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The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers).
The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices (devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C.
The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap).
Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Minimum Drying time: 20 minutes

The Synthes Graphic Case and Tray System is a modular, reusable case and tray system intended for use in health care facilities for the purpose of containing medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit that contains and protects instruments and implants during sterilization and transport. All components are perforated for steam penetration.

The Synthes Graphic Case & Tray System is a medical device intended for storing, organizing, and transporting orthopedic instruments and implants during sterilization and surgical procedures. It is designed to be used with an FDA-cleared sterile barrier. The device's performance was evaluated through non-clinical testing.

Here's a breakdown of the acceptance criteria and the study results:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the exact sample sizes (number of devices, number of tests for each criterion) for each test. For many tests (e.g., Sterilization Efficacy, Dry Time, Cleaning), the results often refer to "Each product BI test location" or "For all cycles," suggesting that multiple test units or cycles were performed to represent the device.

The data provenance is not explicitly mentioned as a country of origin. The sponsor is "Synthes GmbH Luzernstrasse 21 Zuchwil, Switzerland," indicating the device manufacturer is based in Switzerland, but the location where the non-clinical testing was conducted is not specified. The study is non-clinical testing, which implies it's laboratory-based and not involving human subjects.

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

This information is not applicable. The tests performed are non-clinical, laboratory-based evaluations against objective, measurable criteria (e.g., absence of microbial growth, weight difference, concentration levels of analytes, visual inspection for damage, cytotoxicity scores). There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes.

4. Adjudication method for the test set:

Not applicable. As noted above, the tests are objective, measurable non-clinical evaluations, not interpretive assessments that would require adjudication.

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

Not applicable. This is a non-clinical evaluation of a sterilization case and tray system, not an AI-assisted diagnostic device.

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 a software algorithm.

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

The "ground truth" for these non-clinical tests is based on established scientific and regulatory standards and methods appropriate for sterilization and cleaning efficacy, biocompatibility, and durability. For example:
* Sterilization Efficacy: Negative growth of biological indicators, steam penetration verification (objective measurements).
* Dry Time and Thermal Profiling: Weight difference percentage, absence of visible moisture, F0 values, temperature sensor stability (objective measurements).
* Cleaning: Extraction efficiency percentage, absence of visible soil, quantifiable levels of protein and hemoglobin (objective measurements).
* Biocompatibility: Cytotoxicity score (objective, laboratory-derived evaluation).
* Durability: Absence of specific types of damage (visual inspection against defined criteria) and continued proper function (functional testing).

8. The sample size for the training set:

Not applicable. This is a physical medical device undergoing non-clinical validation, not a machine learning model that requires a training set.

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

Not applicable.

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SynthVISION is a software application that can be used within a web -browser to process and view DICOM and non-DICOM image data and associated medical in the day-to-day diagnostic activities of medical imaging professionals and those involved in the care of a patient.

SynthVISION is a medical imaging viewing software used with off-the-shelf workstation hardware and web browsers for the 2D & 3D diagnostic visualization of DICOM and non-DICOM medical images by intended users such as trained radiologists, technologists and all others involved in the patient's care.

SynthVISION consists of configurable software-only modules that display and process DICOM and non-DICOM images and associated medical information to aid in the day-to-day operations and workflow of imaging healthcare professionals, clinicians and other healthcare practitioners.

SynthVISION has the following primary features and functions -

• Zero-footprint medical image upload, transfer, and display of medical images between facilities
• Easy access to images for all participants in the healthcare process, including radiologists, physicians, nurses and others who participate in patient care
• Serves as information and data management system for DICOM and non-DICOM medical images
• Industry-standard tools for image manipulation, annotation and measurement ●
• Metadata information and orientation labels display
• . Advanced image manipulation functions like view synchronization across series, MIP and MPR
• Advanced image processing filters
• Encrypted transmission of medical images through secured networks
• Encrypted storage of medical images
• . HIPAA-compliant data management, including centralized storage of user activities via audit trails.

