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The OsteoSync™ Ti Dental Mesh is intended for stabilization and support of bone grafts in dento-alveolar bony defect sites.

The OsteoSync™ Ti Dental Mesh is a system of dental membranes intended for permanent fixation in adults and designed to aid in the reconstruction and augmentation of the alveolar ridges of the maxilla and mandible. They are available in a variety of sizes and shapes and can be contoured to accommodate the individual anatomic and clinical circumstances of each patient. The implants are sold sterile.

The provided document is a 510(k) Summary for the OsteoSync™ Ti Dental Mesh, which is a medical device. This type of document is concerned with demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study in the way one might for a novel diagnostic AI algorithm.

Therefore, many of the specific questions about acceptance criteria, study types, sample sizes, and expert adjudication as they pertain to algorithm performance are not directly applicable to this device submission. The device is a physical dental mesh, and its evaluation focuses on material properties, mechanical performance, biocompatibility, sterilization, and shelf-life, typically compared against standards and known predicate devices.

However, I can extract information related to the device's "acceptance criteria" in the context of its non-clinical testing and the "studies" that support its substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of acceptance criteria and device performance in the format typically used for AI algorithm evaluation (e.g., sensitivity, specificity). Instead, it lists non-clinical tests and their outcomes, indicating that the device "met the predetermined acceptance criteria."

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

• Mechanical Testing: "worst-case devices were evaluated." (Specific sample size not provided, but implies a selection of device configurations).
• Biocompatibility/Preclinical Animal Studies: Not specified, but animal studies (in a canine model) were leveraged from an FDA-authorized master file. Data provenance is implied to be from these leveraged studies.
• Sterilization Validation: Not specified.
• Shelf-Life Validation: Not specified, but "sterile integrity was verified by visual, seal strength and seal integrity evaluations."
• Pyrogenicity (Bacterial Endotoxin Testing): Not specified.

It is important to note that these are not "test sets" in the context of validating an AI algorithm, but rather samples used for physical and biological testing of the device itself.

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

This question is not applicable as there is no "ground truth" to be established by experts in the context of an AI algorithm's diagnostic performance for this physical medical device submission. The "ground truth" for the non-clinical tests is determined by standardized test methods and criteria (e.g., ASTM standards for mechanical testing, ISO standards for sterilization).

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as #3. There are no "test sets" in the AI sense, and thus no adjudication of expert opinions.

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 question is not applicable. The device is a physical dental mesh, not an AI-powered diagnostic tool used with human readers.

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

This question is not applicable. The device is a physical dental mesh, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests:

• Mechanical Testing: Ground truth is defined by performance against industry standards (e.g., ASTM F564).
• Biocompatibility: Ground truth is established through biological risk assessment and preclinical animal studies.
• Sterilization: Ground truth is a measured sterility assurance level (S.A.L.) meeting ISO 11137-1 and ISO 11137-2 standards.
• Shelf-Life: Ground truth is the maintenance of sterile integrity and functional properties over time, evaluated against ASTM F1886, ASTM F88, ASTM F1929 and ASTM F2096.
• Pyrogenicity: Ground truth is the measured bacterial endotoxin level against ANSI/AAMI ST72 standards.
• Dimensional/Technological Characteristics: Ground truth is the physical measurements and properties of the device compared to predicate devices, and the established safety and effectiveness of those predicates.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical dental mesh, not an AI algorithm that requires a "training set."

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

This question is not applicable for the same reason as #8.

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The MedCAD® AccuPlate® Patient-Specific Plate is intended for prescription use in oral and maxillofacial surgery, trauma and reconstructive surgery.

Specific Indications for Use:

• Primary mandibular reconstruction with bone graft
• Temporary bridging until delayed secondary reconstruction
• Secondary mandibular reconstruction
• Comminuted mandibular fractures
• Fractures of edentulous and/or atrophic mandibles
• Unstable mandibular fractures
• Maxillary reconstruction with or without bone graft
• Maxillary trauma

MedCAD® AccuPlate® Patient-Specific Plates are metal bone plates used in conjunction with commercially available metal bone screws for the fixation to bone, specifically in the areas of the mandible and maxilla. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (CT scan, CBCT scan, or MRI), and the intended anatomy to be fixated as determined from input provided by the surgeon. The plates are designed by MedCAD in consultation with the surgeon and manufactured by MedCAD only. MedCAD® AccuPlate® Patient-Specific Plates are not intended to be bent or modified in surgery. The MedCAD® AccuPlate® Patient-Specific Plates are manufactured from commercially pure titanium, are provided non-sterilized prior to use, and are intended for single use only. Plates are fastened to bone using commercially available bone screws with diameters ranging from 2.0 mm to 2.7 mm and lengths ranging from 4.0 mm to 23.0 mm.

This document is a 510(k) Premarket Notification from the FDA regarding the MedCAD® AccuPlate® Patient-Specific Plate. It is a medical device clearance document, not a study report for an AI/software device. Therefore, it does not contain the information typically presented for acceptance criteria and study results of an AI or software as a medical device (SaMD).

