CloudPoint FastDesign Chairside is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. CloudPoint FastDesign Chairside is intended for use by a dental practitioner or dental laboratory staff for designing the patient-matched component of a two-piece hybrid dental implant abutment. The resulting abutment design is intended to be used by the manufacturer of an endosseous dental implant to create the final device.

Device Description

CloudPoint FastDesign Chairside (also known as FastDesign), is a software suite intended to be used by trained dental practitioners or dental laboratory staff to design the patient-matched component of a two-piece hybrid dental implant abutment. A titanium base-type abutment and hybrid abutment-crown component are combined to make the two-piece hybrid dental implant abutment. The software allows a dental practitioner or dental laboratory staff to design the matching dental abutment based on imported scan data containing topographical characteristics of the patient's dentition. The resulting abutment design will be exported to a remote milling machine to make the final device.

CloudPoint FastDesign Chairside, is restricted to be used with 510(k) cleared abutment systems. The software includes design parameters from the 510(k) cleared abutment systems such as maximum and minimum dimensions (e.g., abutment post height, gingival height, angulation, gingival margin diameter, etc.). CloudPoint FastDesign Chairside designs the endosseous dental implant abutment under the directions of a clinical professional and maintaining accordance to the requirements of the compatible 510(k) cleared abutment systems with cleared design parameter size ranges.

AI/ML Overview

The provided text describes the "CloudPoint FastDesign Chairside," a dental abutment design software. However, it does not contain the detailed acceptance criteria for device performance, nor the specifics of a study proving the device meets those criteria, as typically requested in your prompt.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Abutment Design K200100) based on intended use, indications for use, and technological characteristics. It mentions "Software verification and validation" and "Cybersecurity Analysis" as non-clinical data submitted, but does not provide a table of acceptance criteria with reported device performance.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The document states that software verification and validation were conducted to "verify that the software development output met the input requirements, and to validate that the software specifications confirm to user needs and its intended uses," but it does not list these specific requirements or their direct performance outcomes.
Sample sizes used for the test set and the data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
Adjudication method: Not specified.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or conducted. The document states "No clinical data is included in this submission."
Standalone (algorithm only) performance study: Not explicitly detailed with performance metrics. The software verification and validation focused on confirming design limitations and specifications.
Type of ground truth used: Not specified.
Sample size for the training set: Not applicable as this is a design software, not an AI/ML diagnostic algorithm that typically relies on a training set in the same way. The document highlights "software design verification and validation."
How the ground truth for the training set was established: Not applicable.

What the document does state regarding performance data is:

Non-clinical data submitted:
- Software verification and validation, according to the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued on May 11, 2005.
- Cybersecurity Analysis, according to the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," issued on October 02, 2014.
No clinical data is included in this submission.
Software Verification and Validation details:
- Conducted by Prismatik Dentalcraft, Inc. to verify that software development output met input requirements and validate that software specifications conform to user needs and intended uses.
- Used to address questions related to substantial equivalence based on technical feature differences.
- Provided for the compatible abutment design library to demonstrate use with the software suite.
- Conducted to demonstrate that "restrictions prevent design of the patient-matched component of the two-piece hybrid dental abutment outside of the allowable design limitations, including screenshots under user verification testing."
- Established that "the design limitations and specifications are locked and cannot be modified within the abutment design library."
Cybersecurity Analysis details:
- Risk assessment (hazard analysis, mitigation, design considerations for intentional and unintentional cybersecurity risks) was performed.
- Concluded that benefits outweigh residual risk after mitigation, and all risks were mitigated as far as possible.

In summary, the provided text confirms the device underwent software verification and validation and cybersecurity analysis as non-clinical testing to support its substantial equivalence, but it does not offer the specific device performance acceptance criteria or detailed study results you've requested.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 14, 2024

Prismatik Dentalcraft, Inc. Jiahe Li Sr. Regulatory Affairs Specialist 2144 Michelson Drive Irvine. California 92612

Re: K231529

Trade/Device Name: CloudPoint FastDesign Chairside Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP Dated: February 12, 2024 Received: February 13, 2024

Dear Jiahe Li:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about medical devices and radiation-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,

Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT 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) K231529

Device Name CloudPoint FastDesign Chairside

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/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with a gradient of colors, including pink, magenta, red, orange, yellow, green, blue, and purple. To the right of the triangle is the text "PRISMATIK" in a larger, bold, blue font, with the text "DENTALCRAFT, INC." below it in a smaller, bold, blue font.