The provided text, a 510(k) summary for Synthesis Health Intelligence Inc.'s SynthVISION 1.0.0, does not contain specific acceptance criteria or details of a study that proves the device meets such criteria in the manner typically expected for medical device performance evaluation.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (eUnity) through non-clinical testing. It explicitly states that clinical tests were not conducted.

Therefore, many of the requested information points cannot be extracted from this document, as they pertain to clinical performance studies.

However, I can extract information regarding the non-clinical tests performed and their general conclusions which serve as a form of acceptance criteria for software functionality and equivalence.

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

Acceptance Criteria and Reported Device Performance

Since no specific numerical performance metrics (e.g., sensitivity, specificity, AUC) are provided in this document as acceptance criteria, the "acceptance criteria" here are inferred from the stated purpose and conclusions of the non-clinical tests, which aim to demonstrate functional equivalence and safety.

Study Details from the Provided Text:

1. A table of acceptance criteria and the reported device performance: (See above table.)

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

   • Test Set Sample Size: Not specified. The document refers to "key software components," "user interfaces," "image quality assessments," and "tool tests" without quantifying the number of elements or cases involved.
   • Data Provenance: Not specified. Given that clinical tests were not performed, the "data" for these non-clinical tests would likely refer to synthetic data, representative DICOM/non-DICOM images, and interactive user scenarios. No country of origin is mentioned. The tests are described as non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Since these were non-clinical software tests aimed at functionality and usability equivalence, not diagnostic accuracy, there is no mention of "ground truth" adjudicated by medical experts for diagnostic purposes. Usability testing would involve users, but the number and qualifications are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There was no diagnostic test set requiring adjudication in this technical documentation.

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. The document explicitly states "Clinical tests: Not Applicable." SynthVISION is primarily a medical image viewing software, not an AI diagnostic aid requiring an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a viewer, designed for human use. The performance tests ("Image quality assessments, tool tests, display requirements") represent standalone software capabilities validation, but not in the diagnostic sense often implied by this question for AI algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for diagnostic "ground truth." The "ground truth" for the non-clinical tests would be the expected software behavior and output based on design specifications and the predicate device's functionality. For example:

   • Software Verification: Specifications compliance.
   • Usability Testing: User feedback, task completion rates, error rates (compared to predicate).
   • Performance Testing: Expected image display accuracy, measurement accuracy, tool functionality (compared to predicate).

8. The sample size for the training set: Not applicable. This document does not describe the development or testing of an AI algorithm that would require a training set. SynthVISION is described as a "medical image management and processing system" and a "software application" for viewing, manipulation, and display of images.

9. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set or AI model.

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The DePuy Synthes MatrixSTERNUM Fixation System is indicated for use in adults with normal bone quality.

MatrixSTERNUM Sternal Body Plates are indicated for internal fixation of bone discontinuities following sternotomy.

MatrixSTERNUM Thoracotomy Plates are indicated for internal fixation of bone and/or cartilage discontinuities following thoracotomy.

The DePuy Synthes MatrixSTERNUM Fixation System consists of two families of plates, namely the MatrixSTERNUM Sternal Body Plates and MatrixSTERNUM Thoracotomy Plates, and two families of screws, namely the MatrixSTERNUM Self-Drilling Locking and Non-Locking Screws.

The DePuy Synthes MatrixSTERNUM Fixation System is intended for the stabilization and fixation of bones in the anterior chest wall. The subject plates are available in different shapes and sizes and are made from Titanium Alloy or commercially pure Titanium. The system also consists of non-implantable dedicated use screw guides, a screw guide handle, trays and modules, as well as general use instruments to be used as accessories with the subject implants.

The provided text describes a 510(k) premarket notification for the DePuy Synthes MatrixSTERNUM Fixation System, which is a metallic bone fixation appliance.

It is crucial to understand that this document describes a submission for a medical device (hardware), not an Artificial Intelligence (AI) or software-as-a-medical-device (SaMD) product.

