principles and prior art, not an algorithmic training process.

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

Since the concept of a "training set" is not applicable, this point is also not applicable. The "ground truth" for the device's development (its design specifications and material choices) would be based on surgical requirements, biomechanical principles, and the performance characteristics of predicate devices, which are themselves validated through accepted engineering and clinical practice.

Summary of the Study:

The study presented in this 510(k) notification is a non-clinical bench testing study. It evaluates the physical and mechanical performance of the CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System against recognized industry material and performance standards (ASTM F136, F138, F139 for materials, and F382, F384, F543 for performance). The purpose of this testing is to demonstrate that the device is mechanically equivalent to its predicate devices, thereby ensuring its safety and effectiveness for its intended use. Clinical studies were deemed "not necessary to demonstrate substantial equivalence" because the design, materials, and intended use are similar to already marketed devices.

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GPC BRAND Locking Bone Plates and Screws Osteosynthesis 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.

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System consists of various shape and sizes of plates featuring compression and locking holes, full-threaded-cortical, locking self-tapping screws.

The plates and screws are fabricated from Stainless Steel and Titanium.

GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating 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: like, Reconstruction Plates, T-Plates, Anatomical Plates and Clavicle Hook Plates.

These all are mainly divided into

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

The number of the holes varies from 2 to 22.

The Locking screw implants are in corresponding diameter ranges from 2.4mm, 3.5mm, 5.0mm and 6.5mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 150mm

The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm. The non locking screws 3.5mm and 4.5mm were cleared previously in 510k number K092493

These implants are supplied non-sterile, the products have to be sterilized prior to use.

This document is a 510(k) premarket notification for a medical device, specifically orthopaedic bone plates and screws. For such submissions, the FDA typically evaluates substantial equivalence to legally marketed predicate devices, rather than requiring extensive clinical trials to demonstrate new performance metrics and acceptance criteria in the same way one might for a novel drug or a high-risk, de novo medical device.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a new drug or novel medical device (e.g., sample size for test set, data provenance, expert adudication, MRMC studies, standalone performance, training set details) is not directly applicable or present in this type of 510(k) submission for a Class II orthopedic implant.

Instead, the "acceptance criteria" here are based on demonstrating that the new device is substantially equivalent to existing cleared devices in terms of:

• Indications for Use: The new device is intended for the same purpose as the predicate devices.
• Technological Characteristics: The new device has similar design, materials, and operating principles.
• Performance: The new device performs similarly to the predicate devices, often demonstrated through engineering analysis, material testing, and comparison of specifications rather than large-scale clinical outcome studies.

Let's address the points as best as possible given the provided document's context:

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k), the "acceptance criteria" are primarily established by the performance and characteristics of the predicate devices. The "study" proving acceptance is the demonstration of substantial equivalence through comparison and testing against relevant standards.

• ASTM F 136 (Titanium-6Aluminium-4Vanadium ELI)
• ASTM F 138 (18Cr-14Ni-2.5Mo stainless steel bar/wire)
• ASTM F 139 (18Cr-14Ni-2.5Mo stainless steel sheet/strip) | "We have complied to following material standards"
  "verified the purchased material compliance to these standards and copies of the relevant test results were provided in the submission." |
  | Plate Performance (Bending):
• Engineering analysis of bending moment and bending stiffness as per predicate performance/industry standards. | "The performance of the plates was demonstrated using an engineering analysis of bending moment and bending stiffness based on material properties and the plate shaft dimensions." |
  | Screw Performance (Pull-out Strength & Torque-to-Failure):
• Engineering analysis of pull-out strength and torque-to-failure as per predicate performance/industry standards. | "The performance of the screws was demonstrated using an engineering analysis of pull-out strength and torque-to-failure based on material properties and the screw dimensions." |
  | Indications for Use Equivalence:
• Treat fractures of clavicle, scapula, long bones (humerus, ulna, radius, femur, tibia, fibula), and small bones (metacarpals, metatarsals, phalanges) in adults. Single use. | "Similar intended use in New Device and Predicate device"
  "GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System are indicated for treating fractures of various bones including the clavicle, pelvis (note: pelvis included here but not in the original IU), 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." |
  | Material Equivalence:
• Stainless Steel and Titanium. | "Same material used in New Device and Predicate device"
  "The plates and screws are fabricated from Stainless Steel and Titanium." |
  | Performance Standards Equivalence:
• (Implicitly, adherence to recognized orthopedic implant performance standards, e.g., for fatigue, corrosion, biomechanics, if applicable to the device type and specified by the predicate) | "Same performance standards used in both New Device as well as predicate device" (This suggests the device was tested against or designed to meet the same relevant standards as the predicates, beyond just material standards). |
  | Sterilization Method Equivalence:
• Must be consistent with the predicates for "non-sterile" and subsequent required sterilization prior to use (e.g., autoclave). | "Same method of sterilization used in both New Device as well as Predicate device"
  "These implants are supplied non-sterile, the products have to be sterilized prior to use." |
  | Dimensional Verification Equivalence:
• Dimensions (e.g., hole count, screw diameters, lengths) must be comparable to predicates. | "Same dimensions found in both New Device as well as Predicate device"
  "The number of the holes varies from 2 to 22. The Locking screw implants are in corresponding diameter ranges from 2.4mm, 3.5mm, 5.0mm and 6.5mm diameters with lengths varying as per the requirements and minimum length: 20 mm to maximum length 150mm. The Non-locking screw implants are in 3.5mm and 4.5mm diameter and length range from 10mm to 140mm." |

Based on the provided document, the following points are not applicable or not detailed, as this is a 510(k) for a device demonstrated through substantial equivalence and engineering analysis, not a clinical study of diagnostic performance or human-in-the-loop AI assistance:

• MRMC comparative effectiveness study: Not done/not applicable for this type of device submission.
• Standalone (algorithm only) performance: Not applicable.
• Ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of engineering and material equivalence submission. The "ground truth" here is compliance with established material and performance standards, and similarity to predicate devices.
• Sample size for the training set: Not applicable (no AI/machine learning model).
• How the ground truth for the training set was established: Not applicable.

