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Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries as bone fixation cerclage, specifically:

• Sternotomy indications including the "rewiring" of osteomized sternums;
• Repair of long bone fractures due to trauma or reconstruction.

Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries for internal fixation of discontinued bone structures. The product are not to be used in conjunction with other bone fixation implants, like plates. The surgical sutures and tapes are made of UHMWPE (ultra-high molecular weight polyethylene), the needles are made in AISI300 steel series, according to the standard ASTM F899 and cerclage is assembled on an ABS loader, additional instruments may be used as well. Those materials are identical to those used in other cleared GMReis devices like the reference device cleared under K223114. It is provided in sterile condition sterilized by Ethylene Oxide.

Based on the provided FDA 510(k) clearance letter for the Stitch Cerclage - Suture System, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is an FDA 510(k) clearance letter, which means the device has already been cleared. This letter summarizes the regulatory decision and mentions that studies were performed, but it does not contain the detailed study protocols, results, or data itself. Therefore, I will extract all available information and explicitly state when information is not present in this document.

Acceptance Criteria and Device Performance Study Summary

The acceptance criteria for this device are largely implied through the comparison to a predicate device and the successful completion of specified mechanical tests. The performance study focused on demonstrating substantial equivalence to the predicate device, particularly in mechanical properties relevant to its intended use as a bone fixation cerclage.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of test specimens, number of cycles for fatigue) used for the mechanical testing. It mentions "chemical composition, creep test, tension static and fatigue tests."
• Data Provenance: The studies were conducted by the manufacturer, GM Dos Reis Industria e Comercio Ltda, which is based in Campinas, Brazil. The data is based on mechanical testing, not clinical data, and therefore is not characterized as retrospective or prospective in the usual clinical sense. It's laboratory-based performance data.

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

• For this type of mechanical device clearance, "ground truth" is established through engineering standards, validated test methodologies, and comparison to the known performance of predicate devices.
• The document does not mention the use of human experts (like radiologists) for "ground truth" establishment as would be common for AI/imaging device clearances. The "experts" involved would be engineering and quality control personnel at the manufacturer and potentially external testing laboratories, ensuring compliance with test methodologies.

4. Adjudication Method for the Test Set

• Since this is a mechanical device performance study, no explicit "adjudication method" in the sense of clinician consensus on medical images is applicable or mentioned. The "adjudication" is inherent in the adherence to established mechanical testing protocols and statistical analysis of the results to demonstrate equivalence to the predicate.

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

• No MRMC study was done. This type of study is specifically relevant for imaging devices or AI algorithms where human readers' performance is being evaluated or augmented. The Stitch Cerclage Suture System is a physical medical device, not an imaging or AI diagnosis system.
• The document explicitly states: "No clinical data were included in this submission."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Not applicable. This concept pertains to AI algorithms. The Stitch Cerclage Suture System is a physical product and does not have an "algorithm-only" performance component.

7. Type of Ground Truth Used

• The "ground truth" for this device type is established through objective, quantifiable mechanical properties and material composition, compared against established industry standards (where available) or the performance of a legally marketed predicate device.
• Specifically, the study compared "chemical composition, creep test, tension static and fatigue tests" to information from a published article ("Cerclage Performance Analysis – a Biomechanical Comparison of Different Techniques and Materials", L. M. Hägerich, et al, Musculoskeletal Disorders (2022)) and to the predicate device.

8. Sample Size for the Training Set

• Not applicable / Not mentioned. This device is a physical product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process would involve internal validation and verification activities, but this is distinct from training an AI model.

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

• Not applicable. As there is no AI "training set," there is no ground truth established for one. The "ground truth" for the device's design and manufacturing is derived from engineering principles, relevant material standards (e.g., ASTM F899 for steel), and performance expectations set by the predicate device.

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Versalock Upper Limb Plating System are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, and ulna.

