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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

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.

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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.

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.

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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 output 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 Orthognathic Surgical Guides and the Digitally Integrated Surgical Reconstruction Platform (DISRP).

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 easy collaboration in the planning process. Being web-based allows immediate and convenient sharing without the installation or maintenance of the application at the user's end.

Orthognathic Surgical Guides
Orthognathic Surgical Guides are Patient-Specific single use devices that are designed to assist the surgeon in transferring the pre-surgical plan to the operation room. Surgical Guides are intended for Orthognathic surgeries in adults and have drilling holes and slots for making drillings and osteotomies, as well as they guide the correct positioning of bones and implants.

Orthognathic Surgical Guided into two types: Resin Orthognathic Surgical Guides and Machined Orthognathic Surgical Guides.

• Resin Orthognathic Surgical Guides
  Resin Orthognathic Surgical Guides include surgical guides and splints.

Surgical Guides consist of the Le Fort and Genioplasty surgical quides, which are composed of a body that is manufactured by TECHFIT Digital Surgery and produced by rapid prototyping with the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.

In surgery Surgical Guides must be used with Metal Sleeves. There are three types of metal sleeves: slot metal sleeve, drill metal sleeve and screw metal sleeve. The slot, drill and screw metal sleeves are manually fitted by the healthcare professional during surgery into the slots, drilling holes and fixation holes of the surgical guide. The metal sleeves are produced from commercially pure titanium grade 4 through machining and are manufactured equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199). In addition, the Metal Sleeves are single-use and patient-specific accessories.

The Splints are optional quides used in orthognathic surgery to quide to the correct teeth positioning and to validate the patient's final occlusion. The Splints are manufactured by TECHFIT Digital Surgery and produced by rapid prototyping using the Form 3B printer and Biomed Clear Resin from Formlabs, Somerville, United States.

• Machined Orthognathic Surgical Guides
  Machined Orthognathic Surgical Guides consist of the Le Fort and Genioplasty surgical guides that are manufactured from the same material (commercially pure titanium grade 4) and in a manufacturing process equivalent to the TECHFIT Patient-Specific Maxillofacial System (K203282) and AFFINITY Proximal Tibia System (K220199) manufactured through machining.

Machined Orthognathic Surgical Guides and Metal Sleeves are manufactured with the same material and same manufacturing process.

The provided text describes the TECHFIT DISRP® System, including its indications for use, comparison to predicate devices, and performance data from non-clinical testing. However, it does not contain details about a study evaluating the performance of an AI/algorithm component against specific acceptance criteria related to its accuracy or diagnostic capability, nor does it mention any human-in-the-loop studies (MRMC) or standalone algorithm performance studies.

The "Performance Data" section primarily addresses:

• Safety testing: Validating sterilization methods.
• Performance testing: Dimensional validation (comparing physical guides to digital designs), mechanical testing (withstanding forces), and compatibility testing with other systems.
• Software testing: Verification and validation of the DISRP software itself as per IEC 62304.
• Biocompatibility testing: For the materials used in the surgical guides and metal sleeves.

Therefore, based solely on the provided text, I cannot fill out the requested table and details regarding acceptance criteria for an AI/algorithm and a study proving its performance in the context of diagnostic accuracy or reader improvement. The device described appears to be a software system for planning and producing physical surgical guides and splints, not an AI for image interpretation or diagnosis.

If the "DISRP System" inherently contains an AI component for, say, auto-segmentation or surgical plan optimization that would require diagnostic-like performance evaluation, that information is not present in the provided excerpt.

Assuming the request refers to the acceptance criteria for the overall system's performance as described, rather than an AI's diagnostic accuracy:

Here's how I can address the request based on the available information, while highlighting what's not present:

Response based on the provided document:

The provided document describes the TECHFIT DISRP® System, which is a software system and image segmentation system used for surgical planning and the production of physical surgical guides and splints. It is not an AI diagnostic device in the traditional sense that generates clinical interpretations or provides diagnostic classifications. Therefore, the acceptance criteria and study details commonly associated with AI performance validation (like sensitivity, specificity, MRMC studies, ground truth establishment for diagnostic tasks) are not applicable to the data presented in this FDA 510(k) summary.

The performance data presented focuses on the physical and software validation of the device, ensuring it meets its intended use of accurately transferring imaging information to produce dimensionally correct and mechanically sound surgical guides and splints, and that the software functions as intended.