510(k) Summary

I. SUBMITTER

Prismatik Dentalcraft, Inc. 2144 Michelson Drive, Irvine, CA 92612, USA

Primary Contact Person: Jiahe Li, Sr. Regulatory Affairs Specialist Email: Jiahe.Li@glidewelldental.com Phone: (949) 222-3516

Secondary Contact Person: So Hyun Park, Regulatory Affairs Manager, MS Email: so.park@glidewelldental.com Phone: (949) 863-5479

Date Prepared: March 13, 2024

II. DEVICE

Name of Device: CloudPoint FastDesign Chairside Classification Product Code: PNP Regulatory Class: II Common Name: Dental Abutment Design Software Classification Name: Dental Abutment Design Software for Dental Laboratory (Endosseous Dental Implant Abutment 21 CFR 872.3630)

III. PREDICATE DEVICE

Abutment Design (K200100)

IV. DEVICE DESCRIPTION

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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

FastDesign Chairside designs the endosseous dental implant abutment under the directions of a clinical professional and maintaining accordance to the requirements of the compatible 510(k) cleared abutment systems with cleared design parameter size ranges.

Notes:

Abutment post height is the height of the abutment post above the final gingival height design.
Angulation is the angle correction of the two-piece hybrid abutment off the axis of the implant placement.

V. INDICATIONS FOR USE

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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in a sans-serif font, with the words "PRISMATIK" and "DENTALCRAFT, INC." stacked on top of each other.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI.

TechnologicalCharacteristics	Subject DeviceCloudPoint FastDesign Chairside	Predicate deviceAbutment Design (K200100)	Comparison
Manufacturer	Prismatik Dentalcraft, Inc.	3Shape A/S	N/A
Product Code	PNP	PNP	Same
Prescription Device	Yes	Yes	Same
Intended Use	Dental Abutment Design Software	Dental Abutment Design Software	Same
Indications for Use	CloudPoint FastDesign Chairside isintended as an aid to the restoration ofchewing function in partially or fullyedentulous mandibles and maxillae.CloudPoint FastDesign Chairside isintended for use by a dental practitioner ordental laboratory staff for designing thepatient-matched component of a two-piecehybrid dental implant abutment.The resulting abutment design is intended tobe used by the manufacturer of anendosseous dental implant abutment tocreate the final device.	Abutment Design is intended as an aid tothe restoration of chewing function inpartially or fully edentulous mandiblesand maxillae.Abutment Design is intended for use by adental practitioner or dental laboratorystaff for designing the patient specificcomponent of a two-piece, one-piece, orhybrid dental implant abutment.The resulting abutment design is intendedto be used by the manufacturer of anendosseous dental implant abutment tocreate the final device.	Same except for the rangeof abutment designs thesoftware supports. Thesubject device can designtwo-piece hybrid abutment;while the predicate devicecan design two-piece, one-piece, or hybrid abutment.The difference has noimpact on the substantialequivalence determination.In addition, the minordifferences in device tradenames and the use ofdifferent terminology suchas "patient-matched" v.s."patient specific" do notaffect the substantialequivalence determination.
Graphic UI	Yes	Yes	Substantially equivalent
Specifications/FeaturesWindows OSplatform	Yes	Yes	Substantially equivalent
TechnologicalCharacteristics	Subject DeviceCloudPoint FastDesign Chairside	Predicate deviceAbutment Design (K200100)	Comparison
Uses standard PChardware	Yes	Yes	Substantially equivalent
Digitally importstopography of teethby 3D Scan	Yes. The software receives scan filescontaining topographical characteristicsfrom an intraoral scanner in STL or PLYformat.	Yes. The software receives scan filescontaining topographical characteristicsfrom real teeth, dental impressions, orstone models in STL or DCM format.	Substantially equivalent.The only differences arethat the subject deviceaccepts scan files in STL orPLY format; while thepredicate device acceptsscan files in STL or DCMformat. The difference hasno impact on the substantialequivalence determination.
Uses 3D CADdesign tools	Yes	Yes	Same
Patient specificabutment design	Yes. The software designs the patientspecific component of a two-piece hybriddental implant abutment.	Yes. The software designs the patientspecific component of a two-piece, one-piece, or hybrid dental implant abutment.	Substantially equivalent.The only difference is thatthe subject device candesign two-piece hybridabutment; while thepredicate device can designtwo-piece, one-piece, orhybrid abutment. Thedifference has no impact onthe substantial equivalencedetermination.
Implant Bar design	No	No	Same
Export to remotemilling machine by	Yes	Yes	Same
TechnologicalCharacteristics	Subject DeviceCloudPoint FastDesign Chairside	Predicate deviceAbutment Design (K200100)	Comparison
internet
Network Protocol	Internet/TCP-IP	Internet/TCP-IP	Substantially equivalent
Intended users	Dental practitioners and dental technicians	Dental practitioners and dental technicians	Same
Output type	Digital encrypted or non-encryptedproprietary or .STL/PLY file only of thepatient specific abutment component.	Digital encrypted or non-encryptedproprietary or .STL file only of the patientspecific abutment component.	Substantially equivalent.The only difference is thatthe subject device supportsoutput file in STL or PLYformat. The difference hasno impact on the substantialequivalence determination.
Device submissionincludes pre-manufacturedprosthetics(endosseous dentalimplant abutmentsas per 21 CFR872.3630)	No. The software relies on separateregulatory clearance for the abutmentsystem.	No. The software relies on separateregulatory clearance for the abutmentsystem.	Same

Prismatik Dentalcraft, Inc. 510(k) Notification CloudPoint FastDesign Chairside March 2024

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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with a rainbow of colors. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text.

