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The Arthrex 3.5 mm Locking Compression Plates are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula.

The Arthrex 3.5 mm Locking Compression Plates consists of a series of varying lengths. The Arthrex 3.5 mm Locking Compression Plates range from 70 mm to 278 mm in length and 3.5 mm in thickness. Each plate provides locking screw fixation. The proposed plates are manufactured from Titanium Alloy (ASTM F136) and Stainless Steel (ASTM F138). The proposed plates are sold as sterile (Gamma), single-use, and non-sterile, single-use.

The provided document is a 510(k) premarket notification for a medical device: Arthrex 3.5 mm Locking Compression Plates (K222244). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a new AI-powered diagnostic device meets specific performance criteria.

Therefore, the information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies, is not present in this document. This is because the device described is a physical implant (bone fixation plates), not an AI/medical imaging diagnostic system.

The document describes material testing and mechanical performance to demonstrate equivalence between the new plates and existing predicate devices.

Here's a breakdown of the relevant information provided in the document:

• Device Type: Arthrex 3.5 mm Locking Compression Plates – a physical metallic implant for bone fixation.
• Purpose of Submission: To obtain 510(k) clearance for the new plates by demonstrating substantial equivalence to a predicate device (K123241: Arthrex Fracture Plates).
• Performance Data: The document mentions physical and mechanical testing, not AI model performance.
  • 4-Point Bend Testing (ASTM F382-17): Conducted to demonstrate statistical equivalence in strength to the predicate device.
  • MRI Force, Torque, and Image Artifact Testing: Performed in accordance with FDA guidance and ASTM standards (e.g., ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213) to evaluate MR compatibility.
  • Bacterial Endotoxins Test (BET): Utilizes the Kinetic Chromogenic Method (ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14) to confirm pyrogen limit specifications for sterile devices.
• No AI, Machine Learning, or Diagnostic Study Details: The document does not contain any information about the acceptance criteria or studies typically associated with AI/ML-driven diagnostic devices. There is no mention of:
  • Sensitivity, Specificity, AUC, or other diagnostic performance metrics.
  • Test/training data sets, their sizes, or provenance.
  • Expert involvement in establishing ground truth for diagnostic purposes.
  • Adjudication methods.
  • MRMC studies.
  • Standalone algorithm performance.

In summary, the provided document relates to the 510(k) clearance of a physical medical device (bone plates) and therefore does not contain the information required to answer the prompt regarding AI device acceptance criteria and studies.

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The IRENE Locking Compression Plate System is indicated for patients with age above 21 for fixation of fractures. Indicated facture areas include ulna, radius, humerus, femur, and tibia.

The IRENE Locking Compression Plate System is designed for internal fixation of bones that subject to fracture. The system includes bone plates and screws that can be used with the plate. Various sizes of plate are available for different fracture areas or clinical conditions. Bone screws are incorporated in the system and are intended to fix with plate with appropriate size. The plate has a limited-contact design. The plate system is provided unsterile. And the system is intended for single-use.

This document is a 510(k) Summary for the IRENE Locking Compression Plate System, which is a medical device for orthopedic fixation. It's a regulatory filing, not a research study. Therefore, most of the information requested about acceptance criteria and study details (like sample sizes, expert adjudication, MRMC studies, ground truth) is not applicable or present in this type of document because it describes a submission for regulatory clearance, not the results of a clinical effectiveness study.

Here's an analysis of the provided text based on your request, highlighting what's available and what's explicitly stated as not applicable:

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

The document does not provide a table of acceptance criteria with specific numerical performance targets. Instead, it states that the device's performance was evaluated against predicate devices using recognized ASTM standards. The acceptance criterion implicitly is that the proposed device performs comparably to the predicate devices and meets the requirements of these standards.

The document states:

• "Results of testing indicates no gap between the level of performance of proposed device and the predicate device" (Page 6)

The performance data mentioned are:

• Plate: Static and dynamic testing conducted as per ASTM F382-13.
• Screw: Torsional properties, driving torque, and pull-out strength conducted as per ASTM F543-13.

No specific numerical results for these tests are provided, only the general conclusion of "no gap" in performance compared to predicate devices.

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

• Sample size: Not specified. The document refers to "mechanical testing" and "testing the mechanical properties of the proposed and predicate device" (Page 5, 6) but does not provide the number of units/samples tested for either the proposed or predicate device.
• Data provenance: The mechanical testing was conducted by Tianjin ZhengTian Medical Instrument Co., Ltd. in China, as indicated by the submitter's address (Page 3). It is preclinical (bench) testing, not clinical data from patients.

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

Not applicable. This was preclinical mechanical testing, not a study requiring expert clinical opinion for ground truth.

4. Adjudication method for the test set

Not applicable. This was preclinical mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a bone fixation plate system, not an AI diagnostic or assistive tool. No MRMC study was conducted.

