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Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions.

One-Quarter Tubular Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius). The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Straight Plates 2.4/2.7 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the foot, hand, wrist, and forearm (including radius) and arthrodesis of small bones of the foot and hand.

Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius)

Radius Distal Styloid Plate 2.4/2.7 is indicated for the fixation for fractures of the radial styloid that have metaphyseal comminution or as an adjunct to either volar of dorsal plate fixation when additional support of the radial styloid is required.

The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures.

The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius.

One-Third Tubular Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), and fibula. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus

Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula.

Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia.

The Clavicle Superior Plates 3.5 are indicated for:

• Fractures of the clavicle shaft
• Fractures of the lateral clavicle
• Malunions of the clavicle
• Non-unions of the clavicle

The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus.

The Tibia Proximal Lateral Plates 3.5 are indicated for:

• Split-type fractures of the lateral tibial plateau
• Lateral split fractures with associated depressions
• Pure central depression fractures
• Split or depression fractures of the medial plateau

The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for

• Intraarticular fractures of the distal humerus
• Supracondylar fractures of the distal humerus
• Non-unions of the distal humerus

The Humerus Distal Medial Plates 2.7/3.5 are indicated for

• Intraarticular fractures of the distal humerus
• Supracondylar fractures of the distal humerus
• Non-unions of the distal humerus

The Ulna Proximal Olecranon Plates 3.5 are indicated for

• Complex extra- and intra-articular olecranon fractures
• Non-unions of the proximal ulna
• Osteotomies
• Simple olecranon fractures

Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia.

T Plate 4.5/5.0 is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

T-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

LL-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur

Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia.

The Genostis Osteosynthesis System comprises of fracture fixation plates, corresponding screws and required surgical instruments. Different shapes and sizes are available to accommodate for different anatomical regions and locations of fractures. The plate screw interface is either locking, non-locking or, for some plates, realized by a combination hole offering both options (locking and non-locking).

All plates and screws are made of titanium alloy (Ti 6Al 4V ELI) according to ASTM F136 and ISO 5832-3.

The implants of the Genostis Osteosynthesis System are sterilized by radiation and are delivered sterile.

The provided FDA 510(k) clearance letter for the Genostis Osteosynthesis System does not describe a study involving an AI/software device or human readers. Instead, it describes a traditional medical device (bone fixation plates and screws) and primarily references non-clinical (biomechanical and biocompatibility) testing to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested criteria related to AI/software performance, human reader studies, and ground truth establishment in a diagnostic context are not applicable to this document.

However, I can extract and structure the information that is relevant to the device's acceptance criteria based on the provided text, particularly concerning non-clinical testing.

Here's the breakdown based on the information available:

Acceptance Criteria and Study for Genostis Osteosynthesis System

The Genostis Osteosynthesis System is a traditional medical device (bone fixation plates and screws), not an AI/software diagnostic device. As such, the "acceptance criteria" and "study" proving it meets them are primarily based on non-clinical engineering and biological tests, not AI performance metrics or human-in-the-loop diagnostic studies.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All results were satisfactory" for all tests, indicating the device met the pre-defined acceptance criteria for each test.

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

• Sample Size: The document does not specify the exact number of units or samples used for each biomechanical or biocompatibility test. It generally states that testing was "performed" and "conducted on final sterile product."
• Data Provenance: Not explicitly stated as "country of origin," but testing would be performed in a controlled laboratory environment. The tests are non-clinical (biomechanical and biocompatibility), not data from patients. The study is by nature prospective in that new manufactured devices were tested to meet the standards, not a retrospective analysis of existing data.

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

• Not Applicable. This is a medical device (hardware) clearance, not an AI/software diagnostic device that requires expert ground truth for interpretation of medical images or other diagnostic data. The "ground truth" here is the adherence to established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical mechanical and biocompatibility testing, there is no "adjudication" in the sense of reconciling expert opinions on diagnostic findings. The results are quantitative and objective measurements against established standard thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Not Applicable. MRMC studies are for evaluating clinical interpretation of diagnostic results, typically with AI assistance. This device is a physical implant, not a diagnostic tool or AI.

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

• Not Applicable. This pertains to AI algorithm performance. The device is a bone fixation system and does not rely on an algorithm for its primary function.

7. The Type of Ground Truth Used

• Pre-defined Standards and Controls: The "ground truth" for this device's performance is established by well-defined, internationally recognized (ISO) and American (ASTM) standards for material properties, mechanical strength, and biocompatibility. The device must perform within the specified parameters of these standards. For example, screws must meet certain torque resistance (ASTM F543), and plates must meet specific load-sharing characteristics (ASTM F382).

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not Applicable. There is no "training set" for this type of medical device clearance. The design and manufacturing processes are established based on engineering principles and existing predicate device designs, with performance validated against the standards mentioned above.

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The OsteoCentric Bone Plate and Screw is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including, but not limited to periarticular, and intraarticular fractures

The OsteoCentric Bone Plate and Screw System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bones and bone fragments. The system features nineteen (19) types of plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel (ASTM F138), and offered in various widths and lengths.

The provided text is a 510(k) summary for the OsteoCentric Bone Plate and Screw System. It details the device's characteristics, indications for use, and a comparison to predicate devices, but it does not contain information about an AI/ML-based medical device or any study proving a device meets acceptance criteria related to AI/ML performance.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these concepts are not discussed in this document. The document describes a traditional medical device (bone plates and screws) and relies on substantial equivalence to previously cleared predicate devices, primarily through engineering analysis and existing performance testing of those predicates (ASTM F543 and ASTM F382).