Versalock Upper Limb Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates and screws are made from titanium alloy or pure titanium. The plates range in thickness from 1.4 to 3.5 mm, and the screws range in diameter from 2.0 to 3.5 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. Versalock Upper Limb Plating System are for single use and the devices are provided non-sterile. They must be properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

This document describes the Versalock Upper Limb Plating System, a medical device for internal bone fixation. However, it is a 510(k) Premarket Notification for a Class II medical device, specifically metallic bone fixation appliances and accessories. These types of devices generally rely on mechanical testing to demonstrate substantial equivalence rather than clinical studies involving human patients or AI performance metrics.

Therefore, many of the requested elements for a study proving acceptance criteria (such as sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance) are not applicable in this context. The acceptance criteria and "study" described herein are based on mechanical performance standards.

Here's an analysis of the provided information, focusing on what is available:

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

Explanation: The acceptance criteria for this device are defined by its ability to meet established mechanical testing standards (ASTM F382 for plates and ASTM F543 for screws) and demonstrate substantial equivalence to legally marketed predicate devices. The "reported device performance" is that it successfully met these criteria.

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

• Sample size: Not explicitly stated as a "test set" in the context of clinical or AI performance. For mechanical testing, the sample size would refer to the number of plates and screws tested per configuration. This information is typically detailed in the test reports, which are not included in this summary.
• Data provenance: Mechanical testing is conducted under controlled laboratory conditions, not on human data. The specific lab where the testing was performed is not mentioned, but the manufacturer is based in Brazil.

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

• Not Applicable. This device does not involve expert-established ground truth in the way an AI diagnostic device would. Its performance is assessed through objective mechanical properties.

4. Adjudication method for the test set

• Not Applicable. There is no "adjudication method" as understood in clinical studies with human observers. Mechanical testing results are compared against the accepted performance parameters of the ASTM standards and the predicate devices.

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 not an AI-assisted device, nor is it a diagnostic device that would involve human readers.

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

• Not Applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this medical device is adherence to established mechanical performance standards (ASTM F382 and F543) and factual data demonstrating substantial equivalence in material, design, and performance to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI model.

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

• Not Applicable.

In summary: The provided document is an FDA 510(k) clearance for a bone plating system. The "study" proving the device meets acceptance criteria is a series of mechanical tests conducted according to ASTM standards (F382 for plates, F543 for screws), which confirmed the device is mechanically equivalent to its predicate devices. The acceptance criteria are essentially defined by these standards and the equivalence to existing cleared devices. Information relevant to AI/clinical performance metrics (like expert reviews, reader studies, ground truth establishment for AI) is not relevant to this type of device submission.

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Versalock Mini and Micro Plating System is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and foot. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone.

Versalock Mini and Micro Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates are made from commercially pure titanium allov and the bone screws are manufactured from titanium alloy only. The plates range in thickness from 0.6 to 1.7 mm, and the screws range in diameter from 1.3 to 2.7 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. Versalock Mini and Micro Plating System are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

This document is a 510(k) premarket notification for a medical device called the "Versalock Mini and Micro Plating System." As such, it describes the device and its intended use, and argues for its substantial equivalence to previously cleared predicate devices. It does not present acceptance criteria for a device's performance, nor a study proving it meets such criteria in terms of clinical or diagnostic efficacy.

Instead, the provided text describes the mechanical performance testing conducted to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study effect size, standalone performance, training set details) are not applicable or available in this document.

Here's a breakdown of what is available based on the given text:

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

This document does not present specific acceptance criteria in terms of clinical or diagnostic performance, nor does it report such performance for the device. Instead, it states that:

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

• Test Set Sample Size: Not applicable. This document refers to mechanical testing, not a clinical trial or diagnostic study with a "test set" of patient data. The "sample size" would refer to the number of plates and screws tested mechanically. This specific number is not provided in the document.
• Data Provenance: Not applicable. The data provenance would be from laboratory mechanical testing.

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

Not applicable. This device is for fracture fixation, and the evaluation here is mechanical equivalence, not a diagnostic or clinical efficacy study requiring expert-established ground truth on patient data.

