(206 days)
The implant is designed for use in edentulous sites for support of complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.
The Silhouette™ (hex-top) and Silhouette ™ IC (internal connectivit) incorporate a self-tapping tapered implant design that provides lateral compression of the osteotomy site to meorporate a son-apping tapping aller and is flat in the lower supporting plane of the thread, passing compression forces to the bone and eliminating shear forces common to symmetrical the thead implants. The screw thead portion of the implants are surfaced roughened with Osseo-I ok™ per Bio-Coat, Inc. specifications. Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment.
The provided text is related to a 510(k) submission for a dental implant system. It contains information about the device's description, indications for use, and a summary of testing. However, it does not provide the specific details required to complete your request for acceptance criteria and a study proving those criteria are met.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance: The document states that "sufficient mechanical static and dynamic strength" was found, but it doesn't quantify what "sufficient" means (e.g., specific load values, fatigue cycles). It also mentions "biocompatibility" but doesn't list the criteria or outcomes.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: These are all crucial details for a comprehensive study description that are entirely absent from this 510(k) summary. The summary focuses on regulatory compliance based on existing guidelines and general statements about testing.
Therefore, I cannot fulfill your request as the necessary data is not present in the provided text.
To give you an idea of what a good answer would look like if the information were available, here's a template:
Acceptance Criteria and Study Details (Hypothetical, based on typical medical device submission)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Unit | Acceptance Limit | Reported Device Performance | Meets Criteria? |
|---|---|---|---|---|
| Mechanical Strength (Static) | Newtons (N) | Mean strength ≥ 2000 N (with 95% CI) | Mean strength = 2250 N (95% CI: 2100-2400 N) | Yes |
| Fatigue Life (Dynamic) | Cycles | Survivability ≥ 90% at 5 million cycles @ 300N | Survivability = 95% at 5 million cycles @ 300N | Yes |
| Biocompatibility (Cytotoxicity) | Cell viability (%) | Cell viability ≥ 70% | Cell viability = 92% | Yes |
| Osseointegration (Animal Study) | Bone-Implant Contact (%) | Mean BIC ≥ 50% at 12 weeks | Mean BIC = 65% at 12 weeks | Yes |
| Clinical Success Rate | Proportion / Percentage | SR ≥ 95% at 1 year | SR = 97.2% at 1 year | Yes |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Mechanical Testing: 15 implants per test condition (e.g., 15 for static, 15 for dynamic).
- Animal Study: 10 animals, 2 implants per animal.
- Clinical Study: 100 patients.
- Data Provenance:
- Mechanical Testing: Conducted in a certified independent laboratory in the USA.
- Animal Study: Prospective study conducted in Germany.
- Clinical Study: Prospective, multi-center clinical trial conducted across 3 sites in the USA and 2 sites in Canada.
3. Number and Qualifications of Experts for Ground Truth
- Mechanical & Biocompatibility: No expert ground truth needed; based on objective measurements.
- Animal Study (Histomorphometry): 3 veterinary pathologists, each with >15 years of experience in bone histology and implant evaluation.
- Clinical Study (Outcome Adjudication): 2 independent dentists (oral surgeons) with >10 years of experience in implantology, blind to treatment groups.
4. Adjudication Method for Test Set
- Mechanical & Biocompatibility: N/A (objective measurements).
- Animal Study: Each pathologist independently evaluated all slides. Any discrepancies (e.g., >10% difference in BIC measurement) were resolved by a consensus meeting involving all three pathologists.
- Clinical Study: 2+1 adjudication. Two dentists independently reviewed all patient outcomes. If their assessments agreed, that was the final outcome. If they disagreed, a third senior implantologist (not involved in initial reviews) would review the case and make the final determination.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was performed for this device, as its primary evaluation was based on objective mechanical, biological (animal), and clinical (human outcomes) performance rather than diagnostic interpretation assisted by AI.
6. Standalone (Algorithm Only) Performance Study
- No standalone (algorithm only) study was performed. This is a hardware medical device (dental implant) and does not involve an AI algorithm for diagnostic or interpretative purposes.
7. Type of Ground Truth Used
- Mechanical Testing: Objective physical measurements (e.g., force, displacement, cycle count).
- Biocompatibility: In-vitro laboratory assays (e.g., cell viability, leachables testing).
- Animal Study: Histomorphometric analysis of tissue sections.
- Clinical Study: Patient outcomes as defined by the study protocol (e.g., implant survival, peri-implantitis incidence, marginal bone loss measured from radiographs).
8. Sample Size for Training Set
- N/A. As this is a hardware device without an AI component, there was no "training set."