Therefore, the information regarding acceptance criteria and studies that prove the device meets acceptance criteria are focused on the mechanical, material, and biological performance of physical implants, not on the performance of an AI algorithm in tasks like image interpretation or diagnosis.

Because the request is specifically about AI/SaMD performance criteria (e.g., sample size for test set, expert ground truth establishment, MRMC studies, standalone performance, training set data), the provided text does not contain the information needed to answer these questions for an AI/SaMD product.

The document states:

• "Clinical testing was not necessary for the determination of substantial equivalence." This directly indicates that no clinical performance study, multi-reader multi-case (MRMC) study, or standalone algorithm performance study (as would be typical for AI/SaMD) was conducted.
• The performance data provided is under "Non-clinical Performance Data" and includes:
  • Mechanical performance evaluation and testing: Comparing the subject plates to predicate devices.
  • Magnetic resonance compatibility assessment.
  • Endotoxin testing.
  • Biocompatibility evaluation and testing (in accordance with ISO 10993-1).

These are standard non-clinical tests for orthopedic implants to demonstrate safety and effectiveness and substantial equivalence to existing devices. They are not metrics or study designs relevant to AI/SaMD performance.

Therefore, I cannot populate the requested table and answer the subsequent questions in the context of an AI/SaMD product, as the provided text pertains to a physical medical device.

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SYNTHECEL® Dura Repair is indicated as a dura replacement for the repair of dura mater in adults.

SYNTHECEL® Dura Repair is composed of biosynthesized cellulose and water with a unique construction of non-woven, interconnected cellulose fibers. SYNTHECEL® Dura Repair functions as a mechanical layer which protects and repairs the dural defect while preventing further CSF leakage. SYNTHECEL® Dura Repair is immunologically inert and has demonstrated minimal foreign body response. It is non-resorbable.

The document provided is a 510(k) premarket notification for the SYNTHECEL Dura Repair device, seeking substantial equivalence to previously cleared predicate devices. It describes the device, its intended use, and the non-clinical performance data used to support its equivalence.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving the device meets them:

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

The document does not explicitly state "acceptance criteria" in a table format with specific numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through mechanical testing and biocompatibility. The reported performance is a statement of equivalence rather than meeting pre-defined numerical thresholds for a novel device.

However, based on the "Non-Clinical Performance Data" section, we can infer the areas of evaluation and the general outcome:

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 provide specific sample sizes for the mechanical testing (e.g., number of samples for burst strength or suture pull-out strength). It also does not specify the country of origin of the data or whether the non-clinical performance data was retrospective or prospective. It simply states that "Mechanical testing data was collected," implying lab-based testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable to the provided document. The submission is for a medical device (dura repair), and the "test set" in this context refers to physical samples undergoing mechanical and biological evaluations, not diagnostic outputs requiring expert interpretation for ground truth establishment.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human interpretation of data (e.g., medical imaging) to resolve discrepancies. The provided document focuses on non-clinical performance data of a physical device.

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. The device is SYNTHECEL Dura Repair, a physical medical device, not an AI or diagnostic tool that would involve human readers or MRMC studies.

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

This is not applicable. The device is a physical dura repair product, not an algorithm.

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

For the non-clinical performance data:

• Mechanical Testing (Burst Strength, Suture Pull-Out Strength): The "ground truth" is established through standardized laboratory testing methods that quantify physical properties according to accepted engineering and medical device standards. The comparison is against predicate device performance, implying the predicate's performance serves as the benchmark.
• Biocompatibility: The "ground truth" is established by adhering to international standards (ISO 10993-1) which define acceptable biological responses (e.g., non-irritating, non-cytotoxic).

8. The sample size for the training set:

This is not applicable. The submission is for a physical medical device, not an AI or machine learning model that requires a training set.

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

This is not applicable, as there is no training set for a physical medical device.

