Search Results
Found 1 results
510(k) Data Aggregation
(376 days)
BLT Dental Implant Systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
The proposed devices, BLT Dental Implant Systems, are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The proposed devices can also be used for immediate or early implantation following extraction or loss of natural teeth. The proposed device contains dental implant, healing cap and abutment. The dental implant system is available in two types, NC type and RC type.
The request asks for acceptance criteria and details of the study proving these criteria are met. The provided text is a 510(k) Summary for a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of characteristics, rather than a clinical study with detailed acceptance criteria and performance metrics typically found for AI/ML devices. Therefore, much of the requested information (like effect size, ground truth, sample size for training/test sets, expert qualifications, and adjudication methods) is not applicable or unavailable from this document.
However, I can extract information related to the device's performance based on non-clinical testing and the acceptance criteria implicitly defined by compliance with recognized standards and demonstrated equivalence to the predicate device.
Here's the summary based on the provided document:
Acceptance Criteria and Study Details for BLT Dental Implant System (K212364)
The "acceptance criteria" for this device are implicitly defined by its compliance with various ISO and ASTM standards, and its demonstrated substantial equivalence to a legally marketed predicate device (K150388) and several reference devices. The "study" proving these criteria is a series of non-clinical tests and a comparison of technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit via Standards/Equivalence) | Reported Device Performance | Study that Proves this Performance |
|---|---|---|---|
| Mechanical Performance | No significant difference in dynamic fatigue performance compared to predicate device. (Aligned with ISO 14801) | "The test result does not show any significant difference." (between proposed device and predicate) | Mechanical test performed according to FDA guidance and ISO 14801. |
| Biocompatibility | Materials are biocompatible and do not cause adverse effects. (Aligned with ISO 10993 standards) | "The subject device is as safe... as the legally marketed predicate device..." as materials are identical to previously cleared device (K192274). | Leveraged prior biocompatibility testing for K192274, as materials are identical in formulation, processing, and sterilization. Formal compliance with ISO 10993-1, -5, -10, -11 mentioned. |
| Sterilization | Achieves a Sterility Assurance Level (SAL) of $10^{-6}$. Maintain package integrity. (Aligned with ISO 11137-2) | "Sterilized by irradiation to achieve a SAL of $10^{-6}$." "Vaccuum leak test and sterility test were provided to verify the package integrity." | Sterilization method validated in accordance with ISO 11137-2. Package process is the same as K150388. Complies with ISO 11137-1, ISO 11607-1, -2, ASTM D3078-02(2013), ASTM F88/F88M-15, ASTM F1886/F1886M-16, ASTM F1929-15, ASTM F2096-11. |
| Material Composition | Complies with relevant material specifications (Titanium alloys). | Made of Pure Titanium (for implant), Titanium Alloy (for abutment/healing cap). Meets ASTM F136-13, ASTM F67-13. | Chemical analysis leveraged from K150388 as surface modification is the same. Test reports for ASTM standards cited. |
| Bacterial Endotoxin | Meets bacterial endotoxin limits. | "Bacteria endotoxin limit were evaluated for the each lot device." | USP Bacterial Endotoxin Test. |
| Packaging | Packaging integrity for sterile barrier systems. | Packaging system maintains sterility. | Complies with ISO 11607-1:2019, ISO 11607-2:2019, ASTM D3078-02(2013), ASTM F88/F88M-15, ASTM F1886/F1886M-16, ASTM F1929-15, ASTM F2096-11 (Reapproved 2019), ASTM F1980-07(2011). |
| Shelf Life | 5 years. | 5 years. | (Details not explicitly stated in document, but assumed based on predicate equivalence and compliance with accelerated aging standards like ASTM F1980-07(2011) related to packaging.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific non-clinical tests. Non-clinical tests like mechanical testing (ISO 14801) typically involve a specific number of samples for destructive testing, but the exact count isn't provided in the summary.
- Data Provenance: The tests were conducted by the manufacturer, Bio Concept Co., Ltd. and leverage data from previously cleared devices where materials or processes are identical. The document does not specify the country of origin of the raw test data (e.g., where the mechanical tests were physically performed) beyond the manufacturer's location in China. The data is retrospective in the sense that prior clearance data (K192274, K150388) is referenced for aspects like biocompatibility and surface analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as this is a non-clinical submission for a physical medical device (dental implant system), not an AI/ML device relying on expert-annotated ground truth. The "ground truth" for non-clinical tests comes from physical measurements against established standards.
4. Adjudication Method for the Test Set
- Not applicable as this is a non-clinical submission for a physical medical device.
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 physical dental implant system, not an AI/ML device, so no MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for establishing device performance in this context is derived from:
- Scientific Standards: Compliance with recognized international and national standards (ISO 14801 for mechanical properties, ISO 10993 for biocompatibility, ISO 11137-2 for sterilization, ASTM standards for materials and packaging).
- Predicate Device Equivalence: Direct comparison of technological characteristics, materials, and intended use to an existing legally marketed device (K150388) and numerous reference devices.
- Laboratory Testing: Results from mechanical tests, sterilization validation, bacterial endotoxin tests, and packaging integrity tests.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Ask a specific question about this device
Page 1 of 1