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510(k) Data Aggregation
(238 days)
The implant for dental purposes, used to replace missing dental organs (teeth). The implant is self-tapping (threads) and is screwed into a pilot bore formed in the jawbone. Upon healing, the implant receives a post, which has a stem, and is adapted to carry dental suprastructures (false teeth).
The B.A.S.I.C. Dental Implant is an endosseous dental implant. The implant, healing cap and healing screws will now be provided in a sterilized medical grade Tyvek® pouches in accordance with ISO 11137 (SAL 10to). In addition, implants are now provided in diameter of 6.0 mm and lengths of 8.0 mm and 9.0 mm to provide a wider range of options for the dental professional.
The provided text is a 510(k) summary for the B.A.S.I.C. Dental Implant System. It describes modifications to an existing device rather than a new device that requires a comprehensive clinical study with acceptance criteria and a detailed study report. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics is not explicitly available in this document.
However, based on the context of a 510(k) submission, the "acceptance criteria" are implied to be substantial equivalence to a predicate device, meaning the modified device performs as safely and effectively as a legally marketed device and does not raise new questions of safety or effectiveness. The "study" proving this is primarily a comparison to predicate devices and adherence to relevant standards, rather than a clinical trial with performance targets.
Here's an attempt to answer the questions based on the provided text, recognizing the limitations of a 510(k) summary for device modification:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for device modifications aiming for substantial equivalence rather than a new device with specific performance claims from a clinical trial, the "acceptance criteria" are primarily met through comparison to predicate devices and adherence to standards.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance and Evidence (from 510(k) Summary) |
|---|---|
| No change in Intended Use (Safety & Effectiveness maintained for original purpose) | "The intended use is identical to the predicate device." |
| No alteration of fundamental scientific technology | "Per FDA-CDRH criteria for a Special 510(k), the modifications do not affect the intended use or alter the fundamental scientific technology of the device..." |
| Equivalent technological characteristics (despite modifications) | The updated specifications (new diameters and lengths, sterilized components) are deemed substantially equivalent or improvements, as detailed in the comparison tables. |
| No new health risks posed by modifications | "Risk analysis which includes health risks related to root form endosseous dental implants... An FMEA report is included in Attachment 9." |
| "The dimensional specification changes do not pose any new health risks to the patient as there are other cleared products on the market with similar dimensions." | |
| Sterilization effectiveness (for new sterilized components) | "B.A.S.I.C. Dental Implant Systems, Inc. has contracted with Steris Isomedix Service to establish and maintain a valid gamma-ray sterilization processes in accordance with ISO 11137 (SAL 10⁻⁶)... Substantiation of a routine sterilization dose was established using the VDmax's method, described in ISO 11137." |
| Biocompatibility maintained (as material is unchanged) | "Material of Implants: CP Titanium" (unchanged). This implies continued biocompatibility of the material. |
| Device integrity and functionality maintained (post-sterilization, new dimensions) | "Device integrity and functionality were qualified and/or validated using samples produced under routine manufacturing conditions. The B.A.S.I.C. Dental Implant System meets B.A.S.I.C.'s in-house requirements..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a traditional clinical "test set" in the document. The "samples" referenced for sterilization and device integrity validation are "produced under routine manufacturing conditions," but the quantity is not specified.
- Data Provenance: Not applicable in the context of a clinical study. The data provenance relates to internal testing (sterilization validation, FMEA, in-house requirements) and comparison to existing market data (other cleared devices). This is retrospective in the sense of looking at existing cleared devices and standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Ground truth in this context is established by adherence to recognized standards (ISO 11137, FDA Guidance) and comparison to legally marketed predicate devices, rather than expert consensus on a specific test set.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no clinical PIVOTAL trial of read performance to adjudicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done or required for this 510(k) submission. This type of study is typically associated with new diagnostic devices or AI algorithms where human reader performance is a key outcome.
- Effect Size: N/A.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Study: No, this is not an AI/algorithm-based device. No standalone performance study in that sense was conducted or described.
