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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 traCMF Solution 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 tmCMF Solution, 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 anatomical models, surgical guides, and dental splints for use in maxillofacial and mandibular surgery. The surgical guides and dental splints are intended to the maxillofacial and mandibular bone in mandibular surgery. The tmCMF Solution is also intended as a preoperative software tool for simulating/evaluating surgical treatment options.

The TechMah CMF (tmCMF) Solution is a family of personalized product solutions for trauma and reconstruction procedures in the mandible and midface. The solution is comprised of Surgeon Review Tool (SRT) software, and maxillofacial and mandibular surqical instruments (surgical quides, anatomical models, and dental splints). The surqical instruments are patient-specific devices and are designed utilizing CT and dental scan patient image data.

Surgical guides are patient-specific devices or templates that are based on preoperative software planning and are designed to fit a specific patient. These guides are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the marking of bone for plate fixation screws and the position of the osteotomy marking slots. Surgical guides are available for treatment (maxilla and mandible) and harvesting (fibula, iliac crest, and scapula). Guides can be used in conjunction with anatomical models to verify anatomical positioning and fit.

Anatomical models are patient-specific models that are based on pre-operative anatomy and surgical planning specific to a patient. These models are used to assist a surgeon in transferring the pre-operative plan to the surgery by representing preoperative, intra-operative, and post-operative anatomical models as guidance. Anatomical models are available for treatment (maxilla and mandible), and harvesting (fibula, iliac crest, and scapula) anatomy. Anatomical models can be used to check quide fit.

Dental splints are patient-specific devices or templates that are based on preoperative software surgical planning and are designed to fit a specific patient. Dental splints are available as single splint desired occlusions or combined splint-in-splint option. These templates are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the dental alignment of bone and teeth.

The Surgeon Review Tool (SRT) software is used by surgeons for the review and approval of surgical plans and surgical instrument designs. The SRT software is accessed through a web interface from a surgeon's device.

The tmCMF Solution's acceptance criteria and the study proving it meets these criteria are detailed below.
1. A table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Cadaveric Benchtop Performance Testing" as part of the benchtop performance evaluation. However, it does not specify the sample size (number of cadavers or cases) used for this test set, nor does it explicitly state the country of origin or whether the data was retrospective or prospective. It only states that a comparison of pre-operative surgical plan to post-operative CT measurements was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not provide information on the number of experts used to establish the ground truth for the test set or their specific qualifications. It mentions that the "Surgeon Review Tool (SRT) software is used by surgeons for the review and approval of surgical plans and surgical instrument designs," implying surgeon involvement in the process but not specifically for ground truth establishment for a test set in the regulatory submission context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method (such as 2+1 or 3+1) used for establishing ground truth or evaluating the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The tmCMF Solution is described as a software system for image segmentation, surgical planning, and the production of physical outputs, with the Surgeon Review Tool (SRT) facilitating surgeon review and approval, but not explicitly as an AI assistance tool for human readers in a diagnostic setting that would typically involve a MRMC study.

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

While the document describes the tmCMF Solution as a "software system and image segmentation system," it also highlights the "Surgeon Review Tool (SRT) software is used by surgeons for the review and approval of surgical plans and surgical instrument designs" and "Physician Interaction with Planning and Physician Model / Guide Approval." This indicates that the device is intended for human-in-the-loop performance, with the surgeon involved in the review and approval process. A standalone algorithm-only performance is not explicitly described as a primary evaluation method.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "Cadaveric Benchtop Performance Testing," the ground truth was established by "Comparison of pre-operative surgical plan to post-operative CT measurements." This suggests that the ground truth for accuracy was based on direct measurement from CT scans after the surgical plan was implemented on cadavers, rather than expert consensus, pathology, or long-term outcomes data.

8. The sample size for the training set

The document does not provide any information regarding the sample size used for the training set of the tmCMF Solution's "software system and image segmentation system."

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

The document does not disclose how the ground truth for the training set was established.

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The VSP® Orthopedics System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing osteotomies for adult patients in the distal femur, tibia, and non-sacrum pelvis.