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

Not applicable in the conventional sense of clinical ground truth (e.g., pathology, outcomes). The "ground truth" for this submission's performance evaluation lies in the established mechanical testing standards (ASTM F382-13 and ASTM F543-13) and the performance of legally marketed predicate devices. The goal was to show the proposed device met these standards and was comparable to predicates.

8. The sample size for the training set

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

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

Not applicable. This device is a physical product, not an AI/ML algorithm.

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The Locking Compression Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

The applicant device of Locking Compression Plate System consist of plates and screws, made of titanium alloy (Ti6AI4V ELI ) which meets the requirements of ASTM F136-08e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The validated sterilization method is presented in the user manual. The plates vary through lengths and number of plate holes, and the screws vary through diameters and lengths.

The provided document is a 510(k) summary for a "Locking compression plate system" submitted by Shanghai MicroPort Orthopedics Co., Ltd. It describes the device, its intended use, and the regulatory pathway. However, the document does not contain information related to software or AI/ML-driven medical devices. As such, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not present in this document.

Here's an attempt to answer the questions based only on the provided text, recognizing that it primarily describes a physical orthopedic implant and its mechanical testing for substantial equivalence to predicate devices.

Acceptance Criteria and Device Performance

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

Since this is a physical medical device (orthopedic implant), the "acceptance criteria" and "device performance" are primarily related to meeting specific engineering standards and demonstrating mechanical equivalence to predicate devices. The document states that "bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It also lists the standards used for testing.

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 refers to "bench tests" and "mechanical testing." These typically involve testing physical samples of the device and are not directly analogous to "test sets" in an AI/ML context. The sample size (number of physical devices tested) is not specified.

Data provenance is not applicable in the typical sense for AI/ML. The "data" here refers to mechanical test results. The device sponsor is Shanghai MicroPort Orthopedics Co., Ltd., which implies the testing likely occurred in China or at a contract lab, but the specific origins of the test data (e.g., specific lab location) are not provided. These tests are inherently prospective in terms of the test execution, but they are evaluating a manufactured item, not clinical patient 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. Expert involvement in establishing "ground truth" (as in clinical diagnosis or image interpretation) is not relevant for the mechanical testing of a physical implant. The "ground truth" in this context is adherence to engineering standards and mechanical performance equivalence, evaluated by engineers and testing facilities.

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

Not applicable. This is not a clinical study involving human interpretation or adjudication of results. Mechanical testing has objective pass/fail criteria based on standards.

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 orthopedic implant, not an AI/ML device that assists human readers.

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

Not applicable. This is a physical orthopedic implant.

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

For this device, the "ground truth" is adherence to established international engineering standards (ASTM standards for materials, bone screws, plates, and fretting corrosion) and the demonstrated mechanical performance equivalence to legally marketed predicate devices. It is not an expert consensus on a diagnosis, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set as this is not an AI/ML device.

Summary regarding AI/ML relevance:

The provided document describes a traditional, physical medical device (orthopedic implant), and its regulatory clearance process based on substantial equivalence to predicate devices through mechanical bench testing. The questions posed are highly relevant to the evaluation of AI/ML medical devices, which operate on data (images, signals, etc.) and involve algorithms. Therefore, most of the detailed information requested regarding sample sizes, expert involvement, ground truth establishment, and comparative effectiveness studies is not contained in this document because it pertains to a different type of medical device evaluation.

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The Synthes 3.5mm Curved Narrow and Broad LCP Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibula, particularly in osteopenic bone for adult patients.

The Synthes 4.5mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and non-unions or malunions in adult patients.

The 3.5mm and 4.5mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

The Synthes Curved Narrow and Broad LCP Plates are available in stainless steel and titanium, and consist of limited-contact profile plates in 3.5 mm and 4.5mm narrow and broad sizes. The plates feature Dynamic Compression Plate (DCP) holes combined with locking screw holes. The 3.5mm plates accept 3.5mm cortex and locking screws and 4.0 mm cancellous screws, and the 4.5mm plates accept 4.5 mm cortex screws, 4.0mm and 5.0mm locking screws, 4.5 mm cannulated screws, 5.0 mm periprosthetic screws, and 6.5 mm cancellous screws.

This document is a 510(k) summary for a medical device called "Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad Locking Compression Plates (LCP)". It is a regulatory submission for premarket notification to the FDA, asserting substantial equivalence to an existing device.

Based on the provided text, the document does not describe acceptance criteria for software performance or a study proving software meets such criteria. This document is for a physical medical device (bone plates for fracture fixation), and the information presented is related to its mechanical properties, materials, and intended use, not software performance.

Therefore, the requested information regarding acceptance criteria for a device's (software's) performance, sample size, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available within this document. The document primarily focuses on establishing substantial equivalence to a predicate device based on design, materials, and intended use for mechanical fixation.

