(354 days)
Reflect™ Dental Implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Reflect™ Dental Implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Reflect™ Implant System prosthetic components are compatible with the following implant systems.
| Implant System
Compatibility | Implant Body Diameter
(mm) | Platform Diameter
(mm) |
|---------------------------------|-------------------------------|---------------------------|
| OsseoSpeed™ | 3.5 | 3.5/4.0 |
| | 4.0 | 3.5/4.0 |
| | 5.0 | 4.5/5.0 |
| 3i Certain® | 3.25 | 3.4 |
| | 4.0 | 4.1 |
| | 5.0 | 5.0 |
| NobelActive® | 3.5 | NP |
| | 4.3 | RP |
| | 5.0 | RP |
| NobelReplace Conical | 3.5 | NP |
| | 4.3 | RP |
| | 5.0 | RP |
| Tapered Screw-Vent® | 3.7 | 3.5 |
| | 4.1 | 3.5 |
| | 4.7 | 4.5 |
Reflect™ Implant System implants are root form endosseous dental implants with a tapered body and a grit blasted and acid etched surface intended for bone level placement. The subject device consists of five product lines (Reflect™ Aspire, Reflect™ Certus, Reflect™ Rapid, Reflect™ Recover, and Reflect™ Tapered) and three component designs (Cover Screw, Healing Abutment, and 30° Abutment). The Reflect™ implant sizes are summarized in the following table.
| Reflect TM Implant System | |||
|---|---|---|---|
| Implant Line | Body Ø (mm) | Platform Ø (mm) | Implant Lengths (mm) |
| Aspire | 3.5 | 3.5 | 8, 9, 11, 13, 15 |
| 4.0 | 4.0 | 8, 9, 11, 13, 15 | |
| 5.0 | 5.0 | 9, 11, 13, 15 | |
| Certus | 3.3 | 3.4 | 8.5, 10, 11.5, 13, 15 |
| 4.0 | 4.1 | 8.5, 10, 11.5, 13, 15 | |
| 4.9 | 5.0 | 8.5, 10, 11.5, 13, 15 | |
| Rapid | 3.5 | NP | 8.5, 10, 11.5, 13, 15 |
| 4.3 | RP | 8.5, 10, 11.5, 13, 15 | |
| 5.0 | RP | 8.5, 10, 11.5, 13, 15 | |
| Recover | 3.5 | NP | 8.5, 10, 11.5, 13, 16 |
| 4.3 | RP | 8.5, 10, 11.5, 13, 16 | |
| 5.0 | RP | 8.5, 10, 11.5, 13, 16 | |
| Tapered | 3.7 | 3.5 | 8.5, 10, 11.5, 13, 16 |
| 4.1 | 3.5 | 8.5, 10, 11.5, 13, 16 | |
| 4.7 | 4.5 | 8.5, 10, 11.5, 13, 16 |
The Reflect™ abutment sizes are summarized in the following table. Note: each abutment is provided in each platform diameter listed.
| Reflect™ Implant System - Abutments | Compatible Implants | |||
|---|---|---|---|---|
| Implant Line | Abutments | Abutment | ||
| Platform Ø (mm) | Implant System | |||
| Compatibility | Platform | |||
| Diameters (mm) | ||||
| Aspire | Aspire Cover Screw | 3.5, 4.0, 5.0 | OsseoSpeed™ | 3.5/4.0, 4.5/5.0 |
| Aspire Ø 3.5/4.0 mm Healing Abutment | 3.5, 4.0 | OsseoSpeed™ | 3.5/4.0 | |
| Aspire Ø 4.5/5.0 mm Healing Abutment | 5.0 | OsseoSpeed™ | 4.5/5.0 | |
| Aspire 30° Abutment | 3.5, 4.0, 5.0 | OsseoSpeed™ | 3.5/4.0, 4.5/5.0 | |
| Certus | Certus Cover Screw 3.4/4.1 mm | 3.4, 4.1 | 3i Certain® | 3.4, 4.1 |
| Certus Cover Screw 5.0 mm | 5.0 | 3i Certain® | 5.0 | |
| Certus Healing Abutment | 3.4, 4.1, 5.0 | 3i Certain® | 3.4, 4.1, 5.0 | |
| Certus 30° Abutment | 3.4, 4.1, 5.0 | 3i Certain® | 3.4, 4.1, 5.0 | |
| Rapid | Rapid Cover Screw | NP, RP | NobelActive® | NP, RP |
| Recover/Rapid Healing Abutment | NP, RP | NobelActive® | NP, RP | |
| Rapid 30° Abutment | NP, RP | NobelActive® | NP, RP | |
| Recover | Recover Cover Screw | NP, RP | NobelReplace Conical | NP, RP |
| Recover/Rapid Healing Abutment | NP, RP | NobelReplace Conical | NP, RP | |
| Recover 30° Abutment | NP, RP | NobelReplace Conical | NP, RP | |
| Tapered | Tapered Cover Screw | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 |
| Tapered Healing Abutment | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 | |
| Tapered 30° Abutment | 3.5, 4.5 | Tapered Screw-Vent® | 3.5, 4.5 |
Subject device implants are made of unalloyed titanium conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50400, UNS R50550, UNS R50700) Grade 4, and subject device abutments are made of titanium alloy conforming to ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
The subject device implant surface is produced by blasting with alumina (Al2O3) powder, and etching with hydrochloric acid and sulfuric acid. After etching, the remaining acid is removed by washing with distilled water, followed by cleaning with an alkaline solution using a high temperature and high-pressure hydrothermal method.
