CADImplant is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the CADImplant treatment planning software.

Device Description

The CADImplant software is specifically designed for use in dental implant procedures. It allows the dentist to locate dental implants on three planes (axial, sagittal and frontal) on a pre-treatment CT scan in real-time. Additionally, the software allows for the patient's prosthetic template to be pre-drilled according to the planning.

AI/ML Overview

The CADImplant 510(k) summary provides limited information regarding specific acceptance criteria and detailed study results. Based on the provided text, here's an analysis:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Software Standards Compliance	The CADImplant software was tested for compliance with software standards. (No specific standards or results are provided).
Accuracy	Summaries of accuracy testing using phantoms were provided. (No specific numerical results or metrics are given).
Clinical Experience	Summaries of clinical experience with the system were provided. (No specific outcomes or metrics are detailed).

Study Information:

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided text. The document only mentions "summaries of accuracy testing using phantoms and clinical experience." This implies that phantoms and likely clinical cases were used as test sets, but the number of each is not specified.
- Data Provenance: Not explicitly stated. The mention of "clinical experience" suggests human patient data was used, but details like country of origin or whether it was retrospective or prospective are not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated in the provided text.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated.
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 explicitly stated. The primary focus of this submission is on the CADImplant software itself rather than its comparative effectiveness with or without human readers. The document states its intended use is for "pre-treatment planning for the placement of dental implants," implying assistance to a clinician, but no MRMC study details are provided.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document mentions "accuracy testing using phantoms." It is highly likely that these phantom tests were conducted in a standalone manner to assess the algorithm's performance in measuring implant placement parameters without human intervention. However, the outcomes of this testing are not detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For phantom testing: The ground truth would typically be the known, precisely engineered dimensions and positions within the phantom.
- For clinical experience: The ground truth is not specified, but for pre-treatment planning, it would ideally involve post-operative assessment (e.g., actual implant position relative to planned position, anatomical landmarks, patient outcomes regarding implant stability and function). The document only mentions "clinical experience," which is broad.
The sample size for the training set: Not explicitly stated.
How the ground truth for the training set was established: Not explicitly stated. If machine learning was involved (which is common for "software systems"), ground truth for training data would have been established through expert annotations or referencing known anatomical landmarks from CT scans. However, the document does not elaborate on the training process.

Summary

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K040224

510(k) Summary for CADImplant

Submitter Name and Address 1.

Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France

Contact Name: Stéphane Lavallée Telephone: 33-4 76 54 95 03

Date Prepared: October 22, 2003

2. Device Name

Proprietary Name: CADImplant™ Common/Usual Name: Pre-treatment dental software system Computed tomography x-ray system (accessory) Classification Name:

3. Predicate Device

Columbia Scientific SimPlant (K924810)

4. Intended Use

The CADImplant software is intended for pre-treatment planning for the placement of dental implants using a CT scan which has been input into the CADImplant treatment planning software.

5. Device Description

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Technological Characteristics and Substantial Equivalence 6.

The CADImplant software is substantially equivalent to other predicate software planning systems (e.g., Columbia Scientific SimPlant, K924810) that are currently marketed. It is similar to the other software planning systems in its technological characteristics. It uses a pre-treatment CT scan for 3-D planning as other previously cleared software planning systems. Like the predicate products, it uses accessories during the pre-treatment image acquisition and require decontamination prior to use. The various predicate software systems use a variety of methods for calibration of the alignment of the patient with an image. CADIMplant uses a Reference Cube attached to the outside of the patient's prosthetic template during image acquisition.

7. Performance Testing

The CADImplant software was tested for compliance with software standards. In addition, summaries of accuracy testing using phantoms and clinical experience with the system were provided.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in a simple, bold line style. The eagle is positioned to the right of a circular emblem containing the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. The text is in all caps and is set in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 6 2004

Ms. Christine Meehan General Manager Praxim, Inc 486 High Plain Street WALPOLE MA 02081 Re: K040224

Trade/Device Name: CADImplant™ Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and Communications system Product Code: 90 JAK and 90 LLZ Dated: January 30, 2004 Received: February 3, 2004

Dear Ms. Meehan:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brygdon

Nancy C. Brogdon Director, Division of Reproductive Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K04 0224

Device Name: CADIMPLANT Indications for Use:

CADImplant is intended for pre-treatment software planning for the placement of dental implants using a CT scan which has been input into the CADImplant treatment planning software.

(Please do not write below this line -Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Burgdon

(Division Sigh-Of Division of Reproduc ive. Abdor and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.