(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.
§ 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.