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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.

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).

In terms of previously FDA-cleared indications for use, the Neocis Guidance System (NGS) (K161399) 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 system allows the user to plan the surgery virtually in our Neocis Planning Software Application installed on the NGS planning station or on a 3rd party PC (K191363). 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 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), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint 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 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. 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 implant process occurs in two phases: (1) The dental surgeon plans the surgical procedure with the planning software, on the day of surgery or sometime prior if a pre-operative CT scan was taken at an earlier visit. A virtual dental implant, selected from the dental implant library or using a generic model, both contained within our planning software, is placed at the desired location in the patient model. The software highlights critical anatomical structures to avoid, such as the inferior alveolar nerve. (2) When the dental implant plan is optimized, the NGS provides precise and accurate guidance of the dental surgical instruments according to the preoperative plan. The NGS robotic arm, which holds the surgical instrument, 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 surgeon may modify the plan intraoperatively, if needed, has direct visualization of the patient anatomy, and is always in control of the surgical instrument.

Key safety features include:

• Emergency stop
• Safety pause
• Audio and visual queues
• Drill torque limits
• Surgeon control

The subject device in this submission is the new Clamped Chairside Patient Splint (C-CPS). The C-CPS offers our users an alternative to acrylic-type dental material affixation. The subject device replaces the acrylic-type dental material locking mechanism of affixation with a clamplike mechanism of affixation using softer dental impression (registration) material, alignment slots, and an approximation screw. The clamping screw is not a bone screw, and it does not interact directly with the patient. The screw is positioned above the teeth inside the splint. The subject device is essentially a CPS (K173402) that has been bisected lengthwise with screw holes and alignment slots in each half to approximate the two halves around the patient's stable teeth. The dental impression material is placed inside the splint to form a tight conformational gripping surface between the splint and the teeth. The dental impression material conforms the shape of the patient's teeth to form a large gripping surface area. The C-CPS initial placement is like a dental impression tray. A torque-brake screwdriver with hex bit is used to tighten and loosen the screw. The proper C-CPS model (left/right or anterior/posterior) should be selected based upon the accommodation of the patient's anatomy and the intended surgical location.

The provided text describes a 510(k) premarket notification for the Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS). The submission aims to demonstrate substantial equivalence to a predicate device, the NGS with Chairside Splint (K173402), by introducing a new clamping mechanism for the patient splint.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to the predicate device and lists several identical technological characteristics, including system accuracy specifications.

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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 Neocis Guidance System (NGS) is a stereotaxic medical device that guides surgeons during dental implant surgery. The system allows the user to plan the surgery virtually in software using a CT scan of the patient, and the plan is used by a quidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation.

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 quidance of the dental surgical instruments according to the pre-operative plan.

Physical quidance is provided via the Guidance Arm. The Guidance Arm grips a standard dental drill from the back end, 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.

Visual guidance is provided by 3D graphics and 2D cross sections that indicate the position and orientation of the drill in relation to the pre-operative plan and scan. The visual feedback is updated in real-time so any relative motion between the dental handpiece and the patient properly update the visualization.

The patient tracking portion of the NGS is comprised of the Patient Splint and the Patient Tracker. The Patient Splint is attached to the contralateral side of the patient's mouth. The Patient Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Patient Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient 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 and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.

Several steps are required for calibration and measurement during the procedure. The drill is calibrated using the Calibration Drill Bit inserted into a precise position on the Patient Tracker. During the surgery, each drill bit must be measured with the Depth Gauge to determine the proper length of the bit. These measurements complete the loop so the entire NGS is accurate to the tip of the drill.

The NGS is a supporting device, providing additional information and guidance to the decision- making process during the surgical procedure. It is not intended to replace the surgeon's judqment. The final clinical decisions are the sole responsibility of the surgeon. The surgeon can at any time during the surgical procedure modify the planned implant positions. Under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.

The subject device is the same as the NGS cleared under K182776 (the predicate device), except for a change to the dental drill supplier and dental drill collar design. The dental handpiece and motor have received previous 510(k) clearance under K070084 and K030163.

The splint is a key component for patient tracking for the NGS. The patient tracking portion of the NGS is comprised of the Chairside Splint and the Patient Tracker. The Chairside Splint is attached to the contralateral side of the patient's mouth. The Chairside Splint is affixed to the patient's teeth using dental materials specified in the labeling. The Chairside Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Chairside Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Chairside 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 provided text describes information about the Neocis Guidance System (NGS), a computerized navigational system for dental implantation surgery. However, the document (a 510(k) premarket notification) primarily focuses on demonstrating substantial equivalence to a predicate device due to a change in dental drill supplier and collar design, rather than proving the device meets new acceptance criteria established for this specific submission.

