The Neocis Planning Software Application (NPSA) for 3rd Party PCs is intended to perform the planning (pre-operative) phase of dental implantation surgery. The NPSA provides pre-operative planning for dental implantation procedures. The output of the NPSA is to be used with the Neocis Guidance System.

Device Description

AI/ML Overview

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

Disclaimer: The provided document is a 510(k) summary, which is a regulatory submission to the FDA. It outlines the device's characteristics and demonstrates substantial equivalence to a predicate device. It is not a detailed clinical study report, thus some specific details typically found in such reports (like detailed effect sizes for MRMC studies, specific ground truth methods for clinical trials, or extensive statistical power justifications) may not be present or fully elaborated.

Description of Acceptance Criteria and the Study

The Neocis Planning Software Application (NPSA) for 3rd Party PCs is intended for the pre-operative planning phase of dental implantation surgery. The output of the NPSA is to be used with the Neocis Guidance System.

The provided document describes the verification and validation (V&V) testing performed for the NPSA software. The acceptance criteria are implicitly defined by the successful completion of these V&V activities, demonstrating that the software functions as intended and meets safety and performance requirements.

The device's performance is demonstrated through a series of software and system verification and validation tests, guided by FDA and IEC standards. The submission asserts that the combined software and system testing and analysis of results provide assurance that the device performs as intended and is substantially equivalent to its predicate.

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a single table. Instead, it describes general categories of verification and validation (V&V) testing. The "reported device performance" is implicitly that the software successfully passed all these V&V tests, demonstrating it performs as intended.

Acceptance Criteria Category	Description (Implicit Performance)
Simulated Use	The device performs correctly during typical use cases.
Boundary Condition	The device correctly handles all potential boundary parameters within the application software.
Registration	The registration process functions correctly.
Case File Contents	Features associated with saving/loading cases function correctly during simulated use.
Error Case Injection	All error messages and pop-ups are correctly simulated and handled.
CT Scan Verification	The device correctly verifies the resolution and validity of CT Scans.
File Transfer	The usability of files before and after transfer is verified.
Dental Implant Libraries	The quality and speed of implant rendering from the dental implant libraries are verified.
Generation and Visualization of 3D Reconstruction	All features of CT scan image reconstruction are functioning and accurate.
Installation, Stability, and Removal from 3rd Party PCs	The software can be successfully installed, runs stably, and can be removed from specified 3rd party PCs.
Risk Analysis (uFMEA, dFMEA, sFMEA, cFMEA)	Risks associated with use, usability, performance, design, software functionality, software interaction, and cybersecurity are identified, analyzed, and mitigated, ensuring the device is safe. (Implicitly, the device meets accepted safety thresholds for these risks).

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

The document does not specify a "test set" in the context of clinical data (e.g., patient cases). The testing described focuses on software verification and validation, which often uses synthetic data, simulated scenarios, and internal testing environments rather than a specific clinical test set of patient images with established ground truth.

Sample Size for Test Set: Not specified in terms of patient cases or real-world data. The testing mentioned appears to be software-focused (e.g., boundary conditions, error case injection, file transfers).
Data Provenance: Not explicitly stated. The CT scan verification suggests the use of CT scan data, but the source (e.g., country of origin, retrospective/prospective) is not provided. Since the context is software V&V, it's likely a mix of internally generated data, simulated data, and potentially a limited set of representative real CT scan data.

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

This information is not provided in the document. As the V&V largely focuses on software functionality, the "ground truth" would be defined by engineering specifications and expected software behavior rather than expert clinical consensus on actual patient cases.

4. Adjudication Method for the Test Set

Not applicable/not specified. The V&V described does not involve a multi-reader, multi-case adjudication process for clinical ground truth.

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

No, an MRMC comparative effectiveness study is not mentioned or described in the provided text. The submission focuses on the stand-alone planning software and its functional verification against its own specifications and safety requirements, demonstrating substantial equivalence to a predicate device. It explicitly states: "This submission only includes the planning software. Testing for the software-NGS interactions has been omitted." Furthermore, "This submission is focused on the planning software as a standalone device."

