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The Yomi S Robotic System (Yomi S) is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi S is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi S Robotic System. The output of YomiPlan is to be used with the Yomi S Robotic System.

The Neocis Yomi S is a modified next iteration of the Yomi Robotic System, designed to provide guidance for a dental surgeon during dental implant surgery. Yomi S is a dental stereotaxic medical device (Product Codes PLV, QRY) regulated under 21 CFR 872.4120. The device includes a YomiLink that is placed on the patient prior to the CT scan, and a fiducial array with fiducial markers that is placed on the YomiLink prior to the CT scan so the virtual plan can be related to the physical space of the system. The Guidance Arm secures a standard dental drill, allowing the surgeon to grip the drill as normal. The Guidance Arm does not move unless the surgeon applies a manual force to the drill. The Guidance Arm will constrain the surgeon to drill according to the prescribed surgical plan, preventing deviation. The surgeon is constantly in control of the drilling. The system has a mechanical feedback system that is connected to the YomiLink on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.

The Yomi S Robotic System allows the user to plan the surgery virtually in YomiPlan, cleared for use alone on third-party PCs for preplanning. The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in the planning software. The plan is used for the system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The Yomi S robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument.

The patient tracking portion of Yomi S is comprised of linkages from the patient to Yomi S, which include the Patient Splint (YomiLink Teeth or YomiLink Bone), Tracker End Effector (TEE), and the Patient Tracker (PT). In cases where YomiLink Teeth is utilized, it is attached to the contralateral side of the patient's mouth over stable teeth using on-label dental materials prior to the presurgical CBCT scan. In cases where YomiLink Bone is utilized, it is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required), or after the scan when using the subject YomiLink Arch device.

The subject of this submission is to: introduce the Yomi S Robotic System, a next-generation modification of the Yomi Robotic System, intended to assist dental surgeons by providing guidance during dental implant procedures.

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The Yomi Robotic System (Yomi) is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.

Yomi Robotic System is a dental stereotaxic instrument and a powered surgical device for bone cutting. Yomi Robotic System is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The Yomi Robotic System is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The Yomi Robotic System allows the user to plan the surgery virtually in YomiPlan, cleared for use alone on third-party PCs for preplanning. The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in the planning software. The plan is used for the system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The Yomi robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument.

The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Patient Splint (YomiLink Teeth or YomiLink Bone), Tracker End Effector (TEE), and the Patient Tracker (PT). In cases where YomiLink Teeth is utilized, it is attached to the contralateral side of the patient's mouth over stable teeth using on-label dental materials prior to the presurgical CBCT scan. In cases where YomiLink Bone is utilized, it is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required), or after the scan when using the subject YomiLink Arch device.

The subject of this submission is to: Integrating algorithms that provide automatic segmentation of maxillary sinuses, inferior alveolar nerve, and maxillary and mandibular bone. The integrated software, Relu Creator, was cleared in K233925. The software is not adaptive, it is trained at the manufacturer (Relu), and the weights are locked.

Additionally, since the most recent clearance of Yomi Robotic System (K231018), minor modifications to the Yomi System include the following:
• Planning software improvements
• Restorative planning – Features to support customized crown design
• Dual arch planning – Feature to enable the end user to plan multiple arches in a singe case and a singe scan
• Patient work volume guidance improvements – Added guidance for the angulation of the patient chair
• Added patient proximity for baseline
• YomiLink Bone (YLB) planning – improved placement of the YLB
• Added proximity threshold lower limit value
• Improved alignment between CT scans and imported .stl objects
• Added ability for user to designate soft tissue thickness to assist in bone reduction planning
• Added max depth information to the implant cursor hover info
• VTK Off-the-Shelf software version update
• Added model details to implant selection
• Added restorative planning case feedback option
• Added additional implant models to the implant library

• Control software and behavior improvements
• Updates to handpiece interaction gestures, and optimization of the response of the control software to guide arm joint limits, singularities and potential wrist / base collisions.

• Hardware improvements Tracker Arm Joint

• Accessory improvements
• Updates to the YomiLink Teeth and intraoral fiducial array

• Minor bug fixes

All other aspects of the Yomi Robotic System remain unchanged from prior clearances.

The provided FDA 510(k) clearance letter for the Yomi Robotic System focuses on the substantial equivalence of the modified device to its predicate. While it mentions the integration of an automatic segmentation algorithm (Relu Creator, K233925), it does not contain the detailed acceptance criteria or the specific study that proves the device meets those criteria for the automatic segmentation algorithm.

The document primarily describes:

• The indications for use.
• A comparison of technological characteristics between the subject device (Yomi Robotic System with Automatic Segmentation Algorithm) and its predicate (Yomi Robotic System K231018) and a reference device (Relu Creator K233925).
• General statements about software, cybersecurity, and usability verification and validation testing, but without specific performance metrics or study details.

