(132 days)
TECHFIT Digitally Integrated Surgical Reconstruction Platform (DISRP) System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the DISRP System and the result is an outbut data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including surgical guides and splints for use in maxillofacial surgery. The DISRP System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options.
The DISRP system is compatible with the TECHFIT Patient- Specific Maxillofacial System and the TECHFIT Diagnostic Models and should be used in conjunction with expert clinical judgment.
The TECHFIT DISRP SYSTEM is composed by Anatomic Specificx Guiding System and the Digitally Integrated Surgical Reconstruction Platform (DISRP).
- . The Digitally Integrated Surgical Reconstruction Platform (DISRP) is a web-based collaboration software for digital surgery case flow management and Orthognathic surgery planning that reflects the production process and allows for the interaction of multiple users: surgeons, sales representatives, and the TECHFIT case planning staff (case planning assistant, case planners, and operations director), using multiple devices. It allows collaboration in the planning process. Detail description of the software can be found in later in this section.
- Anatomic Specificx Guiding System is a Patient-Specific single-use device designed to ● assist surgeons in transferring the pre-surgical plan to the operation room. This system includes surqical quides intended for Orthognathic and Reconstructive surgeries in adults. The surgical guides have drilling holes and slots to make osteotomies and ensure the correct positioning of bones and implants.
The Anatomic Specificx Guiding System is divided into two categories: Anatomic Specificx Orthognathic Guides and Anatomic Specificx Reconstruction Guides.
Anatomic Specificx Orthognathic Guides are classified into Titanium and Resin Surgical Guides.
Anatomic Specificx Orthognathic Titanium Guides are manufactured from Commercially Pure (CP) Titanium grade 4; they include mandibular and maxillofacial surgical guides (e.q. Le Fort, Genioplasty, etc). Palatal Splints are also part of Anatomic Specificx Orthognathic Titanium Guides, which are optional quides used in orthognathic surgery to quide and support the correct teeth positioning and validate the patient's final occlusion.
Anatomic Specificx Orthognathic Resin Guides are manufactured through rapid prototyping using the Form 3B and Form 4B printers and Biomed Clear Resin from Formlabs. These guides include Le Fort and genioplasty surgical guides. During surgery, resin surgical guides must be used with slot, drill, and screw metal sleeves. Slot sleeves are made from commercially pure grade 4 titanium, while drill and screw sleeves are made from alloyed titanium (Ti6Al4V). All sleeves are manufactured by machining. The resin quides also include splints (intermediate, final, and palatal), which are optional quides used in orthognathic surgery to quide and support the correct teeth positioning and validate the patient's final occlusion.
Anatomic Specificx Reconstruction Guides
The Anatomic Specificx Reconstruction Guides are intended for mandibular and maxillofacial surqical procedures in adults, using patient grafts/flaps for reconstruction. These guides are made from Commercially Pure (CP) grade 4 titanium, produced through machining and finished with an anodizing process. They are intended for use in the anatomical sites of the maxilla, mandible and fibula. The reconstruction guides provide transfer of the pre-surgical plan to the operating room, facilitating placement and fixation of the patient's bone grafts/flaps at the surgical site.
The TECHFIT DISRP® System is cleared based on non-clinical testing. The device is a software system and image segmentation system intended for use in maxillofacial surgery for transferring imaging information from a medical scanner (such as a CT-based system) to create digital models, or to produce physical outputs such as surgical guides and splints. It also serves as a preoperative software tool for simulating and evaluating surgical treatment options.