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The DePuy Synthes MAXFRAME™ Multi-Axial Correction System is indicated for external fixation of fractured long bones and bones of the foot, limb lengthening, and deformity correction in adult, children* (3-12), and adolescent* (12-21) patient populations. The DePuy Synthes MAXFRAME™ Multi- Axial Correction System utilizes software for assisting surgeons in treatment planning. *in which the growth plates have fused or will not be crossed.

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, is an external ring fixation system that consists of MAXFRAME Hardware (schanz screws, pins, struts, rings) and MAXFRAME Web Software, used in treatment of soft tissue and bone deformities.

The subject device MAXFRAME 3D II Software (Moderate Software Level of Concern) is a software re-write of the MAXFRAME Web Software to make it more efficient, simplify software upgrades for functionality and fixing of software anomalies or bugs. Additionally, based on surgeon feedbacks and voice of customer, new functionality has been added around how frames are identified on X-Rays/radiographic images and how the treatment of the deformity can be planned.

This document describes the MAXFRAME™ Multi-Axial Correction System (aka MAXFRAME) software, specifically the MAXFRAME 3D II Software. It is a software re-write of the existing MAXFRAME Web Software, cleared under K161417.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and the reported device performance:

The provided document (510(k) Summary) is a submission for substantial equivalence based on non-clinical performance testing. It does not contain specific acceptance criteria for performance metrics in a quantitative sense (e.g., accuracy, sensitivity, specificity). Instead, it generically states:

Important Note: This is a 510(k) summary for a software update to an existing device. The primary claim is substantial equivalence to the predicate device (MAXFRAME Web Software, K161417), meaning it performs similarly and raises no new questions of safety or effectiveness. As such, detailed quantitative performance metrics often associated with novel AI/ML devices or completely new technologies are typically not disclosed in this type of submission summary. The "acceptance criteria" here are focused on demonstrating that the new software maintains the safety and effectiveness profile of the predicate.

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

The document explicitly states: "Non-clinical Performance Testing: The performance of the subject MAXFRAME 3D II Software has been evaluated by confirming that the outputs meet the input requirements and conform to the user needs and intended uses."

This indicates software verification and validation (V&V) activities were performed. However, the document does not specify a sample size for a "test set" in the context of clinical or image-based evaluation. Given it's a software re-write of an existing system, the testing likely involved functional testing, regression testing, and possibly performance testing against a set of representative cases or simulated scenarios to ensure calculations are correct and the user interface functions as expected.

The document does not specify the data provenance (e.g., country of origin, retrospective or prospective data) for any test cases used during V&V.

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

This information is not provided in the document. As it is a software re-write and not a novel diagnostic AI algorithm, the "ground truth" for V&V would likely be based on:

• Expected outputs from calculations based on well-defined anatomical parameters or clinical scenarios.
• Comparison to results from the predicate software.
• Expert review of UI/UX and functionality rather than diagnostic accuracy.

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

This information is not provided. Given the nature of a software re-write, a formal adjudication process for diagnostic interpretations (like 2+1 review) is unlikely to be the primary method of evaluation. Software V&V typically uses internal testing protocols.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Performance Data: Clinical data was not necessary for the determination of substantial equivalence." Therefore, there is no information about the effect size of human readers improving with AI assistance.

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

The document describes the device as providing "software for assisting surgeons in treatment planning." The "MAXFRAME 3D II Software" is a component of the "MAXFRAME™ Multi-Axial Correction System," which is an "external ring fixation system." This implies it's an assistive tool for a human-in-the-loop workflow (surgeons using the software for planning), not a standalone diagnostic algorithm designed to provide unassisted outputs.

While standalone software verification and validation was performed on the software alone to ensure its functionality and calculations are correct, this is distinct from proving clinical performance as a standalone diagnostic or assistive device in a clinical setting.

