(168 days)
TSIII BA Fixture is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
TSIII BA Fixture has features of single threads, internal hex connection, taper body, and BA surface treatment. TSIII BA Fixture System is permanent dental implant made with Pure Titanium Grade 4 (ASTMF67-06). The proposed device is sandblasted, acid etched, coated with calcium phosphate by immersing and then finally coated with hydrophilic materials (glucose and NaCl with saline concentrations). Intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is supplied sterile.
This document is a 510(k) premarket notification for a medical device called the "TSIII BA Fixture," which is an endosseous dental implant. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.
Therefore, the requested information regarding detailed acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth definitions is largely not present in this document because it is not typically required for a 510(k) submission that relies on substantial equivalence.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with quantitative acceptance criteria (e.g., specific thresholds for success/failure rates, stress values, etc.) that the device must meet, nor does it present "reported device performance" in terms of clinical outcomes or performance metrics from a dedicated study. Instead, the device's characteristics are compared to those of predicate devices to establish substantial equivalence.
The table below summarizes the comparison points for substantial equivalence:
| Feature/Test | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Comparison to Predicates) |
|---|---|---|
| Biocompatibility | Materials and manufacturing processes must be biologically safe, equivalent to predicate devices. | "Biocompatibility testing on the TSIII BA Fixture was previously conducted. As the material of construction and manufacturing processes are the same as the predicate device, ETIII Bio-SA Fixture (K151626) exactly. Therefore, no additional testing is required to support the biological safety of the subject devices." |
| Sterilization Validation (Radiation) | Must achieve a Sterility Assurance Level (SAL) of $10^{-6}$. Minimum dose 25 kGy. Packaging must maintain sterility for shelf life and be stable under radiation. | "The substantiated 25 kGy sterilization dose for $10^{-6}$ SAL is accepted as the bioburden of 1.000 cfu/unit & the verification test performed by the verification dose is met the acceptance criteria. In accordance with ISO11137 VDmax 25, therefore allows use of minimum dose 25 kGy as a routine sterilizing dose. The results of the evaluation on the material stability show that the packaging materials was inherently less affected by radiation in the maximum acceptable dose 40 kGy." |
| LAL Testing (Endotoxin) | Must meet established endotoxin limits (Guidance Document: "Submission and Review of Sterility Information..."). | "LAL testing of the subject device and information per the FDA Guidance Document..." (Implicitly, the testing met the requirements, as no issues were raised.) |
| Surface Treatment Characterization | Surface treatment (BA surface) must be identical to the predicate device (ETIII Bio-SA Fixture). Manufacturing and surface treatment processes must be unchanged. | "TSIII BA Fixture has BA... surface treatment that is exactly same with the predicate devices, ETIII Bio-SA Fixture (K151626). There has been no change to the manufacturing or surface treatment processes since then; therefore, additional characterization testing is not required." |
| Fatigue Test | Material, shape, and dimension (excluding surface treatment) must be identical to the relevant predicate (TS Fixture System). | "TSIII BA Fixture is exactly same with predicate, TS Fixture System, K121995 in material, shape and dimension except surface treatment. Therefore additional Fatigue testing is not required." |
| Indication for Use | Must be substantially equivalent to predicates. | "Indication for use of subject device is almost same with Predicate devices." (Detail provided in the table on page 4). |
| Design Features (Threads, Taper, Connection) | Must be same as predicate ETIII Bio-SA Fixture System (K151626). | "Same with ETIII Bio-SA Fixture System (K151626)" (listed as Single Thread, Taper body Type, Self tapping, Submerged fixture). |
| Raw Material | Must be same as predicate ETIII Bio-SA Fixture System (K151626), Pure Titanium Grade 4 (ASTM F67-06). | "Same with ETIII Bio-SA Fixture System (K151626)" (listed as Pure Titanium Grade 4 (ASTM F67-06)). |
| Shelf Life | Must demonstrate a 5-year shelf life, validated according to ASTM F1980. | "Validation for the packaging was conducted on the TS Fixture System (K121995) according to ASTM F1980 by accelerated aging and validated a 5 year shelf life. No additional shelf-life validation was performed on the subject device." (Implies the subject device shares this validated shelf life due to identical packaging.) |
| Overall Substantial Equivalence (S.E.) | The subject device should be almost identical in shape, dimension, intended use, technological characteristics, principles of operation, connection structure, and material to the primary predicate, such that any differences do not raise new questions of safety or effectiveness. | "Subject devise, TSIII BA Fixture is almost same with Primary Predicate, ETIII Bio-SA Fixture in shape, dimension, intended for use and they have same Technological Characteristics, principles of operation, same connection structure and material And subject device and Primary predicate device. Although manufacturer of Primary predicate is different from subject device, all subject device and predicate devices are designed by OSSTEM R&D Center. Therefore, TSIII BA Fixture is substantially equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/not explicitly stated in the context of clinical or performance testing on the subject device. The document states "No clinical studies are submitted." Nonclinical tests were primarily based on equivalence to predicate devices, not on new testing of a "test set" of the subject device in the way a clinical trial would. For sterilization, bioburden was 1.000 cfu/unit; for packaging validation, the predicate device was tested.
- Data Provenance: The document does not specify data provenance in terms of country of origin for any "test set" data for the subject device, as most testing was waived or referenced predicate devices.
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)
Not applicable. No clinical or performance studies requiring ground truth from experts for a "test set" of the subject device were submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No studies requiring adjudication by experts were submitted.
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 device is a dental implant, 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 device is a dental implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No new clinical or performance studies requiring ground truth for the subject device were submitted. The basis for approval is substantial equivalence to legally marketed devices, verified through nonclinical tests where applicable (e.g., sterilization dose verification, biocompatibility, LAL testing, material and design comparisons).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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.