The provided document describes a 510(k) premarket notification for the Reflect™ Implant System, a dental implant device. This document does NOT contain information about acceptance criteria and device performance as typically expected for diagnostic or AI-powered medical devices (e.g., sensitivity, specificity, accuracy, F1-score).
Instead, this submission focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means the manufacturer is asserting their device is as safe and effective as a device already on the market, by showing similar indications for use, technological characteristics, and materials.
Therefore, the information requested in your prompt regarding acceptance criteria for device performance (like sensitivity, specificity, etc.) and related studies (sample sizes for test/training sets, expert ground truth, MRMC studies) is not present in this document.
The "Performance Data" section (Page 6) explicitly states: "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, and 17665-2; biocompatibility according to ISO 10993-1, 10993-5, and 10993-12; dynamic compression-bending testing according to ISO 14801; and engineering and dimensional analysis of the OEM implant bodies, OEM abutments, and OEM fixation screws. No clinical data were included in this submission."
This indicates that the performance data for this type of device (dental implant hardware) is primarily based on bench testing and material science, not clinical accuracy or diagnostic performance evaluated against ground truth in a clinical setting.
To answer your prompt with the available information in the document, I will have to explain why the requested information is not present and what type of "acceptance criteria" and "performance data" are typically used for a 510(k) submission for a non-AI hardware device like this.
Based on the provided document (K180924 for Reflect™ Implant System):
This 510(k) submission demonstrates substantial equivalence for a dental implant system. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are related to non-clinical performance benchmarks and comparisons to predicate devices, rather than diagnostic performance metrics (e.g., sensitivity, specificity) typically associated with AI or diagnostic imaging devices.
Here's a breakdown of the requested information based on what is and is not available in the document:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria or reported performance in a table format for diagnostic accuracy or similar metrics. Instead, the "acceptance criteria" for this type of device (dental implant hardware) are implicit in demonstrating substantial equivalence to predicates, meaning the device must perform comparably in terms of:
- Materials: Conforming to recognized standards (e.g., ASTM F67 for unalloyed titanium, ASTM F136 for titanium alloy).
- Mechanical Strength: Meeting or exceeding benchmarks from standards like ISO 14801 for dynamic compression-bending.
- Biocompatibility: Conforming to ISO 10993 series.
- Sterilization: Validation according to ISO 11137 series and ISO 17665 series, and bacterial endotoxin testing per ANSI/AAMI ST72.
- Packaging Integrity: Meeting ASTM standards for sterile barrier shelf testing (F88, F1140, F2096, F1929, F1608).
- Dimensional & Engineering Analysis: Demonstrating compatibility with existing implant systems and consistency with predicate device dimensions.
- Surface Characteristics: Confirmation of no residual material from manufacturing processes (via SEM with EDS).
Reported Device Performance (as described for non-clinical testing):
The document states that tests were "performed according to" or "conforming to" these standards, implying successful completion. For example:
- "sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, and 17665-2;"
- "biocompatibility according to ISO 10993-1, 10993-5, and 10993-12;"
- "dynamic compression-bending testing according to ISO 14801;"
- "engineering and dimensional analysis of the OEM implant bodies, OEM abutments, and OEM fixation screws."
- "bacterial endotoxin testing was performed according to ANSI/AAMI ST72."
- "Sterile barrier shelf testing was performed according to ASTM standards F88. F1140. F2096, F1929, and F1608."
- "Scanning electron microscopy (SEM) with energy dispersive X-ray spectroscopy (EDS) was performed on the implant endosseous threaded surface to confirm there was no residual material from the blasting or cleaning operations present on the final devices."
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in terms of clinical patient data, as "No clinical data were included in this submission." For non-clinical validation (e.g., mechanical testing, biocompatibility), sample sizes would be determined by the specific ISO/ASTM standards referenced, but these are not enumerated in the summary.
- Data Provenance: Not applicable for clinical data. The non-clinical testing data provenance is not specified (e.g., where the testing labs were located).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This submission focuses on hardware components, materials, and mechanical integrity, not diagnostic or AI performance requiring expert truth-labeling of medical images or patient outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set or ground truth labeling requiring adjudication is described.
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 device is a physical dental implant, not an AI or diagnostic imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable for clinical ground truth. The "ground truth" for this device lies in its adherence to material specifications, mechanical performance standards, and biological compatibility, as demonstrated through non-clinical testing and comparison to legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This is a hardware device; there is no AI training set.
9. How the ground truth for the training set was established
- Not applicable. There is no AI training set.
In summary, the provided FDA 510(k) document for the Reflect™ Implant System is for a physical medical device (dental implant hardware), not a diagnostic or AI-powered device. Therefore, the "acceptance criteria" and "performance data" presented are based on non-clinical engineering, materials science, and successful demonstration of substantial equivalence to already-cleared predicate devices, rather than clinical efficacy or diagnostic accuracy metrics.
§ 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.