(78 days)
CAMLOG Implant System Abutments are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch.
This submission covers a series of abutments for the CAMLOG Implant System, including a straight crown and bridge abutment, a prepable abutment, a conical abutment, a cast-on abutment, and a temporary abutment.
This 510(k) summary for the CAMLOG Implant System Abutments is a submission for a new medical device seeking clearance based on substantial equivalence to an existing predicate device. As such, it does not contain specific acceptance criteria and a study demonstrating the device meets those criteria in the way one would expect for a de novo submission or a clinical trial report.
Instead, the primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. The "study" mentioned here is the comparison made by the manufacturer to establish this equivalence.
Here's an breakdown based on the provided document, addressing the requested points:
Acceptance Criteria and Device Performance (in the context of a 510(k) submission)
This document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies against specific acceptance criteria for new device functions. The "acceptance criteria" implicitly revolve around meeting the design principles and indications for use of the predicate devices.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion (Implicit for 510(k)) | Reported Device Performance (as stated in submission) |
|---|---|
| Indications for Use Equivalence | "CAMLOG Implant System Abutments are intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the maxillary and/or mandibular arch." (Matches predicate indications) |
| Design Principles Equivalence | "Altatec GmbH demonstrated that... CAMLOG Implant System Abutments are substantially equivalent in... design principles to predicate devices..." |
| Material Equivalence (Implied) | Not explicitly stated in this summary, but would be part of the substantial equivalence documentation. |
| Biocompatibility (Implied) | Not explicitly stated in this summary, but would be part of the substantial equivalence documentation. |
| Mechanical Performance (Implied) | Not explicitly stated in this summary, but would be part of the substantial equivalence documentation (e.g., fatigue strength, retention). |
Study Details (Relevant to 510(k) Substantial Equivalence)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set: For a 510(k) based on substantial equivalence for a device like this, there isn't typically a "test set" of patient data in the clinical trial sense. The "test" is a comparison of the new device's specifications (design, materials, indications for use, performance data from bench testing if applicable) against those of the predicate device(s). The document doesn't provide details on specific bench tests or "test set" sizes for clinical performance.
- Data Provenance: Not applicable in the context of clinical patient data for this type of submission. The data would primarily be engineering specifications and potentially bench test results.
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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. "Ground truth" in the sense of clinical expert consensus would not be established for a 510(k) substantial equivalence submission for mechanical dental abutments. The assessment is made by the manufacturer and reviewed by the FDA based on documented comparisons to predicate devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no clinical adjudication method described for a "test set" in this 510(k) submission.
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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 abutment, not an AI/software device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical dental implant abutment, not an AI/software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the clinical sense. The "ground truth" for a 510(k) is the established safety and effectiveness of the legally marketed predicate devices, against which the new device is compared. This is based on regulatory standards and previous FDA clearances.
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The sample size for the training set:
- Not applicable. Training sets are relevant for AI/machine learning algorithms. This device is a physical medical device.
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How the ground truth for the training set was established:
- Not applicable. (See #7).
Summary of the "Study" for this 510(k) Submission:
The "study" that proves this device meets the "acceptance criteria" (i.e., substantial equivalence) is the comparison report submitted by Altatec GmbH to the FDA. This report would detail:
- Comparison of Indications for Use: Showing they are identical or very similar.
- Comparison of Technological Characteristics: This would include design, materials, dimensions, manufacturing processes, and possibly results from non-clinical performance testing (e.g., mechanical strength, fatigue, biocompatibility testing if new materials are used or if a new combination of materials is present).
- Performance Data: Presenting any bench testing or engineering analysis demonstrating that the new device performs as safely and effectively as the predicate devices under intended use conditions.
The document states: "Altatec GmbH demonstrated that, for the purposes of FDA's regulation of medical devices, CAMLOG Implant System Abutments are substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices." This sentence is the core "proof" summarized in this public document, with the full details residing in the confidential 510(k) submission.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)