(222 days)
The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults.
The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is a metal bone plate used in conjunction with commercially available, non-locking metal bone screws for the fixation to bone in orbital, midface / maxillofacial, and non-continuity mandibular operations. 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 subject device is not intended to be bent or modified in surgery. If for any reason the surgeon chooses not to use the subject device in surgery, they may use any of the commercially available plates to complete the surgery. The subject device is additively manufactured from Ti-6AL-4V Extra Low Interstitial (ELI) titanium alloy, provided non-sterile, must be sterilized prior to use, and is intended for single use only. Plates are fastened to bone using commercially available non-locking bone screws with diameters ranging from 1.5mm to 2.7mm and lengths ranging from 3.5mm to 22mm.
Here's a summary of the acceptance criteria and study information for the MedCAD® AccuPlate® 3DTi Patient-Specific Plating System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance letter mentions the following non-clinical performance tests. The acceptance criteria are implied to be "equivalent" to identified reference devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1, -5, and FDA guidance. | Results "adequately address biocompatibility for the plates and their intended use." |
| Sterilization Validation: Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ per ISO 17665-1, -2, and FDA guidance. | "All test method acceptance criteria were met." |
| Static and Dynamic Bending (per ASTM F382): Equivalent bending strength and fatigue life to reference device K953385. | "The subject device was shown to have equivalent bending strength and fatigue life as the reference device (K953385)." |
| Axial Screw Pushout (per ASTM F543): Equivalent axial screw pushout strength at the plate/screw interface to reference device K953385. | "The subject device plate / screw interface was shown to have equivalent axial screw pushout strength as the reference device (K953385)." |
| Fit and Form Validation: Produce devices that align with the approved surgical plan. | "The subject device patient specific design process was shown to produce devices that aligned with the approved surgical plan." |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (number of devices or tests) for the non-clinical performance tests (bending, pushout, fit and form validation). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective, as these are non-clinical (mechanical and material) performance tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided in the document. For non-clinical performance tests, "ground truth" is typically established by engineering standards and validated testing procedures, not by human experts in the same way as clinical image interpretation. The "Fit and Form Validation" mentions alignment with an "approved surgical plan," which would involve surgical expertise in its creation, but the number and qualifications of individuals involved in approving these plans or assessing the fit are not detailed.
4. Adjudication Method for the Test Set
Not applicable for these types of non-clinical, objective performance tests. Adjudication methods like 2+1 or 3+1 are typically used for subjective clinical interpretations by multiple readers (e.g., radiologists) in diagnostic accuracy studies.
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
No such study was mentioned. The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is a patient-specific surgical implant, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable. The device itself is an implant. However, the "patient specific design process" for creating the implant is an "algorithm only" type of process in that it uses patient anatomical data to generate the device design. The "Fit and Form Validation" likely assessed the output of this design process against the intended surgical plan. The document states that the design process "was shown to produce devices that aligned with the approved surgical plan," indicating successful standalone performance of the design software.
7. The Type of Ground Truth Used
- Biocompatibility: Established by adherence to ISO 10993 standards and FDA guidance.
- Sterilization Validation: Established by adherence to ISO 17665 standards and FDA guidance, with a specific SAL target.
- Static and Dynamic Bending: Established by ASTM F382 standard, with comparison to a reference device's known performance.
- Axial Screw Pushout: Established by ASTM F543 standard, with comparison to a reference device's known performance.
- Fit and Form Validation: Established by alignment with an "approved surgical plan." This likely involves a comparison of the 3D-printed plate geometry with the virtual surgical plan derived from patient imaging data, which can be considered "design ground truth."
8. The Sample Size for the Training Set
The document does not describe the development or training of an AI algorithm in the traditional sense, so there is no mention of a training set sample size. The "patient-specific design software" is mentioned as being the same as a reference device (K192282), implying it's a previously validated system rather than a newly trained AI model.
9. How the Ground Truth for the Training Set Was Established
As no training set for an AI algorithm is described, this information is not applicable.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.