Therefore, many of the requested details about acceptance criteria, specific performance results, sample sizes, expert qualifications, and ground truth establishment for the automatic segmentation algorithm are not present in the provided text. The document refers to the Relu Creator (K233925) as having been cleared, implying its own performance evaluations would have been submitted in that separate clearance.

Here's a breakdown of the information that can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided for the automatic segmentation algorithm (Relu Creator) in this document. The document states:

• "Yomi Plan 2.7 with Automatic Segmentation Algorithm functionality was successfully verified and user validated."
• "The software has been successfully verified to perform with the PC specifications of the Yomi Robotic System."
• "All changes have been successfully verified and, therefore, not considered to affect the overall safety and efficacy profile of Yomi Plan."
• "The combined testing and analysis of results provides assurance that the device performs as intended."

These are general assurances of performance and validation but do not provide specific quantitative acceptance criteria or reported device performance metrics for the automatic segmentation algorithm itself.

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

Not provided in this document. The document mentions "Software verification and validation testing" and "User Validation testing" but does not specify the sample size of cases or the provenance (country of origin, retrospective/prospective) of the data used for testing the automatic segmentation algorithm.

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

Not provided in this document.

4. Adjudication method for the test set

Not provided in this document.

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 provided in this document. The document does not mention an MRMC study or any results comparing human reader performance with and without AI assistance from the segmentation algorithm. The automatic segmentation algorithm is integrated into the planning software to assist (presumably by providing pre-segmented anatomy), but its impact on human reader performance is not quantified here.

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

Not explicitly detailed for the segmentation algorithm's performance. The document states, "The integrated software, Relu Creator, was cleared in K233925." This implies that the Relu Creator, which performs the automatic segmentation, underwent its own standalone performance evaluation as part of its original clearance (K233925). This current 510(k) focuses on its integration into the Yomi Robotic System, not its primary standalone performance evaluation.

7. The type of ground truth used

Not explicitly provided in this document for the automatic segmentation algorithm. For image segmentation algorithms, ground truth is typically established through manual segmentation by experts, often on a pixel/voxel level, sometimes validated by pathology or clinical outcomes. The document does not specify which method was used for the Relu Creator.

8. The sample size for the training set

Not provided in this document. The document states, "The software is not adaptive, it is trained at the manufacturer (Relu), and the weights are locked." This confirms that training occurred, but the size of the training dataset is not mentioned.

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

Not provided in this document. Similar to item 7, the method for establishing ground truth for the training data is not detailed.

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Yomi Robotic System is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotional guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi Robotic System is intended for use in partially edentulous adult patients who qualify for dental implants.

When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.

Yomi Robotic System is a dental stereotaxic instrument and a powered surgical device for bone cutting. Yomi Robotic System is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The Yomi Robotic System is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The Yomi Robotic System allows the user to plan the surgery virtually in YomiPlan, cleared for use alone on third-party PCs for preplanning. The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in the planning software. The plan is used for the system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The Yomi robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument.

The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Patient Splint (YomiLink Teeth or YomiLink Bone), Tracker End Effector (TEE), and the Patient Tracker (PT). In cases where YomiLink Teeth is utilized, it is attached to the contralateral side of the patient's mouth over stable teeth using on-label dental materials prior to the presurgical CBCT scan. In cases where YomiLink Bone is utilized, it is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required), or after the scan when using the subject YomiLink Arch device.

The subject of this submission is to introduce new accessories, the YomiLink Arch and Probing Bit. The YomiLink Arch allows for CBCT scan acquisition prior to YomiLink Bone placement and enables guided YomiLink Bone placement. This submission also introduces an update to the system planning software to enable use of the YomiLink Arch (YLA).

Following attachment of YomiLink Bone (YLB) to the patient, probing of the YLA is performed utilizing the YLA Probing Bit to transfer registration in the software from YLA to YLB and allow for tracking of the YLB throughout the remaining surgical procedure. The YLA Probing Bit is available in straight and contra-angle configurations corresponding to the handpiece to which they are attached.

All other aspects of the Yomi Robotic System remain unchanged from prior clearances.

This document describes the regulatory approval of the Neocis Yomi Robotic System with new accessories (YomiLink Arch and Probing Bit), indicating substantial equivalence to a previously cleared device. However, it does not provide explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) for an AI device. Instead, it refers to performance testing conducted to ensure the device functions as intended.

Based on the provided text, here's an attempt to structure the information, acknowledging the limitations for a full AI acceptance criteria description:

1. Table of Acceptance Criteria and Reported Device Performance

As the document is a 510(k) summary for a robotic surgical system, not a purely AI diagnostic or prognostic device, the "acceptance criteria" are described in terms of verification and validation testing to ensure the added accessories and workflow maintain the system's intended function and safety. Specific numerical performance metrics for AI algorithms (like sensitivity or specificity) are not provided in this regulatory summary.

