(231 days)
S.I.N. Dental Implant System Zygomatic implants are intended for placement in the maxillary arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System Zygomatic implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The purpose of this submission is to add components to the S.I.N. Dental Implant System. This submission includes zygomatic dental implants, mating abutments for screw-retained, multi-unit prostheses, and the corresponding abutment screws.
The subject device Zygomatic Plus Morse Taper implants have a body diameter of 4.0 mm that tapers to 1.65 mm at the apex. The implants have a Morse taper ("CM") abutment interface connection, with an internal 16° cone taper. The abutment platform is 4.0 mm. All implants are threaded starting at the apex and extending approximately 17 mm in the coronal direction, with a major thread diameter of 4 mm; the thread tapers over the final 6 mm of the implant to the apex. The implants are provided with overall lengths of 30, 32.5, 35, 37.5, 40, 42.5, 45, 47.5, 50, 52.5, 57.5, and 60 mm. The surface of all subject device implants is acid-etched from the implant platform to the apex, followed by application of a hydroxyapatite coating (HA nano).
The subject device abutments are multi-unit, indexed abutments for use only with the subject device Zygomatic Plus Morse Taper implants for maxillary full-arch restorations. The subject device abutments have a prosthetic platform diameter of 4.8 mm, and gingival heights of 2 mm and 3 mm. The prosthetic post is angled 45° to the long axis of the implant. These components are used with subject device abutment and prosthetic screws, or previously cleared screws.
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. All implants have an acid-etched HA1200 surface treatment, identical to that cleared in K200992. All subject device abutments are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F136. All subject device implants, abutments, and abutment screws are provided sterile to the end user.
I am sorry, but based on the provided text, I cannot provide a comprehensive description of the acceptance criteria and the study that proves the device meets them, as requested. The document is an FDA 510(k) summary for a dental implant system. While it mentions performance data, it primarily focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a full study report of the subject device's performance against those criteria.
Here's why I cannot fulfill each requested point:
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A table of acceptance criteria and the reported device performance: The document does not explicitly state acceptance criteria for the new device in a quantifiable way beyond citing compliance with standards like ISO 11137-1, ISO 11137-2, ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119, ASTM F67, and ASTM F136. It mentions mechanical testing was done "to demonstrate that the subject device abutments... have sufficient strength for the intended use," but it doesn't provide specific numerical acceptance limits or the reported performance values against them.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text states "Non-clinical data provided in this submission...mechanical testing conducted using a method modified from ISO 14801 and engineering analysis," but it does not specify the sample size used for this mechanical testing. There is no information about data provenance (country of origin, retrospective/prospective). No clinical data was included in this submission.
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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): This information is not relevant to the type of non-clinical, mechanical, and sterilization testing described in the document. No expert review of a "test set" in the context of clinical interpretation or diagnosis is mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no expert "test set" for clinical evaluation is mentioned.
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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. The device is a dental implant system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a dental implant system, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here would be the physical properties and performance characteristics determined by established engineering and sterilization standards (e.g., sterility assurance level, mechanical strength, biocompatibility, MR compatibility). These are not expert consensus in a clinical sense, pathology, or outcomes data.
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The sample size for the training set: Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
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How the ground truth for the training set was established: Not applicable, for the same reason as point 8.
The document focuses on demonstrating that the S.I.N. Dental Implant System (specifically the new zygomatic implants and abutments) is substantially equivalent to legally marketed predicate devices through non-clinical data, including:
- Gamma irradiation sterilization validation.
- Mechanical testing (modified from ISO 14801).
- MR compatibility testing (referenced from K222231 and standards ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119).
- Sterile barrier shelf life data (referenced from K203725).
- Biocompatibility data (referenced from K200992 and standards ASTM F67, ASTM F136).
The substantial equivalence argument highlights similarities in indications for use, design principles, materials, manufacturing, sterilization, and shelf life to various predicate and reference devices. However, it does not provide detailed acceptance criteria and specific performance results for the subject device beyond qualitative statements like "sufficient strength."
§ 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.