Here's an overview of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Assessment | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization | Validating sterilization methods | Sterilization to a Sterility Assurance Level (SAL) of 10-6 using recommended steam sterilization instructions. | The results of the steam sterilization validation show that Anatomic Specificx Reconstruction Guides and Palatal Splints were sterilized to a SAL of 10-6 using the recommended steam sterilization instructions. |
| Dimensional Accuracy | Scanning of Anatomic Specificx Reconstruction Guides | Scanning comparison between the physical guides and the existing digital files must be successful and meet all acceptance criteria. | The scanning comparison between the Anatomic Specificx Reconstruction Guides and the existing files was successful, meeting all acceptance criteria. |
| Compatibility | Compatibility testing between components: Anatomic Specificx Reconstruction Guides, Patient-specific Maxillofacial System, and TECHFIT Diagnostic Models. For palatal splints: compatibility with Anatomic Specificx Orthognathic Titanium Guides, TECHFIT Diagnostic Models, and Patient-specific Maxillofacial System. | All components must be compatible with each other as specified in their intended use. | Anatomic Specificx Reconstruction Guides were compatible with Patient-specific Maxillofacial System and TECHFIT Diagnostic Models. Palatal Splints were compatible with Anatomic Specificx Orthognathic Titanium Guides, TECHFIT Diagnostic Models and Patient-specific Maxillofacial System. |
| Mechanical Performance | Static and dynamic four-point bending mechanical tests on TECHFIT plates compared to a mandibular plate from KLS Martin. | TECHFIT plates must offer comparable or significantly greater resistance. | TECHFIT plates offer significantly greater resistance. |
| Software Verification & Validation (V&V) | Verifying the item parts for the software. | DISRP meets the Software Design Specification (SDS) and functions as intended in the intended use environment. Rigorous testing for deployment, reliability, and security. | DISRP meets the SDS and testing as intended in the intended use environment. DISRP has rigorous testing, and it is reviewing every time it is deployed working as expected. V&V includes reliability and security processes. |
| Biocompatibility | Cytotoxicity test (ISO 10993-5) | No cytotoxic effect. | No cytotoxic effect. |
| Sensitization test (ISO 10993-10) | No sensitizing properties. | No sensitizing properties. | |
| Irritation/intracutaneous reactivity test (ISO 10993-10 and ISO 10993-23) | No irritant properties. | No irritant properties. | |
| Acute systemic toxicity (ISO 10993-11) | No evidence of systemic toxicity. | No evidence of systemic toxicity. | |
| Material-Mediated Pyrogenicity (ISO 10993-11) | No pyrogenic properties. | No pyrogenic properties. | |
| Genotoxicity (ISO 10993-3) | No genotoxic potential. | No genotoxic potential. | |
| Chemical Characterization and risk assessment (ISO 10993-18 and ISO 10993-17) | Non-toxic. | Non-toxic. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for the test sets in the dimensional validation, compatibility testing, mechanical testing, or software verification and validation. It only states that these tests were conducted.
The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly mentioned for any of the non-clinical tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For instance, in the dimensional validation, it does not state how many individuals assessed the comparisons or their qualifications. For software V&V, it does not specify who conducted the testing or their expertise.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication methods (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results. The conclusions appear to be based on direct measurements and adherence to test standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, the document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. The studies described are non-clinical hardware and software performance tests, not clinical studies involving human readers or comparative effectiveness with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The software verification and validation activities (e.g., "DISRP meets the SDS and testing as intended in the intended use environment") represent standalone algorithm performance testing to some extent. The DISRP system, as a software for planning and segmentation, operates on input data files and produces output data files, which is a core standalone function. However, the overall system still anticipates "expert clinical judgment" as stated in the Indications for Use, meaning it's intended to be used with a human in the loop for clinical application. The V&V focuses on the software's functional correctness.
7. The Type of Ground Truth Used
The type of ground truth used for the non-clinical tests can be inferred as follows:
- Sterilization: Ground truth is established by adherence to recognized international standards (AAMI/ISO 17665-1, ANSI/AAMI/ISO 14937) and demonstrating the specified SAL.
- Dimensional validation: Ground truth would be the original digital design files against which the scanned physical devices are compared. This is a direct comparison to a digital reference.
- Compatibility testing: Ground truth is defined by the functional requirement for components to work together seamlessly.
- Mechanical testing: Ground truth is established by the specified mechanical properties to be achieved or exceeded, often through direct measurement and comparison with known material properties or predicate device performance.
- Software verification and validation: Ground truth is the Software Design Specification (SDS) and the intended functional requirements of the software.
- Biocompatibility testing: Ground truth is established by the pass/fail criteria defined in the referenced ISO 10993 series standards, indicating the absence of adverse biological reactions.
8. The Sample Size for the Training Set
The document does not provide any information about a training set for an AI/ML algorithm. The device is described as a "software system and image segmentation system," but there's no explicit mention of machine learning or deep learning components requiring a dedicated training set. The development described is more akin to traditional software and CAD/CAM processes.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned or implied for an AI/ML component, this information is not applicable and not provided in the document.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.