(66 days)
The ImplantMaster system is indicated for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for use by qualified dental professionals to aid them in the placement of dental implants and surgical treatment. ImplantMaster processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System.
The ImplantMaster system is a software interface used for the transfer of imaging information from a medical scanner such as a CT scanner, processing it and planning dental implant placement and surgical treatment. The ImplantMaster processes output result is used as an input data for CAD or Rapid Prototyping System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ImplantMaster device:
Based on the provided 510(k) summary, the information regarding specific acceptance criteria and detailed study results is very limited. This document is a summary and often refers to more detailed studies that would be available to the FDA during their review but are not publicly disclosed in this format.
Key takeaway: The provided document states that "Bench and clinical data demonstrate that the implant placement positively match the planning. No adverse affects have been detected." However, it does not provide the specific acceptance criteria or detailed results of these studies.
Therefore, many of the requested sections below cannot be fully answered definitively from the provided text alone.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
- Not explicitly stated in the provided 510(k) summary. The document mentions "The device has been designed verified and validated complying to 21CFR 820.30 regulations." and "Bench and clinical data demonstrate that the implant placement positively match the planning." However, specific numerical or qualitative targets for "positively match" are not provided.
Reported Device Performance:
- "Implant placement positively match the planning."
- "No adverse affects have been detected."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for the test set in the provided document. The term "Bench and clinical data" implies multiple tests, but no numbers are given.
- Data Provenance: Not specified. The submitter, I-Dent Ltd., is located in Hod Hasharon, Israel, so the data could originate from Israel or other regions where their studies were conducted.
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The intended use states the software is for "qualified dental professionals," implying that such professionals would be involved, but specific details about how ground truth was established are missing.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not mentioned or described in the provided document. The focus seems to be on the device's ability to match planning to actual placement, rather than comparing human reader performance with and without AI assistance.
- Effect Size: Not applicable, as an MRMC study is not mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: The statement "Bench and clinical data demonstrate that the implant placement positively match the planning" implies a standalone assessment of the software's output accuracy against physical results. The software functions as a planning and simulation tool for professionals, making its direct output accuracy important. However, the exact methodology to demonstrate this "match" and whether it was truly "standalone" from a performance perspective (i.e., not reliant on human interpretation to correct or adjust the output) is not detailed. The phrasing "processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System" suggests the software's output itself is a key component, hinting at a standalone performance evaluation of that output's accuracy.
7. Type of Ground Truth Used
- Type of Ground Truth: The statement "implant placement positively match the planning" suggests that the ground truth for evaluating the planning accuracy would likely be actual post-operative implant placement (e.g., confirmed via post-operative imaging or physical measurements) compared against the pre-operative plan generated by the ImplantMaster system.
8. Sample Size for the Training Set
- Sample Size: Not specified. The document does not provide details on the development or training of any AI/ML components (if present), nor does it mention a "training set" in the context of device validation.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not specified. As no training set details are provided, how its ground truth might have been established is also not mentioned.
{0}------------------------------------------------
Ko4 2.212
OCT 2 1 -2004
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(b))
Device Name
Proprietary Device Name : WBR -HR
Establishment Name and Registration Number of Submitter
Name: 1-Dent Ltd. Corresponding Official: Dan Laor
Yohanan 4, Box 6402 Hod Hasharon 45241. Israel
Device Classification
Classification Code: Regulation Number Common Name: Classification Class: 90 LLZ 892 2050 Picture Archiving and Communications System Class II Product
Reason for 510(k) Submission
Traditional 510(k) Submission
Identification of Legally Marketed Equivalent Devices
SimPlant system (K033847)
Device Description
The ImplantMaster system is a software interface used for the transfer of imaging information from a medical scanner such as a CT scanner, processing it and planning dental implant placement and surgical treatment. The ImplantMaster processes output result is used as an input data for CAD or Rapid Prototyping System.
Intended Use of Device
The ImplantMaster system is indicated for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for use by qualified dental professionals to aid them in the placement of dental implants and surgical treatment. ImplantMaster processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System.
Safety & Effectiveness
The device has been designed verified and validated complying to 21CFR 820.30 regulations. Bench and clinical data demonstrate that the implant placement positively match the planning. No adverse affects have been detected.
Substantial Equivalency
It is I-Dent's opinion that the ImplantMaster is substantially equivalent in terms of safety and effectiveness to the predicate device.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2004
I-DENT % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
Re: K042212 Trade/Device Name: ImplantMaster Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: October 4, 2004 Received: October 6, 2004
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your becaller be substantially equivalent (for the indications for use stated in above and have determinearketed predicate devices marketed in interstate commerce prior to the clevosale) to regary mantowe of the Medical Device Amendments, or to devices that have been May 20, 1770, the clastinent add serovisions of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordantes market approval application (PMA). You may, therefore, market the do not require approvate of a 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 (Premarket 1 ir your device to such additional controls. Existing major regulations affecting your . Apployal), It the Socor 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 I rease of advised that i Dr. I be the complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I cacal statues and regulation 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) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
{2}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow your to ought mading of substantial equivalence of your device to a legally prematice notification: - The sification 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 If you acsife specifice acrise to your be of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, promotion other general information on your responsibilities under the Act from the 601:37). " Ou may octurers, International and Consumer Assistance at its toll-free number (800) DVISIon of Official Manufactures address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. I rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Page 1 of 1
KC4 22/2 510(k) Number (if known):
DEVICE NAME: ImplantMaster
INDICATION FOR USE: The ImplantMaster system is indicated for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a CT scanner. It is also indicated for use as a planning and simulation software for use by qualified dental professionals to aid them in the placement of dental implants and surgical treatment. ImplantMaster processes the dental professional's input information and the result is used as an input data for CAD or Rapid Prototyping System.
(Please do not write below this line - continue on another page if needed)
( Concurrence of CDRH, Office of Device Evaluation (ODE) )
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K042212 |
| Prescription Use ______ | OR Over-the-Counter Use ______ |
|---|---|
| ------------------------- | -------------------------------- |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).