(118 days)
The Simpler Toadstool Mini Implant is intended to be used as an artificial root to provide immediate long term or transitional support for overdentures.
The Simpler Toadstool Mini Implants and the Simpler HA Toadstool Mini Implants are intended to provide long term intra-bony applications for Soft Tissue Supported Over Dentures only. They are designed for immediate loading when there is good primary stability and an appropriate occlusal load. These implants may also be used for temporary soft tissue overdenture support for partial and fully edentulous restoration in the mandible and maxilla. They may be used as a minimally invasive surgical technique option for full or partial edentuloism as an alternative to more invasive surgery involving conventional implants.
The Simpler Toadstool Minis and the Simpler HA Toadstool Minis are Narrow Diameter implants. They are manufactured using 6/4 Titanium alloy 90% titanium 6% aluminum and 4% vanadium for strength. All implants are arit blasted and also acid etched and are available uncoated or coated with hydroxylapatite only on the threaded part of the implant. The diameter is 2.5mm and the lenaths are 10mm. 13mm, 15 mm and 18 mm in both the coated and uncoated implants. The implants are designed as one piece with a flattened toadstool shaped abutment with a hexagonal outline at the top of the implant. The flattened, hex ball fits into a keeper with a rubber o-ring placed in the prosthesis to reduce loading and to help with retention.
The provided document describes a 510(k) premarket notification for an endosseous dental implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through clinical studies as often seen for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert consensus, and comparative effectiveness studies is not applicable or cannot be extracted from this document.
However, I can extract the relevant information from the provided text based on the nature of this submission.
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission concerning an endosseous dental implant, "acceptance criteria" are typically related to material properties, mechanical performance, and substantial equivalence to predicate devices, rather than clinical efficacy metrics like sensitivity or specificity.
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Material Composition | Manufactured using 6/4 Titanium alloy (90% titanium, 6% aluminum, 4% vanadium) for strength. (Implied to be acceptable as it's a common material for dental implants and similar to predicate devices). |
| Surface Treatment | All implants are grit blasted and also acid etched. Available uncoated or coated with hydroxylapatite only on the threaded part. (Implied to be acceptable and not introducing new issues compared to predicate devices). |
| Dimensions | Diameter: 2.5mm. Lengths: 10mm, 13mm, 15mm, 18mm. (These dimensions characterize the device). |
| Design Feature | One-piece with a flattened toadstool shaped abutment with a hexagonal outline. Hex ball fits into a keeper with a rubber o-ring. (Descriptive feature). |
| Intended Use | To be used as an artificial root to provide immediate long term or transitional support for overdentures. (Matches predicate devices). |
| Indications for Use | Long term intra-bony applications for Soft Tissue Supported Over Dentures only. Designed for immediate loading when good primary stability and minimal occlusal load exist. Also for temporary soft tissue overdenture support for partial and fully edentulous restoration in mandible and maxilla. Minimally invasive option for full/partial edentulism. (Matches predicate devices). |
| Safety Testing | "Simpler Toadstool Mini Implants do not introduce new issues for materials, surface treatment, fatigue testing and risk management that have not been addressed in all other approved Simpler Implants." (This statement implies that the device meets established safety standards and is substantially equivalent to predicates in these aspects). |
| Substantial Equivalence | Demonstrated substantial equivalence to: K083886 (Simpler Mini Implants), K031106 (Imtec Sendax MDI and MDI plus), K050586 (Leone Implant System), K70601 (Mini Drive-Lock Implant). (The FDA's decision to clear the device implies this criterion was met). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not describe a clinical "test set" in the context of an AI/ML algorithm evaluation. It's a 510(k) for a physical medical device (dental implant). The "Summary of Testing" section indicates that "Simpler Toadstool Mini Implants do not introduce new issues for materials, surface treatment, fatigue testing and risk management that have not been addressed in all other approved Simpler Implants." This implies equivalence through comparison to existing data and established parameters of the predicate devices. There is no mention of a specific new clinical study with a test set of human subjects described in this document.
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)
Not applicable. This is a physical dental implant, not an AI/ML device requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is about a physical implant, not an AI/ML system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's safety and effectiveness essentially relies on:
- Established engineering and material science principles: for the titanium alloy, surface treatment, and design.
- Performance of predicate devices: The primary "truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices. The new device demonstrates substantial equivalence to these.