7. Type of Ground Truth Used
- Ground Truth: For this device modification, the "ground truth" is established by:
- Regulatory Standards: Compliance with ISO 11137 for sterilization, and internal requirements for device integrity and functionality.
- Predicate Device Equivalence: The existence and safety/effectiveness of previously cleared devices (both the unmodified B.A.S.I.C. Dental Implant System and other manufacturers' devices) with similar dimensions and characteristics serve as the de facto "ground truth" for the new design's safety and effectiveness.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
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(256 days)
3 i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.
In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.
The Certain PREVAIL Implants are parallel walled, straight collared internally connected implants with a lateralized seating surface. They will be available in lengths of 8.5, 10.0, 11.5, 13.0 and 15mm. The diameters will be 4.0 and 5.0mm. The collar diameters will be 4.1mm for the 4.0mm diameter implants and 5.0mm for the 5.0mm implants. The seating surface will lateralize back to 3.4mm for the 4.0mm diameter implants, and 4.1mm for the 5.0mm implants. The material these devices are made out of is Titanium Alloy [Ti6A14V] per ASTM F-136.
The provided text is a 510(k) premarket notification for a medical device (Certain™ PREVAIL™ Implants). It largely focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as one would find in a clinical trial or a standalone AI/software device submission.
Therefore, much of the requested information regarding acceptance criteria, study design elements (sample size, ground truth, experts, adjudication, MRMC, standalone performance, training set details) is not present in the provided document.
However, I can extract the information that is available and highlight what is missing based on the nature of this type of submission.
Here's the breakdown of what can be inferred or explicitly stated:
Acceptance Criteria and Device Performance
This submission is a 510(k) for an implantable dental device, not a software or AI device. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence to a legally marketed predicate device (OSSEOTITE® IOL Dental Implants), rather than meeting specific numerical performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm.
The device performance is described in terms of its technological characteristics being similar to the predicate.
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (as stated in the submission) |
|---|---|
| Technological Characteristics: The device's design, materials, and intended function should be similar to the predicate device to ensure safety and effectiveness. | "The Certain™ PREVAIL™ Implants contain features Technological and functions which are similar to the currently available OSSEOTITE® IOL Implants." |
| "The material these devices are made out of is Titanium Alloy [Ti6A14V] per ASTM F-136." | |
| Indications for Use: The device should have the same indications for use as the predicate, or minor differences that do not raise new questions of safety or effectiveness. | The Indications for Use are provided and deemed substantially equivalent to the predicate, including specific details regarding immediate loading. |
| Mechanical/Physical Properties: While not explicitly detailed as acceptance criteria here, dental implants typically require demonstrating properties like strength, fatigue resistance, and biocompatibility, often through testing to established standards or comparison to predicate device data. (No specific data tables provided in this excerpt) | The device is described as "parallel walled, straight collared internally connected implants with a lateralized seating surface." It specifies available lengths, diameters, and collar diameters. |
| Conclusion of Substantial Equivalence: The FDA's ultimate agreement that the device is substantially equivalent to a legally marketed predicate. | "The Certain PREVAIL Implants are substantially Conclusion equivalent to the legally marketed OSSEOTITE® IOL Implants." (Submitter's conclusion) |
| "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." (FDA's conclusion) |
Study Details (as applicable for this type of submission)
Given this is a 510(k) for a physical implant, the concept of a "study" with test sets, ground truth, and experts as if it were an AI/software device is not directly applicable. Substantial equivalence for such devices often relies on comparisons of design, materials, manufacturing processes, and potentially non-clinical testing (e.g., mechanical, biocompatibility) rather than clinical studies in the sense of comparing performance characteristics against a ground truth dataset.
- Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance on a test set of data. The "test" is demonstrating equivalence through a comparison of device characteristics, not patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for a test set of data is established in this summary. The FDA reviewers (experts in regulatory review) assess the submission for substantial equivalence.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" in a 510(k) for a physical device is generally the established safety and effectiveness of the predicate device. The new device is compared against this standard.
- The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable.
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