(23 days)
The ACE Surgical Secure-Mini™ Locator® Implant System is is designed to provide immediate transitional splinting stability or intra-bony long term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients.
The ACE Secure-Mini™ Locator® Implant System is an additional set of machined surgical grade titanium alloy (Ti-6A1-4V ELI) screw implants to the Secure-Mini™ product family, intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. The implants are supplied sterile in 2.3 mm diameter, and in lengths of the 10, 11.5, 13, and 15 mm, and with Zest Locator® Implant Anchor Abutments (cleared under K994257) and Denture Cap Males (cleared under K072878) in standard tray packaging and include placement instruments. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics to that cleared under K073343. These screws are supplied sterile in standard Tvvek™ travs. The ACE Surgical Secure-Mini™ Locator® Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Secure-Mini™ Implant system.
The provided document is a 510(k) summary for a medical device (ACE Surgical Secure-Mini™ Locator® Implant System) seeking substantial equivalence to existing predicate devices. It focuses on demonstrating equivalence through device description, indications for use, materials, bench test results, and labeling, rather than presenting a detailed clinical study with acceptance criteria and performance metrics for a new AI-powered diagnostic device.
Therefore, most of the requested information regarding acceptance criteria, study design elements for AI performance (like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details), and ground truth establishment is not available in the provided text.
The document states: "In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Secure-Mini™ Locator® Implant System and the specified predicate devices." This implies that the 'acceptance criteria' were met by demonstrating non-inferiority or equivalence to the predicate devices through bench testing. However, the exact quantitative acceptance criteria and the detailed results of these bench tests are not provided.
Here's a breakdown of what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance, safety, or effectiveness equivalent to predicate devices (K073343, K994257, K072878) via bench testing. | "Bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Secure-Mini™ Locator® Implant System and the specified predicate devices." |
2. Sample size used for the test set and the data provenance: Not applicable. This was a bench testing study, not a study involving patient data for an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic AI sense was established by experts; rather, the performance was assessed relative to predicate devices through engineering/bench testing.
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 not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic AI. The "ground truth" for the bench testing would be established engineering standards or the performance of the predicate devices.
8. The sample size for the training set: Not applicable. This is not an AI-powered device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.
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12092594
SEP 1 6 2009
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter Name: ACE Surgical Supply Co., Inc. Submitter Address : 1034 Pearl St., Brockton, MA 02301 J. Edward Carchidi, DDS Contact Person: Phone Number: (508) 588-3100 Fax Number: (508) 523-3140 Date Prepared: August, 2009 Device Trade Name: ACE Surgical Secure-Mini™ Locator® Implant System Device Common Name: Endosseous Implant Screw Classification Name: Implant, Endosseous, Root form, product code DZE Predicate device: ACE Surgical Secure-Mini™ Implant System, K073343 Zest Locator Implant Anchor, K994257 Zest Modification to Locator Implant Anchor, K072878 Reason for submission: Not previously marketed in the USA
Device Description and Materials:
The ACE Secure-Mini™ Locator® Implant System is an additional set of machined surgical grade titanium alloy (Ti-6A1-4V ELI) screw implants to the Secure-Mini™ product family, intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. The implants are supplied sterile in 2.3 mm diameter, and in lengths of the 10, 11.5, 13, and 15 mm, and with Zest Locator® Implant Anchor Abutments (cleared under K994257) and Denture Cap Males (cleared under K072878) in standard tray packaging and include placement instruments.
The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics to that cleared under K073343. These screws are supplied sterile in standard Tvvek™ travs.
The ACE Surgical Secure-Mini™ Locator® Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Secure-Mini™ Implant system.
Intended Use:
The ACE Surgical Secure-Mini™ Implant System is intended to provide Immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients.
Substantial Equivalence/ Device - Technological Characteristics and Comparison to Predicate Device(s):
The ACE Surgical Secure-Mini™ Locator® Implant System is substantially equivalent to the ACE Surgical Secure-Mini™ Implant System, K073343, Zest Locator Implant Anchor, K994257, and Zest Modification to Locator Implant Anchor, K072878.
Among the information and data presented in the 510(k) submission to support the substantial equivalency of the ACE Surgical Secure-Mini™ Locator® Implant System to the specified predicate devices are: 1) device description, 2) indications for use, 3) bench test results, 4) materials, and 5) labeling. In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Secure-Mini™ Locator® Implant System and the specified predicate devices.
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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 consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
SEP 1 6 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
J. Edward Carchidi, DDS President ACE Surgical Supply Company, Incorporated 1034 Pearl Street Brockton, Massachusetts 02301
Re: K092594
Trade/Device Name: ACE Surgical Secure-Mini™ Locator® Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE
Dated: August 17, 2009
Received: August 24, 2009
Dear Dr. Carchidi:
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. Carchidi
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for
Susan Runner, D.D.S., M.A. Acting 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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Indications for Use
510(k) Number: K092594
Device Name: ACE Surgical Secure-Mini™ Locator® Implant System
Indications For Use:
The ACE Surgical Secure-Mini™ Locator® Implant System is is designed to provide immediate transitional splinting stability or intra-bony long term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Moore
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: IC028594
§ 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.