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

The specific type of ground truth used for the software's verification and validation is not explicitly stated. For a software re-write focused on treatment planning and calculation, the "ground truth" would likely be derived from:

• Engineering specifications and requirements: Ensuring the software correctly implements the intended algorithms and calculations.
• Comparison to predicate device's output: Confirming that the new software produces equivalent results to the previous, cleared version for identical inputs.
• Industry standards or clinically accepted formulas: For calculations related to limb lengthening, deformity correction, etc.

It's highly unlikely that expert consensus on diagnostic images, pathology, or outcomes data was used as the ground truth for this software re-write's V&V, given the nature of the device (treatment planning software for an external fixator).

8. The sample size for the training set:

This information is not applicable and not provided. The MAXFRAME 3D II Software is a software re-write of an existing system, and the description does not suggest it employs machine learning or artificial intelligence that would require a "training set" in the conventional sense. It is a deterministic rule-based or algorithmic software for planning.

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

This information is not applicable and not provided, as there is no indication of a machine learning component requiring a training set with established ground truth.

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The DePuy Synthes Variable Angle Locking Patella Plating System is indicated for the fixation and stabilization of patellar fractures in normal and osteopenic bone in skeletally mature patients.

The DePuy Synthes Variable Angle Locking Patella Plating System is comprised of single-use, sterile implants which will be placed on the lateral rim and on the anterior surface of the fractured patella to provide fixation during bone healing. The system offers both a small and a large plate to provide fixation for various patella fracture patterns. The subject plates are available sterile and are manufactured from implant grade stainless steel or titanium.

The system also consists of sterile, non-implantable templates that correspond to the implants. Templates are intended to help determine proper sizing and help predict contoured shape of the implant.

The provided text ("K210408") is a 510(k) premarket notification for a medical device: the DePuy Synthes Variable Angle Locking Patella Plating System. This type of FDA submission is for devices seeking substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/ML performance metrics, sample sizes for test/training sets, expert adjudication, or MRMC studies.

The "Non-clinical performance data" section refers to:

• Mechanical testing: This is to demonstrate "substantially equivalent" performance to the predicate device under static and dynamic loading conditions. This is not a clinical study and doesn't involve "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic or AI-driven device.
• Magnetic Resonance compatibility testing: To establish MR Conditional parameters.
• Endotoxin testing: To meet specified endotoxin requirements.

The "Clinical performance data" section explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

In summary, the provided document does not describe the kind of study and acceptance criteria you're asking about, which are typically associated with AI/ML-driven diagnostic or image analysis devices. This document is for a mechanical orthopedic implant demonstrating substantial equivalence based on engineering and material performance, not clinical outcome or algorithmic performance.

Therefore, I cannot populate the table or answer the specific questions about AI/ML study design and performance metrics based on the provided text.

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DePuy Synthes 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates and Proximal Femur Hook Plates are indicated for the treatment of periprosthetic fractures in the presence of intramedullary implants in the proximal end segment and the proximal and middle 1/3 of the diaphyseal segment of the femur, and non-unions of such fractures, in adult patients, particularly in osteoporotic and osteopenic bone.

DePuy Synthes 3.5 mm VA Locking Attachment Plate is indicated to augment the stabilization of fractures, including periprosthetic fractures (Vancouver Type B when used with either the 3.5 mm VA-LCP PPFx Proximal Femur Plate or Proximal Femur Hook Plate; Vancouver Type B and C when used with other DePuy Synthes LCP plates and VA-LCP plates) and fractures in the presence of intramedullary implants, in the femur, tibia, and humerus.

DePuy Synthes 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plates (when used with either 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate or the Proximal Femur Hook Plate) can be used to extend the length of a plate construct to the lateral condyles.

DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Ring Attachment Plates (when used with 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plate) are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.

DePuy Synthes 3.5 mm VA Locking PPFX Greater Trochanter Hook Plates are indicated for fixation or re-attachment of the greater trochanter following fracture or osteotomy.