The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures. The system contains several physical and digital outputs including patient-specific anatomical models, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs).

Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution.

The VSP® Orthopedics System also contains Stainless Steel Drill Inserts (VSP® Orthopedics System Accessories) which are intended to be used by the physician to guide drilling activities during the surgical procedure. The inserts fit into a standard hole in the cutting / drill guides and can be used across all VSP® Orthopedics System guides and templates.

The VSP® Orthopedics System is intended to assist a surgeon with pre-operative planning and transfer of the pre-operative plan to the surgery in orthopedic procedures.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of numerical acceptance criteria or reported device performance metrics like sensitivity, specificity, or accuracy for the overall system. Instead, it states that:

"All design, process, and other verification and validation testing, which were conducted as a result of risk analyses and design impact assessments, showed conformity to pre-established specifications and acceptance criteria. The acceptance criteria was established in support of device performance, and testing demonstrated substantial equivalence of the system to the predicate device."

This indicates that the acceptance criteria were qualitative and focused on demonstrated compliance with pre-established specifications and substantial equivalence to the predicate device.

The "Performance Testing" section lists the types of tests performed:

2. Sample size used for the test set and the data provenance

The document specifies "Bench and cadaveric testing was conducted" and includes "Cadaver Study" as a test type. However, it does not provide any details on the sample size (number of cadavers or specific test scenarios) used for the cadaver study or any other test set.

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective).

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

The document states: "Outputs of the VSP® Orthopedics System are designed with physician input and reviewed by the physician prior to finalization and distribution." While this indicates physician involvement in the design and review process, it does not specify the number of experts used to establish ground truth for a test set or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size for human readers improving with AI assistance. The system is described as a "surgical instrument to assist in pre-operative planning and/or in guiding..." which implies human-in-the-loop, but no comparative study to measure assistance effectiveness is detailed in this summary.

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

The document does not explicitly state if a standalone (algorithm only) performance study was conducted. The description of the system's outputs ("patient-specific anatomical models, and guides (physical outputs); and patient-specific surgical plans and digital files (digital or documentation outputs)") suggests that the system generates these outputs, which are then reviewed by a physician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document implies that the ground truth for the system's performance, particularly in the cadaver study, would be based on direct observation of surgical guidance and accuracy against the pre-operative plan. Since the system assists in planning and guiding, the "ground truth" would likely be the surgical outcome or accuracy of instrument placement as verified in the cadaveric setting. However, the exact nature of this "ground truth" and how it was established is not detailed. It mentions "physician input" and "reviewed by the physician," suggesting expert judgment forms a basis, but not explicitly as a ground truth for a test set.

8. The sample size for the training set

The document does not provide any information regarding a training set or its sample size. This summary focuses on verification and validation testing, not the development or training of an AI component, if one exists within the system's planning features.

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

Since no information on a training set is provided, there is also no information on how its ground truth was established.

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The FIREFLY™ Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system's cleared indications for use.

Use of the FIREFLY™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of anatomical landmarks. Only compatible OEM taps that are supplied with the pedicle screw spinal systems specified in the instructions for use may be used through the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. All other pedicle screw spinal system components and accessories (including non-guided taps) are to be used after removal of the FIREFLY™ Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use.

This device is intended for single use only.

The FIREFLY ™ Pedicle Screw Navigation Guide is a patient-specific system intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.
The FIREFLY ™ Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan.
Patient-Specific Bone Models may also be provided.

The provided text describes the FIREFLY™ Pedicle Screw Navigation Guide and its performance data. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test/training sets, or information on ground truth establishment, expert consensus, or MRMC studies. The document is a 510(k) summary for FDA clearance, which typically presents a high-level overview rather than detailed scientific study breakdowns.

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific numerical or qualitative acceptance criteria for accuracy and sterilization stability are not detailed in this document.

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

The document mentions "Cadaveric accuracy and sterilization stability testing."

• Sample Size for Test Set: Not specified.
• Data Provenance: Cadaveric testing. (Country of origin is not specified, and it's a prospective study as it was performed for this specific device).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The document describes accuracy testing, but not a comparison of human readers with and without AI assistance to measure improvement effect size.