- Existing knowledge of dental implant outcomes: The contraindications and complications listed are general to dental implants, implying a reference to broad clinical experience.
8. The sample size for the training set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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172
- SUMMARY
510(K) 092674
Dr. Harold Bergman, President Pan Global Implant Corp. Simpler Implants #404 1023 Wolfe Ave. DEC 2 8 2009 Vancouver, BC V6H 1V6 Phone: 604 736 9890 Fax: 604-736-9747 Contact: Karen Bergman. QA Assurance Officer or Dr. Bergman, President
Trade Name: Simpler Toadstool Mini Implant & Simpler Toadstool HA Mini Implant Common Name: Simpler Toadsfool Mini Implants & Simpler Toadstool Mini Implant Classification: Endosseous Dental Implants
Leaally marketed devices to which S.E. is claimed
K083886: Simpler Mini Implants K031106 : Imtec Sendax MDI and MDI plus
K050586: Leone Implant System
K70601: Mini Drive-Lock Implant
Description The Simpler Toadstool Minis and the Simpler HA Toadstool Minis are Narrow Diameter implants. They are manufactured using 6/4 Titanium alloy 90% titanium 6% aluminum and 4% vanadium for strength. All implants are arit blasted and also acid etched and are available uncoated or coated with hydroxylapatite only on the threaded part of the implant. The diameter is 2.5mm and the lenaths are 10mm. 13mm, 15 mm and 18 mm in both the coated and uncoated implants. The implants are designed as one piece with a flattened toadstool shaped abutment with a hexagonal outline at the top of the implant. The flattened, hex ball fits into a keeper with a rubber o-ring placed in the prosthesis to reduce loading and to help with retention.
Intended Use: The Simpler Toadstool Mini Implant is intended to be used as an artificial root to provide immediate long term or transitional support for overdentures.
Indications for Use: The Simpler Toadstool Mini Implants and the Simpler HA Toadstool Mini Implants are intended to provide long term intra-bony applications for Soft Tissue Supported Over Dentures only. They are designed for immediate loading when there is good primary stability and an appropriate occlusal load. These implants may also be used for
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temporary soft tissue overdenture support for partial and fully edentulous restoration in the mandible and maxilla. They may be used as a minimally invasive surgical technique option for full or partial edentuloism as an alternative to more invasive surgery involving conventional implants
Contraindications: Contraindications customary to the placement of any dental implants may be observed. These include, but are not limited to current local infection, vascular impairment, uncontrolled diabetes, chronic high doses of steroids, clotting disorders, current anticoagulant therapy, metabolic bone disease, and other metabolic or systemic disorders which will affect bone or wound healing. Excessive loading or placement of implants in inadequate bone may result in fracture.
Complications: Possible complications with any oral reconstructive surgery include, infection, closure perforation, abscess formation, bone loss, pain soft tissue irregularities and additional complications associated with anesthesia and dental surgery.
Summary of Testing: Simpler Toadstool Mini Implants do not introduce new issues for materials, surface treatment, fatigue testing and risk management that have not been addressed in all other approved Simpler Implants.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Dr. Harold Bergman Chief Executive Officer Pan Global Implant Corporation #404 1023 wolfe Avenue Vancouver, British Columbia CANADA V6H 1V6
DEC 2 8 2009
Re: K092674
Trade/Device Name: Simpler Toadstool Mini Implant, Simpler HA Toadstool Mini Implant Regulation Number: 21CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 17, 2009 Received: December 22, 2009
Dear Dr. Bergman:
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 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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Page 2- Dr. Bergman
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free. number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Cinchin 0.2m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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( 1)
510(k) K092674
Device Name: Simpler Toadstool Mini Implant Simpler HA Toadstool Mini Implant
Indications for Use:
The Simpler Toadstool Mini Implants and the Simpler HA Toadstool Mini Implants are intended to provide long term intra-bony applications for Soft Tissue Supported Over Dentures only. They are designed for immediate loading when there is good primary stability and an minimal occlusal load. These implants may also be used for temporary soft tissue overdenture support for partial and fully edentulous restoration in the mandible and maxilla. They may be used as a minimally invasive surgical technique option for full or partial edentulism as an alternative to more invasive surgery involving conventional implants.
Prescription Use X AND/OR Part 21 CFR 801 Subpart D)
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cunten her
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
4992674 510(k) Number:
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.