(115 days)
The PUR Implant System can be used in dental implant applications, for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The PUR Implant is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading.
The PUR Implant System is only intended for use with straight abutments. The PUR implant body is intended to be placed such no angle correction is necessary.
The PUR is a self-tapping, double thread screw implant with a micro groove section, manufactured from Wrought Titanium 6AL-4V ELI. The implant surface is grit-blasted and acid etched. The implants are manufactured with four body diameters 3.5 mm, 4.3 mm, and 6.0 mm. The 3.5 and 4.3 mm implants have a Narrow Platform (NP) prosthetic head. The 5.0 and 6.0 mm implants have a Regular Platform (RP) prosthetic head. The PUR implants are substantially equivalent to the Zimmer Tapered Screw-Vent® 3.5 mmD Platform and the 4.5 mmD Platform implant systems. They provide for non- rotational single and multiple tooth restorations in both the maxilla and mandible. They are packaged sterile in a double blister, which contains: the implant in a titanium tube. A special driver is available for the implants which simplifies implant insertion by eliminating the need for an implant mount.
This device uses straight abutments with no angles. Sterngold has SA Abutments) which are intended for multi-unit restorations. Sterngold also has UCLA abutments which are twopiece abutments composed of Wrought Titanium 6AL-4V ELI, conforming to ASTM F136-13 and Gold Alloy (64% gold, 22% palladium and 14.0% platinum). These UCLA abutments are intended for single and multiple unit use.
The PUR implant system is not intended to include any angled abutments or allow for any correction of angled implant placement.
The provided document is a 510(k) premarket notification for a dental implant system. This type of document is used to demonstrate that a new medical device is "substantially equivalent" to a legally marketed predicate device, meaning it is at least as safe and effective. The FDA's decision is based on comparing the new device's technological characteristics and intended use to those of the predicate.
Crucially, a 510(k) summary for a dental implant system typically does not include "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way one might find for an AI/ML-driven diagnostic device. The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC is not directly applicable here. Instead, the "acceptance criteria" for a 510(k) are related to demonstrating substantial equivalence through various tests (mechanical, biocompatibility, sterilization validation) and design comparisons.
Therefore, many of the requested points are not applicable to this type of regulatory submission. However, I will extract and describe the relevant information that is present.
Here's an analysis based on the provided text, addressing the points where possible and indicating when they are not applicable for this kind of device and submission:
1. A table of acceptance criteria and the reported device performance
As explained above, this submission does not present acceptance criteria and performance in terms of diagnostic metrics (e.g., sensitivity, specificity, or F1 score). Instead, the "performance" demonstrated for dental implants revolves around mechanical properties, biocompatibility, and sterilization effectiveness to show substantial equivalence to predicate devices.
The document states:
- Performance Testing: "Non clinical Testing was performed following "Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Performance testing demonstrated that the device performs appropriately for the proposed indications for use."
- Surface analysis: "SEM photographs confirm that all residue of blasting material had been removed from the treated implant surface, and the surface chemical analysis confirmed that no contaminants remained on the surface."
- Sterilization, shelf life, and biocompatibility: "PUR Implants have the same sterilization process and radiation dose, same shelf life and biocompatibility as previous cleared Sterngold devices, therefore sterility, shelf life and biocompatibility testing performed on previous cleared Sterngold devices is applicable to the PUR Implants."
Table of Comparison (extract of relevant parts from page 6, representing "performance" in the context of substantial equivalence):
| Property | Subject Device K151928 | Predicate Device K061410 (Primary Predicate) |
|---|---|---|
| Intended Use | The PUR Implant System can be used in dental implant applications, for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The PUR Implant is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal loading. The PUR Implant System is only intended for use with straight abutments. The PUR implant body is intended to be placed such no angle correction is necessary. | For use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. |
| Implant Design | Threaded, Root-form implant | Threaded, Root-form implant |
| Implant Shape | Cylinder | Cylinder |
| Implant Body Diameter | 3.5mm, 4.3mm, 5.0mm, 6.0mm | 3.7mm, 4.1mm, 4.7mm, 6.0mm |
| Implant Length | 8mm, 10mm, 12mm, 14mm | 10.0mm, 11.5mm, 13.0mm, 16.0mm |
| Outer Thread | 0.136 - 0.140 | (Information not provided in table for predicate) |
The "acceptance criteria" here are that the subject device's characteristics and performance testing results are comparable to the predicates and meet the established guidance standards for dental implants, demonstrating that it is as safe and effective.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is "non-clinical testing," which typically refers to benchtop mechanical tests or material characterization rather than human subject trials. Therefore, concepts like "test set" in the context of patient data, data provenance, or retrospective/prospective studies are not applicable.
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)
This is not applicable. The device is a physical dental implant, not a diagnostic AI/ML device requiring expert-labeled medical images for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. As above, there is no "test set" in the context of expert adjudication for diagnostic accuracy.
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
This is not applicable. This is a physical medical device (dental implant), not an AI/ML software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This is a physical medical device (dental implant), not an AI/ML software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical device like a dental implant, "ground truth" refers to its physical, mechanical, and biological properties meeting established standards and performance expectations. The document indicates:
- "Non clinical Testing was performed following 'Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.'" This guidance document essentially defines the "ground truth" or standard for performance.
- "Surface analysis was conducted on the final device. SEM photographs confirm that all residue of blasting material had been removed from the treated implant surface, and the surface chemical analysis confirmed that no contaminants remained on the surface." This refers to chemical and microscopy analysis.
- The reliance on "sterility, shelf life and biocompatibility testing performed on previous cleared Sterngold devices" based on the subject device having the "same sterilization process and radiation dose, same shelf life and biocompatibility." This means previous testing results and established biological safety are the "ground truth."
8. The sample size for the training set
This is not applicable. This is a physical medical device (dental implant), not an AI/ML software device that relies on a "training set."
9. How the ground truth for the training set was established
This is not applicable. As above, there is no "training set" for device performance in this context.
§ 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.