(106 days)
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 instally or fully edentulous patients.
The ACE Surgical Secure-Mini™ Implant System is a set of machined surgical grade titanium alloy screws, intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture instally or fully edentulous patients. The implants are supplied sterile in 2.3 mm diameter, and in lengths of 10, 11.5, 13, and 15 mm, in standard trays 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 K951392. These screws are supplied sterile in standard Tyvek™ trays. The ACE Surgical Secure-Mini™ Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Miniboneplate system.
The provided text describes a medical device, the ACE Surgical Secure-Mini™ Implant System, and its 510(k) submission for market clearance. However, the document does not include detailed information about acceptance criteria or a specific study designed to prove the device meets these criteria in the way typically expected for a diagnostic or AI-powered device.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of:
- Device description
- Indications for use
- Bench test results
- Materials
- Labeling
The key statement regarding performance is: "In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Prov+ Screw System and the specified predicate devices."
Given this, I cannot provide the requested information in the format of acceptance criteria and a study proving their fulfillment as the document implies a comparison study rather than a de novo performance study against defined acceptance criteria.
However, I can extract the available information as it relates to the type of assessment conducted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance: No difference in performance compared to predicate devices. | Bench testing demonstrated "no difference in the performance, safety, or effectiveness" between the ACE Surgical Secure-Mini™ Implant System and predicate devices (Intra-Lock International Mini Drive-Lock™ Implant System, K070601, and ACE Surgical Screw Miniboneplate System, K951392). |
| Safety: No difference in safety compared to predicate devices. | Bench testing demonstrated "no difference in the performance, safety, or effectiveness" compared to predicate devices. |
| Effectiveness: No difference in effectiveness compared to predicate devices. | Bench testing demonstrated "no difference in the performance, safety, or effectiveness" compared to predicate devices. |
| Materials: Identical or substantially equivalent materials to predicate devices. | Raw material is Ti-6-AL-4V ELI per ASTM F136 standard, identical to that cleared under K951392. |
| Indications for Use: Consistent with predicate devices. | The stated Indications for Use are provided. |
2. Sample size used for the test set and the data provenance:
- The document mentions "bench test results" but does not specify the sample size for these tests.
- Data provenance is not explicitly stated, but "bench testing" typically implies laboratory-controlled tests rather than human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the clearance is based on substantial equivalence demonstrated through bench testing, not expert-adjudicated clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as there is no mention of expert adjudication for a test set.
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 device, nor is there any mention of a human-in-the-loop or MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental implant system, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating substantial equivalence relied on measurable physical and mechanical properties compared during "bench testing," and the comparison of device characteristics (materials, indications for use, design) to legally marketed predicate devices.
8. The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. This device does not involve a training set.
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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 |
| Contact Person: | J. Edward Carchidi, DDS |
| Phone Number: | (508) 588-3100 |
| Fax Number: | (508) 523-3140 |
| Date Prepared: | November, 2007 |
| Device Trade Name: | ACE Surgical Secure-Mini™ Implant System |
| Device Common Name: | Endosseous Implant Screw |
| Classification Name: | Implant, Endosseous, Root form, product code DZE |
| Predicate device: | ACE Surgical Miniboneplate system, K951392Intra-Lock International Mini Drive-Lock™ Implant System, K070601 |
| Reason for submission: | Not previously marketed in the USA |
Device Description and Materials:
The ACE Surgical Secure-Mini™ Implant System
is a set of machined surgical grade titanium alloy screws, intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture instally or fully edentulous patients. The implants are supplied sterile in 2.3 mm diameter, and in lengths of 10, 11.5, 13, and 15 mm, in standard trays 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 K951392. These screws are supplied sterile in standard Tyvek™ trays.
The ACE Surgical Secure-Mini™ Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Miniboneplate 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 instally or fully edentulous patients.
Substantial Equivalence/ Device - Technological Characteristics and Comparison to Predicate Device(s):
The ACE Surgical Secure-Mini™ Implant System is substantially equivalent to the Intra-Lock International Mini Drive-Lock™ Implant System, K070601 and ACE Surgical Screw Miniboneplate System, K951392
Among the information and data presented in the 510(k) submission to support the substantial equivalency of the ACE Surgical Secure-Mini™ 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 Prov+ Screw System and the specified predicate devices.
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Public Health Service
Image /page/1/Picture/10 description: The image is a seal for the Department of Health & Human Services in the USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. J. Edward Carchidi President ACE Surgical Supply Company, Limited 1034 Pearl Street Brockton, Massachusetts 02301
Re: K073343
Trade/Device Name: ACE Surgical Secure-Mini™ Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: February 6, 2008 Received: February 7, 2008
MAR 1 3 2008
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 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.
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), please contact the Office of Compliance at (240) 276-0115. 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 Division 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/industry/support/index.html.
Sincerely yours,
Sayte y. Michied m.D.
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
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Indications for Use
510(k) Number: _ K0103343
Device Name: ACE Surgical Secure-Mini™ Implant System
Indications For Use:
The ACE Surgical Secure-Mini™ 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)
Suze Ramos
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
Ko 733 Y3 510(k) Number:
A-2
§ 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.