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510(k) Data Aggregation
(167 days)
Allied Biocompat Abutment for Nobel Replace Interface
The Allied Biocompat abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prostheses in the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the Allied Dental Solutions abutment to the endosseous implant.
Allied Biocompat Abutments are compatible with the following
Implant Manufacturer: Nobel Biocare
Implant Line: Replace Select Straight and Select Straight One Stage, Replace Select Tapered one Stage
Implant Diameters: 3.5 (NP), 4.0 (RP), 5.0 (WP) and 6.0
Allied Biocompat patient-specific abutments are made from Ti-6Al-4V ELI which meets ASTM F136. Two abutment screw designs are included because the standard one does not fit the narrowest platform. The abutment is placed over the shoulder of the implant and fastened with the appropriate abutment screw. The patient-specific abutments designs share the same internal tri-lobe prosthetic interface but there are different implant platform diameters so there are 4 different diameters of abutment. The maximum angulation which can be ordered is 25°.
Allied Biocompat NB internal tri-lobe 3.5mm Allied Biocompat NB internal tri-lobe 4.0mm Allied Biocompat NB internal tri-lobe 5.0mm Allied Biocompat NB internal tri-lobe 6.0mm
These are patient-specific CAD/CAM abutments designed and fabricated under the manufacturing control of Allied Dental Solutions.
The provided text describes a 510(k) premarket notification for the "Allied Biocompat Abutment for Nobel Replace Interface." This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than outlining a study with specific acceptance criteria and detailed performance metrics for a novel medical device like an AI algorithm.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to this document. This submission is for a medical device (dental abutment) and relies on material and fatigue testing, not AI performance evaluation.
However, I can extract the available information related to the device's performance demonstration:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical targets for an AI algorithm's performance (e.g., sensitivity, specificity). Instead, it demonstrates compliance with a standard and equivalence to a predicate device.
| Test/Characteristic | Acceptance Criteria (Implied by Predicate & Standard) | Reported Device Performance (Allied Biocompat Abutments) |
|---|---|---|
| Fatigue Testing | Pass ISO 14801 (as completed by predicate) | Passed testing according to ISO 14801 |
| Fit Analysis | Abutments will fit the listed interfaces | Conducted (reverse engineering compatibility) |
| Sterilization | SAL of ≤ 10⁶ validated, Dry time validated | Validated by biological indicators overkill method |
| Biocompatibility | Cytotoxicity testing according to ISO 10993-5 | Demonstrated by testing cytotoxicity |
| Material | Meet ASTM F136 (as used by predicate) | Ti-6Al-4V ELI which meets ASTM F136 |
| Indications for Use | Substantially equivalent to predicate | Substantially equivalent (with minor stated exceptions) |
| Diameters | Compatible with predicate's diameters | 3.5, 4.3, 5, 6 (compatible with predicate) |
| Interface type/shape | NB internal tri-lobe (same as predicate) | NB internal tri-lobe (same as predicate) |
| Maximum Angulation | Patient-specific of no more than 30° (predicate) | Patient-specific of no more than 25° (smaller than predicate, but deemed acceptable) |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described (e.g., fatigue testing) would involve a sample of physical devices, but the specific number tested is not mentioned. The data provenance is laboratory testing rather than clinical data.
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. This is a physical device, and "ground truth" refers to engineering specifications and material properties, not interpretations by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical 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 is a physical device and not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device and not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on:
- Established engineering standards: ISO 14801 for fatigue testing, ASTM F136 for material specifications, ISO 10993-5 for biocompatibility.
- Predicate device characteristics: Demonstrating that the new device performs comparably to a legally marketed predicate device (Atlantis Abutments K053654 and K981858, among others) in terms of materials, design, and fatigue performance.
- Validated laboratory methods: For sterilization and fit analysis.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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