(142 days)
i-Gen is a titanium bone plate device intended to stabilization and support bone grafts in dentoalveolar bony defect sites.
i-Gen is 3D Pre-Formed titanium membrane is intended for stabilizing and supporting bone graft in dento-alveolar bony defect sites. The devices are made of CP Ti Grade 2 (ASTM F67) and supplied in various sizes and shapes, non-coated, sterile, for single-use and disposable. i-Gen can be chosen according to the size and shape of bone defect. It has seven kind of buccal widths (9, 10, 11, 13, 15, 17, 22 mm) and four kind of buccal lengths (11, 15, 16, 17.5 mm). It has also four types (A B, C, D type), and three sizes (Small, Regular, Wide) for each type according to the location of the part used.
Here's an analysis of the provided text regarding the acceptance criteria and study for the i-Gen device:
It's important to note that the provided 510(k) summary is for a medical device (bone plate) and not an AI/ML (Artificial Intelligence/Machine Learning) device. Therefore, many of the typical acceptance criteria and study components associated with AI/ML systems (like those involving test sets, ground truth, expert consensus, MRMC studies, or standalone algorithm performance) are not applicable in this context.
This 510(k) focuses on demonstrating substantial equivalence to a predicate device, which is a common regulatory pathway for non-AI medical devices. The "study" described is primarily focused on non-clinical testing to ensure the device's safety and performance characteristics are similar to a previously approved device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (i-Gen) |
|---|---|---|
| Intended Use | To stabilize and support bone grafts in dento-alveolar bony defect sites. (Implicit: must match predicate device's intended use). | Matches predicate: "To stabilization and support bone grafts in dento-alveolar bony defect sites" |
| Material Composition | CP Titanium Grade 2 (ASTM F67) (Implicit: must match predicate device's material) | CP Titanium Grade 2 (ASTM F67) |
| Design Characteristics | Similar design principle (3D Pre-Formed titanium membrane), various sizes and shapes for different bone defects. (Implicit: must be comparable to predicate's design without raising new safety/effectiveness concerns). | Described as a "3D Pre-Formed titanium membrane." Has seven buccal widths (9, 10, 11, 13, 15, 17, 22 mm) and four buccal lengths (11, 15, 16, 17.5 mm). Has four types (A, B, C, D) and three sizes (Small, Regular, Wide). Considered similar in size to predicate. |
| Sterilization | Sterile for single-use. (Implicit: must achieve and maintain sterility). | Sterile for single-use. Sterilization validation performed. |
| Biocompatibility | Non-toxic, non-irritating, etc., when in contact with biological tissues. (Implicit: must meet ISO 10993-5 standards). | Biocompatibility testing (cytotoxicity in accordance with ISO 10993-5) performed. |
| Shelf Life | Maintain integrity and sterility over a specified shelf life. | 5 years. Shelf life validation performed. |
| Product Code | JEY (Bone Plate) | JEY |
| Regulatory Class | Class II | Class II |
| Overall Equivalence | Demonstrated substantial equivalence to the predicate device (Neo Titanium mesh K111761) such that no new questions of safety or effectiveness are raised. This is the overarching "acceptance criterion" for a 510(k) submission. | The submission concludes: "i-Gen has same device characteristics, material, and intended use as the predicate device, such as the Neo Titanium mesh." And "i-Gen is substantially equivalent to predicate devices as described herein." |
Study Details (Non-Clinical Testing)
Given that this is a bone plate and not an AI/ML device, the following points are addressed in the context of typical medical device regulatory submissions rather than AI/ML-specific studies:
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Sample size used for the test set and the data provenance:
- N/A (for AI/ML test sets). For physical device testing, specific sample sizes would be determined based on the testing standards (e.g., ISO, ASTM). The document states "biocompatibility testing," "sterilization validation," and "shelf life validation" were performed. These tests would involve a certain number of device samples, but the exact count isn't specified in this summary. The data provenance is from the manufacturer's internal testing as part of their regulatory submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This concept of "ground truth" established by experts for a test set is specific to performance evaluation of diagnostic or interpretive AI/ML systems. For a bone plate, performance is evaluated through physical and chemical testing against established standards, not expert interpretation of outputs.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are used in AI/ML studies to resolve discrepancies in expert ground truth labeling. This does not apply to non-clinical device testing.
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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:
- No, an MRMC study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, which is not relevant for a bone plate.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not have an "algorithm" in the AI sense. Its performance is inherent in its physical and material properties.
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The type of ground truth used:
- For the non-clinical tests, the "ground truth" would be established by compliance with recognized standards (e.g., ISO 10993-5 for biocompatibility, specific ASTM standards for material properties, and validated protocols for sterilization and shelf-life). These standards define acceptable parameters and methods for evaluating a device's performance.
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The sample size for the training set:
- N/A. This device does not use a "training set" as it is not an AI/ML system.
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How the ground truth for the training set was established:
- N/A. As there is no training set for this type of device, this question is not applicable.
Summary regarding the "study" for this device:
The "study" for the i-Gen bone plate consisted of non-clinical tests to ensure its safety and performance characteristics are equivalent to the predicate device. These tests included:
- Biocompatibility testing: Performed "in accordance with ISO 10993-5" to ensure the material is safe for contact with human tissue.
- Sterilization validation: To confirm the device can be consistently sterilized and maintain its sterility.
- Shelf life validation: To demonstrate the device remains safe and effective for its declared shelf life (5 years).
These tests are standard for implantable medical devices to demonstrate that the new device does not raise new safety or effectiveness concerns compared to a legally marketed predicate. The FDA's determination of "substantial equivalence" is based on the satisfactory completion of these types of non-clinical tests and a comparison of the device's characteristics and intended use to the predicate.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.