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Image /page/8/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangular shape with a color gradient that transitions from pink to blue to green to yellow. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text.

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Image /page/9/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The subject device, CloudPoint FastDesign Chairside, is substantially equivalent to the primary predicate device, Abutment Design (K200100), in intended use, indications for use and technological characteristics, including technical specifications/features and principles of operation.

The subject device, CloudPoint FastDesign Chairside, has the same intended use as the predicate device. Abutment Design (K200100). as a dental implant abutment design software and an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The subject device, CloudPoint FastDesign Chairside, has similar indications for use to the predicate device, Abutment Design (K200100). Both software devices are intended to be used by dental practitioners or dental laboratory staff for designing the patient-matched component of a dental implant abutment. The only difference in Indications for Use lies in that the subject device, CloudPoint FastDesign Chairside, is indicated for designing the patient specific component of a two-piece hybrid dental implant abutment; whereas the predicate device, Abutment Design (K200100), has a broader range of indications, which includes designing the patient specific component of a two-piece, one-piece, or hybrid dental implant abutment. The difference has no impact on the substantial equivalence determination.

The subject device, CloudPoint FastDesign Chairside, is substantially equivalent to the predicate device, Abutment Design (K200100), in terms of technical features. Both the subject device, CloudPoint FastDesign Chairside, and the predicate device, Abutment Design (K200100), accept scanned data of digital representations of a patient's dentition to design the patient-matched component of a dental implant abutment using 3D computer aided design tools with Graphic UI. The design outputs are then exported to a remote milling machine through internet connection with TCP/IP protocol. Both the subject device, CloudPoint FastDesign Chairside, and the predicate device, Abutment Design (K200100) are restricted to be used with 510(k) cleared abutment systems and design the endosseous dental implant abutment according to the requirements of the compatible abutment system or directions of a clinical professional. Both the subject device, CloudPoint FastDesign Chairside, and the predicate device, Abutment Design (K200100) receive imported scan data containing topographical characteristics of the patient's dentition and provide the user with the ability to create the matching abutment design using computer aided design.

The subject device, CloudPoint FastDesign Chairside, is substantially equivalent to the predicate device, Abutment Design (K200100), in terms of principle of operation. The fundamental principle of operation of the subject device, CloudPoint FastDesign Chairside, and the predicate device, Abutment Design (K200100), is the same. Both software devices use digital imaging tools for computer aided design (CAD) of dental implant abutments.

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Image /page/10/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in a sans-serif font, with the words "PRISMATIK" and "DENTALCRAFT, INC." stacked on top of each other.

VII. PERFORMANCE DATA

Non-clinical data submitted to demonstrate substantial equivalence include:

Software verification and validation, according to the FDA Guidance . Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005.
Cybersecurity Analysis, according to the FDA Guidance Document "Content . of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on October 02, 2014

No clinical data is included in this submission.

Software Verification and Validation

The software design verification and validation were conducted by Prismatik Dentalcraft, Inc. to verify that the software development output met the input requirements, and to validate that the software specifications confirm to user needs and its intended uses, and that the requirements implemented through software can be consistently fulfilled. The results of the testing were used to address questions related to substantial equivalence based on differences in technical features between the subject device, CloudPoint FastDesign Chairside, and the predicate device, 3Shape A/S (K200100).

Software verification and validation testing was provided for the compatible abutment design library to demonstrate use with the subject device, CloudPoint FastDesign Chairside software suite. Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the patient-matched component of the two-piece hybrid dental abutment outside of the allowable design limitations, including screenshots under user verification testing. In addition, the software verification and validation testing established that the design limitations and specifications are locked and cannot be modified within the abutment design library.

Cybersecurity Analysis

Cybersecurity risk assessment, including hazard analysis, mitigation and design considerations pertaining to the intentional and unintentional cybersecurity risks, was performed for the subject device. CloudPoint FastDesign Chairside. Based on the risk assessment results. it was concluded that the benefits of the final device outweigh the residual risk after the risk control/mitigation, and that all risks were mitigated as far as possible.

VIII. CONCLUSION

Based on the comparison on intended use, indication for use, technological characteristics, as well as non-clinical test data included in this submission, the subject device, CloudPoint FastDesign Chairside, has been shown to be substantially equivalent to the predicate device, Abutment Design (K200100).

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)