(86 days)
The ERA Implant is intended for surgical placement in edentulous anterior regions of the maxiliary and/or mandibular arch to provide temporary support and permit immediate and ongoing fixation of new or existing crown and bridge applications, for full or partial dentures, with minimal invasive surgical intervention. The ERA Implant is also indicated for use as a temporary support, when placed between traditional implants to stabilize a denture during healing period, and to restore the patient's chewing function.
The Sterngold ERA Implant is a titanium Alloy threaded screw intended to have a simpler and quicker installation procedure than is currently used for conventional implants. This design will enable the physician to quickly and efficiently establish an inexpensive temporary restorative solution to patients undergoing longer-term. conventional implantation therapy. The Sterngold ERA Implant is available in 2.2 mm diameter and lengths of 10 mm. 13 mm. and 15 mm. The head features two designs - One implant featuring our ERA abutment interface with 1.2mm. 3mm. 4mm cuff heights and offers a 0°, 5°, 11°, and 17° angle abutments. The second implant with cuff heights of .76mm, 2mm, 3mm, and 4mm with no angles.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:
Based on the provided 510(k) summary for the Sterngold ERA Implant (K02/645), there is no information present regarding specific acceptance criteria, device performance metrics, or a study that explicitly demonstrates the device meets such criteria.
The submission is a Special 510(k): Abbreviated 510(k), which relies heavily on demonstrating conformity with FDA guidance and substantial equivalence to predicate devices, rather than presenting a standalone performance study with defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided documents.
Here's a breakdown of what can be inferred or stated based on the text:
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the submission. The submission states a general "Safety and Performance" conclusion, indicating that "the ERA Implant has been shown to be safe and effective for its intended use" based on "indications for use, technological characteristics, and comparison to predicate devices." This is a regulatory conclusion, not a report of specific performance metrics against defined acceptance criteria from a study.
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Sample size used for the test set and the data provenance: This information is not provided. As no specific performance study is detailed, there's no mention of a test set, its sample size, or data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. There is no mention of a test set or ground truth establishment by experts.
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Adjudication method for the test set: This information is not provided. As no test set is described, there's no mention of an adjudication method.
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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: This information is not applicable/provided. This device is an endosseous dental implant, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not applicable/provided. This device is a physical implant, not an algorithm.
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The type of ground truth used: This information is not provided. Without a specific performance study, there's no mention of ground truth (e.g., pathology, expert consensus, outcomes data). The basis for "safety and effectiveness" is primarily substantial equivalence to predicate devices and conformity to a guidance document.
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The sample size for the training set: This information is not applicable/provided. As this is a physical medical device and not an AI/algorithm, the concept of a "training set" in the context of machine learning is not relevant here.
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How the ground truth for the training set was established: This information is not applicable/provided for the same reasons as point 8.
In summary: The provided 510(k) summary for the ERA Implant explicitly states it is an "Abbreviated 510(k)." This regulatory pathway often relies on demonstrating conformance to recognized standards, guidance documents, and substantial equivalence to legally marketed predicate devices, rather than generating new clinical data from extensive performance studies with defined acceptance criteria in the same way a novel device might. The document does not describe a performance study with detailed acceptance criteria, sample sizes, or ground truth establishment.
§ 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.