Therefore, the information regarding acceptance criteria and study details is largely drawn from previous clearances (K173402 and K161399) as the current submission leverages prior performance testing.

Here's a breakdown of the requested information based on the provided text:

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

The document doesn't explicitly define "acceptance criteria" presented as a single, consolidated list with corresponding performance for the current submission (K191605). Instead, it refers to the performance characteristics of the device, which serve as criteria for substantial equivalence to the predicate. The "Prior Performance Testing" sections (K173402 and K161399) detail various verification and validation activities.

For this submission, the comparison table (Table 1) between the subject device and the predicate device outlines several technical characteristics. The implicit acceptance criterion for these is "no difference" compared to the predicate, as highlighted in the "Comments" column.

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To determine bacterial antimicrobial agent susceptibility. The MicroScan MICroSTREP plus Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35 degrees C +/- 1 degree C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument. This particular submission is for the addition of instrument read capability of the antimicrobial Tetracycline, at concentrations of 0.06 to 16 mcg/ml on the MicroScan MICroSTREP plus Panel. The organisms which may be used for Tetracycline susceptibility testing on this panel are: Streptococcus spp., Streptococcus pneumoniae.

The MicroScan MICroSTREP plus Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 – 24 hours at 35 degrees C +/- 1 degree C in a non-CO2 incubator, and read according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument. The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. The antimicrobial agents are diluted in water, buffer or minute concentrations of broth to varying concentrations in the wells of the panels. Panels are rehydrated with 115 ul Mueller-Hinton broth with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is usually read by observing the lowest antimicrobial concentration that inhibits visible growth of the test organism. Panels may be incubated in and read by a MicroScan WalkAway instrument.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroScan MICroSTREP plus® Panel with Tetracycline:

Acceptance Criteria and Device Performance

Note: The FDA guidance document likely specifies numerical thresholds for "Essential Agreement" and criteria for "acceptable reproducibility" and "acceptable Quality Control results." These specific numerical acceptance thresholds are not provided in the summary. The summary only states that the device met these acceptable criteria.

Study Information

Here's a breakdown of the study details based on the provided text:

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

   • Test Set Sample Size: Not explicitly stated as a single number. The study utilized "stock and CDC Challenge strains." The text notes that the "proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated substantial equivalence with streptococcal isolates when compared with an expected Substantially Equivalent result generated on a CLSI frozen Reference Panel." While the types of strains are mentioned, the exact number of isolates used in the external evaluation for performance assessment is not provided.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The use of "CDC Challenge strains" suggests some US-based origin, but this isn't definitive for the entire "stock" collection. The study was an "external evaluation." It is implicitly prospective in the sense that new data was generated for this specific submission, comparing instrument reads to expected results.

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

   • The text does not specify the number of experts or their qualifications for establishing the "Expected Result" (ground truth). It refers to the "CLSI frozen Reference Panel" as the basis for the "Expected Result," implying that CLSI (Clinical and Laboratory Standards Institute) standards and potentially expert consensus or established methodologies were used to define these reference results.

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

   • Not specified. The "Expected Result" is associated with the "CLSI frozen Reference Panel," implying a standardized, reference-based determination rather than a multi-reader visual adjudication process.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. This study focuses on validating an instrument read method compared to an "Expected Result" based on a reference standard, not on human reader performance or improvement with AI assistance. The "instrument read method" is an automated reading by the MicroScan® WalkAway instrument, replacing or supplementing visual reading, rather than an AI-assisted human reading. The summary states panels "may be incubated in and read by a MicroScan® WalkAway instrument" in addition to visual reading, indicating it's an alternative or supplemental method, but not explicitly an AI-assisted human reading.

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

   • Yes, this was a standalone performance evaluation of the "instrument read method" (referred to as the "proposed instrument read method" and instrument read results). The MicroScan® WalkAway instrument's reading is essentially an algorithm-only or automated standalone performance, independent of a human directly interpreting results for the performance metric of "Essential Agreement."

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

   • The ground truth was established by "Expected Results determined [from] the CLSI frozen Reference Panel." This suggests a reference standard method (broth dilution susceptibility test, as described in the summary) and likely expert-developed CLSI guidelines. It's akin to a "gold standard" derived from established laboratory protocols and reference materials.

7. The sample size for the training set:

   • Not applicable/Not provided. The text describes an evaluation or validation study for a device, not the development or training of a machine learning model. Therefore, a "training set" in the context of AI/ML is not relevant here. The device determines MIC values based on a pre-programmed methodology, not learned from a dataset.

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

   • Not applicable (as it's not an AI/ML model with a training set).

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