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

The document does not specify the sample size for individual tests, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective). The performance testing described appears to be a series of engineering and usability validations rather than a clinical study with a patient-derived test set in the conventional sense of AI performance evaluation. The "test sets" would likely refer to engineering models, simulated environments, and potentially cadaveric or phantom models for accuracy and repeatability testing.

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 a robotic system, "ground truth" often involves highly precise measurement equipment and established engineering benchmarks rather than expert clinical consensus for image interpretation. For human factors validation, usability experts and clinicians would be involved, but specific numbers and qualifications are not listed here.

4. Adjudication Method for the Test Set

This information is not provided.

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

No MRMC study is mentioned. This type of study is typically performed for AI systems that assist human readers in diagnostic or screening tasks. The Yomi Robotic System is a surgical guidance system, and the "AI" component is more embedded in its navigation and planning software, not as a separate diagnostic reader.

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

The performance testing revolves around the integrated system, including the software and new accessories (YomiLink Arch and Probing Bit) as they interact within the existing Yomi Robotic System workflow. While core algorithm accuracy is verified, it's presented within the context of the overall system's function, not as a standalone AI diagnostic output. The YomiPlan software is for preplanning, and its output is to be used with the Yomi Robotic System, not as a standalone diagnostic.

7. The Type of Ground Truth Used

The ground truth for the device's accuracy and performance would be established through a combination of methods typical for robotic systems:

• Physical measurements: Using highly accurate metrology equipment to verify positioning, deflection, and repeatability against known physical standards.
• Engineering specifications: Comparing system performance against pre-defined engineering tolerances and design requirements.
• Simulation/Phantoms: Testing the system's ability to accurately navigate and execute plans on controlled phantom models.
• User requirements: For human factors and software end-user validation, the "ground truth" would be the successful completion of tasks by users in accordance with specified requirements and industry standards for usability.

Specific details about the type of ground truth for each test are not elaborated in this summary.

8. The Sample Size for the Training Set

The document does not mention the sample size for the training set. For a robotic navigational system like Yomi, "training" might refer to the development and refinement of algorithms for spatial recognition, registration, and robotic control. This process typically involves extensive internal validation and iterative development with various datasets (e.g., 3D models, CBCT scans) but does not necessarily align with the concept of a "training set" in the context of supervised machine learning for diagnostic tasks.

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

This information is not provided. Similar to point 7, the "ground truth" for developing such a system would be based on engineering principles, known anatomical landmarks, and precise spatial measurements to ensure accurate digital representations and their correlation with physical reality for robotic guidance.

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Navident is a computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery, using pre-acquired CT scan of the jaw. The device is intended for use by a qualified dental surgeon in the treatment of partially or fully edentulous jaws.

Navident is an image-guided dental navigational system intended to assist with preoperative planning and real-time positioning of drilling tools during implantation surgery. In particular, Navident provides visual, real-time feedback on the location of the working tip of a dental handpiece. It shows the location and direction of the tip relative to a volumetric CT image of the patient's jaw registered to that anatomy, and, when available, relative to a path planned on that image. Navident is comprised of the following parts: The main system is comprised of a cart that carries a stereoscopic video camera and a laptop with pre-installed proprietary software. The Navident system also includes several types of accessories: Jaw motion Tracking Accessories, Dental Handpiece Tracking Accessories, Registration accessories, Calibrator. Navident's four core functions are: Model, Plan, Register, Guide.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

Device: Navident

Product Code: PLV
Regulation Number: 21 CFR 872.4120
Regulation Name: Bone Cutting Instrument And Accessories
Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the performance data of the device rather than explicit "acceptance criteria" presented as pass/fail thresholds against specific metrics, except for the accuracy at the drill tip. Instead, it describes various validation and testing activities that collectively demonstrate the device's acceptable performance.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Data from Literature):

  • Study 1 (Trace Registration Accuracy): 136 implants placed in 59 partially edentulous patients.
  • Study 2 (Pterygoid Implants): 63 pterygoid implants in 39 partially edentulous patients (31 with dynamic navigation/trace registration, 32 with freehand surgery).

• Data Provenance: Clinical studies were conducted outside of the US. The document states that "patient populations, user profiles, use environment, and clinical practices are considered equivalent and applicable to the US population." The studies are retrospective, as they are "published scientific literature" that was collected and analyzed.

• Human Factors/Usability Study: 15 representative users.

• Bench Testing: Sample sizes are not explicitly stated for individual bench tests (reprocessing, electrical safety, EMC, full system accuracy bench testing, stability/repeatability of attachments), but it mentions "representative devices" and "representative master devices."

