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The modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery are intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including cranial bone fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

Modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue.

The bone plates will be manufactured of a titanium 6AI-4V alloy that meets The American Society for Testing and Materials (A.S.T.M.) F136 and/or F1472 Standards. The screws will be manufactured of a titanium 6Al-4V ELI alloy that meets The American Society for Testing and Materials (A.S.T.M.) F136 Standard.

This document is a 510(k) summary for a medical device called "Modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." It is a premarket notification to the FDA, asserting substantial equivalence to previously marketed devices.

Based on the provided text, there is no acceptance criteria or study that proves the device meets specific acceptance criteria in the way you've outlined for an AI/algorithm-based device. This document describes a traditional medical device (bone plates and screws), not an AI or software device that would typically have performance metrics like sensitivity, specificity, or an MRMC study.

Therefore, many of the requested fields cannot be filled as they are not applicable to this type of device submission.

Here's a breakdown of what can be extracted and why other fields are not applicable:

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

   • Not Applicable. This is a hardware device (bone plates and screws). Acceptance criteria for such devices typically relate to material properties (e.g., ASTM standards for titanium alloy), mechanical strength, biocompatibility, and manufacturing quality. The submission asserts that the device meets existing standards for these properties by stating the materials meet ASTM F136 and F1472. There are no performance metrics like sensitivity or specificity.

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

   • Not Applicable. This is a hardware device. There is no "test set" of data in the context of an algorithm's performance. The "testing" mentioned would typically refer to mechanical and material property testing, not clinical data evaluation for performance.

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. There is no "test set" requiring ground truth establishment by experts for performance evaluation in this context.

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

   • Not Applicable. No test set of data for performance evaluation.

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 hardware device, not an AI system. MRMC studies are not relevant.

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

   • Not Applicable. This is a hardware device, not an algorithm.

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

   • Not Applicable. No ground truth in the context of an algorithm's performance. For a hardware device, "ground truth" would relate to whether the manufacturing met specifications, the material properties were as stated, and mechanical tests confirmed expected behavior. These are typically verified by engineering and quality control procedures.

8. The sample size for the training set

   • Not Applicable. This is a hardware device, not an AI system. There is no training set.

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

   • Not Applicable. No training set.

Summary regarding the device in the provided text:

The document is a 510(k) submission for "Modified plate designs for use with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." The basis for its acceptance (substantial equivalence to predicate devices) is primarily rooted in:

• Material Equivalence: The plates are made of titanium 6Al-4V alloy meeting ASTM F136 and/or F1472 Standards, and screws from titanium 6Al-4V ELI alloy meeting ASTM F136 Standard. These standards specify material composition, mechanical properties, and other characteristics considered safe and effective in predicate devices.
• Intended Use Equivalence: The device has the same indications for use as listed predicate devices.
• Technological Characteristics Equivalence: The submitter states that "All of the technical characteristics of the modified plate designs... are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." This implies that design, dimensions, and mechanical performance are comparable to the predicate devices, which are already deemed safe and effective.

The FDA's letter (K021684) grants clearance based on this "substantial equivalence" finding, meaning the new device is considered as safe and effective as the legally marketed predicate devices. It does not involve performance metrics or studies relevant to an AI/algorithm-based device as requested in your prompt.

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