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The Ni2 Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller Ni2 dental implants (Ø3.6, 4.0, 5.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger Ni2 Implants (Ø6.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

The Ni2 Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The Ni2 Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations.

The Ni2 Implant System, fixtures are made of commercial pure titanium, grade 4 (ASTM F67) which have a S.L.A (Sand blasted large grit acid etched) treated surface and supplied sterile (gamma radiation). These fixtures can be used one stage surgery method or two stage surgery method. And that are surgically inserted into the upper and/or lower jawbone. The fixtures replace tooth root as providing a stable foundation for restorations.

Geometrically, the implant is screw type. An abutment is connected to the implant through a tapered joint. The Ni2 fixtures are compatible with the abutments which have been previously cleared in K221866.

The non-threaded section of the implant body is also SLA surface treated.

Here's an analysis of the provided text regarding the acceptance criteria and study proving a device meets them.

Based on the provided document (K221847 for the Ni2 Implant System), there is NO information about AI/ML device performance or associated studies.

The document is a 510(k) premarket notification for a dental implant system, and it focuses on demonstrating "substantial equivalence" to existing predicate devices through non-clinical testing. It explicitly states: "No clinical studies are submitted."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device, as the provided text pertains to a traditional medical device (dental implant).

To answer your request, if this were an AI/ML device, I would need a document that describes studies related to the AI/ML algorithm's performance.

However, I can extract information relevant to the dental implant system's equivalence, which might be mistaken for "acceptance criteria" in a broader sense within the context of a 510(k) submission.

If we interpret "acceptance criteria" as the parameters used to demonstrate substantial equivalence for this traditional dental implant device:

Here's how the document addresses the device's characteristics and how its equivalence is proven:

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

The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML algorithm (e.g., sensitivity, specificity thresholds). Instead, it demonstrates substantial equivalence by comparing the characteristics of the Ni2 Implant System to predicate and reference devices. The "performance" is implicitly deemed acceptable if it is substantially equivalent to legally marketed devices.

Here's a summary of the comparative characteristics:

Study to prove device meets the acceptance criteria (Substantial Equivalence):

The "study" refers to the non-clinical tests performed to demonstrate that the Ni2 Implant System performs as safely and effectively as, or is substantially equivalent to, legally marketed predicate devices.

2. Sample sized used for the test set and the data provenance

• Sample size: Not explicitly stated in terms of number of physical implants tested for each mechanical or material property. The document refers to "non-clinical test data" validating substantial equivalence.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would typically be a laboratory/bench-test setting.
• Retrospective or prospective: The tests appear to be prospective, performed specifically for this 510(k) submission or leveraged from prior submissions (e.g., K221866).

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

• This question is not applicable as there is no "test set" in the context of human expert review for an AI/ML algorithm. The "ground truth" for a traditional dental implant device is established through engineering specifications, material standards (ASTM, ISO), and validated test methods (e.g., fatigue testing, biocompatibility testing).

4. Adjudication method for the test set

• Not applicable as there is no "test set" requiring human adjudication in the context of an AI/ML algorithm.

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 is explicitly stated: "No clinical studies are submitted." An MRMC study is relevant for AI/ML diagnostic devices, not traditional dental implants.

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

• No. This is not an AI/ML algorithm.

7. The type of ground truth used

• For this traditional device, the "ground truth" is established by:
  • Engineering specifications and design parameters: Dimensions, tolerances, connection types.
  • Material standards: ASTM F67 (for CP Ti Grade 4).
  • Biocompatibility standards: ISO 10993-1.
  • Sterilization standards: ISO 11137-1, 2, 3.
  • Sterile barrier shelf-life standards: ASTM F1980.
  • Imaging analysis techniques: SEM (Scanning electron microscopy) and EDS (Energy Dispersive X-ray Spectroscopy) for surface characteristics.
  • Mechanical/Fatigue testing: Although specific results are not detailed, these are implied by the broad statement "non-clinical test data submitted for the Ni2 implant system validates its substantial equivalence."

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

In conclusion, the provided document clearly indicates that the Ni2 Implant System is a traditional medical device (dental implant). The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and adherence to recognized standards, not through AI/ML algorithm performance studies or clinical trials involving human readers/interpreters.

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Oneday Implant Abutment is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implants with diameters larger than 5 mm are intended to be used in the molar region.

The Oneday Implant Abutment is a material for dental surgery and is an abutment used to support and maintain prosthetic restored teeth in case of partial or total loss of teeth. It is used in combination with a fixture implanted in the jawbone.

This document describes a 510(k) premarket notification for the "Oneday Implant Abutment," a dental device. The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.

The provided text details the device description, indications for use, comparison to predicate devices, and non-clinical test data. It is crucial to understand that this document does NOT describe the acceptance criteria and a study proving a device meets those criteria in the context of clinical performance or AI/software validation. Instead, it describes mechanical, material, and biocompatibility testing for a physical dental implant component to demonstrate its substantial equivalence to an existing device.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for AI systems, training set sample size) are not applicable to this type of device submission. This is a traditional medical device submission, not a submission for a software-as-a-medical-device (SaMD) or an AI/ML-driven device that would involve performance metrics related to diagnostic accuracy or clinical outcomes.

