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Indications for Use for iPhysio® Profile Designer:

iPhysio® System Profile Designers are indicated to be placed in the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The healing abutments should be used only with comections. The healing abutments are intended for use up to 6 months.

Compatible Implant Systems:

Indications for Use for iPhysio® PEEK Temporary Abutment:

The iPhysio® System PEEK Temporary Abutment is an abutment placed on the iPhysio® System Profile Designer to provide support for prosthetic structures for up to 6 months. It can be used in single- or two-stage procedures and is intended to be placed out of occlusion.

The iPhysio® System is a set of two-piece titanium healing abutments (iPhysio® Profile Designers) be screwed into the implant using compatible anodized titanium screws during the 1st or the 2nd surgical intervention. The iPhysio® Profile Designer abutment is manufactured from titanium alloy (Ti-6Al-4V ELI) per ISO 5832-3 and includes a zirconium nitride (ZrN) coating. iPhysio® Profile Designers are available in multiples anatomical shapes and gingival heights, and are compatible with Nobel BioCare (NobelActive®, NobelReplace®, NobelParallel™), Straumann (Bone Level / Bone Level Tapered), and Zimmer Biomet (Trabecular Metal, Tapered Screw-Vent®) implants. All iPhysio® Profile Designers are straight (0°). Supporting screws are manufactured from titanium alloy (Ti-6Al-4V ELI) per ISO 5832-3 and are anodized to a color that aligns with its corresponding height. The iPhysio® Profile Designer healing abutment screw is for placing the iPhysio® Profile Designer in the implant in the patient's mouth.

The iPhysio® Profile Designer remains in place throughout the bone and gingival healing process as well as during the taking of a digital or conventional impression, preserving the emergence profile during the impression. The abutment is only removed once to place and finally screw in the final abutment. Anatomical healing, implant impression, and placement of the temporary crown may all be done without removing the iPhysio® Profile Designer.

A compatible PEEK temporary abutment may be clipped to the iPhysio® Profile Designer to which a non-load bearing temporary crown may be then placed for improved aesthetics during healing. To use the PEEK temporary abutment, the iPhysio® Profile Designer healing abutment screw is replaced with a compatible temporary abutment screw. The temporary crown is placed over the PEEK temporary abutment following modification of the abutment to the appropriate shape. The PEEK temporary abutment is connected onto the iPhysio® Profile Designer by a combination of friction and cement. All iPhysio® temporary abutments are manufactured from PEEK per ASTM F2026.

This document is part of a 510(k) summary for a medical device called "iPhysio® System." It details the comparison of the subject device to predicate devices to establish substantial equivalence, which is a key requirement for FDA clearance. The document focuses on non-clinical performance testing rather than studies involving human data or AI.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided directly from this document as it pertains to clinical performance and AI algorithm validation, which are not the primary focus of this 510(k) submission for this specific type of dental device.

However, I can extract the information related to acceptance criteria for the non-clinical performance testing and the reported results:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Testing)

Note: The document explicitly states "Device met all predetermined acceptance criteria" or "Coating met all predetermined acceptance criteria" for several tests, which implies the acceptance criteria were established prior to testing and the device successfully met them. The specific numerical or qualitative thresholds for these criteria are not detailed in this summary for each test but are generally understood to align with relevant international standards (e.g., ISO 14801 for fatigue).

The following points cannot be answered from the provided text, as this is a 510(k) summary for a dental implant accessory, primarily relying on non-clinical (bench) testing and substantial equivalence arguments, rather than clinical trials or AI/image analysis studies.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. The "tests" referred to are non-clinical bench tests (e.g., mechanical fatigue, material characterization), not clinical studies with human patient data. Sample sizes would refer to the number of physical device units tested for each non-clinical performance test. Data provenance in this context would be the lab where the bench tests were performed, which is not specified.

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 / Not provided. Ground truth, in the context of diagnostic AI or clinical studies, refers to disease labels or interpretations. For non-clinical bench testing, the "ground truth" is adherence to established engineering standards and material properties, validated by testing methodologies. No human experts are establishing "ground truth" in the clinical sense for these types of tests.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable / Not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations in clinical or imaging studies. This document describes bench testing, where outcomes are determined by physical measurements and adherence to engineering standards.