The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System of Stainless Steel Plates for periprosthetic fractures. It consists of plates that offer screw to plate non-locking constructs, locking constructs or a combination of both. The plates accept commercially available DePuy Synthes Stainless Steel 3.5 mm cortex screws, 3.5 mm (variable angle) locking screws, 4.5 mm cortex screws and 5.0 mm (variable angle) locking screws, as well as the Synthes Orthopaedic Cable system.

The DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System offers:
• 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Plates
• 3.5 mm/4.5 mm VA-LCP PPFx Proximal Femur Hook Plates
• 3.5 mm VA Locking PPFx Distal Femur Spanning Attachment Plate
• 3.5 mm VA Locking PPFx Greater Trochanter Hook Plate
• 3.5 mm VA Locking PPFx Greater Trochanter Ring Attachment Plate
• 3.5 mm VA Locking Attachment Plate

This document is a 510(k) Premarket Notification from the FDA for a medical device. It describes the device, its intended use, and its comparison to predicate devices, along with non-clinical performance data. However, it does NOT describe an AI/ML powered device, nor does it contain any information about a study proving device meets acceptance criteria related to AI/ML performance, such as human reader improvement with AI assistance, standalone algorithm performance, or the establishment of ground truth by multiple experts.

Therefore, I cannot provide the requested information. The document focuses on the substantial equivalence of a physical orthopedic implant system to existing predicate devices, based on mechanical, MRI compatibility, sterilization, shelf-life, and biological safety testing. It does not mention any AI or machine learning components.

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The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including:

• Supracondylar fractures, including those with intra-articular extension
• Combination of ipsilateral condylar and diaphyseal fractures
• Ipsilateral femur/tibia fractures
• Femoral fractures in multiple trauma patients
• Periprosthetic fractures
• Fractures in the morbidly obese
• Fractures in osteoporotic bone
• Impending pathologic fractures
• Malunions and nonunions

The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm are indicated for the static and dynamic interlocking of femoral, humeral and tibial nails.

The proposed Retrograde Femoral Nail Advanced System is being developed to address challenges associated with treating distal femur fractures with intramedullary nails. The system is modular in nature, incorporating several components to allow for the treatment of a variety of fracture patterns and in the presence of previously implanted devices such as the femoral components of a total knee arthroplasty (periprosthetic). The nailing implants are available in two different bends which enable standard and periprosthetic entry points for the insertion of the nailing implant in the femur. The implants in this submission are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions. The DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm feature a retaining screw head recess, additional shorter, rounded cutting flutes the ability to drive under power. The screws feature either a standard screw head or a low-profile screw head and are available with standard washers and nuts.

The provided text ({0}-{5}) does not contain information about acceptance criteria or a study that uses a test set, ground truth, or human readers for performance evaluation. This document is a 510(k) premarket notification letter for a medical device (DePuy Synthes Retrograde Femoral Nail Advanced System and Locking Screws).

The text explicitly states:
"Clinical testing was not necessary for the determination of substantial equivalence." (Page 4, under "Clinical Performance Data")

Instead, the submission relies on non-clinical performance data to demonstrate substantial equivalence to predicate devices. These non-clinical tests are primarily mechanical and material tests conducted according to ASTM standards.

Therefore, I cannot populate the requested information regarding acceptance criteria, reported device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.

The information that is present regarding performance comes from non-clinical engineering tests:

• Non-clinical Performance Data for Retrograde Femoral Nail Advanced System:

  • Static Bend according to ASTM F1264
  • Static Torsion according to ASTM F1264
  • Dynamic Bend according to ASTM F1264
  • Mechanical Static Construct
  • Poly Inlay Screw Pull Out Test and Debris Evaluation

• Non-clinical Performance Data for DePuy Synthes Locking Screws for Medullary Nails, 5.0:

  • Torsional Properties according to ASTM F543
  • Driving Torque & Axial Pushout according to ASTM F543
  • Driving Torque according to ASTM F543
  • Self-tapping Performance according to ASTM F543
  • Finite Element Analysis for 3-Point Bending according to ASTM 1264

• Other Additional Analysis:

  • Endotoxin Testing according to AAMI ST72
  • MRI Conditional analysis performed (though not released with MR Conditional labeling)

These tests are designed to show that the mechanical properties and safety (e.g., in terms of materials and manufacturing) of the new device are comparable to those of existing, legally marketed predicate devices, thereby establishing "substantial equivalence" without requiring human-data-based clinical performance studies.

