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The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment.

The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment. The physical properties and designs of the additional implants and accessories in the NSI Hexed and Non-Hexed Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable.

The provided text is a 510(k) Premarket Notification Summary for a dental implant system. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data with specific acceptance criteria as you might see for a novel drug or a high-risk device.

Based on the document, here's an analysis of the requested information:

1. A table of acceptance criteria and the reported device performance

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

The document primarily discusses engineering studies (fatigue testing). It does not specify a "test set" in the context of human subjects or clinical data.

• Sample Size: Not specified for engineering studies, but typically these involve a defined number of devices tested to destruction or specific load cycles.
• Data Provenance: Not applicable in the context of clinical data for this submission. The engineering studies were conducted under ISO standards, implying a controlled laboratory environment.

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 510(k) submission did not involve clinical studies or expert-driven ground truth establishment in the way you'd expect for an AI diagnostic device. The evaluation relied on engineering testing and comparison to predicate devices, which is typically overseen by engineers and regulatory specialists.

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

Not applicable. No clinical test set or expert adjudication process was performed for this 510(k) submission.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "Brief Discussion of Clinical Studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." This device is a physical implant, not an AI-assisted diagnostic tool.

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

No, a standalone performance study was not done. This device is a physical implant, not an algorithm.

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

The concept of "ground truth" as it relates to expert consensus or pathology is not applicable here. The primary "truth" established for this device was:

• Material properties: Measured against ASTM standards.
• Mechanical performance: Measured against ISO 14801:2003 (E) for fatigue, demonstrating physical stability.
• Technological characteristics and intended use: Established by comparison to existing legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This submission is for a physical medical device (dental implant) and does not involve AI or machine learning models that require a training set.

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

Not applicable. As above, no training set was used.

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The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The NSI MAX Implant System is intended for implantation in the maxilla or mandibular molar region where bone exists and the surgeon has determined a wider implant would increase the probability of placement of a narrow implant, or increased surgical procedures leading to complications. This MAX implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It also adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The provided document is a 510(k) premarket notification for an Endosseous Dental Implant System. It does not describe acceptance criteria for an AI-powered device, nor does it detail a study proving such a device meets acceptance criteria.

Instead, this document focuses on demonstrating substantial equivalence of a dental implant system to previously marketed predicate devices. Key aspects covered are:

• Device Description and Intended Use: The NSI Implant System for supporting dental prostheses in the upper or lower jaw, with an option for immediate loading.
• Performance Standards: There is no FDA performance standard for endosseous implants. The materials used meet applicable voluntary standards (ASTM F67-95 Grade III or IV Titanium).
• Sterilization Methods: Achieved using Co60 irradiation, validated against ISO 11137, ISO 11737-2, and ISO 13409.
• Packaging Method and Validation: Packaging involves plastic tubing, blister packs, and clear plastic boxes, validated against various ASTM, EN, and ISO standards related to performance testing, seal strength, leak detection, accelerated aging, and general requirements for sterile medical device packaging.
• Technological Characteristics: Compared with predicate devices and found to be comparable.
• Surface Modifications: Blasted with 100 micron alumina particles, with visual inspection and SEM testing.
• Clinical Studies: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." This explicitly states that no clinical performance study was performed or considered necessary to establish substantial equivalence for this particular submission.

Therefore, since the request is about an AI-powered device and the provided document describes a physical medical device (dental implant) and explicitly states no clinical studies were conducted, I cannot provide the requested information about acceptance criteria and a study proving an AI device's performance based on this document.

The document does not contain any information about:

• Acceptance criteria for an AI device.
• Reported device performance for an AI device.
• Sample size for a test set or data provenance for an AI device.
• Number of experts or their qualifications for establishing ground truth for an AI device.
• Adjudication methods for an AI device's test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone AI algorithm performance.
• Type of ground truth used for AI.
• Sample size or ground truth establishment for a training set for AI.

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The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The 4.0 co-axis implant is not intended, nor should it be used, in conjunction with an angled abutment.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Endosseous Dental Implant System (K070841).

It's important to note that this document is a 510(k) Premarket Notification Summary, which focuses on demonstrating substantial equivalence to a predicate device rather than strictly proving performance against pre-defined acceptance criteria through a clinical trial. Therefore, the "acceptance criteria" here are generally related to compliance with standards and demonstration of comparable performance to predicate devices, rather than specific sensitivity/specificity metrics.

