(336 days)
The Fin-S Orthodontic/Dental Microimplant is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. This device is intended for single use only.
The Fin-S Orthodontic/Dental Microimplant is composed of Titanium-6 Aluminum-4 Vanadium Alloy Grade 5 (ATSM F1472-08, ISO 5832-2:1999) material. It has been designed specifically for orthodontic or dental use and has a head which includes two round holes for insertion of various ligatures, coil springs, and elastomers. It also includes two rectangular slots which accept various forms of orthodontic archwires. The smaller diameter of implant, allows its insertion into many areas of the upper and lower jaws and between the roots of teeth. It is divided into four groups of various lengths. Round Head (6,8,10,12mm), Palatal (4,6,8,10mm), Reverse Thread (6,8,10,12mm), and Long Head (6,8,10,12mm). The round head design is the primary device which includes all of the design elements. The Palatal design is essentially the same as the Round Head Design, but has a shortened soft tissue collar. The Reverse Thread design is the same as the basic Round Head Design but has threads that are reversed and allow for counter-clockwise insertion. Finally, The Long Head design is the same as the basic Round Head Design, but has a lengthened soft tissue collar.
The provided text describes a 510(k) submission for the Fin-S Orthodontic/Dental Microimplant. This submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and product comparison, rather than an AI-driven device requiring extensive performance studies against acceptance criteria in the manner of diagnostic algorithms.
Therefore, many of the requested points, particularly those related to AI algorithm performance (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of device submission.
However, I can extract information related to the non-clinical testing performed and the comparison to predicate devices, which serve as the "acceptance criteria" for substantial equivalence in this context.
Here's the breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Fin-S Orthodontic/Dental Microimplant are primarily based on demonstrating substantial equivalence to predicate devices, and non-clinical testing to ensure biocompatibility and sterility.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic (ISO 10993-5:1999 and ISO 10993-12:2004) | The Fin-S Orthodontic/Dental Microimplant demonstrated to be non-cytotoxic. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-5 (ISO 17665-1, -2 for moist heat; ISO 20857 for dry heat) with overkill method | Moist heat sterilization instructions were validated to a SAL of 10^-5. Dry heat instructions were validated to a SAL of 10^-5. |
| Material | Composed of Titanium-6 Aluminum-4 Vanadium Alloy Grade 5 (ATSM F1472-08, ISO 5832-2:1999) | The device is composed of Titanium-6 Aluminum-4 Vanadium Alloy Grade 5 (ATSM F1472-08, ISO 5832-2:1999) material, matching industry standards for dental implants. |
| Intended Use | Provide a fixed anchorage point for orthodontic appliances in adolescents (>12) and adults; temporary; single use. | The intended use matches that of the predicate devices. (This is a qualitative match for substantial equivalence, not a performance metric in this context). |
| Design Dimensions | Comparable to predicate devices (Diameter, Length) | Diameter: 1.4mm (within range of predicate devices: 1.2mm-1.8mm, 1.2mm, 1.4-2.0mm, 1.8mm) |
| Length: Round Head 6mm-12mm, Palatal Head 4mm-10mm, Reverse Thread 6mm-12mm, Long Head 6mm-12mm (These ranges are comparable to predicate devices which vary from 4.0mm-12mm, 8.0mm-10mm, 6.0mm-12mm, 6.0mm-10mm). |
Study Information (as applicable to a 510(k) for a physical device)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cytotoxicity Test: "An established cell line was obtained from a recognized cell repository." The specific number of cell cultures or replicates is not stated. Data provenance is not specified beyond "recognized cell repository."
- Sterilization Test: "Bacillus atrophaeus and Geobacillus Stearothermophilus spore strips and inoculated microimplants." The specific number of strips or microimplants tested is not stated. Data provenance is not specified.
- Note: For a physical device like a microimplant, "test set" and "data provenance" typically refer to samples used in laboratory testing (biocompatibility, sterility, material characterization), not clinical data or imaging data.
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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):
- Not Applicable. The ground truth for biocompatibility (cytotoxicity) is determined by observing cell cultures under a microscope against predefined criteria, not by human expert consensus on images. The ground truth for sterility is determined by microbiological assay results (killing of specified spore organisms). For material composition and dimensions, it's objective measurement/testing.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As described above, the assessments are objective laboratory tests, not subjective interpretations requiring adjudication.
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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. This is not an AI-driven device or an imaging diagnostic device.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Biocompatibility: Microscopic examination of cell cultures for visual clues of cytotoxicity against a control culture.
- Sterilization: Microbiological testing (e.g., absence of growth from spore strips or inoculated microimplants post-sterilization).
- Material Composition & Dimensions: Laboratory analytical techniques and metrology.
- Substantial Equivalence: Comparison of device characteristics (materials, dimensions, intended use) against legally marketed predicate devices.
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The sample size for the training set:
- Not Applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set.
§ 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.