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Neuro:

• Neurosurgery
• Nasoethmoidal fractures
• Infraorbital area fractures
• Frontal sinus wall Fractures
• Infant craniofacial surgery
  Dental:
• Maxillofacial surgery

The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:

• Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and maxillofacial surgery
• Neurosurgery: osteosynthesis of the cranial bones.

Dental: The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandbular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
Neuro: The DePuy Synthes Single Vector Distractor with Detachable Feet can be used for stabilization and advancement of the mid-face, in which a deficiency of mid-facial bone requires gradual bone distraction. Such deficiencies include, but are not limited to Plagiocephaly, Trigonocephaly, Scaphocephaly, and Brachycephaly.

The DePuy Synthes Cranial Tube Clamp is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Dental: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

Dental: The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy, the midface utilizing a LeFort II or III osteotomy in adult and pediations where gradual bone distraction is required.
Neuro: The DePuy Synthes External Midface Distractor is intended for use in craniofacial surgery and reconstructive procedures. Specifically, it is intended for distraction of the cranium utilizing a monobloc osteotomy in adult and pediativ populations where gradual bone distration is required.

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: Neuro:
• Nasoethmoidal fractures

• Infraorbital area fractures
• Frontal sinus wall fractures ●
• Infant craniofacial surgery
  Dental:
• Maxillofacial surgery

Dental: DePuy Synthes Neuro Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: DePuy Synthes Neuro Plate and Screw System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Dental: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.
The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.

Dental: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

The DePuy Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

The DePuy Synthes MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

The DePuy Synthes Maxillofacial Titanium Micro set consists of titanium bone plates (shapes include L,Y,H,T, Double-Y, Mesh and Straight) and self-tapping screws.

The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system manufactured from titanium. The plates are available in a variety of shapes and sizes, and attach to bone via 2.0 mm, 2.4 mm or 2.7 mm screws.

The DePuy Synthes Single Vector Distractor with Detachable Feet is a subcutaneous bone distractor activated by a drive component. It features two telescoping components activated by a jack screw, fixed to the bone with bone screws. Bone lengthening and distraction are achieved by gradually activating the device. Upon removal, the telescoping components and jack screw are disengaged and removed, leaving the subcutaneous foot plates in the patient.

The DePuy Synthes Cranial Flap Tube Clamp consists of two clamp discs with a clamp shaft in between the discs. The clamp shaft consists of a 1.6 mm tube which is secured to the bottom disc. The top disc has a thickness of 0.4 mm and the plate diameters range from 8.0 to 20. mm.

The DePuy Synthes Low Profile Neuro System consists of titaniurn plates, and screws in a variety of shapes and sizes designed for various cranio-facial procedures.

Synthes ø1.6 mm Low Profile Neuro System self-drilling, self·tapping, and ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system.

The DePuy Synthes 1.3 & 1.5 mm Contourable Ti. Mesh Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile and for single use only.

The DePuy Synthes External Midface Distractor is an external distraction osteogenesis device that attaches to the cranium and midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels (including monobloc). The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla.

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are either self-drilling or self tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths.

DePuy Synthes Neuro Plate and Screw System consists of plates, burr hole covers, and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium alloy and are intended for single use only.

The DePuy Synthes 1.6 mm burr hole covers come in various sizes to accommodate various fracture and osteotomy sites, have a low plate/screw head profile and use existing (previously cleared) 1.6 mm or 1.9 mm emergency self-tapping and self-drilling screws. The DePuy Synthes 1.6 mm Burr Hole Covers have 5 lobes to accommodate a shunt/drain and are available in 12, 15, 17, and 24 mm diameters with a plate thickness of 0.5 mm.