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

Not applicable. There is no "adjudication method" described for mechanical testing.

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

Not applicable. This is a physical bone plating system, not an AI-powered diagnostic device, and therefore no MRMC study would be relevant.

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

Not applicable. This is a physical bone plating system, not an algorithm.

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

Not applicable. For the mechanical testing, the "ground truth" would be established by the ASTM standard test methods (e.g., defined load limits, displacement measurements, failure points).

8. The sample size for the training set

Not applicable. This is a physical device, and the evaluation is for mechanical equivalence to predicate devices, not an AI model requiring a training set.

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

Not applicable. See above.

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GMReis Ankle Plating System are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle.

GMReis Ankle Plating System consists of plates and screws in a variety of designs and sizes that are commonly used in trauma and reconstructive surgery. The bone plates and screws are made from titanium alloy. The plates range in thickness from 1.8 to 3.6 mm, and the screws range in diameter from 2.7 to 3.5 mm. They are available on different sizes and shapes, according to the implantation site and the extension of the fracture. GMReis Ankle Plating System are for single use. The devices are provided non-sterile and must being properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

This document, K242998, describes a 510(k) premarket notification for the "GMReis Ankle Plating System." This is a medical device, specifically bone plates and screws, and the submission aims to demonstrate its substantial equivalence to previously marketed predicate devices.

The request asks for information about the acceptance criteria and the study that proves the device meets them, specifically in the context of an AI/software-driven medical device. However, the provided document does NOT contain information about an AI/software component, nor does it detail acceptance criteria related to a diagnostic or analytical performance study typical of AI/software devices.

Instead, this document focuses on establishing substantial equivalence for a physical orthopedic implant through:

• Comparison of Technological Characteristics: Showing similarity in design, intended use, materials, manufacturing processes, and sterilization methods to predicate devices.
• Performance Data (Mechanical Testing): Demonstrating the physical performance of the plates and screws according to well-established ASTM standards for metallic bone fixation devices.

Therefore, I cannot provide the requested information regarding AI/software specific acceptance criteria, test set sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone AI performance, or training set details, as this information is not present in the provided document.

The "acceptance criteria" for this specific device (GMReis Ankle Plating System) are implicitly met by demonstrating that its mechanical performance is comparable to or better than the predicate devices, and that its materials and manufacturing processes are substantially equivalent.

Here's a breakdown of what can be extracted from the document, tailored to the spirit of your request but acknowledging the different nature of the device:

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

Note: The document states "Based on submitted testing data, the subject device is equivalent to the predicate devices." The specific numerical or statistical results of these mechanical tests that demonstrate equivalency are not provided in this summary, but the assertion is that the acceptance criteria for mechanical performance (i.e., meeting or exceeding predicate performance as per ASTM standards) were met.

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

• No information provided regarding sample sizes for human clinical data or diagnostic test sets, as this is a mechanical device primarily evaluated through engineering tests, not a diagnostic AI.
• Data Provenance: The mechanical testing data would typically be generated in a lab setting, presumably by the manufacturer (GM Dos Reis Industria e Comercio Ltda) from Brazil, as they are the submitter. The document does not specify the country of origin of the test data directly, but it would be expected to come from their internal or contracted testing facilities.

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

• Not applicable. This pertains to establishing ground truth for diagnostic accuracy, which is not relevant for this physical device. Mechanical testing results are based on objective physical measurements against standards, not expert interpretation.

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

• Not applicable. No expert adjudication is described or required for mechanical testing of this nature.

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

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

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

• Not applicable. This refers to AI algorithm performance.

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

• Not applicable directly. For mechanical testing, the "ground truth" is defined by the objective performance requirements outlined in the ASTM standards (e.g., specific load-bearing capacities, fatigue life). Compliance with these standards serves as the "truth" for the device's physical performance.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set."

In summary, the provided FDA 510(k) clearance letter and summary for the GMReis Ankle Plating System clearly indicate that this is a physical implant device, and its safety and effectiveness (specifically substantial equivalence) are demonstrated through a comparison of physical characteristics and mechanical performance testing, not through AI/software validation studies.

