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The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant

The Bioplate® Titanium Fixation System includes a variety of plate configurations for different anatomical applications. Unalloyed commercially pure Grade 1, Grade 2 and Grade 4 titanium and titanium allov plates, and titanium allov screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial bony tissues. These materials have been implanted safely for many years. The predicate device had been approved under K022033.

The bone plates will be manufactured of unalloyed, commercially pure titanium and titanium 6A1-4V Eli alloy. The materials adhere to the American Society of Testing and Materials (A.S.T.M.) F67 Standards and the American Society of Testing and Materials ( A.S.T.M.) F136 Standard.. The screw will be manufactured of a titanium 6A1-4V Eli alloy that meets the American Society of Testing and Materials (A.S.T.M.) F136 Standard.

The plate and screw fit configurations are sterilized by gamma radiation sterilization, using VD Max dose setting method. Successful completion of sterilization validation and packaging validation studies provides a high level of assurance that sterility of the device has been achieved and can be maintained.

The provided text is a 510(k) summary for a medical device (Modified Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System) and primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria as would typically be seen for a new or novel device.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document states:

• Comparison of the device's technological characteristics with those of the predicate devices: "All the technical characteristics of the sterile plate and screw kit configurations for use Bioplate® Titanium Fixation System are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy."
• The materials used have been implanted safely for many years.
• Sterilization validation and packaging validation studies were successfully completed, providing a high level of assurance of sterility.

The "acceptance criteria" in this context are effectively demonstrating that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The study proving this involves comparing the new device's specifications (materials, sterilization method, intended use) against those of established predicate devices.

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The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use in non-load bearing fixation, including, but not limited to cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System includes a variety of plate confiqurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. 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 unalloved, commercially pure titanium and titanium 6AI-4V ELI allov. The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards and The American Society for Testing and materials (A.S.T.M.) F136 Standard. 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.

The plate and screw kit confiqurations are sterilized using gamma radiation sterilization methods. Successful completion of sterilization validation and packaging validation studies provides a high level of assurance that sterility of the devices has been achieved and can be maintained.

This submission K022033 does not contain a study that describes acceptance criteria for device performance in the manner typically seen for software or AI/ML devices. This is a 510(k) premarket notification for a Class II medical device, specifically Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System.

For devices like bone plates and screws, the "acceptance criteria" and "study" proving they meet those criteria are typically focused on substantial equivalence to predicate devices and adherence to established material and sterilization standards, rather than performance metrics like sensitivity, specificity, or accuracy.

Here's a breakdown based on the provided document, addressing the requested points where applicable, and noting where the information is not present or not relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

• Plates: Unalloyed, commercially pure titanium and titanium 6Al-4V ELI alloy, adhering to ASTM F67 and ASTM F136 Standards.
• Screws: Titanium 6Al-4V ELI alloy, meeting ASTM F136 Standard. |
  | Sterilization Efficacy: |
• Successfully completed sterilization validation studies proving sterility has been achieved.
• Successfully completed packaging validation studies proving sterility can be maintained. |
  | Intended Use Equivalence: |
• Intended for use in non-load bearing fixation, cranial bone fixation, brow fixation, and treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton.
• Matches the indications for use of predicate devices: Bioplate, Inc., Wurzburg, Synthes, TiMesh, and KLS-Martin.
• Intended for single use only. |
  | Technological Characteristics Equivalence: |
• Same indications for use as predicate devices.
• All technical characteristics are "substantially equivalent" to predicate devices.
• "Minor differences raise no new issues of safety and efficacy." |
  | Manufacturing Quality System: |
• Implicitly meets Good Manufacturing Practice (GMP) requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), as mandated by FDA for all medical devices. (Mentioned in FDA letter as a general requirement, not a specific claim from the submitter). |
  | Safety and Efficacy (Overall Substantial Equivalence): |
• Found substantially equivalent by FDA to legally marketed predicate devices, allowing it to proceed to market. The FDA letter states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." |

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

This information is not applicable and not provided in the document. This type of device (bone plates and screws) does not typically involve a "test set" in the context of diagnostic or AI/ML performance evaluation studies. The "testing" refers to material and sterilization validation, which are engineering and manufacturing tests, not clinical performance tests with patient data.

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)

This information is not applicable and not provided. "Ground truth" for this device is established by adherence to engineering standards (ASTM), manufacturing specifications, and successful physical/chemical testing for material properties and sterility. It doesn't involve expert medical interpretation in the way an AI diagnostic device would.

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

This information is not applicable and not provided. Adjudication methods are relevant for disputes in expert-labeled datasets, which is not the case here.

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

This information is not applicable and not provided. MRMC studies are used for evaluating diagnostic performance, often involving human readers and AI/ML systems. This is not a diagnostic device; it's a surgical implant.

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

This information is not applicable and not provided. This device does not involve an algorithm.

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

The "ground truth" for this device is effectively established by:

• Adherence to Material Standards: ASTM F67 and ASTM F136 specifications define the "truth" for material composition and properties.
• Validation of Manufacturing Processes: Successful completion of sterilization validation and packaging validation studies (likely per ISO standards or similar) serves as "ground truth" for sterility.
• Substantial Equivalence: The ultimate "ground truth" for marketing approval is that the device is substantially equivalent to predicate devices already on the market, meaning it performs as intended and introduces no new safety or efficacy concerns.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of an AI/ML algorithm for this device.

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

This information is not applicable and not provided. There is no "training set" or "ground truth" establishment in the AI/ML sense for this device.

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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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