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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 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 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)

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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