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The EXPERT - Flexible Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting. The EXPERT - Flexible Joint Fixation System are intended to provide fixation during the healing process following:

EXPERT FAST - SYNDESMOSIS and EXPERT FAST DUAL:

Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

EXPERT ACL and EXPERT ACL II:

Fixation of bone to bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, these models are offered for Anterior Cruciate Ligament (ACL) Repair.

EXPERT FAST - CORACOID PLATE and EXPERT FAST- AC:

Specifically, these models are intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The EXPERT - Flexible Joint Fixation System was designed for fixation, being used as a biomechanical structure to simulate a support pillar distributing the tensions in the suture wire or tape. The plates are manufactured in titanium alloy conforming to ASTM F136. The sutures are manufactured from UHMWPE. The devices are sold sterile and are single use. The EXPERT - Flexible Joint Fixation System is a line extension to the EXPERT - Joint Fixation System consisting of new models.

The provided text describes a medical device, the "EXPERT - Flexible Joint Fixation System," and its 510(k) summary for FDA clearance. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical or algorithmic performance study would.

The document discusses equivalence to predicate devices based on "submitted testing data" but does not detail the nature of these tests, specific acceptance criteria, or the results. It mentions:

• Performance Data: "Based on submitted testing data, the proposed EXPERT - Flexible Joint Fixation System is equivalent to the Arthrex ACL TightRope (K100652) and TightRopeTM Acromioclavicular (K052776) predicate devices." (Page 6)
• Conclusion: "Any differences between the proposed device and the predicate device are considered minor and do not raise new or different questions concerning safety or effectiveness." (Page 6)

This refers to engineering testing or benchtop studies to demonstrate the mechanical equivalence or biocompatibility of the device's components to previously cleared predicate devices, rather than a study evaluating diagnostic or prognostic capabilities of an AI/ML algorithm.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to a study proving the device meets these criteria in the context of AI/ML or clinical performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this particular device based on the provided text.

The information requested, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training set ground truth was established, is not present in the provided FDA 510(k) summary for the EXPERT - Flexible Joint Fixation System. This is typical for a 510(k) for a physical medical device like a fixation system, which focuses on substantial equivalence to predicate devices through technical, material, and mechanical comparisons, rather than AI/ML algorithm performance.

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The Versalock Rib and Sternum Plates System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternal reconstructive surgical procedures, rib and sternum fractures, fusions and osteotomies.

The Versalock Rib and Sternum Plates System is indicated for the stabilization and rigid fixation of chest wall fractures, including sternal reconstruction processes, trauma and/or planned osteotomies. The physical principle is based on rigid fixation, where the screws have a specific thread profile in their head, which, when fixed, allows the surgeon to fix it with a variable angle of ±15° in the threaded hole of the plate. The system also allows fixation with non-threaded head screws when the surgeon so desires. The devices are presented in Titanium Alloy according to the standard ASTM F136 and Pure Titanium According to ASTM F67.

This document describes a 510(k) premarket notification for the "Versalock Rib and Sternum Plates System". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel, high-risk device.

Therefore, the sections of your request related to "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample sizes used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for the training set was established" are not directly applicable in the context of this 510(k) submission for a metallic bone fixation appliance.

Instead, the submission relies on demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical performance testing to recognized consensus standards.

Here's a breakdown of the relevant information from the provided text, addressing your questions where possible within the context of a 510(k) submission for this type of device:

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

The document does not present a table of acceptance criteria and reported device performance in the manner typically seen for clinical diagnostic studies or novel performance claims. For a 510(k) for a metallic bone fixation device, "acceptance criteria" are generally met by demonstrating that the device's mechanical properties are comparable to or meet the requirements of established ASTM standards, which are considered sufficient to ensure safety and effectiveness for its intended use, similar to predicate devices.