Here's a breakdown based on the provided text, addressing the points where information is available or noting its absence:

1. Table of Acceptance Criteria and Reported Device Performance

Details Regarding Studies (as pertains to this type of device):

2. Sample sizes used for the test set and the data provenance:

   • The document mentions "Scanning of orthognathic surgical guides" and "Bending and compressive strength" tests but does not specify the sample size (number of guides or tests performed) for these non-clinical performance validations.
   • The data provenance is not explicitly stated in terms of country of origin for test materials or whether tests were retrospective or prospective, beyond general statements about testing performed for FDA submission. These are typical engineering validation tests, not clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable for this type of device validation. The "ground truth" here is based on engineering specifications, material properties, and adherence to digital designs, not expert clinical interpretation of images.

4. Adjudication method for the test set:

   • Not applicable. This is not a human-reader study requiring adjudication for diagnostic accuracy.

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. An MRMC study was not described. This device is for surgical planning and guide production, not for AI-assisted diagnostic interpretation by human readers.

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

   • The "Software testing" indicates that the "DISRP software was verified and validated as per IEC 62304," which is a standard for medical device software lifecycle processes. This constitutes a standalone validation of the software's functionality and safety, but not a performance evaluation in terms of diagnostic accuracy or interpretation, as it is not a diagnostic AI.

7. The type of ground truth used:

   • The ground truth for the dimensional validation is the original digital design files of the surgical guides.
   • For mechanical testing, the ground truth is engineering specifications for load-bearing capacity (e.g., maximum bite force, drilling force).
   • For software validation, the ground truth is the specified software requirements and the IEC 62304 standard.
   • For biocompatibility, the ground truth is the ISO 10993 series of standards for biological evaluation of medical devices.

8. The sample size for the training set:

   • Not applicable. This document does not describe a machine learning algorithm that requires a training set. The "DISRP System" is described as a "software system and image segmentation system for the transfer of imaging information," implying rule-based or conventional image processing for segmentation rather than a data-driven AI model that learns from large training datasets.

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

   • Not applicable as no training set for an AI model is described.

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AFFINITY Proximal Tibia System is intended to treat fractures, nonunions of the proximal tibia including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.

• · Simple metaphyseal fractures (Classification AO 41-A2)
• · Multifragmentary metaphyseal fractures (Classification AO 41-A3)
• · Simple bicondylar fractures (Classification AO41-C1, 41-C2)
• Multifragmentary bicondylar fractures (Classification AO 41-C3)
• · Simple joint, simple metaphyseal fractures (Classification AO 41-C1)
• · Diaphisary fractures (Classification AO 42A and 42B)

AFFINITY Proximal Tibia System consists of anatomical plates and screws for the placement of the proximal tibial condyles, improving the restoration of the original structure. Similarly, in combination with the variable angle technique, it allows for the placement of screws in different configurations providing appropriate support for the correct healing of fractures.
AFFINITY Proximal Tibia System consists of pre-contoured bone fixation plates and screws. The plates are made from biocompatible commercially pure titanium grade 4 according to ISO 5832-2 and ASTM F67 standard. The screws are made from biocompatible titanium alloy (Ti6Al4V) according to ISO 5832-3 and ASTM F136 standard.
The AFFINITY Proximal Tibia System plates can be fixed with variable angle technique.

The provided text is an FDA 510(k) summary for the AFFINITY Proximal Tibia System. This document describes a medical device (a bone plate and screw system for tibial fractures) and its claim of substantial equivalence to existing predicate devices.

Crucially, the document states that "Clinical testing was not necessary for the substantial equivalence determination." This means that the device's acceptance criteria and the proof it meets them do NOT involve human clinical studies or AI-driven performance metrics such as accuracy, sensitivity, specificity, or human-in-the-loop improvements.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets the acceptance criteria in the context of AI/machine learning performance. The provided text details non-clinical performance testing for a medical implant, focusing on mechanical, biocompatibility, and sterilization aspects.

Here's why I cannot provide the requested information based on the given text:

• No AI or algorithm present: There is no mention of any AI component, algorithm, or software in the device description or its testing.
• No clinical performance data (e.g., accuracy, sensitivity): The document explicitly states "Clinical testing was not necessary." The performance testing described is mechanical (bend, torsion, pullout strength), biocompatibility, and sterilization, which are relevant for physical implants, not AI diagnostic or assistive devices.
• No human reader studies (MRMC): Since no AI is involved, there are no studies assessing how human readers improve with AI assistance.
• No ground truth establishment for diagnostic performance: The "ground truth" mentioned in your prompt (expert consensus, pathology, outcomes data) is typically for validating diagnostic or classification algorithms. For a bone plate, ground truth relates to its mechanical integrity and biological safety, which were assessed through laboratory tests.

In summary, the provided document describes the regulatory approval of a physical medical device (a bone plate and screw system) through established non-clinical testing and comparison to predicates, not the validation of an AI/ML medical device.

If you have a document describing an AI/ML medical device's performance study, I would be happy to analyze it according to your detailed criteria.

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