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IDCAM Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients esthetics and chewing function. IDCAM implants are intended for single or multiple unit restorations on splinted applications. They are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period.

The ID CAM Dental Implant is a tapered conical implant system with two designs. IDCAM M (with mini-threads), and IDCAM ST. IDCAM ST has large flat threads at the top and sharp threads at the bottom and comes in diameters of 3.7, 3.9, 4.2 and 5.2 mm. Lengths of 9.4, 11.4, and 14.4 mm are available. The IDCAM M has mini-threads at the top and with sharp threads below. It comes in 4.2, and 5.2 mm diameter with lengths of 8.5,9.4, 11.4, and 14.4mm. The bottom of both IDCAM designs is convex.

All implants and abutments are made of ASTM F136 Ti 6Al 4V ELI. The implants have a grit blasted and acid etched surface.

ID CAM abutments for single unit restorations are all attached by Morse taper fit as well as a screw. Morse taper cone straight abutments come in 3.6 and 4.2mm diameter with gingival heights of 1.4, 3, and 5mm. Morse taper cone shouldered straight abutments come in 5.4mm diameter at the upper platform with a 3.6mm diameter at the platform and gingival heights of 1.3, 2.2, 3.2, and 5mm. Morse taper angled cone abutments come in 7°, 15°, and 23° angles in diameters of 3.6 and 4.2 and gingival heights of 1.4 (7° only) or 1.63 (15° and 23°), 3, and 5mm. Morse taper angled cones abutments with shoulder come in 7°, 15°, and 23° angles in a diameter of 5.4 at the upper platform with a 3.6mm diameter at platform bottom and gingival heights of 0.9, 3, and 5mm in 7°, and gingival heights of 0.9, 2.35, 3.30, and 5.03mm in 15°, and 23°.

PLAN abutments in 5.4mm diameter at shoulder top with a 3.6mm diameter at shoulder bottom and come in gingival heights of 1.5 and 3mm and there are straight, 15°, and 23° versions. Plan abutments can be used for single or multiple unit restorations but are not used for removable prostheses.

Straight IDUnit abutments, angled IDUnit abutments, IDLoc abutments, and ball attachments are permanent threaded abutments which are for multi-restorations only. IDLOC is 3.6mm diameter at platform and comes in gingival heights of 2.5, and 7.5 mm. Ball attachments are in 3.5 diameter and come in gingival heights of 1, 2.5, 4, or 6mm. Straight IDUnits are in 3.6mm diameter with 4.9mm diameter at top of shoulder and come in gingival heights of 1, 2.5, 4 or 6 mm. 17° angled IDUnits come in 3.6mm diameter with 4.9mm diameter at top of shoulder and in a gingival heights of 1.35,3.02 or 5 mm. 30° angled IDUnits come in 3.6mm diameter with a 4.9mm diameter at top of shoulder and in a gingival heights of 1,3.01 or 5 mm. Straight and angled IDUnit mounted dentures can only be removed by the dentures mounted on IDLoc or ball attachments can be removed by the patient.

Provisory abutments are temporary use abutments which allow placement of a temporary restoration. These come in 3.6mm diameter and varieties of nonrotational (4.8mm diameter at top of shoulder, gingival height of 1.5mm and post height of 7.5mm), nonrotational tall (4mm diameter at top of shoulder, gingival height of 1.5mm and post height of 12.5mm), rotational (gingival height of 1.5mm and post height of 7.5mm) and provisory IDUnit (4.9mm diameter at the base and a post height of 10.5mm).

Healing caps are temporary use abutments used during the healing phase which come in different gingival heights shapes in order to account for tissue thickness differences and space differences. Cylindrical shape healing caps come in diameters of 3.2mm with heights of 3.5 and 5mm, 4 & 5 mm with heights of 2, 4, 6, and 8mm. Conical profile healing caps come in 3.6mm diameter at the platform with a 6mm cone top diameter and 4mm gingival height, or a 3.6mm diameter at platform with a 6mm cone top diameter and gingival height of 6mm. There is also a healing cap for the IDUnit.

This document is a 510(k) Premarket Notification summary for the IDCAM Dental Implants. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria based on clinical outcomes or AI performance.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/device performance study are not applicable to this type of regulatory submission for a dental implant.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with numerical performance data in the way you'd expect for an AI or diagnostic device assessing clinical outcomes (e.g., sensitivity, specificity).
Instead, it demonstrates substantial equivalence to predicate devices for a physical implant. The "acceptance criteria" here are more about meeting recognized standards and being comparable to legally marketed devices.

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical images. For mechanical testing (like ISO 14801), the sample sizes would be a small number of physical implant components tested in a lab, not patient data. These details are typically in a separate test report, not summarized in the 510(k) summary itself.
• Data Provenance: The data comes from in-vitro (lab-based) physical and chemical testing of the device components, not from clinical studies on patients. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context refers to the defined properties of the materials and the performance under standardized mechanical tests, not clinical diagnoses made by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this relates to expert review of clinical data, which was not the basis of this submission.

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 is a medical device (dental implant), not an AI diagnostic software. No human reader studies were conducted or required for this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is established by:

• Adherence to recognized international standards (e.g., ISO 14801 for fatigue testing, ISO 10993-5 for cytotoxicity, ISO 11137 for sterilization).
• Material specifications (ASTM F136).
• Comparison to the established, legally marketed predicate device's characteristics and performance under these same standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not applicable.

Summary of the Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" in this context is a series of engineering and biocompatibility tests designed to demonstrate that the IDCAM Dental Implants are substantially equivalent to a legally marketed predicate device (SpiralTech Dental Implant System Ultimate Conical K170372, and reference predicates Cortex K090709 and K163385).

• Objective: To show that the new device is as safe and effective as the predicate device, and does not raise new questions of safety or effectiveness.
• Methodology:
  • Indications for Use Comparison: The Indications for Use statement for IDCAM Dental Implants was compared directly to that of the predicate device and found to be "same."
  • Material Comparison: The device material (ASTM F136 Ti 6Al 4V ELI) was confirmed to be identical to the predicate device. Biocompatibility testing per ISO 10993-5 was performed.
  • Design Comparison: Detailed design specifications (diameters, lengths, connections, screw types, abutments, etc.) were compared. Minor differences in specific sizes were acknowledged but deemed not to change substantial equivalence given similar use, materials, and technology.
  • Performance Testing (In-Vitro):
    • Dynamic fatigue testing according to ISO 14801: This standard evaluates the endurance limit of endosseous dental implants under cyclic loading. The reported performance was that IDCAM implants "exhibited a run out limit equivalent to other implant systems," specifically comparable to the predicate.
    • Surface Modification Information: Provided per FDA Guidance Document for Endosseous Dental Implants and Abutments.
    • Sterilization Validation: Conducted per ISO 11137-1,-2,and -3 for implants and ISO 17665-2 and ANSI/AAMI ST79 for abutments.
    • Package Integrity Testing and Accelerated Aging: Per ISO 11607-1 and -2.
    • Endotoxin Testing: Per USP 161.
• Conclusion: Based on these comparisons and performance tests demonstrating equivalence in indications for use, materials, design, and fatigue performance, the FDA determined that the IDCAM Dental Implants are substantially equivalent to the predicate device.

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