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

Yes, the core of the evaluation described is for the "standalone" performance of the NPSA software. The document states: "This submission is focused on the planning software as a standalone device." The V&V described in Table 2 directly assesses the software's functional performance (e.g., CT scan verification, 3D reconstruction, implant library rendering) without human intervention in the loop of the primary assessment of these features. It's a software-only performance evaluation, though its intended use is by a human user for planning.

7. The Type of Ground Truth Used

The ground truth for the software verification and validation is based on:

Engineering Specifications: The expected behavior and output of the software as defined during its development.
Compliance with Standards: Adherence to standards like IEC 62304 for software lifecycle processes, ISO 14971 for risk management, and FDA guidance documents.
Predicate Device Performance: Implicitly, the NPSA's functional performance must be equivalent to or better than the planning features of the predicate device (Neocis Guidance System K182776).

It does not appear to involve clinical ground truth such as expert consensus on patient pathology or outcomes data.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning. The NPSA's functionality, as described, doesn't suggest it's primarily an AI/ML algorithm that requires a training set for learning. It's a planning software that reconstructs 3D images and allows for virtual implant placement based on predefined instructions and algorithms.

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

Not applicable, as no training set for machine learning is described.

Summary

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October 2, 2019

Neocis Inc. Thomas E. Claiborne, Ph.D. Regulatory Affairs Manager 2800 Biscayne Blvd Suite 600 Miami, Florida 33137

Re: K191363

Trade/Device Name: Neocis Planning Software Application (NPSA) for 3rd Party PCs Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: PLV Dated: August 28, 2019 Received: September 3, 2019

Dear Thomas E. Claiborne:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting Division Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191363

Device Name

Neocis Planning Software Application (NPSA) for 3rd Party PCs

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font and is colored in yellow. Above the word is a gray horizontal line that extends to the left and right of the word. At the end of the line on the right is a gray circle with a vertical line extending upwards and downwards from the circle.

510(k) Summary

l. Submitter

Neocis Inc. 2800 Biscayne Blvd. Suite 600 Miami, FL 33137 Tel: 1-855-9NEOCIS

Contact Person: Thomas Claiborne, Ph.D., Regulatory Affairs Manager Date Prepared: October 1, 2019

II. Device

Trade Name:	Neocis Planning Software Application (NPSA) for 3rd Party PCs
Common Name:	Dental Stereotaxic Instrument
Classification Name:	Bone cutting instrument and accessories (21 CFR 872.4120)
Classification:	Class II
Product Code:	PLV

III. Predicate Devices

Neocis Guidance System (NGS) (K182776) ●

IV. Indications for Use

The Neocis Planning Software Application (NPSA) for 3rd PCs is intended to perform the planning (pre-operative) phase of dental implantation surgery. The NPSA provides preoperative planning for dental implantation procedures. The output of the NPSA is to be used with the Neocis Guidance System.

V. Device Description

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 guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation.

The Neocis Planning and Software Application (NPSA) for 3rd PCs is intended to facilitate dental implant procedure planning on any properly equipped PC so that procedures may be preplanned in advance of the surgical procedure. The NPSA is designed to upload CT scan images in DICOM file format, reconstruct and optimize 3D images of the patient anatomy, and plan the surgical procedure via defining implant placement location. We can install the NPSA on any personal computer (PC) that is convenient for our customers provided it is running Windows 7 Operating System (OS) or newer and meets the system requirements listed in our NPSA User Manual.

The NPSA is similar to the cleared planning and guidance software installed on the NGS Planning Station (PS). However, when the planning and guidance software is used on 300 party PCs, the quidance features are inactive. When the preplan is uploaded to the PS, the planning and guidance software installed on the PS performs checks against a CT scan of the patient taken on the day of the procedure and uploaded to the PS. Any discrepancies would require a new plan to be made. The ability to make operative plan adjustments pre- or intraoperatively is a feature of the NGS.

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Image /page/4/Picture/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font in a golden color. Above the word is a gray horizontal line that extends over the word. There is a small circle above the "i" in "neocis" with a vertical line extending above and below the circle.

