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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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The GMReis Fibula Nail System is intended for fixation of fractures and osteotomies of the fibula.

The GMReis Fibula Nail System is a system of locked intramedullary nails for osteosynthesis of fibular fractures. It has multiple lengths (110mm to 180mm) and diameters (3.0mm and 3.6mm). The arrangement of the holes in the intramedullary nails allows the surgeon to block the implant in different planes. The screws have a specific profile that reduces the risk of skin prominence and have threaded locking in the nail holes. GMReis Fibula Nail System are manufactured with titanium alloy, are for single use and the devices are provided non-sterile and must be properly cleaned and sterilized before use, according to the recommendations provided in the Instructions for Use.

The provided FDA 510(k) Clearance Letter for the "GMReis Fibula Nail System" (K250559) establishes substantial equivalence based on mechanical performance data, not clinical performance or AI/software-driven insights. Therefore, many of the requested points regarding acceptance criteria, study design, ground truth establishment, and expert involvement for an AI/software-based device cannot be extracted from this document.

The clearance is for a mechanical medical device (an intramedullary fixation rod), not a software or AI device. The type of acceptance criteria and study design are fundamentally different for a mechanical device versus a software/AI device.

However, I can extract the information relevant to this specific device's clearance process from the provided document:

Acceptance Criteria and Device Performance for GMReis Fibula Nail System (K250559) - A Mechanical Device

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated as a number of devices tested, but implicitly refers to a sufficient number of samples to satisfy the requirements of the ASTM standards (ASTM F1264 for Intramedullary Fixation Rods and ASTM F543 for Metallic Medical Bone Screws). These standards outline specific testing configurations and sample numbers for mechanical characterization.
• Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being in Brazil. The data is retrospective in the sense that it's generated for a regulatory submission rather than a prospective clinical trial.

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

• Not Applicable. This is a mechanical device. "Ground truth" in the context of expert consensus or clinical outcomes is not relevant for the primary evidence of substantial equivalence for this type of device. The "ground truth" here is the physical properties demonstrated by mechanical testing, measured by calibrated equipment.

4. Adjudication method for the test set:

• Not Applicable. As this is mechanical testing to specific ASTM standards, there is no expert adjudication process in the sense of reviewing images or clinical data. The results are quantitative measurements against predefined engineering specifications.

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 mechanical implant device, not an AI or software product. MRMC studies are for evaluating diagnostic or interpretive AI systems with human-in-the-loop.

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

• Not Applicable. This is a mechanical implant device, not an AI algorithm.

7. The type of ground truth used:

• Quantitative Mechanical Properties: The "ground truth" for this device are the quantifiable mechanical properties (e.g., stiffness, strength, fatigue life) as determined by standardized laboratory tests (ASTM F1264 and ASTM F543).

8. The sample size for the training set:

• Not Applicable. This is a mechanical device, so there is no "training set" in the context of machine learning or AI.

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

• Not Applicable. (See point 8)

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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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