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510(k) Data Aggregation
(84 days)
Quantum™ Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implants may be immediately loaded when good primary stability is achieved and the functional load is appropriate. Delayed loading is required when using the push-in technique for fin-type or threaded implants. The Ø3.0 mm Quantum Dental Implant is limited to replacement of maxillary lateral incisors and mandibular central and lateral incisors.
The Quantum Dental Implant System implants included in this submission are root form, endosseous dental implants with a Morse taper and external hex abutment interface. They are made of titanisous alloy, with three surface options. Implants are provided in both a threaded and a grooved (fin-ype) design. The implants are 3.0 mm in diameter and are available in four lengths (8, 9, 11, & 14 m(1)
Here's an analysis of the provided text regarding the Quantum™ Dental Implant System, focusing on acceptance criteria and the study that proves the device meets them:
Acceptance Criteria and Device Performance for Quantum™ Dental Implant System (K130787)
This 510(k) summary for the Quantum™ Dental Implant System (K130787) focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel safety and effectiveness criteria through
a de novo clinical study with specific acceptance thresholds. As such, the "acceptance criteria" are primarily defined by the performance of the predicate devices and the relevant ISO standard for dental implants.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Quantum™ Dental Implant System) |
|---|---|---|
| Functional Equivalence | Same intended use as predicate devices. | "has the same intended use." This is explicitly stated and supported by the "Indications for Use" which mirrors that of predicate devices. |
| Technological Equivalence | Same operating principles, basic design, and materials as predicate devices. Similar packaging and sterilization processes. | "uses the same operating principle," "incorporates the same basic design," "incorporates the same or very similar materials," and "has similar packaging and is sterilized using the same materials and processes." |
| Physical Dimensions & Characteristics | Encompasses same range of physical dimensions and characteristics as predicate devices. | "The subject device and the predicate devices encompass the same range of physial dimensions and characteristics, including implant diameter, length, and surface traatment." |
| Mechanical Performance (Static and Dynamic) | Meets or exceeds the static and dynamic compression-bending requirements of ISO 14801, demonstrating equivalence to predicate devices. | "Performance testing is provided to demonstrate substantial equivalence and includes static and dynamic compression-bending testing according to ISO 14801. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above." |
| Safety and Efficacy Equivalence | Differences in technological characteristics do not raise new issues of safety or efficacy. | "Any differences in the technological characteristics between the subject device and the predicate devices do not raise new issues of safety or efficacy." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a sample size for a clinical "test set" or human subjects. The performance testing referenced is bench testing for mechanical properties.
- Data Provenance: The data provenance for the performance testing is in vitro (bench test), conducted according to ISO 14801. There is no information regarding country of origin for any human data, as none was used directly for this submission to demonstrate substantial equivalence. The study is not a retrospective or prospective human study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This question is not applicable to this 510(k) summary. The "ground truth" for the mechanical performance testing (static and dynamic compression-bending) is established by the ISO 14801 standard itself and the measured physical properties of the device and predicate devices, not by expert consensus on clinical outcomes or diagnoses.
4. Adjudication Method for the Test Set
- This question is not applicable for the reasons stated above. There was no "test set" involving human data or expert review requiring an adjudication method.
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
- No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a dental implant, a physical medical device, not an AI-powered diagnostic or interpretive tool. Therefore, the concept of human readers improving with AI assistance is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone (algorithm-only) performance study was not done. This is a physical dental implant, not a software algorithm.
7. The type of ground truth used
- The primary "ground truth" used for demonstrating equivalence in this 510(k) submission is:
- Mechanical properties benchmarks defined by the ISO 14801 standard for dental implants (static and dynamic compression-bending).
- Design specifications and materials that are comparable to legally marketed predicate devices.
- Intended Use comparison to predicate devices.
8. The sample size for the training set
- This question is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device. The device's design, manufacturing, and testing inform its performance, not a training set of data.
9. How the ground truth for the training set was established
- This question is not applicable as there was no training set for an algorithm. The "ground truth" for the device's development was based on established engineering principles, biocompatibility requirements for titanium alloys, and the design parameters of existing, legally marketed dental implants.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a bench test (in vitro) performance study conducted according to ISO 14801. This study assessed the static and dynamic compression-bending strength of the Quantum™ Dental Implant System. The results from this testing demonstrated that the device's mechanical properties were substantially equivalent to those of the identified predicate devices, which themselves meet the safety and effectiveness standards for dental implants. The 510(k) did not rely on clinical trials or human data, but rather on direct comparison of technological characteristics and recognized performance standards for physical properties.
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