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

The clinical studies referenced are "published scientific literature" and involve "qualified dental surgeon(s)" performing the procedures. The ground truth for the clinical accuracy studies (Study 1 & 2) appears to be derived from actual implant placement compared to the pre-planned position (likely measured from post-operative imaging).

• Number of Experts: Not explicitly stated as "number of experts for ground truth establishment." The studies were performed by treating surgeons. Study 2 mentions "the same surgeon" for comparative data, implying single-surgeon data collection for parts of the comparison.
• Qualifications of Experts: "Qualified dental surgeon(s)." One of the authors in the referenced papers (Stefanelli LV, Mandelaris GA) are typically oral and maxillofacial surgeons or periodontists who are experts in implant surgery.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is described for the ground truth of the clinical studies. The accuracy metrics appear to be derived from quantitative measurements comparing planned vs. actual outcomes, likely without a separate expert adjudication panel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not explicitly performed in the context of comparing human readers with and without AI assistance, as Navident is a surgical navigation system, not an AI-assisted diagnostic imaging device for human reading. The "comparison" is between different surgical techniques (dynamic navigation with trace registration vs. freehand surgery, or dynamic navigation with new trace registration vs. old fiducial registration) or system accuracy benchmarks, not human interpretation of images. However, the studies demonstrate the clinical effectiveness of the device-assisted procedure.

• Effect Size for AI vs. Without AI Assistance:
  • Study 1 (Trace Registration vs. Fiducial-based): The 95th percentile values for the trace registration method were "favorable" compared to the fiducial-based registration method (cleared predicate). This implies an improvement, but specific effect sizes are not quantified here beyond the descriptive "favorable." This is a comparison of system performance, not human performance.
  • Study 2 (Dynamic Navigation with Trace Registration vs. Freehand Surgery): Dynamic navigation was "more accurate." The mean deviations for dynamic navigation were significantly lower across all metrics (e.g., 0.66 mm coronal vs. 1.54 mm for freehand; 2.64° angular vs. 12.49° for freehand). This provides a clear quantitative effect size for the improvement in surgical accuracy when using the device compared to freehand.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The "Full system accuracy bench testing" and the clinical accuracy studies (comparing planned vs. actual implant positions) inherently represent the performance of the algorithm and system, as they quantify the accuracy of the guidance provided by the device. While a human surgeon provides the input and executes the drilling, the accuracy metrics are a direct measure of the system's ability to guide to the planned position. The "Accuracy at the drill tip: ≤1.0mm" is a standalone performance metric.

7. Type of Ground Truth Used

• Clinical Studies: Ground truth for implant accuracy was based on comparison of the pre-planned position (from CT scan) with the actual post-operative implant position (derived from post-operative imaging). This is a form of outcomes data or objective measurement of surgical execution.
• Bench Testing: Ground truth for system accuracy was established through controlled measurements conducted on test setups designed to measure the mapping accuracy and stability.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its size. This is a surgical navigation system, not typically a machine learning or AI model trained on a large imaging dataset in the conventional sense. The "training" for the device's development would be more akin to algorithm development and calibration rather than data-driven machine learning, although some components might use statistical models or optimizations. The clinical literature cited pertains to validation of the device's performance, not training data for an AI.

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

Given that a specific "training set" for an AI algorithm is not mentioned, the method for establishing its ground truth is also not described. The device's core functionality relies on stereoscopic optical tracking and registration algorithms, whose "ground truth" and performance are verified through precise engineering and bench testing rather than large-scale data labelling for AI training.

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Yomi is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. Yomi is intended for use in partially edentulous adult patients who qualify for dental implants.

When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.

The subject of this submission is YomiPlan Go, a feature of the Yomi Robotic System which enables the use of the system without the uploading of a preoperative CT scan. The dynamic planning feature in K202264 requires a pre-operative CT scan for use. This submission includes a new workflow called YomiPlan Go and provides instructions on how to use this feature without the need of uploading a CT scan to the Yomi system. This planning involves placing the robotic arm drill tip to the point where an osteotomy is to be performed i.e., the surgeon performs planning with their direct visualization of the anatomy and with the use of the robotic arm to select where the osteotomy is to be performed. YomiPlan Go gives surgeons the ability to perform an osteotomy under robotic guidance at the point that the surgeon selects on the patient's anatomy. The selected point, axis, and trajectory are maintained by the robotic arm while the surgeon performs the osteotomy.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 44 implants placed in 15 patient arches.
• Data Provenance: Prospective, multi-center, single-arm study (G210363) involving partially or fully edentulous patients. The study was conducted clinically with actual patients. The specific country of origin is not explicitly stated, but the submission is to the US FDA, implying it would be relevant to US practice.

