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510(k) Data Aggregation
(84 days)
QUANTUM DENTAL IMPLANT SYSTEM
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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(269 days)
QUANTUM DENTAL IMPLANT SYSTEM
Quantum™ Dental Implant System implants are intended for immediate or delayed placement in the bone of the maxillary or mandibular arch. Quantum Dental Implant System abutments are intended for use as support for crowns, bridges or overdentures. When a one-stage surgical approach is applied, threaded implant 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, or when using any 5 mm or 6 mm length implant.
The Quantum Dental Implant System includes root form, endosseous dental implants with internal Morse taper and external hex abutment interfaces. The implants are made of titanium alloy with three surface options (RBM, acid etch, HA coated), and are provided in both threaded and a grooved (fin-type) designs. There are four sizes of the internal Morse taper (implant well), designated as the 2.0, 2.5, 2.75, and 3.0 Series. For all series, the threaded and fin-type implant designs are each provided in the following sizes: diameters of 4.5, 5.0, 5.5, and 6.0 mm, with each diameter in lengths of 5, 6, 9, 11, and 14 mm. The 2.0 Series of the threaded and fin-tvpe implant designs also include: 4.0 mm diameter in 5 and 6 mm lengths, 8.0 mm diameter implants in 5 and 14 mm lengths, and 5.0 mm diameter available only in lengths of 5 and 6 mm. The 2.5 Series of the threaded and fin-type implant designs also include 4.0 mm diameter in lengths of 5, 6, 9, 11, and 14 mm.
Abutments for cement-retained prostheses are provided for each diameter implant. All abutments are made of titanium alloy. Abutments with a Morse taper interface are provided for all implant series in straight, 15° and 25° angled designs. The 2.0 Series Morse taper abutments are provided in 5 mm and 7 mm platforms; all other Series are provided in 3.5, 4, and 5 mm platforms. External hex interface abutments are provided for the 2.5. 2.75. and 3.0 Series implants in straight, 15° and 25° angled designs. The 2.5 Series hex abutments are 4 mm platform; the 2.75 and 3.0 Series hex abutments are 4.5 mm platform. Healing plugs are provided for each implant series in titanium alloy and polyethylene.
The Quantum™ Dental Implant System is a medical device and its 510(k) summary does not contain information typically found in a study for AI/Software as a Medical Device (SaMD) products. Therefore, the questions related to AI/SaMD specific criteria, such as acceptance criteria based on performance metrics, ground truth establishment for algorithms, and human-in-the-loop studies, cannot be fully answered from the provided document.
This submission is for a traditional dental implant system, and its "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical testing, rather than performance metrics of an AI algorithm.
However, I can extract information regarding the non-clinical testing performed to establish substantial equivalence.
1. A table of acceptance criteria and the reported device performance
Since this is a dental implant system (a hardware device), the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices. The performance criteria are therefore related to mechanical and physical properties rather than diagnostic accuracy.
| Acceptance Criteria (based on predicate device equivalence) | Reported Device Performance (as demonstrated by non-clinical testing) |
|---|---|
| Same intended use | The device has the same intended use as the predicate devices: immediate or delayed placement in the bone of the maxillary or mandibular arch, and abutments for support of crowns, bridges, or overdentures. |
| Same technological characteristics | The device has the same technological characteristics (design principles, implant and abutment dimensions, materials (titanium alloy), and surface options (RBM, acid etch, HA coated)) as the predicate devices. |
| Same range of physical dimensions | The device encompasses the same range of physical dimensions for implants (diameter and length) and abutments (diameter, height, and angulation) as the predicate devices. Specifically, the subject device implant largest diameter and shortest lengths are the same as predicates K092035, K050712, K010185 and K101732. |
| Same materials and surface options | The subject device implant and abutment designs, materials, and surfaces are the same as predicates K011223, K002241 and K991250. This includes titanium alloy for implants and abutments, and RBM, acid etch, and HA coated surface options. |
| Similar packaging and sterilization methods | The subject device and predicate devices are packaged in similar materials and sterilized using similar methods, or provided nonsterile to be sterilized using similar methods. |
| Mechanical strength and durability | Detailed engineering analysis, dimensional analysis, surface area and bone-to-implant contact area analysis, and static and dynamic compression-bending testing according to ISO 14801 were conducted and provided or referenced to demonstrate substantial equivalence. These tests would demonstrate that the Quantum™ Dental Implant System meets the mechanical requirements for dental implants, similar to the predicate devices. [Specific numerical performance values from these tests are not provided in the summary.] |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a premarket notification (510(k)) for a medical device (dental implant system), not an AI/SaMD product. Therefore, the concept of "test set" in the context of an algorithm's performance data does not apply here. The "testing" refers to non-clinical laboratory tests.
- Sample size for testing: Not specified in terms of number of devices tested, but the non-clinical tests mentioned are: "detailed engineering analysis, dimensional analysis, surface area and bone-to-implant contact area analysis, and static and dynamic compression-bending testing according to ISO 14801." These are laboratory-based tests typically conducted on a representative sample of finalized devices.
- Data provenance: Not applicable in the context of clinical data for AI/SaMD. The non-clinical testing would have been conducted by the manufacturer or a contracted testing facility.
3. 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 is not applicable to this 510(k) submission. "Ground truth" in this context would refer to objective measurements and standard test methods (e.g., ISO 14801) for evaluating the physical and mechanical properties of the dental implants, rather than expert consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/SaMD datasets where expert disagreement needs to be resolved. This document focuses on non-clinical engineering and material equivalence.
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
Not applicable. This is a conventional medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and the concept of "human readers" and "AI assistance" do not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or software.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" or reference for evaluating performance would be recognized ASTM or ISO standards (specifically ISO 14801 for static and dynamic compression-bending testing), engineering specifications, and established material properties for titanium alloys. These are objective, scientifically defined standards, not subjective expert consensus or clinical outcomes data.
8. The sample size for the training set
Not applicable. There is no software algorithm or AI model being trained for this device.
9. How the ground truth for the training set was established
Not applicable. There is no software algorithm or AI model being trained for this device.
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