The "reported device performance" is indicated by its successful testing against these standards, implying it met the performance expectations set forth by those standards.

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

• Sample Size: The document does not specify the exact number of samples used for each mechanical test. This level of detail is typically found in the full test reports, not in the 510(k) summary. However, recognized consensus standards like ASTM F543 and F382 usually dictate the minimum number of samples required for robust testing.
• Data Provenance: The testing was "non-clinical" and performed against recognized consensus standards (ASTM F543, ASTM F382, USP ). This implies laboratory-based mechanical and biological (pyrogen) testing. The country of origin of the data is not explicitly stated, but the manufacturer is based in Brazil, suggesting the testing could have occurred there or by a certified lab elsewhere. The data is prospective in the sense that these tests were conducted specifically for this submission.

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

N/A. For mechanical and biological performance testing of a bone fixation device, "experts" in the sense of establishing clinical ground truth (like radiologists reading images) are not applicable. The "ground truth" for this device is its physical and material properties, assessed by engineering and laboratory methods against established standards.

4. Adjudication method for the test set

N/A. Adjudication methods (like 2+1 reader consensus) are relevant for clinical studies, particularly in image interpretation or diagnostic pathways. This submission relies on objective mechanical and biological test results.

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

N/A. This is a medical device for physical fixation, not an AI/software device or a diagnostic tool requiring human reader interpretation. No MRMC study was conducted or is relevant for this device.

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

N/A. This device is not an algorithm or AI. It is a physical implant.

7. The type of ground truth used

The "ground truth" for this device, in the context of its 510(k) submission, is established through:
* Mechanical properties: Measured values obtained from testing according to ASTM F543 and ASTM F382, which serve as objective standards for bone fixation devices.
* Material composition: Conformance to ASTM F136 (Titanium Alloy) and ASTM F67 (Pure Titanium).
* Biocompatibility/Sterility related: Meeting pyrogen limit specifications per USP .
* Substantial Equivalence: Comparison to the design, materials, and intended use of legally marketed predicate devices (K161590, K161896).

8. The sample size for the training set

N/A. This is not an AI/machine learning device, so there is no training set in that context. If "training set" is meant as in "samples used for development and iterative testing," that information is not provided in the summary.

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

N/A. Not applicable for this type of device and submission.

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Quick - Radius Disposable Set is intended for fracture fixation, arthrodesis, reconstruction, and osteotomy fixation of the hand and wrist. The use of locking plate and screw systems is suited for treatment of fractures in osteopenic bone.

Quick - Radius Disposable Set are plate and instruments kit, for osteosynthesis procedures of the distal radius, in sterile condition, single use and disposable instruments after use. This sterile set must be used with 2.4mm screws, also sterile and individually packaged. The surgeon selects the best combination of plate size, left or right and screw designs and quantities, as needed. Single use and sterile templates are available, individually packed, for determining the size of the plate to be used. Also, as an option, individually packed plates, instruments only kit, and instruments with plates and screws kit, are available in sterile condition.

The plates and screws are produced with Titanium Alloy, according with standard ASTM F136, and the instruments are made of Stainless Steel, according with standard ASTM F899.

The provided text describes a 510(k) submission for a medical device, the "Quick - Radius Disposable Set." The document primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study against specific acceptance criteria for a novel device or an AI/algorithm-based diagnostic tool.

Therefore, the information required to populate the fields related to acceptance criteria, specific performance metrics, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/algorithm-based device is not present in the provided text.