The 510(k) clearance process for this type of device does not involve the kind of performance studies (e.g., clinical trials, AI algorithm validation) that would generate the data you're asking about.

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The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.

The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.

Gruber Lapidus

The Gruber Lapidus Plates 2.7 combined with the Standard/Locking/ MiniCAN screws 2.7 are indicated for TMT I joint arthrodesis with cuneiforme transfixation for correction of hallux valgus deformity.

Plantar Lapidus

The Plantar Lapidus Plates 2.7 combined with the Standard/Locking Screws 2.7 and the MiniCAN screws 3.5 are indicated for TMT I joint arthrodesis.

Tarsalis

The Tarsalis Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for Lisfranc fusions and fracture fixation of the forefoot and midfoot.

The RECON system – Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:

• Gruber Lapidus Plates 2.7, .
• . Plantar Lapidus Plates 2.7,
• Tarsalis Plates 2.7, ●
• Locking Screws 2.7 ●
• Standard Screws 2.7
• Minican Screws 2.7/3.5

of different sizes and designs.

The plates and screws are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).

The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.

This document describes a 510(k) premarket notification for the RECON system - Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics. Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and detailed ground truth establishment) are not applicable to this type of regulatory submission.

However, based on the provided text, here's an attempt to address your request:

Acceptance Criteria and Study for the RECON system - Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and not a standalone performance study with predefined clinical acceptance criteria, the "acceptance criteria" are implied by the performance characteristics demonstrated to be "similar" or "substantially equivalent" to legally marketed predicate devices. The "reported device performance" is characterized by meeting these similarity benchmarks.

The non-clinical performance data aimed to demonstrate that the subject device's mechanical properties and biocompatibility are comparable to those of the predicate devices, thereby ensuring similar safety and effectiveness.

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

This is a non-clinical (bench) testing study, not a clinical trial. Therefore, the concept of a "test set" for clinical performance, with associated data provenance, is not applicable. The non-clinical tests involved physical samples of the devices. The document does not specify the exact number of physical samples used for each mechanical test. Data provenance is internal to Normed Medizin-Technik GmbH in Germany, as described in the "Submission Sponsor and Correspondent" section. The data is prospective, generated specifically for this submission.

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

Not applicable. Ground truth for non-clinical engineering tests is established by standardized testing methods and measurement instruments, not by expert consensus.

4. Adjudication Method for the Test Set

Not applicable, as it's a non-clinical bench testing study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This device is not an AI/software device that would typically undergo such a study.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device (plates and screws), not an algorithm or AI.

7. Type of Ground Truth Used

For non-clinical performance, the "ground truth" is defined by the physical properties of the materials and designs, measured through standardized mechanical tests. For biocompatibility, it's adherence to international standards (ISO 10993-1).

8. Sample Size for the Training Set

Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a training set.

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

Not applicable, as there is no training set for this type of device.

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The implants are intended to support normal bone healing for osteotomies, fractures, non-unions and reconstructions.

The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, non-unions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in both adult and pediatric patients.

The RECON system – V-TEK-IVP Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:

• V-TEK™ IVP Micro XS Plate 2.7, ●
• V-TEK™ IVP S Plate 2.7, .
• V-TEK™ IVP S. L-Plate 2.7 .
• . V-TEK™ IVP M Plate 2.7
• V-TEK™ IVP M Plate 3.5 .
• . V-TEK™ IVP L Plate 2.7
• V-TEK™ IVP L Plate 2.7 / 3.5
• . Titanium Screw Fully Treaded 2.7/3.5

of different sizes and designs.

The plates and screws are made of titanium alloy Ti-6AI-4V (ASTM F136).

The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.

This document is a 510(k) premarket notification for the RECON system - V-TEK-IVP Plates and Screws. It describes the device and its intended use, and argues for its substantial equivalence to several predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail sense for device performance. Instead, it relies on comparison to predicate devices and established standards. The reported device "performance" is primarily described as having "similar mechanical properties and performance" to the predicate devices.

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

The document describes non-clinical performance data which includes biocompatibility and mechanical testing.

• Sample Size: The document does not specify the exact sample sizes used for the mechanical testing or biocompatibility studies. It only states that testing was "conducted and evaluated."
• Data Provenance: The data is from non-clinical laboratory testing performed on the devices themselves, not from human or animal subjects. Thus, there is no country of origin of data or retrospective/prospective classification in the clinical sense.

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

This document does not involve a study with a "test set" requiring expert ground truth establishment in the context of diagnostic or interpretive performance. The studies are engineering and biocompatibility tests of a physical medical device (bone plates and screws).

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" requiring expert adjudication for ground truth.

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 submission for a physical orthopedic implant (bone plates and screws), not a diagnostic or AI-assisted device. Therefore, no MRMC study or AI performance evaluation was conducted or is relevant.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical performance data, the "ground truth" is based on:

• Biocompatibility: Adherence to the Pass/Fail criteria defined within the ISO 10993-1 standard for biological evaluation of medical devices.
• Mechanical Testing: Comparison of the measured mechanical properties (proof load, bending strength, fatigue strength, torque, pullout, etc.) of the subject device against those of the legally marketed predicate devices, with the aim of demonstrating "similar" performance. The implicit ground truth here is that the predicate devices have established safety and effectiveness.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or AI, and therefore has no "training set."

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

Not applicable. There is no training set for this type of device submission.

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