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The DePuy Synthes TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally mature adults and adolescents (12-21)* for maintaining the relative position of bone grafts and/or bone graft substitutes within bone voids or surgical resections in the nonarticular regions of the humerus, femur, or tibia. The implant must be used in conjunction with traditional, rigid fixation.
*The TruMatch Graft Cage – Long Bone implant is indicated for use in skeletally immature adolescents, only if the device is not used across open physes.
The TruMatch Graft Cage – Long Bone implant is for patients only when the treating physician deems there is appropriate time to conduct surgical planning, personalization, and manufacturing of a patient specific device. When considering the use of the TruMatch Graft Cage - Long Bone, please ensure that you request information on the amount of time needed to manufacture and ship the device from your local DePuy Synthes sales representative. There is a delay between when the device is ordered and when the device can be delivered.

DePuy Synthes TruMatch Graft Cage - Long Bone, is a 3D-printed personalized resorbable implant that optimizes support of bone graft in large, segmental defects of the humerus, femur, and tibia.

This is a medical device 510(k) summary, not a study describing the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance is not applicable to this document.

The document describes the regulatory review for a medical device called the "TruMatch Graft Cage - Long Bone" and concludes its substantial equivalence to a predicate device. The performance data provided are related to the mechanical and biological properties of the implant, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information based on the input text.

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The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth plates have fused or will not be crossed with hardware: fracture fixation (open and closed) pseudoarthrosis of long bones limb lengthening (epiphyseal or metaphyseal distraction) joint arthrodesis infected fractures or nonunions correction of bony or soft tissue deformities correction of segmental defects.

The DePuy Synthes MAXFRAME™ Multi-Axial Correction System, with adult and pediatric indications, is an external ring fixation system that is combined with web-based software in treatment of soft tissue and bone deformities. In the MAXFRAME system, implanted transfixion wires, Schanz screws and pins are attached to the rings and plates surrounding the deformity using bolts, nuts and connecting plates. Upper and lower rings are then connected to one another using six telescoping struts, creating a "Stewart Platform" type device. Adjusting the strut length allows for correction of length, rotation, and angular deformity at the same time. The modular nature of a ring fixation frame allows multiple frame options. A ring fixation frame is assembled individually by the surgeon to address the different characteristics of each case. The materials of construction for this system include aluminum, elgiloy, stainless steel and various polymeric materials. This system has been validated as MR Conditional.

The provided text describes the DePuy Synthes MAXFRAME™ Multi-Axial Correction System, a medical device, and its FDA 510(k) summary. However, it does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The device itself is a physical external ring fixation system combined with web-based software for treatment planning, not an AI diagnostic or predictive tool in the context of typical AI performance studies.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to AI, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for an AI component.

The document discusses performance in terms of:

• Construct testing: ASTM 1541-02 (2011)
• Component testing: Static & Dynamic Compression testing, Static Torsion, Static Cantilever, Static and Dynamic Fatigue, Wire Slip and Ring to Wire Interface Testing
• System Validation
• Software Verification: In accordance with Special Controls & EN IEC 62304:2006-05 Medical device Software life cycle processes
• MR Conditional Technical Data: In accordance with FDA Guidance and ASTM F2503-13
• Reprocessing of SUD in accordance with Special Controls

The conclusion states that "The objective evidence presented demonstrates that the mechanical performance of the proposed device is comparable to that of the predicate device(s) and supports substantial equivalence for safety and effectiveness."

No clinical evaluation was deemed necessary for the determination of substantial equivalence for this device.

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The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The plate and four screw system has been designed for use with structural allograft to provide stabilization as an adjunct to cervical fusion. Indications for use of this plate system include degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis or scoliosis), tumor, pseudarthosis or failed previous fusion. The plate is intended for one level in the cervical spine, from C2 to T1.

The Zero-P Natural Plate is intended for anterior plate and screw fixation of the cervical spine. The Zero-P Natural Plate and four screw system has been designed to provide stabilization as an adjunct to cervical fusion. The Zero-P Natural Plate is secured to the spine through unicortical fixation with bone screws. The plate is positioned flush with the adjacent vertebral bodies. Four bone screws attach to the plate for fixation through the adjacent vertebral bodies; two screws are directed into the superior and inferior vertebrae through the endplates.

The Zero-P Natural Plate has been designed for use with a Musculoskeletal Transplant Foundation (MTF) allograft spacer. Size pairings of the Zero-P Natural Plate and the allograft spacer are identified in the labeling to ensure a proper fit and height relationship of the allograft spacer to the Zero-P Natural Plate.

This document describes a 510(k) premarket notification for the "Zero-P Natural Plate System," a spinal intervertebral body fixation orthosis. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a specific performance level of an AI device through a clinical study. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly applicable to this type of regulatory submission.