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

• Number of Experts:
  • 3 investigators (general dentists) who performed the procedures.
  • 1 independent 3rd party oral surgeon who performed an independent clinical assessment of all 15 cases.
• Qualifications of Experts:
  • Investigators: General dentists.
  • Independent Assessor: 3rd party oral surgeon. Specific years of experience are not mentioned for any of the experts.

4. Adjudication Method for the Test Set:

• The text describes case-by-case feedback from investigators (through CRF feedback) and an independent 3rd party clinical review of all 15 cases. This suggests a form of independent review rather than a strict 2+1 or 3+1 consensus process among multiple readers for ground truth establishment. Agreement between these groups (investigators' safety feedback, 3rd party review), especially regarding "no vital anatomical structure concerns," served as a form of "ground truth" for clinical safety and acceptability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• No, an MRMC comparative effectiveness study was not explicitly stated to have been done in the traditional sense of evaluating human readers with and without AI assistance.
• The study primarily focused on the standalone performance of "YomiPlan Go" relative to freehand techniques and comparison metrics with the predicate device. The "human factors" evaluation was for the new YomiPlan Go workflow itself by the operating surgeons, not a comparison of human interpretation/performance with and without AI.
• The benefits assessment does highlight how YomiPlan Go assists surgeons (e.g., depth stop, prevention of skiving, parallelism, precision in repeated drilling), which could be interpreted as improving human performance, but this wasn't quantified through an MRMC study design measuring specific effect sizes of human improvement.

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

• Yes, in part, a standalone assessment of the algorithmic component's performance (precision, depth, and lateral error) was conducted as a secondary objective of the clinical study, comparing pre-operative plans (ideal locations) to post-operative implant placement.
• The system's precision specification (Upper 95% Probability with 95% Model Fit < 1.00 mm) is also mentioned as supported by benchtop verification testing, which would typically be a standalone performance test. However, the accuracy is explicitly stated as "N/A for YomiPlan Go" as it's not a specification for this specific mode, which relies on the surgeon's real-time visual assessment rather than a pre-loaded CT.

7. The Type of Ground Truth Used:

• The ground truth for the performance metrics (depth, lateral, and angular error) was established by comparing preoperative clinical plans (ideal planned implant locations on CBCT scans) with postoperative CBCT scans capturing the actual placement of implants.
• For clinical safety and acceptability, the ground truth was based on the assessment and feedback from the investigators and an independent 3rd party oral surgeon, specifically their confirmation of "no vital anatomical structure concerns."

8. The Sample Size for the Training Set:

• The document does not provide information on the sample size for the training set for the Yomi or YomiPlan Go system. The focus of this submission is on the clinical validation of a new feature (YomiPlan Go) for a previously cleared device.

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

• The document does not provide information on how the ground truth for the training set was established. Since the details of the training set size or methodology are not given, the ground truth establishment method for it is also absent.

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The INLIANT Surgical Navigation System (INLIANT) is a computerized navigational system intended to provide assistance in both pre-operative planning and the intra-operative surgical phase of dental implantation procedures. INLIANT provides software to pre-operatively plan dental implantation procedures and provides navigational guidance of surgical instruments.

INLIANT is intended for use for partially edentulous adult patients who require dental implants as part of their treatment plan.

INLIANT is a dynamic surgical navigation system designed to allow a clinician to plan a dental procedure and then provide accurate guidance in real-time as to the location of dental surgical tool's drill tip relative to the patient's anatomy and plant position during the dental surgical procedure.

INLIANT includes a stand-alone cart which provides mobility and structural support for the computer, monitor and the camera which consists of two high resolution optical image sensors and lens assemblies. The system also includes the handpiece (model WI-75 LED G cleared under K080939), Patient Trackers and Fiducial Kit.

Operation of INLIANT is based on optical tracking. Stereoscopic images of the markers on the Patient Tracker and a handpiece are captured by the camera above the surgical site. INLIANT software processes the captured images to determine the location and orientation of the hand piece with respect to the Patient Tracker which is rigidly attached to the patient. The position of the handpiece, drill and the planned implant position is overlaid on existing CBCT scans of the patient's jaw and displayed to the clinician.

The submitted document describes the K213392 510(k) summary for the INLIANT® Surgical Navigation System. This device is a computerized navigational system intended for dental implantation procedures, assisting in pre-operative planning and intra-operative guidance. The primary purpose of the validation study was to demonstrate substantial equivalence to a predicate device (K150222, X-Guide Surgical Navigation System) in terms of accuracy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison table (page 5-6) outlining performance characteristics. The critical performance characteristic for this device is its accuracy at the drill tip.

Note: The document explicitly states that the INLIANT system performed identically to the predicate device in terms of "Accuracy at the Drill Tip" and "Presentation Update Rate." The clinical study (described below) then aimed to confirm that the angular non-inferiority was met compared to the predicate's performance against freehand.

