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PerioType Rapid Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients for loading after healing or immediate loading provided that stability requirements are satisfied.

PerioType Rapid Implants are threaded, root-form dental implants

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental implant device called "Periotype Rapid." This document does not contain information about acceptance criteria, device performance, study details for a test set, ground truth for training or testing, or a multi-reader multi-case comparative effectiveness study. It primarily focuses on the device's substantial equivalence to predicate devices and the regulatory framework.

Therefore, I cannot extract the requested information from the given text. The text does not describe a study that proves the device meets specific acceptance criteria in the context of AI/ML performance metrics.

The document states:

• Trade/Device Name: Periotype Rapid
• Regulation Number: 21 CFR 872.3640
• Regulation Name: Endosseous Dental Implant
• Regulatory Class: Class II
• Product Code: DZE
• Indications for Use: PerioType Rapid Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients for loading after healing or immediate loading provided that stability requirements are satisfied.

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PerioType X-Pert Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients. PerioType X-Pert Dental Implant Systems are indicated for delayed loading.

The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction with the PerioType. X-Pert dental implant fixture to aid in prosthetic rehabilitation.

PerioType X-Pert Implants are threaded, root-form dental implants intended for use in the upper and lower jaw to support prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function to partially or fully edentulous patients. PerioType X-Pert Dental Implant Systems are indicated for delayed loading. The Dental Implant System has an internal octagonal connection between the implant and the abutment. The surface structure of the implant is PerioCoat-R which allows for osseointegration of the implants that is substantially equivalent to the TilUnite surface from Nobel Biocare. The Dental Implants and the abutments are made of Titanium Grade 4. The PerioType X-Pert features an implant-abutment interface with a tapered tight metal fit and an integrated platform switch. The abutments are coated with ZircoSeal™ - a hard coating layer of zirconium nitride. The implants are provided sterile, with sterility achieved by gamma radiation pursuant to ISO 11137.

The PerioType X-Pert Abutments are straight and angled dental implant Abutments to be used in conjunction with the PerioType X-Pert dental implant fixture to aid in prosthetic rehabilitation.

The provided text describes a 510(k) premarket notification for the PerioType X-Pert dental implant system. This application focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo performance criteria typically seen in clinical trials for new medical devices.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical performance study with specific endpoints and ground truth determinations, as might be expected for an AI/ML device, does not directly apply here. Instead, the study's goal is to show that the new device is as safe and effective as existing legally marketed predicate devices.

The document highlights the PerioType X-Pert's characteristics and compares them to predicate devices, primarily the Nobel Biocare NOBELSPEEDY Implants (K050406) for the implant and Nobel Estehtik Abutments (K111581) and other Branemark System abutments for the abutments.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission, the "acceptance criteria" are not explicit performance metrics for the device itself against a clinical gold standard. Instead, the acceptance criteria are implicit in demonstrating that the new device is as safe and effective as the predicate devices. The "reported device performance" is primarily a comparison of materials, design, intended use, and mechanical testing results to assert this equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

• Implants: The document mentions "direct comparative test between the device and the predicate device" for the surface coating and "mechanical tests" and "Endolab Fatigue test for endosseus dental implants in accordance with the ISO 14801" for performance.
  • The sample size for these tests is not explicitly stated in the provided text (e.g., number of implant samples tested for fatigue). It only refers to appendices (A22-A25 for fatigue, A42 for surface coating).
  • Data Provenance: The tests appear to be conducted by the manufacturer or their designated testing facilities (e.g., "Meyer&Horn-Salmondelkin Gbr" laboratory for surface, "Endolab" for fatigue). The nature of the tests (mechanical, chemical, morphological) implies a retrospective laboratory testing environment rather than a prospective clinical study involving human patients. The country of origin for the testing is not specified, though the manufacturer is in Switzerland.
• Abutments: Mention of tests "quested by the Guidance of Modified surfaces" and biocompatibility testing to ISO 7405. No specific sample sizes for these tests are provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

For a 510(k) submission based on substantial equivalence and mechanical testing, the concept of "ground truth" established by experts in a clinical context (like radiologists for image analysis) is not directly applicable.

• For the surface coating comparison, the "Meyer&Horn-Salmondelkin Gbr" laboratory is mentioned as having judged "morphological and chemical view points." The specific number and qualifications of the experts within this laboratory are not detailed in the provided text.
• For mechanical testing (fatigue), the "Endolab" entity is mentioned. Again, the specific number and qualifications of experts overseeing or performing these tests are not provided.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies involving interpretation of data (e.g., medical images, pathology slides) by multiple human readers, which is not the type of study described here. The studies involve laboratory-based comparisons and mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance on various cases, which is irrelevant for a submission concerning dental implants where the primary goal is substantial equivalence through material properties and mechanical performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone (algorithm-only) performance study was not done. This device is a physical dental implant system, not a software algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established through laboratory-based analytical and mechanical testing methodologies, comparing the new device's properties directly against those of the predicate device.

• Material Composition: Chemical analysis and material specifications (Titanium Grade 4).
• Surface Morphology/Chemistry: Morphological and chemical examinations performed by the "Meyer&Horn-Salmondelkin Gbr" laboratory.
• Biocompatibility: Conformance to ISO 7405 standards.
• Mechanical Performance: Fatigue testing according to ISO 14801.

8. The Sample Size for the Training Set:

Not applicable. As this is not an AI/ML device, there is no "training set" in the sense of data used to train an algorithm. The testing described focuses on evaluating the physical and mechanical properties of the device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable for the same reason as above.

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