Regarding the other specific requested information:

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

• Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical data for performance evaluation. For material and mechanical testing, the "sample size" would refer to the number of components tested according to the relevant ASTM standards or internal protocols. This level of detail on the number of physical samples tested is typically in the underlying test reports, not summarized in the 510(k) summary provided.
• Data Provenance: The device manufacturer (GPC Medical Limited) is located in India. The "testing" involved non-clinical (material and engineering) analyses. The data provenance would be from the manufacturer's internal testing or accredited test labs. The submission explicitly states "copies of the relevant test results were provided in the submission" for material compliance.

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

• Not applicable in the context of this 510(k). "Ground truth" here is about compliance with engineering and material standards, which are established by consensus standard organizations (e.g., ASTM) and verified by qualified engineers/technicians in labs. It does not involve expert clinical readers establishing a "ground truth" for a diagnostic task.

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

• Not applicable. There's no clinical adjudication process for this type of submission.

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, this was not done. This device is a bone plate and screw system, not an AI-assisted diagnostic tool.

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

• No, this was not done.

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

• The "ground truth" for this device's acceptance is based on:
  • Material Standards: Adherence to established ASTM material specifications for surgical implants.
  • Engineering Performance Standards: Meeting performance characteristics (e.g., bending moment, stiffness, pull-out strength, torque-to-failure) demonstrated through engineering analysis and potentially mechanical testing, comparable to the predicate devices and industry norms.
  • Predicate Device Equivalence: The characteristics and intended use being substantially similar to already legally marketed devices.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable.

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Locking Bone Plates and Screws are intended for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

The proposed products, Locking Bone Plates and Screws, contain (1) locking plats with various specifications, (2) locking screws with various specifications and (3) Various specific instruments.

The bone plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used for completing the surgery.

Locking Screws are available in two kinds, which are self-dapping and self-drilling. Both of them share the same dimensions and materials.

These devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10th by hospital prior to use.

The requested information is detailed below, based on the provided text:

Acceptance Criteria and Device Performance Study

The submission focuses on establishing substantial equivalence for medical implants (Locking Bone Plates and Screws) rather than a diagnostic AI device. Therefore, the "acceptance criteria" and "device performance" are related to mechanical and material specifications, and regulatory standards, rather than diagnostic metrics like accuracy, sensitivity, or specificity. The study confirming these criteria is a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of individual plates/screws, but rather through the scope of the specifications (e.g., bone plate lengths from 26-312mm). The testing was conducted on samples representative of the proposed device's various specifications.
• Data Provenance: The tests were "Bench tests" conducted by the manufacturer, Weigao Orthopaedic Device Co., Ltd. in Weihai, Shandong, China. The data is retrospective in the sense that it's a pre-market submission based on completed testing, but it's not clinical data; it's engineering test data.

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

This section is not applicable as the submission describes a medical device (bone plates and screws), not an AI/diagnostic device that would require expert consensus for ground truth on disease states. The "ground truth" here is defined by established engineering and material standards (ASTM and ISO).

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically for clinical or AI performance studies involving interpretations, not for engineering bench tests where outcomes are measured against predefined specifications.

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 is not applicable. No MRMC study was conducted as this is a submission for a medical implant, not an AI-assisted diagnostic tool.

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

This is not applicable. This submission is for a physical medical device, not a standalone AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device type is based on established industry standards and specifications:

• ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates.
• ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws.
• ANSI/AAMI/ISO17665-1: 2006 for sterilization.
• Material specifications: ASTM F67-06 for Titanium and ASTM F136 for Ti6Al4V ELI.

The performance of the proposed device was compared against the specifications and mechanical performance of the predicate devices, which are also compliant with these standards.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a submission for a physical medical device, not an AI/machine learning model.

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

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

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The Smith & Nephew Locking Bone Plate System is used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixations for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones (particularly in osteopenic bone); treatment of the calcaneal; hip arthrodesis, and provisional hole fixation.

Components in the Smith & Nephew Locking Bone Plate System are for single use only.

The Smith & Nephew Locking Bone Plate System is a modification of the Smith & Nephew Bone Plate System cleared under K993106. Like the predicate devices listed below, components include various sizes of contoured and straight, locking bone plates, locking bone screws, and compression screws made from stainless steel. Implantable locking plates/screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.

The provided text does not contain information about acceptance criteria, device performance, or any studies with specific details like sample sizes, ground truth establishment, or expert involvement. The document is a 510(k) summary for the Smith & Nephew Locking Bone Plate System, primarily focused on establishing substantial equivalence to previously cleared predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the specified information.

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