(194 days)
TECHFIT Patient-Specific Maxillofacial System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial/midface and mandibular skeletal regions.
TECHFIT Patient-Specific Maxillofacial system is comprised of patient-specific metallic bone plates used in conjunction with commercially available screws cleared by the US FDA, for stabilization. fixation, and reconstruction of the maxillofacial/midface and mandibular bones.
The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs, modified by trained TECHFIT engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure that its dimensional properties allow an adequate fit.
Implants are provided non-sterile, range in thickness from 0.6 to 10 mm, and are manufactured using traditional (subtractive) methods from CP Titanium (ASTM F67).
The provided text describes the TECHFIT Patient-Specific Maxillofacial System and its substantial equivalence to predicate devices, focusing on non-clinical performance testing.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions specific non-clinical performance tests and their outcomes.
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Bending & Fatigue Testing (ASTM F382) | Substantially equivalent to K032442 plates. |
| Biocompatibility (ISO 10993-1:2018) | Procedures and provisions were applied. (Implies compliance, but no specific performance metric is stated beyond adherence to standards). |
| Sterilization (ISO 17665-1, ISO 17665-2, and ISO 14937 to SAL of 10^-6) | All test method acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size for the bending & fatigue testing. It refers to comparing "the subject plates against plates previously cleared in reference device K032442," suggesting a comparative test, but the number of plates tested is not specified.
- Data Provenance: The data provenance is implicitly from laboratory testing ("Mechanical testing was conducted") as part of the regulatory submission by Industrias Medicas Sampedro S.A.S. The geographic origin of this specific testing (e.g., country) is not mentioned. It is non-clinical, ex-vivo data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes non-clinical, mechanical, and biocompatibility testing, not studies requiring expert ground truth for a clinical test set.
4. Adjudication Method for the Test Set
This information is not applicable as the document describes non-clinical, mechanical, and biocompatibility testing, not studies requiring adjudication for a clinical test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for the substantial equivalence determination."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not directly applicable in the context of this device. The TECHFIT Patient-Specific Maxillofacial System is a physical implant, not an algorithm. However, the design process involves "virtual planning" with "input from the physician during virtual planning and prior to finalization and production of the device." In this sense, the "device" (the physical implant) is designed with human-in-the-loop involvement, but there isn't an "algorithm only" performance that would typically be evaluated for AI/software devices. The verification involves "virtually fitting the generated implant over a 3D model of the patient's anatomy."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described:
- Bending & Fatigue Testing: The "ground truth" or reference was the performance of plates from the previously cleared reference device K032442, as measured by standard mechanical testing protocols (ASTM F382).
- Biocompatibility: The "ground truth" was compliance with established international standards (ISO 10993-1:2018) and FDA guidance for biological evaluation.
- Sterilization: The "ground truth" was achieving a Sterility Assurance Level (SAL) of 10^-6 according to international standards (ISO 17665-1, ISO 17665-2, and ISO 14937).
8. The Sample Size for the Training Set
This information is not applicable as the document describes a physical medical device and its non-clinical testing, not an AI/ML algorithm that would require a "training set" in the conventional sense. The device is manufactured based on patient-specific CT scan data, which informs the design of each individual implant rather than training a general model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" in the context of this physical device. The device design relies on patient-specific medical imaging (CT scans) and physician input for virtual planning, not on a generalized training dataset with pre-established ground truth labels.
§ 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.