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The modified plate designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial surgery are intended for use in the reconstruction of the cranium (skull) following surqical decompression procedures of the posterior fossa or transcervical skull-based approach, with or without duraplasty including but not limited to procedures to treat Chiari I Malformation. The plate designs are also intended for use in non-load bearing fixation, including but not limited to cranial bone fixation. Each device is intended for single use only, and only in conjunction with other titanium and titanium alloy implants.

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery include a variety of plate configurations for different anatomical applications. Unalloyed commercial pure Grade 1, 2 and 4 titanium, titanium alloy plates as well as titanium alloy screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial tissues.

The provided document does not contain information about acceptance criteria or a study proving the device meets them. It's a 510(k) premarket notification for a medical device (bone fixation plates for craniomaxillofacial surgery), and the FDA letter indicates that the device has been found substantially equivalent to predicate devices.

Therefore, I cannot provide the requested table and study details.

Here's why the information isn't present in this document:

• 510(k) Substantial Equivalence: This regulatory pathway (510(k)) primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics and intended use, not necessarily providing new performance studies against specific acceptance criteria.
• Lack of Clinical Study Details: The document focuses on regulatory classification, intended use, and comparison to predicate devices, not on detailed clinical trial results or performance against quantitative acceptance criteria for a novel technology like an AI device would require.
• Device Type: The device described is a physical medical implant (bone fixation plates), not an AI/software as a medical device (SaMD). Performance for such physical devices is often evaluated through bench testing, material properties, and sometimes animal studies, rather than the types of clinical or reader studies described in your prompt for AI.

If you are looking for information regarding acceptance criteria and performance studies for an AI/SaMD, you would typically find that in a much more detailed clinical study report or a different section of a regulatory submission.

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The washers are intended to be used to provide additional surface area contact between the screw head and bone surface, when used in combination with bone screws between the occord froution of the mandible, hand, foot and the midfacial skeleton where there exists a condition of a thin cortex or osteoporotic bone.

The Howmedica® and Howmedica® Leibinger Bone Screw Washers consist of sizes ranging from .8 mm internal diameter to 3.5 mm internal diameter. The washers are used in conjunction with screws, of like or similar material, currently available in Luhr® and Leibinger®-Luhr® plating systems, which were cleared under various 510(k) notifications (K761228, K854886, K862482, K862534, K882454, K901941, K913355, K923861, K935448, K950595, K951415, K961485, K961497, K963739, K963740, K970912,) and any future styles of Howmedica® and Howmedica Leibinger® screws found substantially equivalent.

This document is a 510(k) summary for medical devices, specifically bone screw washers. It details the device's intended use, materials, and establishes substantial equivalence to previously cleared devices. However, it does not contain the kind of performance study data, acceptance criteria, ground truth establishment, or sample size details that would typically be found in a clinical study report or a more detailed technical submission for a diagnostic AI/ML device.

Therefore, many of the requested points cannot be answered from the provided text.

Here is what can be inferred or explicitly stated from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance for this type of device (bone screw washers) is based on substantial equivalence to predicate devices in terms of intended use, materials, design, and operational principles.
• Reported Device Performance: Not applicable in the context of diagnostic performance metrics. The document asserts that the device is substantially equivalent to predicate devices.

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

• Sample Size (Test Set): Not applicable. There was no "test set" in the sense of a dataset of patient cases used to evaluate diagnostic performance. The substantial equivalence argument relies on a comparison of device characteristics rather than a performance study on a test set.
• Data Provenance: Not applicable for a performance study. The "data" here refers to the specifications and characteristics of the bone screw washers and their predicate devices.

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

• Not applicable. There was no test set requiring ground truth establishment by experts for diagnostic performance.

4. Adjudication method for the test set:

• Not applicable.

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/ML diagnostic device, and no MRMC study was conducted.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" in this context is the safety and effectiveness of the predicate devices. The device is deemed safe and effective because it is substantially equivalent to devices already cleared for market. This isn't "ground truth" in the diagnostic sense, but rather regulatory precedent.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device requiring a training set.

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

• Not applicable.

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