Acceptance Criteria and Reported Device Performance

The submission relies on demonstrating substantial equivalence to previously cleared predicate devices and adherence to relevant standards for manufacturing, sterilization, and packaging. There are no explicit performance metrics in the format of sensitivity, specificity, accuracy, etc., as would be found for a diagnostic device.

Study Details

This 510(k) submission states explicitly that clinical studies were not conducted or deemed necessary. The "study" here refers primarily to engineering bench tests and comparisons to predicate devices and standards.

1. Sample size used for the test set and the data provenance:

   • Test Set (Engineering Studies): The document mentions "sample implant is sent for SEM testing four times a year" for surface evaluation. For fatigue testing, it states "Modification to the testing protocol was discussed with the FDA prior to conducting the test (Enclosure 8 Appendix B). Testing revealed a stable screw joint at the highest forces tested (Enclosure 8)." The exact number of implants tested for fatigue is not specified in the provided text, but it implies a representative sample.
   • Data Provenance: The engineering studies (fatigue, surface analysis) were conducted internally or by a contracted lab as part of the manufacturing and submission process. The submission does not specify a country of origin beyond the submitter's address (Fairfax, VA, USA). The studies are by nature prospective as they are conducted for the specific purpose of this submission or as part of ongoing quality control.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the typical sense. For engineering tests like fatigue, the "ground truth" is the established pass/fail criteria of the test method itself, which is based on an FDA guidance document. For material composition and sterilization, the ground truth is adherence to the specified ASTM/ISO/EN standards.
   • Visual Inspection/SEM: Manufacturing protocol includes visual inspection by trained personnel, and SEM testing is conducted by qualified lab personnel.

3. Adjudication method for the test set:

   • Not applicable as this is not a study requiring human reader consensus for "ground truth". The "adjudication" is compliance with engineering and quality standards.

4. 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 type of study is not relevant for an endosseous dental implant system, as it is not an imaging or diagnostic AI device.

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

   • No. This is not an algorithm-based device.

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

   • The "ground truth" for this device's evaluation is primarily compliance with established engineering standards (ASTM, ISO, EN), FDA guidance documents for mechanical testing, and material specifications. For surface characteristics, it involves direct physical measurement and visual/SEM verification against internal specifications and biocompatibility principles.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this device, as it is not an AI/machine learning product.

8. How the ground truth for the training set was established:

   • Not applicable. See above.

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The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prosteses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The NSI Implant System is intended to the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary for an endosseous dental implant system, and it primarily focuses on describing the device, its intended use, and establishing substantial equivalence to predicate devices. It does not contain details about performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

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The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

This 510(k) submission (K053478) for the NSI Hexed and Non-Hexed Endosseous Implant System did not include a study or defined acceptance criteria related to device performance in an AI/software context. This submission is for an endosseous dental implant system, which is a physical medical device, not an AI or software-based device.

The "acceptance criteria" and "device performance" in this context refer to the physical and manufacturing properties of the dental implants, as well as their sterilization and packaging. There are no performance metrics like sensitivity, specificity, or accuracy that would be associated with AI/software devices.

Here's a breakdown of the information provided in the context of a physical device submission:

1. A table of acceptance criteria and the reported device performance

The submission details specific standards that the device and its manufacturing processes meet, rather than specific numerical performance metrics in the way one would describe AI.

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. This submission explicitly states: "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." Therefore, there is no "test set" in the context of clinical performance data or AI evaluation. The "data" refers to the results of testing against the physical/manufacturing standards mentioned in point 1. These tests are typically performed in a laboratory setting by the manufacturer.

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. As no clinical studies or AI evaluations were conducted, there was no need for experts to establish ground truth in this context. The "ground truth" for the physical device relates to its adherence to material, manufacturing, sterilization, and packaging standards, which are verified through established engineering and quality control procedures.

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

• Not Applicable. No clinical studies or AI evaluations were performed.

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 dental implant, not an AI or imaging device that would involve human readers.

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

• Not Applicable. This device is an implant, not an algorithm.

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

• Not Applicable (in the AI/clinical sense). The "ground truth" for this device's acceptance is its compliance with established engineering, material, sterilization, and packaging standards (e.g., ASTM, ISO standards) and its substantial equivalence to predicate devices. This is verified through laboratory testing and documentation, not clinical outcomes or expert consensus on interpretations of data.

8. The sample size for the training set

• Not Applicable. No AI or machine learning model was developed or trained for this device.

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

• Not Applicable. As no AI training occurred, no ground truth for a training set was established.

