(83 days)
The S-mini active Fixture is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
S-mini active Fixture is one body type mini implant which will be placed in the alveolar bone to replace the function of the missing tooth. It is made of Ti-6Al-4V ELI based on ASTM F136. The surface treatment of device is SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The feature of S-mini active fixture is one body implant which has thread body design include cutting edge for self-tapping. The fixtures' diameters and lengths are available as: Ø 2.5 mm (D) X 8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.0 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L), Ø 3.5 mm (D) X 7.0/8.5/10.0/ 11.5/13.0/15.0mm (L). Tolerance of dimension shall be within ± 1% range. S-mini active Fixture is provided sterilized.
The provided text is a 510(k) summary for the "S-mini active Fixture," an endosseous dental implant. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this document does not describe a study that proves the device meets specific acceptance criteria based on performance metrics like sensitivity, specificity, or human reader improvement with AI assistance. This is because the device in question is a dental implant, a physical medical device, not a software or AI-based diagnostic tool.
Therefore, many of the requested points in your prompt are not applicable to the information contained within this document. The "acceptance criteria" here refers to demonstrating substantial equivalence to a predicate device based on material, design, sterilization, and non-clinical bench testing.
Here's how the provided information relates to your request, with an emphasis on what's not applicable:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria for a 510(k) for a physical device like a dental implant are primarily centered around demonstrating "substantial equivalence" to a predicate device, as opposed to performance metrics like sensitivity or specificity for a diagnostic algorithm.
The document states:
- "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device."
- "Performance testing has been finished to ensure the devices comply with the applicable International and US FDA Guidance."
Acceptance Criteria (Implicit from Non-Clinical Testing):
The device must meet the criteria of the following standards and tests, demonstrating bio-compatibility, structural integrity, and durability:
| Test / Standard | Acceptance Criteria (Implied: Met Standard) | Reported Device Performance (Implied: Passed) |
|---|---|---|
| Biocompatibility testing (ISO 10993 series) | Requirements for biocompatibility (e.g., non-cytotoxic, non-irritating, non-sensitizing, non-hemolytic, non-genotoxic, non-toxic) | "demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device" |
| Bench testing (visual, dimension, compressive, fatigue, adaptation accuracy, torque) | Specific engineering tolerances and performance thresholds for each test (e.g., dimensions within ±1% range, specific load-bearing capabilities, resistance to fatigue) | "The results of the above tests have met the criteria of the standards" |
| Fatigue Testing (ISO 14801:2007) | Withstand specified cycles/loads under worst-case scenario without failure | "performed... under the worst-case scenario" and implied successful completion ("met the criteria") |
| Bacterial Endotoxin Test (ANSI/AAMI ST72:2011, USP) | Endotoxin levels below specified limits to ensure sterility and prevent pyrogenic reactions | "met the criteria of the standards" |
| Sterilization Validation | Ensured sterility with a specified Sterility Assurance Level (SAL) per relevant standards. | "demonstrates the sterilization... safety of the subject device" |
| Shelf Life Testing | Maintained integrity and sterility over the declared shelf life (5 years). | "demonstrates the... packing validation safety of the subject device" |
| SLA Surface Assessment (SEM, Chem Analysis) | Surface characteristics (morphology, chemical composition) comparable to predicate or established standards. | "exactly same for the subject device" as reference predicate (K120503) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of patient data. The "test set" here refers to the number of physical devices tested in the non-clinical bench studies (e.g., how many implants were used for fatigue testing), which is not specified.
- Data Provenance: The tests are non-clinical, meaning they are laboratory/bench tests, not studies on human patients. The manufacture is located in South Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes a physical medical device (dental implant), not an AI or diagnostic software. Therefore, there is no "ground truth" in the diagnostic sense, nor experts interpreting images or data for a test set. The "truth" is established through engineering and biological testing against predefined standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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 physical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical device.
7. The type of ground truth used:
- Not Applicable in the context of diagnostic AI. For this physical device, "ground truth" is defined by established engineering standards (e.g., ISO, ASTM, ANSI, USP) and the physical properties and performance characteristics demonstrated by the predicate devices. For instance, the "ground truth" for biocompatibility is defined by meeting the criteria of the ISO 10993 series.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning model.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" and thus no "ground truth" establishment process for one.
§ 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.