The document states:

• "The proposed device is a line extension to the predicate device with new presentation forms." (Page 3, Section VI)
• "The proposed and predicate devices have the same basic design, intended use and biocompatibility profile." (Page 3, Section VI)
• "Difference between the proposed device and the predicate includes addition of a presentation form in a sterile condition." (Page 3, Section VI)
• "The subject Quick - Radius Disposable Set components possess the same technological characteristics as the predicate devices. These include: performance, shape and dimensions, material and manufacturing, sizes, biocompatibility and device usage." (Page 3, Section VII)
• "The EO sterilization has been validated to a sterility assurance level (SAL) of 10-6, according to ISO 11135" (Page 3, Section VII)
• "Any differences between the proposed device and the predicate device are considered minor and do not raise new or different questions concerning safety or effectiveness." (Page 3, Section VI and Page 4, Section VIII)

In conclusion, this submission is for a physical medical device (bone plates and screws set) seeking 510(k) clearance based on substantial equivalence to predicate devices, mainly through demonstrating equivalent design, materials, and a validated sterilization process. It does not involve software, AI, or diagnostic claims that would necessitate the types of performance studies and acceptance criteria typically associated with those technologies.

Therefore, I cannot fill in the requested table and answer the specific questions about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm, as the provided text does not contain such information. The "performance data" section in the document (Section VII) refers to the performance of the physical components (e.g., mechanical performance, biocompatibility) rather than diagnostic accuracy metrics.

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Cut Screw - Percutaneous Compression Screw are single use devices indicated for fixing and stabilizing the bones of the mid foot, metatarsal and phalanges of the foot using an appropriate relation bone-screw size.

The Cut Screw - Percutaneous Compression Screw for bone synthesis, with a hole in the center in order to allow the passage of the guide wire, thus facilitating its placement, as the surgeon is able to verify the positioning of the screw through the radiological image of the guide wire before its placement. In addition, the Cut Screw -Percutaneous Compression Screw, provides anatomical reduction, stable fixation, and preservation of blood supply by using a percutaneous incision. The screws have a hexagonal connection for a wrench. They are found in a variety of diameters to meet the range of anatomies of the patients, are presented in Titanium Alloy according to the standard ASTM F136, it could be provided in sterile condition sterilized by Ethylene Oxide or non-sterile condition to end user and must be cleaned, and steam sterilized before use.

The provided document is a 510(k) Premarket Notification for a medical device called "Cut Screw - Percutaneous Compression Screw." This document focuses on demonstrating substantial equivalence to an already legally marketed device (predicate device) rather than clinical performance (e.g., diagnostic accuracy of an AI/ML algorithm). Therefore, the information requested in your prompt, which pertains to the acceptance criteria and study design for proving the performance of a device, particularly for AI/ML-based medical devices, is not present in this document.

Specifically, the document states:

• "No clinical data were included in this submission." (page 5)
• The performance data provided is limited to non-clinical mechanical testing (Torsional Properties, Driving Torque, Axial Pullout Strength per ASTM F543) to demonstrate safety and efficacy in terms of mechanical properties. (page 5 & 6)

Therefore, I cannot provide answers to the questions regarding acceptance criteria, study types (MRMC, standalone), ground truth, sample sizes for test/training sets, or expert qualifications as these are not relevant to this type of device submission as described in the provided text.

The document's purpose is to show similarity in design, materials, and mechanical performance to an already approved device, rather than proving a new diagnostic or therapeutic capability through clinical studies.

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The Versalock Periprosthetic Femur Plates is indicated for temporary internal fixation and stabilization of fractures and osteotomies of the femur, including:

• · Periprosthetic fractures
• Comminuted fractures
• Supracondylar fractures
• Trochanteric fractures
• · Fractures in normal and osteopenic bone
• Non-unions and Malunions.

The purpose of this submission is to obtain marketing clearance for the Versalock Periprosthetic Femur Plates System which is composed of plates, screws and, a cerclage cable and related device.

The subject devices are designed for the treatment of femur fractures, particularly, periprosthetic femur fractures. The plates are available in the following design-types to be used according to the fracture location: Proximal and Distal Femur Periprosthetic Plates, Trochanteric Periprosthetic Plates and Condylar Femur Plates.

The plates are for use with the subject device screws to fix them to the bone. The following compatible screws are available for this purpose: Cortical Screws, Versalock Variable Angle Locking Screws, Versalock Variable Angle Screws, Versalock Variable Angle Cannulated Screws and Versalock Variable Angle Periprosthetic Screw. The Trochanteric Plate Fastening Screw is to connect one plate to another when a Trochanteric Periprosthetic Plates is used. The Versalock Spacer Screw is threaded into the plate hole prior to plate insertion to act as a spacer providing no contact between the plate and the bone surface.