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

• Sample Size: A total of 23 implants were placed among 22 adult subjects in the clinical performance study.
• Data Provenance: The study was a single-clinic, confirmatory, non-randomized study. The subjects were dental clinic patients. The document does not explicitly state the country of origin, but given the FDA submission, it's typically assumed to be within the US or a region with comparable regulatory standards. The study appears to be prospective as it involved placing implants and following patients post-surgery.

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

The document does not specify the number of experts used to establish the ground truth or their qualifications for the clinical performance study. It states that "Four investigators used INLIANT to place the dental implants." These investigators are presumably qualified dental professionals, but their specific qualifications (e.g., years of experience, specialization) are not detailed.

4. Adjudication method for the test set

The document does not describe an explicit adjudication method for the test set, such as 2+1 or 3+1 consensus. The ground truth (deviations between planned and placed implant positions) was established by "registering pre-operative and post-operative CBCT scans in a common reference," suggesting an objective measurement process rather than a subjective expert adjudication.

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 study was a clinical performance study of the device (INLIANT), not a multi-reader, multi-case study comparing human readers with and without AI assistance. The study's objective was to confirm the device's accuracy and non-inferiority to the predicate device by measuring implant deviations, rather than assessing human reader performance improvement. The "AI" component here is the navigational system assisting a human operator, not a diagnostic AI analyzing images by itself or providing a read.

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

This device is a surgical navigation system, inherently designed for human-in-the-loop use. It provides real-time guidance to a clinician during a procedure. Therefore, a standalone (algorithm only) performance assessment would not be relevant or feasible for this type of device. The accuracy assessment (≤1.0mm drilling accuracy) is a system-level performance metric that includes the device's software and hardware in operation.

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

The ground truth for the clinical performance study was primarily objective measurements based on imaging data. Specifically, "lateral (coronal and apical) and angular deviations between the pre-planned implant positions and actual implant positions were measured by registering pre-operative and post-operative CBCT scans in a common reference." This method uses the physically placed implant's position as "ground truth" compared to the pre-planned position.

8. The sample size for the training set

The document does not provide a sample size for a "training set." This device is a surgical navigation system, not a machine learning model that typically undergoes a distinct training phase with a labeled dataset in the same way an image classification AI would. It's an engineered system with algorithms for real-time tracking and guidance. Its development would involve engineering design, calibration, and verification, rather than "training" on a large dataset of patient cases to learn to perform a task.

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

As there is no "training set" in the context of a machine learning model, the concept of establishing ground truth for it does not apply in this document. The device's performance is validated through non-clinical bench testing (e.g., performance testing to evaluate tolerance analysis, latency, positional and tracking accuracy per ASTM F2554) and the clinical study described. The ground truth for these non-clinical tests would involve highly controlled experimental setups with known reference points and precise measurement instruments.

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The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous adult patients who qualify for dental implants.

When Yomi Plan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. Yomi Plan provides pre-operative planning for dental implantation procedures. The output of Yomi Plan is to be used with the Neocis Guidance System (NGS).

The purpose of subject device is for modification of the Neocis Guidance System (K202264) to allow for Wi-Fi to be continuously active in the Yomi Plan v2.0.1 while it is powered on. All other software and hardware features/functions remain identical to the predicate. In terms of FDA regulations, the Neocis Guidance System (NGS) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120).

The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

Major components include: Monitor, Planning Station Laptop PC, Lift Column, Base Cart, Robotic Guide Arm, and Patient Tracker.

The system allows the user to plan the surgery virtually in Yomi Plan (K191363-cleared for use alone on third party PCs for preplanning). The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in our planning software. The plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The NGS robotic arm holds and guides a standard FDAcleared third party powered bone cutting instrument (K191605).

The patient tracking portion of the NGS is comprised of linkages from the patient to the NGS, which include the Chairside Patient Splint (CPS) (K173402) or Edentulous Patient Splint (EPS) (K200805), the End Effector (EE) and the Patient Tracker (PT).

The request is to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for the Neocis Guidance System (NGS) with Yomi Plan v2.0.1.

Based on the provided text, the submission does not contain a study proving that the device meets specific performance acceptance criteria for its clinical function. Instead, it modifies an existing, previously cleared device (NGS with Yomi Plan v2.0) to allow continuous Wi-Fi activity and describes the testing conducted to ensure this modification maintains safety and effectiveness, primarily through software verification, wireless coexistence testing, and EMC testing.

Therefore, the following information is extracted and presented in relation to the modification and associated testing, rather than a clinical performance study with acceptance criteria for the device's primary function of dental implantation guidance.

Acceptance Criteria and Study Proving Device Meets Criteria

The Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is a modification of a previously cleared device (Neocis Guidance System (NGS) with Yomi Plan v2.0, K202264). The primary change in this submission is to allow Wi-Fi to be continuously active in the Yomi Plan v2.0.1 while it is powered on. Therefore, the "acceptance criteria" and "study" described below relate to the safety and effectiveness of this change and the overall system's compliance with relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify sample sizes for test sets related to clinical performance. The testing described relates to technical compliance (software, wireless, EMC).