However, I can extract information related to the device's performance data as presented in the document, which focuses on mechanical and biomechanical testing demonstrating equivalence to predicate devices, rather than AI performance.

Here's the information that can be extracted from the provided text:

Acceptance Criteria and Device Performance:

The document describes performance data through mechanical and biomechanical testing, compared to predicate devices, to establish substantial equivalence. It does not provide specific numerical "acceptance criteria" and "reported device performance" in the format of AI metrics (e.g., sensitivity, specificity). Instead, it states that the mechanical and biomechanical properties were evaluated and found to be "consistent with those of the predicate devices," thereby establishing substantial equivalence.

Study Details (as applicable to a medical device, not an AI model):

1. Sample size used for the test set and the data provenance:

   • Mechanical Testing: Not explicitly stated as a "sample size" in the context of an N-number for a test set. ASTM F1717-14 specifies methodologies for testing implants.
   • Biomechanical Testing: "cyclic cadaveric range of motion study." The number of cadaveric specimens used is not specified.
   • Data Provenance: Not specified, but likely laboratory testing data rather than patient data.

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

   • Not Applicable. This is a physical and biomechanical testing study for a medical implant, not an AI study requiring expert consensus for ground truth on clinical data.

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

   • Not Applicable. No human adjudication process is described for this type of testing.

4. 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 device or an MRMC study.

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

   • Not Applicable. This is not an AI algorithm.

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

   • For mechanical testing, the "ground truth" would be the physical properties and failure modes under defined loads as measured by testing equipment, adhering to ASTM standards.
   • For biomechanical testing, the "ground truth" would be the measured range of motion and stability characteristics in cadaveric models. This is not "expert consensus" or "pathology" in the AI/clinical sense.

7. The sample size for the training set:

   • Not Applicable. This is not an AI model.

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

   • Not Applicable. This is not an AI model.

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The Synflate Vertebral Balloon System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

The Synflate Vertebral Balloon System is a comprehensive array of instrumentation (Vertebral Access Kit as well as a Biopsy Kit), vertebral augmentation balloons (inclusive of balloon-catheter, stiffening wire, and syringe with luer lock), and Inflation System (previously cleared via K110604). All instruments and implants are provided sterile and packaged separately.

The Synflate balloon catheter includes a stiffening wire and syringe with luer lock. The balloon is inflated within the vertebral body via the Inflation System.

The Synflate balloon catheter is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.

Here's a breakdown of the acceptance criteria and study information for the Synthes Synflate Vertebral Balloon System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific, quantifiable acceptance criteria or detailed reported device performance in a table format. It broadly mentions:

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

• Sample Size: Not explicitly stated. The document mentions "Mechanical and biomechanical testing was performed" but does not give specific numbers of units or tests performed.
• Data Provenance: The tests were "performed in order to provide data to support a substantial equivalence determination." This implies the tests were conducted by the manufacturer, Depuy Synthes Spine, as part of their 510(k) submission. It is a non-clinical (benchtop) study, not involving human subjects. Therefore, country of origin related to patient data or retrospective/prospective classification is not applicable.

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

This question is not applicable to this submission. The "test set" in this context refers to the physical devices undergoing mechanical and biomechanical testing, not a dataset requiring expert interpretation for ground truth. The "ground truth" for these tests would be the measured physical properties and performance characteristics against engineering specifications.

4. Adjudication Method for the Test Set

This question is not applicable. Since the "test set" consists of physical devices undergoing objective mechanical measurements, there is no need for expert adjudication of results in the way commonly seen in clinical image-based studies. The "adjudication" would be based on comparison of measured values against predefined engineering acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed to demonstrate the safety and effectiveness of this system." The submission relies solely on non-clinical (mechanical and biomechanical) testing to demonstrate substantial equivalence to predicate devices.

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

This question is not applicable as this device is a medical instrument (vertebral balloon system), not an algorithm or AI-powered device.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests would be engineering specifications and established mechanical testing standards/methods. The device's performance was compared against these predefined physical and functional requirements, and against the established performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

This question is not applicable. Since this is a physical medical device and not an AI/machine learning algorithm, there is no "training set."

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

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

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The Synthes Radial Head Prosthesis System is intended for:

1. The replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with
   a. Joint destruction and/or subluxation visible on x-ray
   b. Resistance to conservative treatment
2. Primary replacement after fracture of the radial head.
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty.

The Synthes Radial Head Prosthesis is a two-piece modular system comprised of titanium alloy stem and cobalt chrome head components with an integral screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need.

This document is a 510(k) Summary for the Synthes Radial Head Prosthesis System. It is focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way one might for a novel diagnostic or AI device.