The Gama Cable is a cerclage cable indicated to provide fixation and/or stabilization of the bone when it is not possible the usage of any screw. The Gama Cable related devices are the Gama Cable Lock and the Versalock Connector Screw. During the installation of the Gama Cable Lock is crimped to lock the movement of the cable, maintaining the tensioning applied while the Versalock Connector Screw , which holds the cable to the plate and set the proper cable routing position. The Gama Cable and related devices are used in conjunction with the Proximal or Distal Femur Periprosthetic Plates, or Condylar Femur Plates

The subject devices are made of made of titanium alloy (ASTM F136) with exception of the Gama Cable Lock which it is made of commercially pure titanium (ASTM F67). All the subject devices are coloredanodized.

The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in orthopedic surgeries.

The provided document is a 510(k) summary for the Versalock Periprosthetic Femur Plates System - GMReis. This document outlines the regulatory submission for a medical device and, as such, does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Therefore, many of the requested sections related to clinical studies, sample sizes for test and training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance will not be available in this document.

Here's a breakdown of the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of explicit acceptance criteria with specific numerical targets. Instead, it states that performance was demonstrated through mechanical testing according to established ASTM standards. The "performance" in this context refers to the device's mechanical integrity and functionality, rather than a clinical outcome.

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

• Sample Size: Not applicable. This document describes mechanical testing of physical device components, not a study involving patient data or a "test set" in the context of AI/diagnostic device performance. The sample sizes would refer to the number of plates, screws, and cables tested in the lab. This specific number is not provided, though it would typically be defined by the ASTM standards.
• Data Provenance: Not applicable. The data comes from internal mechanical testing, not patient data from a specific country or collected retrospectively/prospectively.

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

• Not applicable. Ground truth as typically defined for diagnostic AI/clinical studies (e.g., expert consensus on images, pathology results) is not relevant to this type of device submission. The "ground truth" here is the adherence to mechanical engineering standards, which is determined by test procedures and measurement against those standards.

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

• Not applicable for the reasons stated above.

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. This is not a diagnostic AI device, and therefore, an MRMC study is not relevant or mentioned.

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

• No. This is a physical medical implant device, not an algorithm.

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

• For the non-clinical performance (mechanical testing), the "ground truth" is adherence to established engineering standards (ASTM F382, ASTM F543, ASTM F2180) and a risk assessment based on biocompatibility standards (ISO 10993-1).
• For the substantial equivalence claim, the "ground truth" is the characteristics of the predicate device, which the subject device is compared against.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

• Not applicable. There is no training set.

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The EXPERT - Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting.

The Mini EXPERT, EXPERT Knotless and EXPERT Knotless Dual are intended to provide fixation during the healing process following:

Mini EXPERT

When used for fixation of bone, the Mini EXPERT is intended as fixation posts, distribution bridges, or for distributing suture tension over areas of ligament or tendon repair, such as:

• Syndesmotic trauma, such as fixation of dorsal distal radioulnar ligament (DRUL) disruptions;

• Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and

• Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of the ligament at the base of the thumb metacarpal by providing stabilization between the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

EXPERT Knotless and EXPERT Knotless Dual

Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The EXPERT – Joint Fixation System is available in three models. Each model is composed of different medical devices (i.e. plates, surgical suture) assembled together for the purpose of use as a set. Each set is composed of plates from different sizes and shapes made of Titanium Alloy (ASTM F136) associated with non-absorbable surgical sutures and/or surgical meshes made of an Ultra-High Molecular Weight Polyethylene (UHMWPE).

The metallic components are manufactured by GM dos Reis Indústria e Comércio Ltda and the nonabsorbable Surgical Sutures and Surgical Suture Meshes are purchased in bulk from River Point Medical (K100006).