Summary:

This 510(k) submission is for a physical medical device (dental implants). The "acceptance criteria" and "study" described in the document relate to the manufacturing process, materials, sterilization, and packaging of the implants, rather than clinical performance studies or AI/software validation. The claim for substantial equivalence is based on the device's similar technological characteristics and intended use to legally marketed predicate devices, and its compliance with relevant voluntary industry standards for materials, sterilization validation, and packaging. No clinical studies were conducted or deemed necessary for this particular submission.

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The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

This implant is not intended, nor should it be used, in conjunction with an angled abutment.

The NSI Implant System is intended in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

This implant is not intended, nor should it be used, in conjunction with an angled abutment.

The provided text is a 510(k) Premarket Notification Summary for an Endosseous Dental Implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel devices.

Therefore, many of the requested sections (e.g., acceptance criteria, detailed study design with sample sizes, expert ground truth, MRMC studies) are not applicable in this context. The document explicitly states that "Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission."

However, I can extract information related to what was conducted and what the overall conclusion implies regarding its "acceptance."

Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

• N/A: Clinical studies were not conducted. The "test set" for this submission primarily consisted of the engineering tests (fatigue and torsion) performed on the new device iterations. The sample size for these engineering tests is not specified in this summary. Data provenance is not applicable as there are no human subject 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)

• N/A: Clinical studies were not conducted, so there was no "ground truth" derived from expert review of patient data in the context of this 510(k) submission. For the engineering tests, the "ground truth" is established by the accepted standards and protocols for mechanical testing.

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

• N/A: No clinical studies were performed requiring adjudication of results from human subjects.

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

• N/A: This is for an endosseous dental implant, not an AI-powered diagnostic device. No comparative effectiveness studies involving human readers or AI assistance were conducted.

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

• N/A: This is not an algorithm or AI device.

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

• For the substantive equivalence claim: The "ground truth" is the established safety and effectiveness of the predicate devices and the accepted engineering standards (ASTM F67-95, FDA Class II Special Controls Guidance Document) for material and mechanical performance.
• For engineering studies: The "ground truth" is defined by the passing criteria of the specific fatigue and torsion tests, derived from the FDA guidance and discussions with the FDA.

8. The sample size for the training set

• N/A: No clinical studies were conducted, and this is not a machine learning device that requires a "training set."

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

• N/A: No clinical studies were conducted, and this is not a machine learning device.

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The Atlantis Abutment is intended for use as an accessory to 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 prosthesis, in the mandible or maxilla. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented restorations. The Atlantis™ Abutments for 3i Certain™ Implant and abutment screws are made from Titanium grade Ti-6A1-4V ELI (Meets ASTM Standard F-136). The abutment is placed over the implant shoulder and is mounted into the implant with a screw. The abutments are compatible with 3i Certain Standard Implants with 4.1mm, 5.0mm, 6.0mm diameters; the OSSEOTITE® XP Certain Implants with 5.0mm and 6.0mm diameters; and the OSSEOTITE® NT® Certain™ Implants with 4.0mm, 5.0mm and 6.0mm diameters.

The provided text describes a 510(k) premarket notification for a medical device called the Atlantis™ Abutment for 3i Certain™ Implant. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

Therefore, the document does not contain information regarding:

• Acceptance criteria and reported device performance in a table. The summary focuses on equivalence to a predicate device rather than specific performance metrics against pre-defined acceptance criteria.
• A study that proves the device meets acceptance criteria. No specific study design, methodology, or results are presented that would demonstrate the device meeting particular performance targets.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document focuses on:

• Device Identification: Trade Name, Common Name, Classification Name, Regulation Number, Product Code.
• Predicate Device: Identification of the legally marketed device to which equivalence is claimed.
• Description of the Device: Material used (Titanium grade Ti-6A1-4V ELI), compatibility with various implant diameters, and its function as an abutment and abutment screw.
• Intended Use: As an accessory to an endosseous implant to support a prosthetic reconstruction in partially or completely edentulous patients, supporting single and multiple tooth prostheses in the mandible or maxilla, with cement-retained prostheses.
• Basis for Substantial Equivalence: Stating that the device is substantially equivalent in intended use, material, design, and performance to the predicate device cleared under K981858.
• Regulatory Outcome: FDA's determination of substantial equivalence, allowing the device to be marketed.

In summary, this document is a regulatory submission demonstrating equivalence, not a clinical or performance study report with specific acceptance criteria and detailed study results. Therefore, it does not provide the information requested in the prompt regarding acceptance criteria, study details, and ground truth establishment.