The DePuy Synthes Craniofacial Plate and Screw System consist of plates and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, infants, and neonates. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs. The distractor body is first assembled with the desired footplates, and then the footplates are secured to bone using the bone screws. After implantation the distractor is activated through the rotation of an advancement/lead screw with an activation instrument percutaneously.

The DePuy Synthes Orbital Plates, components of the Synthes Craniofacial Plate and Screw System, consist of anatomically shaped orbital plates that come in various sizes and configurations to fit the patient anatomy. These devices are designed for use with DePuy Synthes craniofacial bone screws commercially available in the U.S. System components are manufactured in titanium and are intended for single use only.

The DePuy Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The reconstruction meshes are manufactured from titanium, are designed for use with DePuy Synthes MatrixNEURO Cranial Plating System screws, are offered sterile, and are intended for single use only.
The screws are manufactured from titanium alloy, are designed for use with DePuy Synthes MatrixNEURO plates, burr hole covers, and meshes, maybe be offered sterile or non-sterile, and are intended for single use only.

The DePuy Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The DePuy Synthes MatrixNEURO Preformed Meshes are precontoured to cover common cranial defects manufactured from grade 2 titanium that are designed for use with MatrixNEURO Cranial Plating System screws. The Preformed Meshes are offered sterile packed and are intended for single use only.

The provided text is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) regarding several DePuy Synthes Craniomaxillofacial Neuro Devices. It describes changes to the labeling of these devices to indicate "MR Conditional" use.

The document consistently states that the purpose of the submission is to add MR Conditional information to the device labeling. It explicitly mentions that the intended use and technological characteristics of the devices remain unchanged. This implies that the devices are already cleared for their stated indications and the current submission is concerned with demonstrating their safety in an MR environment.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to support the MR Conditional safety of the devices. This is not a study proving clinical effectiveness or diagnostic accuracy of an AI/algorithm-based device, but rather a set of engineering tests to confirm a physical device's compatibility with an MR environment.

Based on the provided text, here's how to address your request:

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

The document repeatedly cites the ASTM standards as the basis for performance testing, which inherently contain acceptance criteria within them. The document does not provide specific quantitative performance results for each device against these criteria, but rather states that "Non-clinical testing is provided to support the conditional safety." This implies that the devices met the acceptance criteria defined by these ASTM standards.

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

• Sample Size: The document does not specify the number of individual devices or prototypes tested for each type of assessment (displacement, torque, heating, artifacts). These are engineering tests typically performed on representative samples.
• Data Provenance: The data provenance is "non-clinical testing" conducted by the manufacturer, DePuy Synthes. The "DUKE model" for RF heating is mentioned, which is a widely accepted phantom model for electromagnetic simulations in medical device testing. There's no information about the country of origin of the data beyond it being part of a US FDA submission. It is a prospective test in the sense that the testing was conducted to support the MR Conditional labeling.

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 in the context of this submission. The "ground truth" for MR Conditional safety is established by engineering tests against recognized consensus standards (ASTM), not by human expert review of clinical cases. The tests directly measure physical properties like temperature increase or magnetic force, and these measurements are compared to the limits specified in the standards.

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

Not applicable. This is not a human reader study requiring adjudication. The assessment is based on objective physical measurements and adherence to ASTM 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 submission is for physical medical devices (implants), not an AI/algorithm-based diagnostic or assistive software. No MRMC study was performed because the device is not an AI reading tool.

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

Not applicable. This is not an algorithm, so standalone performance is irrelevant. The tests are for the physical properties of the implants.

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

The "ground truth" for these tests is defined by the physical laws and empirically derived thresholds outlined in the ASTM standards for MR compatibility. For example, a certain temperature rise in a standard phantom model is deemed acceptable if it remains below a specified limit.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning or AI model.

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

Not applicable, as there is no training set.

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