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Stryker Temporary Condylar Prostheses are intended for temporary (not exceeding 24 months) reconstruction in patients undergoing ablative tumor surgery requiring removal of the mandibular condyle.

The Stryker Temporary Condylar Prosthesis is an independent solid condylar head which is rigidly connected to a standard or locking Stryker Reconstruction plate via fastening screws. The Temporary Condylar Prosthesis is provided in a left and right configuration and is intended for temporary use only (not exceeding 24 months). The Condylar Prosthesis is made of commercially pure titanium and the head of the condyles is PVD (Physical Vapor Deposition) coated which differentiates it from the rest of the condyles giving it golden color. The Temporary Condylar Prosthesis is accompanied by connecting screws which are made of commercially pure titanium alloy and are specifically designed to fixate the Prosthesis with a Stryker plate.

Here's an analysis of the provided text regarding the Stryker Temporary Condylar Prosthesis, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the Study:

The provided document describes a 510(k) submission for a modification to the Stryker Temporary Condylar Prosthesis. The modification is a change in the material composition of the coating used on the head of the prosthesis. The study performed aims to demonstrate substantial equivalence to the previously cleared predicate device (K020199) by proving that this change in coating material does not adversely affect the safety and effectiveness of the device.

The study employed a series of Verification and Validation testing focused specifically on the new coating material and its impact on the device's overall performance.

2. Sample Sizes Used and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample sizes (e.g., number of devices, number of tests conducted per device) used for the friction, roughness, thickness, wear resistance, adhesion strength, hardness, biocompatibility, and corrosion tests. It generally states that "Various tests... were conducted."
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given it's a 510(k) submission for a device modification, these studies are typically internal validation tests performed by the manufacturer (Stryker Leibinger GmbH & Co. KG, Germany) or their contracted labs, and are prospective in nature for the modified component.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• The document describes engineering and laboratory tests (friction, wear, biocompatibility, etc.), not clinical studies requiring expert ground truth or diagnoses. Therefore, the concept of "experts establishing ground truth" in the medical diagnostic sense is not applicable here. The "ground truth" for these tests would be established by validated test methodologies and acceptance criteria for mechanical and material properties.

4. Adjudication Method for the Test Set

• Adjudication methods like "2+1" or "3+1" are relevant for clinical studies involving human observers or diagnoses. This document describes laboratory verification and validation testing. Therefore, such adjudication methods are not applicable. The assessment of test results would be based on comparison against predefined engineering specifications and standards.

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

• No MRMC study was done. This document describes a submission for a modified medical device focusing on material properties and performance. MRMC studies are typically conducted for diagnostic devices (e.g., AI algorithms for image analysis) to assess the impact of AI assistance on human reader performance. This is not a diagnostic device.

6. Standalone (Algorithm Only) Performance Study

• No standalone performance study was done. This is not a software algorithm or AI-powered device. Its performance is assessed through physical and chemical testing of the material and mechanical design.

7. Type of Ground Truth Used

• For the performance testing, the "ground truth" was based on engineering specifications, material science standards, and predefined acceptance criteria for mechanical, chemical, and biological properties. For example, a "ground truth" for wear resistance would be a maximum allowable wear rate as defined by relevant standards or internal specifications, against which the test results are compared. For biocompatibility, it would be compliance with ISO 10993 standards.

8. Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, so there is no "training set." The development process would involve iterative design, prototyping, and testing, but not a data-driven training set in the AI sense.

9. How Ground Truth for Training Set Was Established

• Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant.

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Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

The Synthes Condylar Head Add-on System is an adjustable height add-on system for use with the 2.4 mm Locking Reconstruction Plate System and MatrixMANDIBLE Plate System. It consists of a condylar head, 2 screws, and one of four (4) fixation plates, each with a different screw hole spacing that determines the height of the condylar head.

The provided documents do not contain information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, adjudication methods, or MRMC comparative effectiveness studies.

The documents are a 510(k) summary and an FDA clearance letter for the "Synthes (USA) Condylar Head Add-on-System - Modification". These documents focus on establishing substantial equivalence to a predicate device, an existing Synthes Condylar Head Add-on-System.

