(238 days)
The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).
The B.A.S.I.C. Dental Implant is an endosseous dental implant. The implant, healing cap and healing screws will now be provided in a sterilized medical grade Tyvek® pouches in accordance with ISO 11137 (SAL 10to). In addition, implants are now provided in diameter of 6.0 mm and lengths of 8.0 mm and 9.0 mm to provide a wider range of options for the dental professional.
The provided text is a 510(k) summary for the B.A.S.I.C. Dental Implant System. It describes modifications to an existing device rather than a new device that requires a comprehensive clinical study with acceptance criteria and a detailed study report. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not explicitly available in this document.
However, based on the context of a 510(k) submission, the "acceptance criteria" are implied to be substantial equivalence to a predicate device, meaning the modified device performs as safely and effectively as a legally marketed device and does not raise new questions of safety or effectiveness. The "study" proving this is primarily a comparison to predicate devices and adherence to relevant standards, rather than a clinical trial with performance targets.
Here's an attempt to answer the questions based on the provided text, recognizing the limitations of a 510(k) summary for device modification:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for device modifications aiming for substantial equivalence rather than a new device with specific performance claims from a clinical trial, the "acceptance criteria" are primarily met through comparison to predicate devices and adherence to standards.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance and Evidence (from 510(k) Summary) |
|---|---|
| No change in Intended Use (Safety & Effectiveness maintained for original purpose) | "The intended use is identical to the predicate device." |
| No alteration of fundamental scientific technology | "Per FDA-CDRH criteria for a Special 510(k), the modifications do not affect the intended use or alter the fundamental scientific technology of the device..." |
| Equivalent technological characteristics (despite modifications) | The updated specifications (new diameters and lengths, sterilized components) are deemed substantially equivalent or improvements, as detailed in the comparison tables. |
| No new health risks posed by modifications | "Risk analysis which includes health risks related to root form endosseous dental implants... An FMEA report is included in Attachment 9." |
| "The dimensional specification changes do not pose any new health risks to the patient as there are other cleared products on the market with similar dimensions." | |
| Sterilization effectiveness (for new sterilized components) | "B.A.S.I.C. Dental Implant Systems, Inc. has contracted with Steris Isomedix Service to establish and maintain a valid gamma-ray sterilization processes in accordance with ISO 11137 (SAL 10⁻⁶)... Substantiation of a routine sterilization dose was established using the VDmax's method, described in ISO 11137." |
| Biocompatibility maintained (as material is unchanged) | "Material of Implants: CP Titanium" (unchanged). This implies continued biocompatibility of the material. |
| Device integrity and functionality maintained (post-sterilization, new dimensions) | "Device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. The B.A.S.I.C. Dental Implant System meets B.A.S.I.C.'s in-house requirements..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a traditional clinical "test set" in the document. The "samples" referenced for sterilization and device integrity validation are "produced under routine manufacturing conditions," but the quantity is not specified.
- Data Provenance: Not applicable in the context of a clinical study. The data provenance relates to internal testing (sterilization validation, FMEA, in-house requirements) and comparison to existing market data (other cleared devices). This is retrospective in the sense of looking at existing cleared devices and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth in this context is established by adherence to recognized standards (ISO 11137, FDA Guidance) and comparison to legally marketed predicate devices, rather than expert consensus on a specific test set.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical PIVOTAL trial of read performance to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done or required for this 510(k) submission. This type of study is typically associated with new diagnostic devices or AI algorithms where human reader performance is a key outcome.
- Effect Size: N/A.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study: No, this is not an AI/algorithm-based device. No standalone performance study in that sense was conducted or described.
7. Type of Ground Truth Used
- Ground Truth: For this device modification, the "ground truth" is established by:
- Regulatory Standards: Compliance with ISO 11137 for sterilization, and internal requirements for device integrity and functionality.
- Predicate Device Equivalence: The existence and safety/effectiveness of previously cleared devices (both the unmodified B.A.S.I.C. Dental Implant System and other manufacturers' devices) with similar dimensions and characteristics serve as the de facto "ground truth" for the new design's safety and effectiveness.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
§ 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.