(40 days)
This device is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices and to restore the patient's chewing function.
This device 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, and to restore the patient's chewing function.
The CRYSTAL Implants System implants are post-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. This CRYSTAL-SEAL system is most similar to the Crystal and Crystal Plus Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-954432. Like many commercial implants, the CRYSTAL devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). CRYSTAL Implants also are available in coated form, either hydroxyapatite or titanium plasma spray.
The provided text is a 510(k) summary for a dental implant system (CRYSTAL and CRYSTAL-SEAL Implants System). It does not contain information about acceptance criteria, device performance metrics, or a study design that would prove the device meets specific performance criteria. This document is focused on establishing substantial equivalence to pre-amendment devices and other already-cleared devices.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Here's what can be inferred and what is explicitly stated concerning the lack of a traditional performance study:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| N/A (No specific performance criteria for substantial equivalence are defined in this document beyond material and design similarity to predicate devices) | N/A (No quantitative performance data is provided). The document states, "Endosseous implants, and especially those of titanium or titanium alloy, in the 'post' or 'screw' configuration, have been proved safe and effective through the years." This refers to the general category of devices, not specific performance metrics for the CRYSTAL system. |
2. Sample size used for the test set and the data provenance:
- N/A. No formal test set or clinical study specific to the CRYSTAL and CRYSTAL-SEAL Implants System is described in this 510(k) summary. The submission relies on substantial equivalence to predicate devices and general literature on endosseous implants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No test set or ground truth establishment process for performance evaluation is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No test set or adjudication method 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:
- N/A. This device is a dental implant, not an AI software or a diagnostic imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a physical medical device (dental implant), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. Given the type of submission (510(k) based on substantial equivalence), the "ground truth" for proving safety and effectiveness relies on the long-standing history of similar pre-amendment devices and contemporary legally marketed predicate devices. The document cites literature reviews and a 10-year study (Toronto study by Zarb) on the Branemark implant technique as evidence of safety and effectiveness for endosseous implants in general, not specifically for the CRYSTAL system.
8. The sample size for the training set:
- N/A. No "training set" in the context of an algorithm or AI model is applicable here.
9. How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for an algorithm.
Conclusion regarding the "study that proves the device meets the acceptance criteria":
The provided text does not describe a specific study for the CRYSTAL and CRYSTAL-SEAL Implants System that establishes acceptance criteria and directly proves the device meets them. Instead, the submission relies on the concept of Substantial Equivalence (SE).
The core argument for the device's safety and effectiveness is made by:
- Similarity to pre-amendment devices: Stating that it is "equivalent to devices manufactured and sold before 1976."
- Similarity to currently marketed predicate devices: Explicitly referencing K-954432 (Crystal and Crystal Plus Implants System) and other examples cleared by the FDA (e.g., Bofors Nobelpharma, Core-Vent Corp., etc.).
- General acceptance and literature review: The document includes a "Clinical Discussion and Brief Literature Review" which summarizes that "Endosseous implants...have been proved safe and effective through the years." It references a Medline search, a Consensus Development Conference on Dental Implants (NIH, 1988), and specifically the Toronto 10-year study by Zarb on the Branemark implant technique. This literature supports the general safety and effectiveness of the class of devices, implying that because the CRYSTAL system is substantially equivalent in design, materials, and intended use, it also shares this established safety and effectiveness.
In essence, the "proof" is through demonstrating that the device is fundamentally the same as other devices already proven safe and effective, rather than presenting a de novo study for this specific product.
§ 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.