Therefore, many of the specific questions regarding acceptance criteria, device performance metrics (e.g., sensitivity, specificity), sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not directly applicable or explicitly detailed in this type of submission for a medical implant device.

However, I can extract the relevant information regarding the performance testing and the approach to demonstrating substantial equivalence.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:

Context: The Synthes Radial Head Prosthesis System is a medical implant (a modular radial head prosthesis) intended for the replacement of the radial head in specific orthopaedic conditions. The 510(k) submission aims to demonstrate that this new device is "substantially equivalent" to existing, legally marketed predicate devices. This means it has the same intended use, fundamental technological characteristics, and similar materials, and that performance testing shows it is as safe and effective as the predicates.

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

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics typical of, for example, diagnostic accuracy (like sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices through various tests and analyses.

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: The document does not specify a "sample size" in terms of patients or anatomical specimens as one would for a clinical trial or diagnostic study. The "test set" here refers to the actual physical devices (or components thereof) that underwent in vitro performance testing and surface analysis. The number of such devices or samples tested is not disclosed in this summary.
• Data Provenance: The tests are described as "in vitro performance testing," "Macro Surface Analysis," "Scanning Electron Microscopy (SEM)," and "X-Ray Photoelectron Spectroscopy (XPS)." These are laboratory-based studies, not clinical studies involving patient data from specific countries or populations. The data provenance is controlled laboratory conditions.

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 type of device submission. The "ground truth" for a mechanical implant is its physical and mechanical properties, not expert-derived diagnostic labels. The performance is assessed through engineering and materials science testing, not clinical diagnosis by experts.

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

• This question is not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations of clinical data or images. This submission focuses on the objective physical and mechanical properties of an implant.

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

• This question is not applicable. The device is a physical implant, not a diagnostic imaging or AI algorithm that would involve human readers or AI assistance.

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

• This question is not applicable. The device is a physical implant, not an algorithm.

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

• The "ground truth" for this device's performance is established by engineering and materials science standards and measurements. This includes:
  • Mechanical properties: The ability to withstand clinical loads.
  • Material properties: Chemical composition and physical and macro/micro surface characteristics.
  • Peer-reviewed literature: Used to demonstrate how these material and surface characteristics relate to physiological responses.

8. The sample size for the training set

• This question is not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a physical implant. The design and manufacturing processes are based on engineering principles and prior knowledge from predicate devices, rather than machine learning training.

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

• This question is not applicable, as there is no training set. The "ground truth" for the device's design and material selection would be established through established engineering principles, materials science, and conformity to relevant ASTM/ISO standards (though specific standards are not named in this summary).

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The Synthes ACIS is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the spacer of the Synthes ACIS should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes ACIS is intended to be used with supplemental fixation.

The Synthes Vertebral Spacer CR is an anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the Synthes Vertebral Spacer CR should be packed with autogenous bone graft and implanted via an anterior approach. The Synthes Vertebral Spacer CR is intended to be used with supplemental fixation.

The Synthes ACIS is a radiolucent cervical intervertebral body fusion device. The Synthes ACIS is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Ti-6Al-4V ELI; TAV; ASTM F136-2a) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant.

The Synthes Vertebral Spacer CR is a radiolucent cervical intervertebral body fusion device. The Vertebral Spacer CR is fabricated from Invibio® PEEK-Optima® LT-1 (ASTM F2026-10) with two anterior and one posterior titanium alloy (Titanium-6Aluminum-7Niobium ASTM F1295-05) radiopaque markers. The markers allow intra-operative radiographic assessment of the position of the implant.

The Synthes Vertebral Spacer CR is available in a range of heights, and is available in three different sagittal profiles. Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. The open architecture of the device allows it to be packed with autogenous bone graft material, i.e., autograft.

The provided text describes two medical devices, Synthes ACIS and Synthes Vertebral Spacer CR, and their 510(k) submissions to the FDA. However, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for artificial intelligence (AI) or an algorithm. Instead, it details the non-clinical performance (bench testing) of these intervertebral fusion devices.

Therefore, most of the requested information regarding AI device acceptance criteria and study details cannot be extracted from the provided text.

Here is what can be inferred or stated based on the provided document:

Acceptance Criteria and Device Performance (based on non-clinical testing)

Information NOT Available from the provided text:

The document clearly states: "Clinical data and conclusions were not needed for this device." This implies that the device achieved substantial equivalence based solely on non-clinical testing against predicate devices. Therefore, the following AI-specific study details are not applicable or provided:

• Sample size used for the test set and the data provenance: Not applicable as no clinical or AI-specific test sets were used.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth for image interpretation or diagnosis was established.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes traditional medical device approval based on non-clinical bench testing and substantial equivalence to existing predicate devices, not an AI or algorithm-driven device with corresponding performance criteria and studies.

