(119 days)
Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients.
Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options.
The devices covered by this submission are Atlas Fixtures, and Atlas Shoulder Abutments which are placed into dental implant to provide support for prosthetic reconstruction.
The non-hexa-shoulder abutment is designed for single crown use only. The hexa-shoulder abutment is designed for bridge use only
Allfim Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous which dostyled in the more and Atlas Fixtures and Atlas Shoulder Abutments) consists of two-stage, root-form dental implants, associated abutment systems, which provide the clinician with cement-retained, screw-retained and overdenture-type restorative options. The devices covered by this submission are Atlas Fixtures, and Atlas Shoulder Abutments which are placed into dental implant to provide support for prosthetic reconstruction.
The provided text is a 510(K) summary for a medical device (Allfim Implant Systems) seeking FDA clearance. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, expert evaluations, or specific statistical results as would be found in a clinical trial report.
Therefore, most of the requested information cannot be extracted from this document. The submission explicitly states:
"10-8. Performance: Laboratory testing was conducted to determine device functionality and conformance to design input requirements."
This indicates that internal laboratory testing was performed, but no specific data, acceptance criteria, or a detailed study report for these tests are included in this 510(K) summary. The summary's primary purpose is to compare the new device to existing, legally marketed predicate devices to assure safety and effectiveness, rather than to present novel performance data from human or extensive standalone studies.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided based on the input. The document states "Laboratory testing was conducted to determine device functionality and conformance to design input requirements" but does not specify what those requirements or acceptance criteria were, nor does it report any specific performance metrics or outcomes from such testing.
2. Sample size used for the test set and the data provenance:
- Cannot be provided based on the input. No sample sizes for a test set are mentioned, and no specific data provenance (country of origin, retrospective/prospective) is detailed for any performance evaluation. The document refers to "laboratory testing," which typically does not involve patient data or independent test sets in the way clinical studies do.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided based on the input. No mention of experts or ground truth establishment relevant to a test set's performance evaluation is present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided based on the input. No adjudication method is described as there is no detailed test set analysis.
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:
- Cannot be provided based on the input. This device is an endosseous dental implant system, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Cannot be provided based on the input. This device is a physical implant system, not an algorithm, so a standalone performance test in this context is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided based on the input. No ground truth is described in the context of performance testing as would be relevant for devices that generate diagnostic outputs. The "performance" mentioned is about device functionality and conformance to design requirements, likely assessed through engineering and mechanical tests.
8. The sample size for the training set:
- Cannot be provided based on the input. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Cannot be provided based on the input. Not applicable (see point 8).
Summary of available information regarding acceptance criteria and study:
The 510(K) submission for the Allfim Implant Systems primarily relies on substantial equivalence to predicate devices (BIOPLANT Implant Systems (K041655) and Branemark Systems (K925777, K925779, K961728, K971706)).
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Acceptance Criteria & Reported Performance:
- The document states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements."
- It implicitly accepts that if the device performs functionally and conforms to design requirements (likely mechanical and material properties similar to predicate devices), then it is substantially equivalent.
- No specific quantitative acceptance criteria or performance metrics (e.g., fracture resistance in Newtons, fatigue life cycles) are reported in this summary. The "performance" is demonstrated by its similarity in design and materials ("threaded, root form implants constructed of titanium with roughened surfaces") to devices already on the market.
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The Study (or lack thereof):
- The "study" cited is "Laboratory testing."
- No details are provided about this laboratory testing, such as specific protocols, results, or comparison against predefined acceptance criteria.
- The core of this 510(K) is the Substantial Equivalence Comparison, arguing that because "Allfim Implant Systems (Atlas Fixtures and Atlas Shoulder Abutment Systems) and predicate implants share a substantially equivalent intended use" and are "similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with roughened surfaces," "no new questions of safety or effectiveness have been raised for the Implant system."
In essence, for this type of device and 510(k) submission, the "study" demonstrating that the device meets "acceptance criteria" is largely implied through its similarity to already cleared devices, supported by general statements about internal laboratory testing. Detailed direct human performance data or specific quantitative acceptance criteria and results are not typically required or provided in such a summary unless a significant new technological characteristic is introduced that deviates from known predicates.
§ 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.