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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. As with the predicate devices, the subject device is indicated for use in areas with available bone, including posterior regions with sufficient transverse bone and limited vertical bone height.

The ITI Wide Diameter Implant is a one-stage root-form design made of commercially pure titanium Grade 4 conforming to ASTM Standard Specification F67. It differs from the previously cleared 11 4.1 mm Solid Screw Implant (K894595, K920769) only in the diameter. The portion of the implant intended to be implanted into bone has an anchorage surface of a titanium plasma-sprayed coating 20 - 30 um thick. The neck of the implant, intended to remain above the crest of the bone upon implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. It is 2.8 mm in height and tapers to 4.8 mm in diameter at the coronal end to permit all standard 171 The abutment mates with a tapered internal cone of the abutments to be used. implant; at its apex is a threaded region into which the matching thread of the The implant shoulder, which forms a mating surface for abutment is screwed. prosthetic components, is machined with a 45° chamter to maximize prosthesis The diameter at the coronal end, the internal taper, and thread for stability. attachment of the abutment and the 45° chamfer are identical to those of the 177 4.1 mm Solid Screw Implant.

For the junction between the primary part (the implant) and the secondary part (the abutment), a cone-screw construction is used, which helps ensure an accurate marginal tit within the implant, reducing risk of loosening or rotation of the abutment. All ITI abutments have a tapered cone-to-screw base which screws into the coronal portion of the implant and creates a mechanically locking triction fit (similar to Morse taper, a principle that has been used in machine shops for many years).

The external shape of the ITI Wide Diameter Implant consists of a solid body of 4.95 mm diameter with an external spiral screw having a major diameter of 5.6 mm. The principal teature of the thread form is the fact that the compressive (flank) songce of the thread is oriented at 75° to the implant axis, directing compressive forces into gre bone, rather than parallel to the implant axis. The thread pitch and thread form are identical to those of the ITI 4.1 mm Solid Screw Implant. The most apical 2 mm of the implant and the first 1.5 mm below the crest of the bone have no threads. The apex has a near-hemispherical shape. The implant is manufactured in sink depths (the depth intended to be implanted into bone, excluding the 2.8 mm neck) of 8 and 10 mm.

Accessories: The surgical technique intended for the implant includes initial use of the same IT 2.2 mm and 2.8 mm pilot drills as are used for other ITI solid screw implants, followed by The use of the standard ITI 3.5 mm twist drills of 4.2 mm and 5.0 mm and 5.0 mm diameter, included in this submission, are then used, followed by a thread tap. All IT twist drills and thread taps are made from martensitic stainless steel (DIN 1.4] 12, equivalent to AISI 440B) and include grooves to show the correct placement depth for each implant length. The depth gauge provided for use with the ITI Wide Diameter is made from austenitic stainless steel (DIN 1.4305, equivalent to AISI 303).

The provided document is a 510(k) Summary for the ITI Wide Diameter Implant. While it details the device's characteristics and compares it to predicate devices, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

The study described is a nonclinical test comparing the strength of the ITI Wide Diameter Implant to a predicate device. This is a performance test for a medical device (an implant), not a study for an AI/ML device.

Therefore, I cannot provide the requested information for an AI/ML device based on this document.

However, I can extract information about the nonclinical test described:

1. Table of Acceptance Criteria and Reported Device Performance (Nonclinical Study)

Explanation of Implied Acceptance Criteria: The stated objective of the nonclinical test was to demonstrate the substantial equivalence of the new device by showing it performs at least as well as, and in this case, better than, a predicate device specifically in terms of strength and bending. The acceptance criteria are implicitly defined as "exceeding" or being "substantially stronger than" the predicate device's performance.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The text says "Implants were imbedded..." and "Force vs. deflection curves were recorded for each test." It does not specify the number of implants or tests performed.
• Data Provenance: Not specified, but given it's a nonclinical test performed by the applicant (Straumann USA), it's likely internal lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This was a physical strength test, not an AI/ML study requiring expert ground truth for image interpretation or diagnosis.

4. Adjudication method for the test set:

• Not applicable. This was a physical strength test.

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 was a physical strength test, not an AI/ML study.

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

• Not applicable. This was a physical strength test, not an AI/ML study.

7. The type of ground truth used:

• Ground Truth: Physical measurement of failure loads and observation of failure modes during mechanical testing.

8. The sample size for the training set:

• Not applicable. This was a nonclinical performance test, not an AI/ML study involving training data.

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

• Not applicable. This was a nonclinical performance test, not an AI/ML study involving training data.

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