(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.
§ 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.