VI. Comparison of Technological Characteristics

This submission is focused on the planning software as a standalone device. This submission includes minor changes to the planning software. There are no changes to the hardware (NGS).

TechnologicalCharacteristics	Subject Device	Predicate K182776	SE Analysis
Indications forUse (IFU)	The Neocis PlanningSoftware Application (NPSA)for 3rd Party PCs is intendedto perform the planning (pre-operative) phase of dentalimplantation surgery. TheNPSA provides pre-operative planning for dentalimplantation procedures.The output of the NPSA is tobe used with the NeocisGuidance System.	The Neocis Guidance System(NGS) is a computerizednavigational system intended toprovide assistance in both theplanning (pre-operative) and thesurgical (intra-operative) phasesof dental implantation surgery.The system provides accuratenavigational guidance of surgicalinstruments, with regard to pre-operative planning in dentalimplantation procedures.	The indicationsfor use are asubset of thepredicate's. Theintended use isthe same.
NGS Technology	No changes	Described in predicate	No differences
NPSA	v1.8.1 Guidance featuresare disabled.*	v1.2	Minor changesbetweenversions andthe guidancefeatures wereevaluated in therisk analysisand verificationtesting
Level of Concern	Moderate	Moderate	Same LOC

Table 1: Comparison of technological characteristics to the predicates

*Changes since v1.2 include minor functional updates, bug fixes, and an implant library for visualization.

VII. Performance Testing

This submission only includes the planning software. Testing for the software-NGS interactions has been omitted.

Planning Software Verification and Validation

Software and system verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this submission was considered as a "minor" level of concern, since a failure or latent flaw in the software could not directly result in result in minor injury to the patient or operator.

Software Development and Testing was performed per IEC 62304: 2006 Medical Device Software - Software Lifecycle Processes, FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002).

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Image /page/5/Picture/1 description: The image shows the logo for Neocis. The word "neocis" is written in a sans-serif font in gold color. A gray line is above the word. The "o" in neocis has a gray circle above it, and a gray line extends vertically from the circle.

Risk analysis was conducted in compliance with ISO 14971:2012 and includes FMEA analysis to review the following:

risks associated with the use, usability and performance of the device (uFMEA)
the risks associated with and specific to the design aspects of the device (dFMEA)
the risks associated with software functionality and software interaction with the user (sFMEA)
· Cybersecurity risks (cFMEA)

The combined software and system testing and analysis of results (details in Table 2 below) provide assurance that the device performs as intended.

	Table 2: Summary of planning software V&V.	ิ

Software Verification / ValidationType	Description
Simulated Use	Run through of Typical Use Case
Boundary Condition	Testing of all potential boundary parameters in theApplication Software
Registration	Testing of registration process
Case File Contents	Simulated use testing of features associated with saving /loading Cases
Error Case Injection	Simulating all error messages and pop-ups.
CT Scan Verification	Verification of the resolution and validity of CT Scans
File Transfer	Verification of usability of file before and after transfer
Dental Implant Libraries	Verification of quality and speed of implant rendering
Generation and Visualization of 3DReconstruction	Verification that all features of CT scan image reconstruction arefunctioning and accurate

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Image /page/6/Picture/1 description: The image shows the logo for Neocis. The logo consists of the word "neocis" in a sans-serif font, with the letters in a yellow-gold color. Above the word is a gray horizontal line that extends over the "neo" portion of the word. A gray vertical line intersects the horizontal line at the "o" in "neocis", and there is a small circle at the intersection of the two lines.

Software Verification / ValidationType	Description
Installation, Stability, and Removalfrom 3rd Party PCs	Verification that the software can be installed, runs, and can beremoved from specified 3rd party PCs

VIII. Conclusion

This submission includes software (NPSA) only. There are no technological changes to the hardware (NGS) in this submission. There are no changes to the intended use in this submission. There are no fundamental changes to the technology. Our performance testing demonstrates substantially equivalent performance of the NPSA as compared to the predicate.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.