• Data Provenance: Not applicable in the context of clinical data for this specific 510(k) submission, as it doesn't describe a clinical study for performance. The testing pertains to engineering and regulatory standards for the device modification.

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

• Not applicable. This submission focuses on engineering testing (software, wireless, EMC) rather than a clinical study requiring expert-established ground truth for device performance validation in a patient setting.

4. Adjudication Method for the Test Set

• Not applicable. This submission focuses on engineering testing, not a study requiring adjudication of clinical outcomes or interpretations.

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 comparative effectiveness study was not done as described in the provided text. The device is a computerized navigational system for dental implantation, not an AI-assisted diagnostic or interpretation tool for human readers. This submission focuses on a software modification (continuous Wi-Fi) and its impact on technical safety and performance.

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

• Not explicitly detailed. The described testing pertains to the integrated system's technical compliance and software behavior (Yomi Plan v2.0.1) in the context of continuous Wi-Fi. While individual software components would undergo standalone verification, the submission does not describe a standalone clinical performance study. The device is described as providing "navigational guidance of the surgical instruments" and "haptic feedback to the surgeon by constraining the motion of the bone cutting instrument to the plan," implying human-in-the-loop operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. For the technical testing (software verification, wireless coexistence, EMC), the "ground truth" is adherence to established engineering standards, cybersecurity protocols, and functional specifications, rather than clinical ground truth (e.g., pathology, expert consensus on images).

8. The Sample Size for the Training Set

• Not applicable. The submission does not describe a machine learning or AI model that requires a training set. The software is a planning and guidance system not explicitly described as employing AI in a way that requires a training set for model development.

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

• Not applicable. As no training set is described for an AI/ML model.

Ask a specific question about this device

The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

In terms of FDA regulations, the Neocis Guidance System (NGS) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). The NGS is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants. The system allows the user to plan the surgery virtually in Yomi Plan. The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in our planning software. The plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The NGS robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument. The patient tracking portion of the NGS is comprised of linkages from the patient to the NGS, which include the Chairside Patient Splint (CPS) or Edentulous Patient Splint (EPS), the End Effector (EE) and the Patient Tracker (PT). A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the CPS prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the CPS on the patient, which relays information to the NGS in order to track patient movement. The subject of this submission is adding Intraoral Fiducial Array (IOFA) as a new device accessory based on a previously cleared design. The IOFA is intended for use in clinical sites with reduced scan volumes. The IOFA is designed to reside with all the fiducial beads within the patient's mouth. The IOFA can only be used with the C-CPS.

Here's a summary of the acceptance criteria and study information for the Neocis Guidance System (NGS) with Intraoral Fiducial Array (IOFA), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on Acceptance Criteria: The document primarily uses "Same as the subject device" or similar phrasing for the predicate/reference devices, indicating that these performance metrics are consistent across the devices and establish the acceptance criteria for the new IOFA.

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

The document does not explicitly state the sample size for the test set for all verification activities. However, it mentions an "IOFA End User Validation" which is described as a "nonclinical surrogate that simulates the process of applying, qualitatively evaluating rigidity, and removing a Intraoral Fiducial Array directly to a patient." The specifics of this "validation" and its sample size are not detailed.

The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text.

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):

For the "IOFA End User Validation," it states the validation was "as performed by a surgeon (end user)." The specific number of surgeons or their qualifications are not specified. For other performance tests like accuracy, the ground truth is likely established through a combination of manufacturing specifications, calibrated measurement tools, and engineering standards, rather than expert consensus on a test set.

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

The document does not describe any adjudication method for establishing ground truth from multiple experts. Given that most performance metrics are objective measurements (e.g., RMS accuracy), formal adjudication methods typically used for subjective clinical assessments are unlikely to be applied.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed. The device is a "computerized navigational system" providing guidance, not an AI for image interpretation or diagnosis that would typically involve a multi-reader study. The text explicitly states, "Animal or clinical testing was not conducted for the subject device."

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

The device (NGS with IOFA) is described as a "computerized navigational system intended to provide assistance" and "provides navigational guidance of the surgical instruments." It also emphasizes that the "surgeon may modify the plan intraoperatively...and is always in control of the surgical instrument." This indicates a human-in-the-loop system. Therefore, a standalone (algorithm only) performance assessment as would be done for an AI diagnostic algorithm is not applicable in the same way. The performance metrics focus on the accuracy of the system's guidance (lateral, depth, angular accuracy), which are inherently tied to the interaction with the human user and surgical instruments.