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

• No. This document explicitly states: "No clinical data was included in this submission." Therefore, no MRMC study or AI assistance evaluation was performed as part of this submission. The device (dental healing abutment) does not involve AI.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No. As noted above, this device is a physical dental implant component, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable / Not provided. For this submission, which relies on non-clinical testing, the "ground truth" is adherence to established engineering specifications, material standards (e.g., ISO 5832-3 for titanium alloy, ASTM F2026 for PEEK), and performance test methods (e.g., ISO 14801 for fatigue testing).

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

• Not applicable. This device does not involve machine learning or a "training set."

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The device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.

Euroteknika's range of implants refer to sets of root form endosseous dental implants made of pure titanium (grade iv) and titanium alloy (TA6V) and components for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in endentulous or partially edentulous patients.

Here's an analysis of the provided text regarding the dental implants' acceptance criteria and study, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for K083670 is a 510(k) summary for dental implants. 510(k) submissions primarily focus on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria for novel device functions like an AI algorithm. Therefore, explicit, quantitative acceptance criteria and corresponding performance metrics are not present in the provided document.

Instead, the "performance" demonstrated is that the Euroteknika dental implants (AESTHETICA, UNIVERSAL, NATURA, NATEA) were found to be substantially equivalent to their listed predicate devices. This equivalence is based on:

• Identical Intended Use: All devices share the same intended use: "surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients."
• Similar Design and Material: The devices are described as "sets of root form endosseous dental implants made of pure titanium (grade iv) and titanium alloy (TA6V) and components for surgical placement." This description aligns with the common materials and forms for dental implants, implicitly similar to the predicate devices.
• Laboratory Testing: The document states, "Laboratory testing was conducted to determine device functionality and conformance to design requirements." While the specific tests and their passing criteria are not detailed, the conclusion drawn is that the devices are "Substantially equivalent to the cited predicate devices."

Therefore, the "acceptance criteria" is implicitly that the new devices perform comparably to predicate devices in terms of safety and effectiveness for their intended use, as demonstrated through laboratory testing.

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

The document does not describe a "test set" in the context of an AI algorithm or a clinical study with a specific patient sample size. The testing mentioned is "Laboratory testing" for functionality and conformance. Therefore, there is no information provided regarding a sample size for a test set, data provenance (country of origin, retrospective/prospective), or any human subject data.

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

Since this is not an AI or diagnostic device requiring human interpretation for a "ground truth" test set, there is no information provided regarding the number or qualifications of experts for establishing ground truth.

4. Adjudication Method for the Test Set

As there is no "test set" or human subject data requiring adjudication, there is no information provided regarding an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or reported. This submission is for a medical device (dental implant), not a diagnostic or AI-driven imaging device that would typically involve an MRMC study. Therefore, no effect size for human reader improvement with AI assistance is applicable or provided.

6. Standalone (Algorithm Only) Performance Study

This device is a physical dental implant, not an algorithm. Therefore, no standalone algorithm performance study was conducted or reported.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI or diagnostic studies (e.g., pathology, expert consensus) does not apply to this submission. The "truth" for this device rests on its physical and mechanical properties demonstrated through laboratory testing and engineering principles, showing it functions as intended and is comparable to existing, legally marketed devices.

8. Sample Size for the Training Set

This submission is for a physical medical device, not an AI algorithm. Therefore, there is no "training set" or sample size mentioned in the context of machine learning.

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

As there is no training set mentioned (this being a physical device), this question is not applicable.

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Surgical placement in mandibular arch to support overdentures in edentulous patients.

A set of root form endosseous dental implants and components for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in endentulous or partially edentulous patients.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary and FDA clearance letter for the OBI dental implant, which establishes substantial equivalence to predicate devices based on laboratory testing for functionality and design conformance.

Therefore, I am unable to provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not present. The text only mentions "Laboratory testing" without details on sample size or data origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study with ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
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. The device is a dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The testing was described as "Laboratory testing... to determine device functionality and conformance to design requirements."
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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