Each EXPERT model comes with a transient use guidewire accessory in the same package. The guidewire is made of Stainless Steel (ASTM F138) to aid in the EXPERT - Joint Fixation System placement.

In order to promote a correct placement of EXPERT – Joint Fixation System, GMReis has also available a range of instruments (class I exempt) to serve the surgeon such as drill bits, drill guides, plier, among others. GMReis recommends the use of these instruments in order to ensure the compatibility with the subject devices and promote the success of the procedure.

This document describes the EXPERT - Joint Fixation System and its substantial equivalence to predicate devices, focusing on the mechanical performance of the device rather than AI/software performance. Therefore, many of the typical acceptance criteria and study design elements found in AI/ML medical device submissions (such as ground truth establishment involving expert consensus, MRMC studies, or standalone algorithm performance) are not applicable here.

The "study" in this context refers to mechanical testing that demonstrates the device's physical performance characteristics are comparable to legally marketed predicate devices.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to existing predicate devices through mechanical testing. The document states:

• "The performance of the subject devices compared with the predicate devices are demonstrated through mechanical testing."
• "The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices."

Since this is a 510(k) submission for a physical medical device (joint fixation system) and not an AI/ML diagnostic or prognostic tool, the "performance" is related to its physical and functional characteristics (e.g., strength, durability, fixation capability) as compared to the predicates. The document does not explicitly list quantitative acceptance criteria values or detailed reported device performance data in a table format. Instead, it relies on the conclusion that mechanical tests confirm comparability.

Table of Acceptance Criteria and Reported Device Performance (Inferred from 510(k) Context):

Study Information (Mechanical Testing for Substantial Equivalence)

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not specified in the provided summary. For mechanical testing of medical devices, sample sizes are typically determined by statistical rationale to ensure robustness and representativeness of the device's performance.
   • Data Provenance: The testing was conducted as part of the submission by GM dos Reis Indústria e Comércio Ltda, a Brazilian company. The data would be prospective, as it was generated specifically for this 510(k) submission.

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

   • Not Applicable. This is a submission for a physical joint fixation system, not an AI/ML device requiring human expert annotation of medical images or clinical outcomes for ground truth. Ground truth for mechanical performance is established through standardized engineering tests and material science evaluations.

3. Adjudication Method for the Test Set:

   • Not Applicable. See point 2.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not Applicable. This type of study is relevant for AI/ML devices that assist human readers (e.g., radiologists) in diagnostic tasks. The EXPERT - Joint Fixation System is a physical implant.

5. Standalone (Algorithm Only) Performance:

   • Not Applicable. No algorithms or software are involved in the primary function or assessment of this physical device.

6. Type of Ground Truth Used:

   • Engineering Specifications and Standardized Test Methods: For mechanical performance, ground truth is established by universally accepted engineering principles, material standards (e.g., ASTM, ISO), and validated test methods (e.g., fatigue testing, tensile strength). For biocompatibility, it's established by adherence to ISO 10993 series standards and AAMI/ANSI ST72.

7. Sample Size for the Training Set:

   • Not Applicable. There is no "training set" in the context of mechanical testing for a physical medical device. Device design and manufacturing processes are refined through engineering iterations.

8. How the Ground Truth for the Training Set Was Established:

   • Not Applicable. See point 7.

Summary of Information NOT Applicable to this Submission:
Due to the nature of the device (a physical joint fixation system) and the regulatory submission (510(k) based on substantial equivalence through mechanical testing), the following elements, commonly associated with AI/ML device evaluations, are not found in the provided document:

• Detailed quantitative performance metrics in a readily available table.
• Specific sample sizes for a "test set" in the context of clinical/image data.
• Data provenance involving patient demographics or retrospective/prospective medical data collection.
• Number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC studies.
• Standalone algorithm performance.
• Training set information.

The document unequivocally states: "No clinical data were included in this submission." This further confirms that the evaluation focused on physical and mechanical properties, not clinical outcomes or human performance with AI assistance.

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