Specifically, the 510(k) summary states that "Documentation is provided which demonstrates the Synthes (USA) Condylar Head Add-on-System - Modification to be substantially equivalent to other legally marketed devices such as: Synthes (USA) Condylar Head Add-on-System." This implies that the device's acceptance is based on its similarity to an already approved device, rather than a new study proving specific performance metrics against defined acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

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Intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

The Synthes (USA) Condylar Head Add-on System is an adjustable height system intended for use with Synthes' 2.4 mm Locking Reconstruction Plate (LRP) System. The system consists of an elliptical shaped condylar head, four different fixation plates which allow the surgeon to adjust the height of the condylar head, and two fixation screws for mounting the condylar head and fixation plate onto a 2.4 mm locking reconstruction plate.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Synthes (USA) Condylar Head Add-on System, which focuses on device description, intended use, and substantial equivalence to predicate devices, rather than performance studies or clinical trials.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance based on the given information.

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Indicated for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not intended for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). Implants are intended for single patient use.

The OsteoMed Temporary Condylar Attachment system is a solid condylar head which attaches with fastening screws to an OsteoMed Fracture Reconstruction Plate. The OsteoMed Temporary Condylar Attachment is available for right and left placement. System instruments include drivers.

This 510(k) submission document for the OsteoMed Temporary Condylar Attachment System does not contain information regarding an acceptance criteria table or a study proving the device meets acceptance criteria.

The document provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting new performance data or clinical study results to establish de novo acceptance criteria.

Here's what can be inferred from the document regarding the device's assessment:

• Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The submission relies on substantial equivalence to predicate devices.
• Study That Proves the Device Meets Acceptance Criteria: This information is not provided in the document.

Explanation Based on the Document Content:

The core of this 510(k) submission is the claim of "substantial equivalence" to predicate devices. The document states:

"Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin Temporary Condylar Implant (K990667), the W. Lorenz Add-On Condyle (K002790), and the Stryker Leibinger Locking Screw Mandibular Reconstruction Plate (K000594)."

"Due to the similarity of materials and design to predicate devices, OsteoMed believes that the OsteoMed Temporary Condylar Attachment System does not raise any new safety or effectiveness issues."

This indicates that instead of conducting a new study to establish performance against specific acceptance criteria, OsteoMed is asserting that its device is safe and effective because it is similar to already legally marketed devices that have been deemed safe and effective. Therefore, a clinical study demonstrating performance against specific acceptance criteria, as typically seen for novel devices or those requiring a PMA (Pre-Market Approval), is not present in this 510(k) summary.

In summary, based only on the provided text, none of the requested information (acceptance criteria table, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) can be extracted because the submission relies on substantial equivalence rather than new performance data.

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The KLS-Martin Temporary Condylar Implant is only intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

The KLS-Martin Temporary Condylar Implant is a solid condylar head which attaches with fastening screws to a KLS-Martin Fracture/Reconstruction Plate. The KLS-Martin Temporary Condylar Implant is available for left and right placement.

This 510(k) premarket notification describes a medical device, the KLS-Martin Temporary Condylar Implant, and establishes its substantial equivalence to a predicate device. It does not contain information about a study that assesses the device's performance against specific acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them because such information is not present in the provided text.

The document is a regulatory approval letter and a summary of the device for FDA submission, focusing on:

• Device Identification: KLS-Martin Temporary Condylar Implant.
• Classification: Temporary Condylar Implant.
• Predicate Device: Leibinger Temporary Condylar Implant.
• Intended Use: Temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures for tumor removal.
• Limitations: Not for permanent implantation, TMJ/traumatic injuries, or TMD treatment.
• Substantial Equivalence: The FDA's determination that the device is substantially equivalent to legally marketed predicate devices.

There is no mention of specific performance metrics, clinical or non-clinical study design, sample sizes, expert ground truth establishment, or any form of AI performance evaluation.

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Synthes (USA) Locking Reconstruction Plate with Condylar Head is intended for temporary reconstruction in patients undergoing ablative tumor surgery requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).

The Locking Reconstruction Plate with Condylar Head is a one piece reconstruction plate with a solid condylar head. The plate features compression screw holes that are internally threaded to accept the 2.4 - 3.0 mm locking screws or standard 2.4 mm self-tapping cortex screws and has notched sides and undersides to facilitate contouring. The plates are available in three sizes for right and left placement.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is primarily a 510(k) submission letter and a summary of safety and effectiveness information for a medical device (Synthes (USA) Locking Reconstruction Plate with Condylar Head). It details the device's description, intended use, classification, and regulatory status, but it does not include details on performance acceptance criteria or study results to demonstrate those criteria were met.

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