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The DeRoyal non-sterile locking compression plate system is intended for internal fixation of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and bones of the hand and foot.

The DeRoyal Non-Sterile Locking Compression Plate System consists of disposable locking plates and screws in either stainless steel or titanium. The plates have alternating holes to accept either cortical, malleolar, shaft, cancellous or locking screws.

The provided text describes a 510(k) summary for the DeRoyal Non-Sterile Locking Compression Plate System. This document focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance through a clinical study with acceptance criteria.

Therefore, many of the requested categories regarding acceptance criteria, study details, expert involvement, and ground truth establishment are not applicable based on the information provided in this 510(k) summary. A 510(k) summary typically references bench testing and comparison to predicate devices, not clinical effectiveness studies with explicit acceptance criteria for device performance as a standalone system.

Here's a breakdown of what can be extracted and what cannot:

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

• Not Applicable. The 510(k) summary evaluates "substantial equivalence" to a predicate device, not against specific, pre-defined performance acceptance criteria in a clinical or standalone study. The primary "performance" reported is that the device is "substantially equivalent" to the predicate.

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

• Not Applicable. This document does not present data from a clinical test set in the way described. Substantial equivalence is typically demonstrated through design, material, and mechanical property comparisons to a predicate device, often leveraging existing data on the predicate.

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. There is no mention of experts establishing ground truth for a test set in this 510(k) summary.

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

• Not Applicable. No test set or adjudication method is described.

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 document describes a surgical implant, not an AI-assisted diagnostic device. Therefore, MRMC studies and AI effect sizes are irrelevant.

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

• Not Applicable. This is a physical medical device (surgical plate), not an algorithm or software. Standalone performance as described is not applicable.

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

• Not Applicable. No explicit ground truth is mentioned. The submission relies on establishing equivalence to a legally marketed predicate device. This implies that the predicate device's established safety and effectiveness serve as the "ground truth" to which the new device is compared in terms of design, materials, and intended use.

8. The sample size for the training set:

• Not Applicable. There is no mention of a "training set" in the context of this device. This is not an AI or machine learning device.

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary based on available information:

The 510(k) summary for the DeRoyal Non-Sterile Locking Compression Plate System aims to demonstrate substantial equivalence to predicate devices (Synthes Locking Compression Plates and Synthes Locking Screws). This process primarily involves comparing the new device's design, materials (stainless steel or titanium), manufacturing processes, and intended use to those of the predicate devices. The "study" mentioned, implicitly, is the submission of information that "supports substantial equivalence." This is a regulatory pathway that relies on comparison to existing, legally marketed devices, rather than de novo clinical trials with acceptance criteria for a novel device.

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Synthes 3.5 mm Locking Compression Plate (LCP) System:
The Synthes 3.5 mm LCP is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olectranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients.
These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
Synthes 4.5 mm Locking Compression Plate (LCP) System:
The Synthes 4.5 mm LCP is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients.
These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.

Synthes 3.5 mm and 4.5 mm LCP Plates with Expanded Indications consist of 3.5 mm LCP plates, 4.5 mm Narrow LCP Plates, 4.5 mm Broad LCP plates and 4.5 mm Curved Broad LCP Plates for fracture fixation in adults and pediatric patients. These plates accept locking, cortex and cancellous screws.

The provided document is a 510(k) premarket notification letter for a medical device: Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications.

This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, the document does not contain the detailed information typically found in a clinical study report that would establish acceptance criteria and show the device meets them.

Specifically, the document does not provide any of the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set and data provenance.
• Number of experts and their qualifications used to establish ground truth.
• Adjudication method for a test set.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone algorithm-only performance study.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on:

• Device Name: Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications.
• Regulation Number and Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories.
• Predicate Devices:
  • Smith & Nephew Locking Bone Plate System (K033669)
  • Smith & Nephew Bone Plate System (K993106)
  • Synthes Locking Compression Plates (K000682, K000684, K041911)
• Device Description: Consists of 3.5 mm LCP plates, 4.5 mm Narrow LCP Plates, 4.5 mm Broad LCP plates, and 4.5 mm Curved Broad LCP Plates for fracture fixation in adults and pediatric patients. These plates accept locking, cortex, and cancellous screws.
• Intended Use/Indications for Use:
  • 3.5 mm LCP System: Fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients. Also for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
  • 4.5 mm LCP System: Fixation of various long bones (humerus, femur, tibia) and for use in fixation of peri-prosthetic fractures, osteopenic bone, and fixation of non-unions or malunions in adult patients. Also for fracture fixation of diaphyseal areas of long bones in pediatric patients.
• Substantial Equivalence: The document states, "Information presented supports substantial equivalence." This is the primary "proof" in a 510(k) submission, meaning the device is as safe and effective as a legally marketed predicate device.

