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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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Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

The Implantmed SI-1015 is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
The new Implantmed SI-1015 is a redesigned version of the old one.
The submission consists of :

• the control unit,
• a motor with cable with or without light (EM-19 LC/EM-19),
• a wireless or wired foot control (S-NW or S-N2),
• the Osstell Module (SI-SQ)
• and as an attachment the surgical handpieces
• (WS-56 L, WS-75 L, WS-91 L, WS-92 L and S-11 L).
  The user can select five different programs. Switching between these programs is performed by foot control or via touch display.
  Programs 1-3 are used for adjusting the speed and programs 4-5 are for adjusting the torque.
  The control unit is intended to be used with the EM-19 or EM-19 L motor.
  The Implantmed SI-1015 will be delivered with software on the control unit.
  To run the Implantmed SI-1015 according to its intended use, W&H provides five different surgical handpieces.

This document concerns the 510(k) premarket notification for the "Implantmed SI-1015 incl. Accessories," a dental handpiece and accessories, and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as accuracy, sensitivity, specificity, and the involvement of ground truth, expert opinions, sample sizes for training/testing, MRMC studies, or standalone algorithm performance) is not applicable here.

Instead, the document focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (Implantmed SI-915/923, cleared under K052741) based on non-clinical performance testing and functional comparison.

Here's a breakdown of the provided information, reinterpreted to align with device performance and comparison for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance (Reinterpreted as comparison to predicate and safety standards)

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ANTHOGYR's IMPLANTEO implantology and dental surgery motor unit are indicated to perform dental implant surgery, such as perforating the bone and tapping and threading procedures required before placement of implant prosthetics.

ANTHOGYR has developed "IMPLANTEO" implantology and dental surgery motor unit intended to perform dental implant surgery which is substantially equivalent to legally marketed and FDA cleared predicate devices. The ANTHOGYR "IMPLANTEO" implantology and dental surgery motor unit consist of design improvement of non essential characteristics of the device. The ANTHOGYR "IMPLANTEO" implantology and dental surgery motor unit has the same fundamental scientific technology, operating principle and intended use as ANTHOGYR IMPLANTEO (K041279) with ANTHOGYR implantology contra-angle (K090676) or BIEN-AIR CHIROPRO L (K092214) with NSK contra-angle (K970953) or W&H implantMED (K052741) with contra-angle (K080939).

Here's a breakdown of the acceptance criteria and study information for the "IMPLANTEO" Implantology and Dental surgery motor unit, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are primarily established by conformity to recognized industry standards for dental handpieces and medical electrical equipment. The "reported device performance" is essentially that the device conforms to these standards and is substantially equivalent to predicate devices. The document does not provide specific quantitative performance metrics like accuracy, sensitivity, or specificity, as it's a hardware device designed for mechanical tasks.

Note: This is a 510(k) submission for a Class I mechanical device, so the "study" is primarily focused on demonstrating conformance to established safety and performance standards and substantial equivalence to existing devices, rather than a clinical trial with statistical performance metrics like those for diagnostic AI devices.

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

This document does not describe a "test set" or "data provenance" in the way one would for an AI/software device. The performance data presented refers to conformity with technical standards for the physical device and its components. Therefore, there isn't a sample size of patient data or clinical images mentioned. The "test set" would implicitly be the manufactured device units themselves undergoing testing against the listed standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For a mechanical device being validated against engineering standards, "experts" in a clinical sense (e.g., radiologists) are not used to establish a "ground truth." The ground truth is defined by the requirements outlined in the engineering and safety standards themselves.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as would be used for subjective data in diagnostic evaluation. Conformity to standards is typically assessed through objective measurements and verification processes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-assisted diagnostic tools where human readers are involved. This submission is for a mechanical dental surgery motor unit.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a mechanical motor unit, not an algorithm or AI. Its operation inherently requires a human operator.

7. The Type of Ground Truth Used

The "ground truth" for this device's validation is defined by:

• Engineering and Safety Standards: The technical specifications and requirements outlined in the explicitly listed ISO, IEC, and NF EN standards (e.g., electrical safety, mechanical dimensions, electromagnetic compatibility).
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate devices to which this device claims substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical motor unit, not an AI or machine learning model that requires a training set of data.

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

Not applicable, as there is no training set for this type of device.

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