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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-weight bearing fixation. including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The modified screw designs for use in conjunction with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and may be used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.

The provided text does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification for a medical device (Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery) which asserts "substantial equivalence" to previously marketed predicate devices.

The document states: "All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." This indicates that the device's characteristics were compared to existing, approved devices, and no new studies demonstrating performance against specific acceptance criteria were necessary for this 510(k) clearance process.

Therefore, I cannot provide the requested information in the table or address points 2 through 9, as they pertain to a type of study that was not described or performed for this specific submission based on the provided text.

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The Bioplate® Riqid 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-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The supplementary label/labeling material will be used for training and promotional purposes and does not affect the intended use of the devices.

The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium alloy screws of varying diameters and lengths and are used for fixation of unalloyed, commercially pure titanium and titanium allov plates to the craniofacial bony tissue.

The provided text is a 510(k) premarket notification for a medical device – The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery. This document primarily focuses on establishing "substantial equivalence" to predicate devices, rather than detailing a specific clinical study with acceptance criteria and performance metrics in the way a robust clinical trial with AI would.

Therefore, many of the requested sections (e.g., AI performance, MRMC study, ground truth for training data) are not applicable to this type of submission. The document relies on a comparison of characteristics and intended use to predicate devices that were already legally marketed.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present quantitative acceptance criteria or device performance measurements in the typical sense of a clinical study. Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to existing legally marketed predicate devices. The "reported device performance" is implicitly that the device performs equivalently to the predicates.

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

Not applicable. This 510(k) submission does not describe a clinical "test set" in the context of evaluating a new performance claim or an AI algorithm’s accuracy. Substantial equivalence is typically demonstrated through bench testing (mechanical properties, material composition, etc.) and comparison to predicate devices, rather than a prospective clinical study with a patient test set for performance comparison. The document does not provide details on specific bench tests conducted or the data generated from them beyond general statements.

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

Not applicable. As there is no "test set" for performance evaluation against a ground truth in the context of an AI device, this information is not provided. The 'ground truth' here is essentially established by the historical performance and regulatory approval of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable. No "test set" and corresponding adjudication method are described for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a physical medical implant (bone plating system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in the context of this 510(k) submission is the established safety and efficacy of the predicate devices already on the market. The Bioplate® system is deemed safe and effective because it is substantially equivalent to these already accepted devices. This is a regulatory "ground truth" rather than a clinical ground truth like pathology or outcomes data for a novel performance claim.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As above, there is no AI algorithm or training set for this device.

In summary, this 510(k) submission for The Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery demonstrates substantial equivalence to existing predicate devices by showing it has the same intended use and similar technological characteristics, raising no new safety or efficacy concerns. The requested information regarding acceptance criteria, study details, and AI performance metrics are primarily relevant for AI/ML-based medical devices or devices demonstrating novel clinical performance, which this implantable device is not.

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The modified plates 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-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The modified plate designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes a variety of plate configurations for different anatomical applications. Commercially pure titanium plates, and titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxilloffacial bony tissue. The bone plates will be manufactured of commercially pure titanium (Grade 4). The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards.

The provided text describes a 510(k) premarket notification for a medical device, the "Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." This submission focuses on modifications to existing predicate devices.

Crucially, this document does not contain acceptance criteria or a study that proves the device meets specific performance criteria in the way one might expect for a new AI/software device or a device requiring clinical performance validation.

Instead, this 510(k) summary is centered on demonstrating substantial equivalence to previously cleared predicate devices. The "study" here is essentially a comparison to existing devices, asserting that the modified plate designs are functionally the same and raise no new safety or efficacy concerns.

Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown based on the provided text, indicating where information is present and where it is absent/not applicable:

Acceptance Criteria and Device Performance Study for Bioplate® Rigid Fixation Bone Plating System

As this is a 510(k) premarket notification affirming substantial equivalence for device design modifications, the "acceptance criteria" and "study" are framed around similarity to predicate devices rather than novel performance benchmarks.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This submission doesn't describe a clinical or performance "test set" in the traditional sense for evaluating a new device's performance against specific metrics. It's a comparison to existing predicate devices.
• Data Provenance: Not applicable. No new efficacy data from human subjects or retrospective/prospective studies are presented for the modified designs. The data "provenance" here relates to the established safety and efficacy of the predicate devices.

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

• Number of Experts & Qualifications: Not applicable. No "ground truth" for a test set was established by experts for this submission. The determination of "substantial equivalence" is made by the FDA based on the comparison provided by the manufacturer.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was conducted or described.

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

• MRMC Study: No. This type of study is not mentioned as it is irrelevant for a submission focused on demonstrating substantial equivalence of minor design modifications to existing hardware. There is no AI component or human-in-the-loop performance being evaluated.
• Effect Size of Human Readers with/without AI: Not applicable. No AI component is described.

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

• Standalone Study: Not applicable. This device is a physical bone plating system, not an algorithm or software.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the established safety and efficacy profile of the legally marketed predicate devices. The submission argues that the modified device is equally safe and effective due to its substantial equivalence. There is no new "ground truth" derived from pathology, outcomes data, or expert consensus specifically for these modified plates beyond the assertion that they are functionally similar to the predicates.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.

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

• Ground Truth for Training Set: Not applicable. No training set for an algorithm was used.

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The modified screw 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-weight bearing fixation, including cranial bone fixation, brow fixation and orbital fixation. Each device is intended for sinqle use only and only in conjunction with other titanium and titanium alloy implants.

Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery includes titanium allov screws of varving diameters and lengths and are used for fixation of unalloved, commercially pure titanium and titanium alloy plates to the craniofacial bony tissue.

