(241 days)
SurgPLAN and PanPLAN are Software packages that scan film using optical scanner or Direct Digital Capture using Solid State Sensors (from the Sensor) and store images produced by Imaging Sciences International's (or other manufacturer's) Tomographic, Panoramic and Cephlometric imaging machines. Additionally, the software has the ability to import DICOM images from volumetric data sets for analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of the imaging modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.
SurgPLAN / PanPLAN is a comprehensive software package that can scan films or certain solid state detectors, read DICOM images or DICOM volumetric data sets and display the images for the practitioner to perform analysis, measurements and surgical demonstrations for dental implants.
The provided text is a 510(k) Summary for the SurgPLAN / PanPLAN software, a device for dental implant planning and analysis. While it mentions performance testing and validation, it does not explicitly detail specific acceptance criteria or the study that proves the device meets those criteria. The summary focuses on establishing substantial equivalence to predicate devices and addressing potential hazards.
Therefore, for several of your requested points, the information is not available in the provided document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
Information Not Available in the Document. The document states: "The performance testing of the Imaging Sciences International Inc. SurgPLAN / PanPLAN would indicate that the system is substantially equivalent to both predicated devices." However, it does not provide specific performance metrics or acceptance criteria for these metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Information Not Available in the Document. The document mentions "performance testing" but does not specify the sample size, type of test data (e.g., patient cases), or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Information Not Available in the Document. The document does not describe how ground truth was established for any testing, nor does it mention the involvement or qualifications of experts in that process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information Not Available in the Document. The document does not describe any adjudication method used for testing or ground truth establishment.
5. 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
Information Not Available in the Document. The document does not mention an MRMC study or any study comparing human reader performance with and without AI assistance. The device's primary function described is analysis and planning, not necessarily aiding human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Information Not Available in the Document. While the software performs analysis and measurements, the document does not distinguish between standalone algorithm performance testing and performance in a human-in-the-loop scenario. The overall context suggests it's a tool for the practitioner: "The software allows the practitioner to perform analysis, measurements and surgical demonstrations..."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Information Not Available in the Document. The document does not specify the type of ground truth used for performance testing or validation.
8. The sample size for the training set
Information Not Available in the Document. The document does not mention a training set or its size. While software often involves training data (especially if it uses AI/machine learning, which isn't explicitly stated here), this information is not provided.
9. How the ground truth for the training set was established
Information Not Available in the Document. As no training set or its ground truth establishment is mentioned, this information is not provided.
Summary of what is available:
The 510(k) summary for SurgPLAN / PanPLAN focuses on:
- Substantial Equivalence: Claiming substantial equivalence to SimPlant (Materialise/Columbia Scientific) and CDRPan and CDR DICOM (Schick Technologies Inc.).
- Device Description: A software package that scans films or solid-state detectors, reads DICOM images/volumetric data, and displays images for analysis, measurements, and surgical demonstrations for dental implants.
- Intended Use: Providing a convenient method for visualization in planning (implants, cephlometric analysis, bone graft), facilitating communication, and demonstrating treatment plans.
- Hazards Control: Stating that potential hazards (e.g., incorrect measurements, imprecision) are controlled by the software development and validation system.
The document is a regulatory submission demonstrating a belief in equivalence and safety, but it is not a detailed technical report of performance criteria and empirical study results.
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DEC 2 3 2004
510 (k) Summary
K041078 Page 1 of 2
Submitters Information
Name: Address:
Phone Number: Fax Number:
Person To Contact:
Date Of Summary:
Trade Name Of The Device:
Common Or Usual Name:
Classification Name:
Imaging Sciences International Inc. 1910 North Penn Road Hatfield PA, 19440 215-997-5666 215-997-5665
Edward J Marandola Vice President & General Manager
November 15, 2004
SurgPLAN / PanPLAN
X-Ray Software
X-Ray, Software
Substantial Equivalence Claim: The Imaging Sciences International Inc. SurgPLAN / PanPLAN is substantially equivalent to the devices listed below:
| Device | SimPlant |
|---|---|
| Manufacturer | Materialise/Columbia Scientific810-x Cromwell Park DriveGlen Burnie, MD 21061 |
| Device | CDRPan and CDR DICOM |
| Manufacturer | Schick Technologies Inc.31-00 47th AvenueLong Island City, NY 11101 |
Description Of The Device: SurgPLAN / PanPLAN is a comprehensive software package that can scan films or certain solid state detectors, read DICOM images or DICOM volumetric data sets and display the images for the practitioner to perform analysis, measurements and surgical demonstrations for dental implants.
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L 84/078
Cage 2082
Intended Use Of The Device: SurgPLAN / PanPLAN is a Software package that Intention Ose Online optical scanner or Direct Digital Capture using Solid State Scalls (sean Inni abing operation on one of the sciences International's (or other School / and stores mages pic, Panoramic and Cephlometric imaging machines. manufacturers to , software has the ability to import DICOM images from Additionally, the box reporting analysis and reporting. The software allows voluments auta between surgical demonstrations for dental implant planning, the practitioner to perform surgers and bone graft visualizations. The purpose of ecphioneerie andrysiale the doctor with a convenient method for visualization of the software to to prove modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.
Comparison with Predicate devices: SurgPLAN / PanPLAN is a software comparison with the predicated devices. SurgPLAN / PanPLAN is a software package that combines functionality from both predicated devices in one simple package that comently it allows film-based users (through flatbed scanning) to have similar functions as digital users.
Conclusions: The performance testing of the Imaging Sciences International Inc. SurgPLAN / PanPLAN would indicate that the system is substantially equivalent to both predicated devices. The potential hazards (e.g. incorrect measurements or to both preciseare controlled by the software development and validation system. mischaghould) are complies with the requirements of 21 CFR 807.87 and does not pose any new safety risks or effectiveness issues.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2004
Mr. Edward J. Marandola Vice President & General Manager Imaging Sciences International, Inc. 1910 North Penn Road HATFIELD PA 19440
Re: K041078
Trade/Device Name: SurgPLANTM and PanPlan™ Regulatory Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 24, 2004
Received: November 29, 2004
Dear Mr. Marandola:
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 (Premarket Approval), 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 Scetion 510(k) I his letter will anow you to begin manteling of substantial equivalence of your device to a legally premarket nothleanon. The I DA midnig of bactuation 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 II you desire specific acvice for your de resert 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, please note the regulation on your responsibilities under the Act from the 807.97). Tou may obtain other general missistance at its toll-free number (800) DWISION of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsmaldsmamain.html
Sincerely yours,
Nancy C. brogdon
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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K041078
510(k) Number (if known): ___
SurgPLAN and PanPlan
Device Name:
Outgi D.A.V. and I line 1.
Indications For Use:
SurgPLAN and PanPlan are Software packages that scan film using optical scanner SurgELAN and I am un are Bereinale from the Sensor) and store images produced by of Difect Digital Capture using Bone Beats Senefacturer's) Tomographic, Panoramic and Intagring Sciences International b (on the software has the ability to import Cepillometric miagniz machines: Addition, analysis and reporting. The DICOM miages thom voluments causers surgical demonstrations for dental implant soltware anows the practitions to easurements and bone graft visualizations. The plaining, cephnometre andryble, vice the doctor with a convenient method for purpose of the software is to provide is and communication between multiple visuatizationers and to demonstrate treatment plan for the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR |
|---|---|
| (Per 21 CFR 801.109) |
David A. KaramOver-The-Counter Use_
(Optional Format 1-2-96)
Division Sign-Off) i. dominal, ai negrodur uve. and Radigical Device 510(k) Number
§ 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).