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

The device is a "Pedicle Screw Navigation Guide," which implies it is a physical guide used by a surgeon during surgery. It is not an AI algorithm in the traditional sense that would have "standalone" performance independent of human interaction in the operating room. Therefore, the concept of "standalone algorithm performance" as typically applied to AI image analysis is not relevant here. The accuracy refers to the guide's precision in directing the surgical instruments.

7. The Type of Ground Truth Used

• Ground Truth: For accuracy, the "ground truth" would likely be the actual placement of the pilot holes or screws in the cadavers, as measured post-procedure (e.g., via CT scanning and comparison to pre-operative plans). This is implied by the term "accuracy testing," but the specific method of establishing this ground truth (e.g., using a gold-standard imaging technique and detailed measurements) is not specified.

8. The Sample Size for the Training Set

The device is a physical navigation guide, not a machine learning algorithm that requires a "training set" in the computational sense. The planning software uses patient CT images, but these are for individual patient planning, not for training a generalized model. Therefore, this question is not applicable.

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

Not applicable, as there is no "training set" in the context of an AI algorithm.

Summary of Study that Proves Device Meets Acceptance Criteria:

The document states: "Cadaveric accuracy and sterilization stability testing of the FIREFLY Pedicle Screw Navigation Guide was performed. The results demonstrated that the acceptance criteria were met and that the FIREFLY Pedicle Screw Navigation Guide performance is adequate to perform as intended."

This indicates that an experimental study was conducted using cadaveric specimens to evaluate the precision of the guide in directing surgical instruments and to confirm its sterility after processing. However, the details of these studies, including specific methodologies, data collected, statistical analyses, and the actual numerical results against defined acceptance criteria, are not provided in this 510(k) summary.

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These devices are implantable bone plates and bone screws for facial procedures including: 1. Fractures - 2. Osteotomies - 3. Reconstructive procedures - 4. Revision procedures where other treatments or devices have failed

The Biomet Microfixation Facial PreBent Plates with Virtual Surgical Planning is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation for Facial reconstruction procedures. The plates include variations of straight, angle, curved, L-shape, Tshape, double T-shape, Z-shape, Y-shape, double Y-shape, H-shape, triangle, square, rectangle, matrix, orbital floor, LeFort, and chin options with various lengths and thickness. Plates are offered flat or 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 K121589 (cleared 9/21/12). This bending process is conducted at Biomet Microfixation based on our process specification and inspection criteria previously cleared with K121589.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Biomet Microfixation Facial PreBent Plates with Virtual Surgical Planning:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. No clinical or non-clinical testing was performed as the device was deemed substantially equivalent based on its identical characteristics to a previously cleared predicate device, with an additional pre-bending service.
• Data Provenance: Not applicable. No test set data was generated for this submission. The rationale for substantial equivalence relied on the predicate device's existing clearance and the verification process for the pre-bending.

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

• Not applicable. No test set was used, and therefore no ground truth was established by experts for a test set. The pre-bent plate's congruence to the anatomical model is verified through an internal inspection process by Biomet Microfixation, which aligns with their process specification and inspection criteria.

4. Adjudication Method for the Test Set

• Not applicable. No test set was used.

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

• Not applicable. This device is a physical bone plate and not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• Not applicable. This device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

• For the verification of the pre-bent plates, the "ground truth" is the patient-specific anatomical model created by Medical Modeling from CT scans. The plates are 100% verified against this model. This is essentially a form of design verification/conformance to a patient-specific digital template/model.
• For the overall device clearance, the ground truth is implicitly tied to the established safety and effectiveness of the predicate device (K121589).

8. The Sample Size for the Training Set

• Not applicable. This document describes a medical device (bone plates) submission, not an AI algorithm that requires a training set. The "VSP System" mentioned generates patient-specific anatomical models and guides, but the submission does not detail its development as an AI system requiring a 'training set'.

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

• Not applicable, as no training set for an algorithm is described.

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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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