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

The ground truth for the verification tests (Registration Testing, Kinematic Mount Repeatability, Scan Artifact Testing, Fit Clearance Simulation, Total System Accuracy, IOFA Deflection Test) appears to be based on:

• Engineering measurements and calibrated standards: For system accuracy (lateral, depth, angular), sensor ranges, and physical properties.
• Established industry standards: For electrical safety, electromagnetic disturbances, ingress protection, biocompatibility (ISO standards), and sterilization (ISO standards).
• Design specifications: For CT scan quality requirements, guidance arm speed, and storage requirements.

For the "IOFA End User Validation," the ground truth is implied to be a qualitative assessment of rigidity and usability by a surgeon, simulating real-world application.

8. The sample size for the training set:

The document does not mention a training set size. The device is a "computerized navigational system" and its software (Yomi Plan v2.0) was cleared previously. This type of device relies on engineering design, calibration, and deterministic algorithms for guidance, rather than a machine learning model that requires a "training set" in the conventional AI sense.

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

As no training set is described for an AI/machine learning model, the process for establishing ground truth for a training set is not applicable or mentioned. The system's functionality is verified against established engineering and safety standards.

Ask a specific question about this device

The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The Neocis Guidance System (NGS) (K161399) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides precise and accurate navigational guidance of surgical instruments, with regard to planning in dental implantation procedures. The system allows the user to plan the surgery virtually in software using a cone beam computed tomography (CBCT) scan of the patient, and the plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The holds and guides a standard FDA-cleared powered bone cutting instrument.

The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS provides haptic feedback to the surgeon by constraining the motion of the bone cutting instrument to the plan. This allows the surgeon to feel resistance to attempts at motions that may deviate from the plan.

The patient tracking portion of the NGS is comprised of linkages from the NGS, which for partially edentulous patients include the Chairside Patient Splint (CPS) (K173402) or the Clamped Chairside Patient Splint (CCPS) (K202100), the End Effector (EE) and the Patient Tracker (PT). The CPS or CCPS is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials (K182776) prior to the presurgical CBCT scan. A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the splint prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.

The subject of this submission is a design change to the sleeves in our Edentulous Patient Splint (EPS) (K200805). The EPS enables use of the NGS in fully edentulous patients. It is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS and CCPS, the EPS serves as rigid connection to the patient for robotic tracking of the patient during the procedure. The EPS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The provided text discusses the Neocis Guidance System (NGS) with Edentulous Patient Splint (EPS) and a design change to its sleeves. However, it does not contain a detailed study proving the device meets acceptance criteria for performance, especially not in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Neocis Guidance System (NGS) with Patient Splints, K200805) after a design change to the EPS sleeves. The "Performance Testing" section lists various tests conducted, primarily related to the physical and biological aspects of the device, rather than a clinical performance study.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth for training) are not available in the provided text for a clinical performance study.

Here's what can be extracted and inferred from the text, focusing on the design change and the tests mentioned:

Acceptance Criteria and Device Performance (Design Change Validation)

The document describes a design change to the sleeves within the Edentulous Patient Splint (EPS) component of the Neocis Guidance System (NGS). The acceptance criteria are implicitly related to ensuring this design change does not negatively impact the safety and effectiveness of the device, and that it remains substantially equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for performance tests like "EPS Weighted Deflection Test" or "Total System Accuracy". These are typically engineering verification tests, and the "sample size" would refer to the number of units tested.
• Data Provenance: Not specified for these engineering tests. "Sawbones®" is mentioned, indicating laboratory testing on synthetic bone models. This is not clinical data.

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

• Not applicable for the reported tests. The tests are engineering verification tests, not diagnostic accuracy studies requiring expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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 MRMC study was mentioned or conducted. The device is a surgical guidance system, not a diagnostic AI tool for human readers.

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

• Not explicitly described as a standalone algorithm performance study. The "Total System Accuracy" test would assess the device's accuracy in guiding the surgical instrument, which is its primary function (albeit with a human surgeon operating the instrument under guidance). The text focuses on the mechanical and system accuracy of the guidance mechanism itself, not a diagnostic algorithm.

7. The type of ground truth used:

• For mechanical tests: Engineering specifications, precision measurements, or established physical benchmarks are the "ground truth."
• For biological tests: Standards (e.g., ISO 10993) and established laboratory protocols define the "ground truth" for material properties and effects.

8. The sample size for the training set:

• Not applicable. The document does not describe the development or training of an AI algorithm in the context of a "training set" for diagnostic performance.

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

• Not applicable. See point 8.

Summary of Device Performance (from the document's conclusion):
The primary conclusion is that "The design changes to the EPS sleeves have been verified using well established methods. The new design is functionally the same as the predicate device. The subject device different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate." This implies that all the listed performance tests were successfully passed, ensuring that the modified device remains as safe and effective as its predecessor.

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