The document concerns a patient-specific bone plate used in oral and maxillofacial surgery. The "performance data" section refers to non-clinical functional and material testing (e.g., static and dynamic bending, screw pushout testing, sterilization, and biocompatibility validation) to demonstrate substantial equivalence to predicate devices, not performance metrics of an AI or software.

Therefore, I cannot provide the requested information regarding acceptance criteria and study results for an AI/software medical device because this document does not describe such a device or study.

Specifically:

1. A table of acceptance criteria and the reported device performance: The document mentions "All test method acceptance criteria were met" for sterilization validation and that mechanical tests showed the device "meets the performance of the predicate / reference devices." However, it does not provide specific acceptance values or performance metrics for these non-clinical tests in a table format that would be relevant to an AI/software device.
2. Sample sizes used for the test set and the data provenance: Not applicable to this type of device. The "test set" would refer to physical prototypes in mechanical testing, not a dataset for software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance is established through engineering specifications and standardized testing protocols.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for clinical tasks, which is not the scope of this bone plate device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: For physical performance testing, the ground truth is defined by engineering standards (e.g., ASTM F382 for bending, ISO 10993-1 for biocompatibility).
8. The sample size for the training set: Not applicable. This is a manufactured physical device, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

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For use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.

The Biomet Microfixation PreBent Plates with Virtual Surgical Planning is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation for mandible reconstruction procedures. The plates include variations of straight, angle, curved, Y-shape, double Y-shape, and matrix, options with various lengths and thickness. Plates are offered flat or pre-bent. Pre-bent plates are contoured by Biomet Microfixation per surgeon specifications or patient specific anatomical model and include patient specific guides and instruments, of the VSP System (K120956, cleared December 12, 2012). The VSP System is used by Medical Modeling to create the guides, instrumentation and a patient specific anatomical model from CT scans provided by a surgeon. Medical Modeling uses the surgeon information to create the anatomical patient specific model. The anatomical patient specific model is then used to aide in proper alignment and bending of the plates previously cleared under K063052 (cleared 01/12/07), K113152 (cleared 06/29/12), and K081067 (cleared 05/09/08). This bending process is conducted at Biomet Microfixation based on our process specification and inspection criteria previously cleared with K063052.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

Acceptance Criteria and Study for Biomet Microfixation PreBent Plates with Virtual Surgical Planning

Based on the provided 510(k) summary, the device submission does not include specific acceptance criteria or performance data for the "PreBent Plates with Virtual Surgical Planning" device itself. Instead, the submission relies on the substantial equivalence principle, arguing that the new device is essentially the same as previously cleared predicate devices, with an added option of using the VSP system for pre-bending.

The core argument is that the pre-bent plates are "100% verified to the Medical Modeling output, anatomical model, for every case," which implies that the accuracy of the bending process is continuously checked against a patient-specific anatomical model created by Medical Modeling.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "no additional testing was conducted on the subject plates" because they "are identical" to cleared predicate devices, with the only difference being the method of shaping (using the VSP system and patient-specific guides/instruments). The acceptance criteria are, therefore, implicitly tied to the established safety and effectiveness of the predicate devices and the verification of the custom bending process.

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

• Sample Size for Test Set: Not applicable. No dedicated test set, clinical, or non-clinical testing was performed for the current submission. The justification for safety and effectiveness is based on substantial equivalence to predicate devices and a process specification for bending and inspection.
• Data Provenance: Not applicable, as no new testing data was generated for this submission. The "provenance" for the justification comes from the cleared status of the predicate devices and Biomet Microfixation's internal process specifications for plate bending and inspection.

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

• Number of Experts: Not applicable. No specific expert review of a test set for this submission is mentioned. The "ground truth" for the pre-bent plates is the patient-specific anatomical model generated by Medical Modeling from CT scans provided by the surgeon.
• Qualifications of Experts: The CT scans are provided by a "surgeon," and Medical Modeling creates the anatomical model. The document does not specify the qualifications of the surgeons or the personnel at Medical Modeling involved in creating the anatomical models.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No test set requiring expert adjudication was used. The verification process is described as "100% verified to the Medical Modeling output, anatomical model, for every case," implying a direct comparison rather than an adjudication process.

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

• Was an MRMC study done? No.
• Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable. This device is a physical medical implant (bone plates) and a virtual surgical planning process for custom-bending these plates, not an AI diagnostic algorithm that assists human readers in interpreting images.

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

• Was a standalone study done? No. This device is not an algorithm for standalone performance evaluation in the typical sense (e.g., diagnostic image analysis). The "Virtual Surgical Planning" aspect refers to the use of software (the VSP System) to create patient-specific models and guides that aid in the manual pre-bending of plates, which is then verified.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the custom bending of the plates is the patient-specific anatomical model created by Medical Modeling from the patient's CT scans. This model dictates the precise contours to which the plates are bent.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device submission is for a physical implant (pre-bent plates) and a process, not a machine learning algorithm that requires a training set. The VSP system (K120956), which creates the anatomical model, would have had its own validation/verification at the time of its clearance, but details of its training set are not part of this submission.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device in the context of the current submission.

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