9. How Ground Truth for Training Set was Established
- N/A. Not applicable for a hardware device.
This hypothetical example illustrates the detail typically expected in such a request, showing what specific information is missing from the provided 510(k) summary. The provided document is a high-level summary for regulatory clearance, not a detailed scientific study report.
{0}------------------------------------------------
MAR - 4 2004
510(k) Summary
SUBMITTER:
Submitted on behalf of:
| Company Name: | Bio-Lok International Inc. | |
|---|---|---|
| Address: | 312 South Military TrailDeerfield Beach, FL 33442 | |
| Telephone: | (954) 698-9998 | |
| Fax: | (954) 698-9925 | |
| by: | Elaine Duncan, M.S.M.E., RACPresident, Paladin Medical, Inc.PO Box 560Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 | |
| Fax: | 715-549-5380 | |
| CONTACT PERSON: | Elaine Duncan | |
| DATE PREPARED: | August 7, 2003 | |
| TRADE NAME: | Silhouette™ & Silhouette™ IC dental implant system withLaser-Lok™ surface treatment | |
| COMMON NAME: | Dental implant, Endosseous |
SUBSTANTIALLY EQUIVALENT TO: Silhouette™ and Silhouette™ IC dental implants with SUBS I ANY IALD I BQ OT PREECT * * * * * * * * * * * * * * * implants [see manufacturer's various predicate 510(k)'s]. Additional substantially equivalent predicate devices with predicate vallous production 216(15) by break are the Astra Tech Fixture ST, Osseotite NT from 31, and Prialit-2 by Dentsply Friadent Ceramed.
DESCRIPTION of the DEVICE: The Silhouette™ (hex-top) and Silhouette ™ IC (internal connectivit) incorporate a self-tapping tapered implant design that provides lateral compression of the osteotomy site to meorporate a son-apping tapping aller and is flat in the lower supporting plane of the thread, passing compression forces to the bone and eliminating shear forces common to symmetrical the thead implants. The screw thead portion of the implants are surfaced roughened with Osseo-I ok™ per Bio-Coat, Inc. specifications. Laser-Lok™ is a surface technology in which two laser generated patterns of microscopic grooves are applied to the collar of the implant to engineer the biological width and tissue attachment.
INDICATIONS FOR USE: The implant is designed for use in edentulous sites for support of complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.
SUMMARY of TESTING: The Laser-Lok surface treatment does not introduce new issues for SUMMAN I of I DS I I W. The Base mary of all testing conducted to-date. Mechanical testing was blocompanibility as decambation for premation for premarket notification submissions for screwtype endosseous implants" issued on December 9, 1996. Results from an independent laboratory showed the Silhouette™ and Silhouette™ IC with Laser-Lok™ surface treatment to have sufficient mechanical slatic and dynamic strength. Additional test reports include finite element analysis, animal and clinical testing.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 2004
Biolock International, Ir.corporated Ms. Elaine Duncan President Paladin Medical, Incorporated P.O. Box 560 Stillwater, Minnesota 55082-0560
Re: K032454
Nob2454
Trade/Device Name: Bio-Lok International, Incorporated Silhouette™ and Silhouette TM IC Endosseous Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE, NHA Dated: December 10, 2003 Received: December 11, 2003
Dear Ms. Duncan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your because mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, of to de rises and Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 000; Drag, and Commay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include confrols provisions of 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 If your device is classinod (obs acc iditional controls. Existing major regulations affecting (1 Wri), it may of backed of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be four of forther announcements concerning your device in the Federal Register.
{2}------------------------------------------------
Page 2 - Ms. Falk
Please be advised that FIDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements Incall that I DT may Federal statutes and regulations administered by other Federal agencies. of the Act of ally I outstal but is requirements, including, but not limited to: registration Tou must comply with as a mart 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 Or rel art 007), lacelity systems (QS) regulation (21 CFR Part 820); and if requirements as set fortis in the quadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in Jour Jo The FDA finding of substantial equivalence of your device to a premarket notified.com - The Pice 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), If you desire specific at 110 to 100 login at (301) 594-4613. 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 from the may obtain 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,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known) __
Device Name: Bio-Lok International, Inc. Silhouette™ and Silhouette™ IC endosseous implant
Indications for Use:
The implant is designed for use in edentulous sites for support of complete denture I no implant is accrg. or intermediate abutment for fixed bridgework or partial dentures, or a single tooth replacement, overdenture, or hybrid denture.
(Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over -The-Counter Use_
(Optional Format 1-2-96)
Suse Rumm
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032431
§ 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.