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The Synthes 2.7 mm/ 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle 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 Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System consists of plates of various lengths and variable angle screws that provide the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole. The system features medial and lateral plates that are precontoured to match the anatomy of the clavicle and a limited contact, low profile design. The plate with lateral extension features Variable Angle (VA) Locking holes and Dynamic Compression Plate (DCP) holes. The medial plate features Dynamic Compression Plate (DCP) holes combined with VA locking screw holes.

The provided document describes a 510(k) premarket notification for a medical device, the Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System. This is a bone fixation appliance used in orthopedic surgery, not a diagnostic or AI-driven device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/diagnostic device is not applicable directly to this submission. The "acceptance criteria" here relate to demonstrating substantial equivalence to predicate devices for regulatory approval, primarily through mechanical testing and comparison of design characteristics.

Here’s an adaptation of your requested table and information, focusing on what is available in the document for this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance (Adapted for Medical Device Equivalence)

• Pre-contoured for the clavicle.
• Incorporate combination dynamic compression/threaded locking screw holes.
• Similar geometric dimensions (thickness, shaft width, overall length, number of screw holes).
• Limited contact designs.
• Allow additional contouring.
• Allow the same size cortex, locking cortex, and cancellous screws. |
  | Performance (Mechanical/Engineering): Equivalent or superior mechanical performance to predicate devices in relevant tests. | Static Compression ultimate load strength testing: Showed "much higher bending strength" than predicate plate systems.
  Engineering Calculations: Confirmed bending strength is "greater than the bending strength of the predicate plate system." |
  | Safety and Effectiveness: Presents no new issues of safety or effectiveness compared to predicate devices. | Based on design characteristics and test results, the device "presents no new issues of safety or effectiveness." |

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

• Sample Size: The document does not specify exact sample sizes for the "Static Compression ultimate load strength testing." It refers to "the proposed plate system (plate/screw construct)" and "the predicate plate systems" in a general sense, implying typical engineering test runs but not providing specific numbers of constructs tested.
• Data Provenance: The testing and engineering analysis were performed by Synthes (USA), a medical device manufacturer. This data is part of their internal validation and verification processes for their product development.

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

• This concept is not directly applicable to this type of device submission. The "ground truth" for mechanical testing is established by engineering standards, test methods, and material science principles, not by expert consensus in a clinical sense. The experts involved would be engineers, material scientists, and regulatory affairs personnel within Synthes and at the FDA, reviewing the data against established benchmarks for mechanical stability and equivalence.

4. Adjudication Method for the Test Set

• Not applicable in the AI/diagnostic sense. Mechanical testing results are objective measurements against defined criteria. Any "adjudication" would involve review by subject matter experts (engineers) to ensure test protocols were followed and results interpreted correctly, but not a concensus process like for clinical image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for diagnostic devices where human interpretation needs to be compared or augmented by an AI. This submission is for a bone fixation plate, which is a surgical implant.

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

• No. This refers to an AI algorithm's performance without human interaction. This device is a passive mechanical implant.

7. The Type of Ground Truth Used

• The "ground truth" for establishing substantial equivalence for this device is based on objective mechanical performance metrics (e.g., ultimate load strength, bending strength) derived from standardized engineering tests (e.g., static compression testing) and comparative analysis of design and material properties against legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set. The design of the plate is based on anatomical considerations and biomechanical engineering principles, informed by previous product development and clinical experience with bone fixation.

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

• Not applicable. As there is no training set in the AI sense, there is no corresponding ground truth establishment process.

Summary of the Study Proving Device Meets "Acceptance Criteria" for Substantial Equivalence:

The document indicates that the Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System demonstrated substantial equivalence through:

• Comparison of Design Characteristics: The device shares core technological characteristics, materials (same alloys), and geometric aspects with its predicate devices (Synthes 3.5mm LCP Reconstruction Plate System, K000684, and Synthes 3.5mm LCP Superior Anterior Clavicle Plate System, K073186). This includes features like pre-contoured plates, combination screw holes, limited contact designs, and compatibility with standard screws.
• Mechanical Testing and Engineering Analysis:
  • Static Compression ultimate load strength testing was performed on plate/screw constructs.
  • Engineering Calculations were used to further confirm performance.
  • These tests showed that the proposed plate system exhibited "much higher" and "greater" bending strength compared to the predicate plate systems.

These lines of evidence, reviewed by the FDA, supported the conclusion that the device is substantially equivalent to the predicates and presents no new issues of safety or effectiveness, allowing for its 510(k) clearance.

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