(103 days)
The Atlas Implant System - Mini Plus is intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
The Atlas Implant System - Mini Plus is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
The provided text describes the "Atlas Implant System - Mini Plus" dental implant. The performance data section states:
"All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, mechanical testing of the implants demonstrated that the Atlas Implant System - Mini Plus possess mechanical strength at least equivalent to the predicate devices."
This sentence indicates that the acceptance criteria for the device's performance are based on mechanical strength at least equivalent to the predicate devices, as determined by mechanical testing consistent with the referenced FDA guidance document. The study proving this involved mechanical testing of the Atlas Implant System - Mini Plus.
However, the provided document does not contain the specific details required for the table or other requested information. It functions as a summary of a 510(k) submission, confirming substantial equivalence, but it does not include the raw data, specific test results, detailed acceptance limits, or methodological specifics of the performance study beyond the type of test (mechanical) and the comparison to predicate devices.
Therefore, many of the requested fields cannot be accurately populated from the provided text.
Here's how much of the information can be extracted or inferred based on common 510(k) practices for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (based on text) | Reported Device Performance (based on text) |
|---|---|---|
| Mechanical Strength | At least equivalent to the predicate devices (Intermezzo™ Implant System (K051018), IMTEC Sendax MDI and MDI Plus (K031106), Maximus™ OS Implant (K041938)). | Possesses mechanical strength at least equivalent to the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. Mechanical testing for dental implants typically involves a statistically relevant number of samples to ensure robust results, but the exact number is not included in this summary.
- Data Provenance: Not specified, but likely from laboratory testing conducted by or for the manufacturer (Cowellmedi Co., Ltd.). Origin country (South Korea) could be inferred for where the manufacturer is located, but not explicitly for the test data itself. Retrospective or prospective is not applicable for this type of mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the "ground truth" for mechanical testing is based on objective physical measurements and engineering standards, not expert clinical assessment.
4. Adjudication method for the test set
- This question is not applicable for mechanical testing. Adjudication is used for subjective assessments, typically in clinical studies or image interpretations.
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
- This question is not applicable. The device is a physical dental implant, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical dental implant, not an algorithm.
7. The type of ground truth used
- For mechanical testing, the "ground truth" is established by objective physical measurements against predefined engineering standards and comparison with established performance of predicate devices, following the FDA guidance. It is not based on expert consensus, pathology, or outcomes data in the usual sense for this type of performance evaluation.
8. The sample size for the training set
- This question is not applicable as the device is a physical dental implant, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as above.
Summary of what can be definitively stated from the text:
- Acceptance Criteria: Mechanical strength at least equivalent to predicate devices.
- Study Type: Mechanical testing of implants.
- Proof: The mechanical testing demonstrated the device possesses mechanical strength at least equivalent to the predicate devices.
- Predicate Devices: Intermezzo™ Implant System (K051018), IMTEC Sendax MDI and MDI Plus (K031106), Maximus™ OS Implant (K041938).
- Guidance Followed: FDA guidance document "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004."
The document focuses on establishing substantial equivalence to legally marketed predicate devices, which is common for 510(k) submissions. It confirms that the necessary performance data (in this case, mechanical testing) was provided and met the standards for equivalence, but it does not detail the specifics of that data as would be found in a full study report.
§ 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.