To obtain the kind of detailed performance data requested, one would typically need to refer to a premarket approval (PMA) submission, a De Novo classification request, or a clinical trial report for a device that has undergone a more rigorous pathway for demonstrating safety and effectiveness.

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Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

Synthes VA-LCP Distal Radius System consists of machined metallic plates and screws that offer screw to plate locking designed for various fracture modes of the distal portion of the radius. Synthes VA-LCP Distal Radius System enhances fragment-specific fracture fixation by providing the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole.

This document is a 510(k) summary for the Synthes Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System. It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information. This document focuses on the regulatory clearance process based on substantial equivalence, rather than performance testing against specific acceptance criteria.

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Intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in the fixation of osteopenic bone and fixation of non-unions and malunions.

Synthes Locking Compression Plate (LCP) System - T Plate is a buttress plate and screw system. The primary feature of the plate is round holes combined with locking screw holes. The locking screws form a locked, fixed angle construct with the plate, while the standard screws facilitate reduction and create compression between the plate and bone. The plates accept 4.5 mm cortex, 6.5 mm cancellous, 4.5 mm cannulated, 7.0 mm cannulated, 7.3 mm cannulated, 4.0 mm and 5.0 mm locking screws

Here's an analysis of the provided text regarding the Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate:

Based on the provided document (K010766), this is a 510(k) premarket notification for a Class II medical device (bone plate and screw system). The document describes the device, its intended use, and its classification.

Crucially, the provided text does not contain any information about acceptance criteria or a study demonstrating device performance as it relates to clinical effectiveness or specific quantitative metrics like accuracy, sensitivity, or specificity. This type of information is typically found in performance testing reports, clinical study summaries, or validation reports, none of which are present in these excerpts.

The 510(k) process for devices like this primarily focuses on demonstrating substantial equivalence to a previously marketed predicate device, rather than requiring extensive de novo clinical efficacy trials. Substantial equivalence is often established through materials testing, mechanical testing, and comparison of design features and intended use.

Therefore, for aspects related to acceptance criteria and device performance studies (items 1 through 9 in your request), the information is not available in the provided document.

Here's a breakdown of what can be inferred from the provided text, and where information is missing:

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

• Information Not Available in Excerpt. The document does not specify quantitative acceptance criteria or report performance metrics (e.g., in terms of strength, fatigue life, or other mechanical properties) for the device. The 510(k) summary focuses on description and 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)

• Information Not Available in Excerpt. No details on clinical or performance test sample sizes, test set provenance, or type of study (retrospective/prospective) are mentioned.

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 / Information Not Available in Excerpt. For mechanical devices like bone plates, "ground truth" as it pertains to expert interpretation (like in imaging AI) is generally not relevant. The document doesn't describe expert-adjudicated test sets for clinical studies.

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

• Not Applicable / Information Not Available in Excerpt. No adjudication method is mentioned as there are no expert-interpreted test sets described.

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 hardware medical device (bone plate and screw system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with/without AI assistance is not relevant or described.

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)

• Not Applicable / Information Not Available in Excerpt. For a bone plate, "ground truth" would typically relate to successful bone healing, implant stability, or other clinical outcomes. These are not discussed in the provided regulatory communication. Performance testing for such devices typically involves biomechanical lab tests (e.g., fatigue, static strength), but the details of such tests are not provided in this 510(k) summary.

8. The sample size for the training set

• Not Applicable / Information Not Available in Excerpt. As this is not an AI/machine learning device, there is no "training set."

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

• Not Applicable / Information Not Available in Excerpt. As this is not an AI/machine learning device, there is no "training set" or ground truth for it in this context.

Summary of what the document does provide:

• Device Name: Synthes (USA) Large Fragment Locking Compression Plate (LCP) System - T Plate
• Sponsor: Synthes (USA)
• Device Classification: Class II (21 CFR 888.3030 and 888.3040)
• Predicate Device: Synthes T Plates (This is the key piece of information for a 510(k) – the device is substantially equivalent to this predicate).
• Description: Buttress plate and screw system with round holes and locking screw holes, forming a fixed-angle construct. Accepts various screw sizes.
• Indications for Use: Buttress metaphyseal fractures of the proximal humerus, medial tibial plateau, and distal tibia; fixation of osteopenic bone, non-unions, and malunions.
• Material: 316L Stainless Steel, Titanium
• Regulatory Determination: Substantially equivalent to devices marketed prior to May 28, 1976. This allows the device to be marketed.

To get the information you asked for regarding acceptance criteria and performance data, one would need to consult a more detailed technical file, design validation report, and/or mechanical testing reports, which are usually part of the full 510(k) submission but not typically released in the public 510(k) summary letters.

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