The provided document is a 510(k) premarket notification for a medical device (Modified screw designs for use with the Bioplate® Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery). It is a declaration of substantial equivalence to predicate devices, not a study describing acceptance criteria and a device performance study as typically seen for AI/ML-driven devices.

Therefore, the document does not contain the information requested to fill out the table and answer the questions related to acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication, or MRMC studies.

This type of submission (510(k) for a traditional medical device like screws and plates) primarily focuses on demonstrating that the new device has the same technological characteristics and intended use as devices already legally marketed (predicate devices). The "study" here is essentially a comparison to predicate devices to prove substantial equivalence, rather than a clinical trial or performance study against predefined acceptance criteria for a novel technology.

Here's why the requested information is not available in the provided text:

• Acceptance Criteria & Reported Device Performance: These are not defined because the submission aims to demonstrate equivalence, not to meet specific performance metrics through a clinical study. The "performance" is implicitly deemed equivalent to the predicate devices.
• Sample Size (Test Set & Training Set), Data Provenance, Ground Truth, Experts, Adjudication, MRMC Study, Standalone Study: These concepts are relevant to the evaluation of AI/ML or complex diagnostic devices, where performance is measured against a ground truth. For a bone screw, the "study" is likely mechanical testing and a review of materials, not a clinical study involving human readers or expert consensus on images.
• How Ground Truth was Established: Not applicable in this context.

In summary, the provided document does not describe the kind of study and acceptance criteria typically associated with performance evaluation of AI/ML or diagnostic devices. It is a regulatory submission for a physical medical device (bone screws and plates) demonstrating substantial equivalence to already approved predicate devices.

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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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The plate designs for use in conjunction 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, 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 Fixation System is manufactured of commercially pure titanium and a titanium 6AI - 4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.) The plates are substantially equivalent in construction and design to the predicate devices manufactured by Howmedica, Medicon, KLS and W.L. Lorenz.

This document is a 510(k) summary for the Bioplate Fixation System, which is a rigid bone plating system for craniomaxillofacial surgery.

Based on the provided text, the device is not an AI/ML powered device, nor does it seem to be an imaging or diagnostic device. Therefore, the requested information regarding acceptance criteria, study details (sample sizes, ground truth, expert involvement, MRMC studies, standalone performance), and training set details are not applicable to this submission.

The 510(k) summary only states:

• The device is made of commercially pure titanium and titanium 6AI - 4V ELI alloy.
• These materials have been implanted safely for many years and are recognized as acceptable for implantation through device classification (e.g., 21 CFR sections 888.3030).
• The plates are "substantially equivalent in construction and design" to predicate devices manufactured by Howmedica, Medicon, KLS, and W.L. Lorenz.

The FDA's letter confirms substantial equivalence to pre-amendment devices, subject to general controls and GMP regulations. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than new clinical trials with specific performance metrics against acceptance criteria in the way a novel diagnostic or AI device might.

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The plate and screw designs for use in conjunction 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, 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 plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery.

The provided text is a 510(k) premarket notification letter from the FDA to Biomedics, Incorporated, regarding their "Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery." This document does not contain the acceptance criteria, reported device performance, or details of any studies demonstrating the device meets such criteria.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This means the device does not need to submit clinical trial data to demonstrate safety and effectiveness for this review pathway. Instead, substantial equivalence relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or different technological characteristics but no new questions of safety and effectiveness and is as safe and effective as the predicate device.

Therefore, I cannot provide the requested information based on the given text.

To be clear:

• Acceptance criteria and reported device performance: Not present.
• Sample size and data provenance for test set: Not applicable, as no study results are provided.
• Number and qualifications of experts for ground truth: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone algorithm performance: Not applicable (this is a medical device, not an algorithm).
• Type of ground truth used: Not applicable.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

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The plate and screw designs for use in conjunction with the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery is intended for use in the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton and non-load bearing fixation, including: cranial fixation, midface fixation, mandibular fixation, orbital rim fixation, maxillary fixation, graft fixation, bone fixation, brow fixation, zygomatic fixation. The 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 is manufactured of commercially pure titanium and a titanium 6A1-4V ELI alloy, materials that have been implanted safely for many years. These materials are recognized as acceptable for implantation purposes through device classification (for example, see 21 Code of Federal Regulations, sections 888.3030.) The plates are substantially equivalent in construction and design to the predicate devices manufactured by Biomedics, Inc., W.L. Lorenz and Synthes (USA.) The screws are manufactured of a titanium alloy that is at least equivalent to commercially pure titanium in strength and they are substantially equivalent in design to the predicate devices.

The provided document is a 510(k) summary for the Bioplate Rigid Fixation Bone Plating System for Craniomaxillofacial Surgery. It declares substantial equivalence to predicate devices but does not contain acceptance criteria or the results of a study proving the device meets specific performance criteria.

The document focuses on:

• Materials: Commercially pure titanium and titanium 6Al-4V ELI alloy, stating they are recognized as acceptable for implantation.
• Substantial Equivalence: Claiming the plates are substantially equivalent in construction and design to predicate devices by Biomedics, Inc., W.L. Lorenz, and Synthes (USA). The screws are also claimed to be substantially equivalent in design and at least equivalent in strength to commercially pure titanium.
• Indications for Use: Listing various applications in craniomaxillofacial surgery, such as treatment of fractures, reconstructive procedures, and fixation of specific facial bones.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details because this document does not contain that level of detail. The FDA's 510(k) clearance process for this type of device typically relies on demonstrating substantial equivalence to existing devices rather than requiring new, full-scale clinical trials with extensive acceptance criteria and detailed performance studies like those seen for novel, high-risk devices or software algorithms.

In summary, the provided document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, nor data provenance.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study.
6. A standalone performance study.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for the training set was established.

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