Here's an analysis of the provided information relative to your request:

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

The acceptance criteria here are standards for mechanical performance, biocompatibility, and sterilization, rather than performance metrics for an AI algorithm.

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

• Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., number of abutments tested for fatigue, sterilization, or biocompatibility). This information is typically detailed in the full test reports referenced in the submission, not summarized in the 510(k) summary letter.
• Data Provenance: The tests are non-clinical (laboratory-based) performed on "subject device" or "worst-case test article" samples. There is no patient data involved for these tests. The country of origin for the data generation (the testing laboratories) is not specified in this summary. These are prospective tests performed specifically for this submission.

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

• This is not applicable. The "ground truth" for mechanical testing, sterilization, and biocompatibility is based on established ISO and ANSI standards. There are no "experts" establishing a "ground truth" in the clinical imaging or diagnostic sense. The evaluations are objective measurements against predefined thresholds.

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

• This is not applicable. Adjudication methods are typically used in clinical studies, particularly for subjective assessments (e.g., image interpretation). These are objective non-clinical tests.

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:

• This is not applicable. The device is a physical dental implant abutment, not an AI-powered diagnostic or assistive tool. No MRMC study would be performed for this type of device.

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

• This is not applicable. There is no algorithm or software for which standalone performance would be relevant for this physical device.

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

• For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria specified by the referenced ISO/ANSI standards for mechanical properties, sterility assurance levels, and biocompatibility endpoints. There is no clinical "ground truth" in the sense of pathology or outcomes data for this specific submission, as it relies on non-clinical testing for substantial equivalence.

8. The sample size for the training set:

• This is not applicable. This is a physical medical device, not a software/AI product requiring a training set for model development.

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

• This is not applicable. See point 8.

In summary: The provided document is a 510(k) summary for a physical medical device, the Oneday Implant Abutment. It demonstrates substantial equivalence primarily through comparisons of design, materials, intended use, and adherence to established performance standards through non-clinical (laboratory) testing. It does not involve AI/ML technology or associated validation studies typically seen in software medical device submissions, and therefore, many of the detailed questions regarding AI performance criteria and study design are not relevant to this specific document.

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Indications for Use for Eco Abutment

The Eco Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

Indications for Use for Multiunit Abutment

The Multiunit Abutment is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

The Eco Abutment is a two-piece abutment. It consists of a base abutment which is used with temporary post, cemented post, angled post and healing cap. The base abutment is first secured to the dental implant with a base screw and the post is secured to the base abutment with post screw. The Eco Abutment has 4.5, 4.8, 5.5 and 6.5 of diameter and consists of 0, 6, 12 and 18 degree.

The Multiunit Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single unit loading (i.e., crown) or multi-unit loaded restorations (i.e., bridge, bars, overdentures). It is consists of Multiunit Straight Abutment, Multiunit Angled Abutment and Temporary Cylinder. The Multiunit Abutment has 4.8mm of diameter and consists of two kind of design that has three angles. The Multiunit Straight abutment has 0 degree and the Multiunit Angled abutment has 20 or 30 degree

The Eco Abutment and Multiunit Abutment are made from titanium alloy conforming to ASTM F136. It is provided non-sterile and is steam sterilized before use.

Non-Hex connection abutments are intended for multi-unit restorations only.

The provided text is a 510(k) summary for dental implant abutments, focusing on regulatory approval based on substantial equivalence to predicate devices. It does not contain information about a clinical study with acceptance criteria for device performance relevant to AI/ML devices or studies involving human readers.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size, or improvement with AI assistance.
• Standalone performance (algorithm only).
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical testing (sterilization validation, biocompatibility, mechanical properties, MR environment condition) to demonstrate substantial equivalence to existing predicate devices, which is a common pathway for medical device clearances that do not involve AI/ML components or comparative effectiveness studies with human readers. The document explicitly states "No clinical studies are submitted."

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The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.

UF(II) Bar holder abutment and set screw is used for prosthetic restoration. Bar holder abutment is intended to be used in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients. UF(II) Bar holder abutments are made from Ti-6Al-4V ELI (ASTM F136). The UF(II) Bar holder abutment has two type shape which are Single body type and Cap type.

The UF(II) Bar holder abutment of single body type consists of abutment screw and set screw. The UF(II) Bar holder abutment of cap type consists of abutment screw, set screw and abutment cap. Both type Bar holder abutment has Hex, Non-Hex connection. Subject abutments are only intended for multi-unit restorations. It is provided non-sterile, this should be user steam sterilized before use. It is used for overdentures with clip for bar retention. The clip is fixed to the overdenture and used to supplement the retention of the bar and denture. The bar is used to fix the abutment and overdenture. It is held in place with the set screw. The cap is used to cover the bar holder abutment Cap Type. The components-clip, bar, and cap--are included in the device system.

Here's an analysis of the provided text regarding the acceptance criteria and study for the UF(II) Bar holder abutment:

This document is a 510(k) summary for a medical device (UF(II) Bar holder abutment). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through clinical or standalone studies for a new type of AI/diagnostic device.

Therefore, the requested information elements related to AI algorithm performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable in this context. This is a traditional medical device submission for an implant component, where the focus is on mechanical integrity, materials, and intended use comparison to existing devices.

However, I can extract the relevant information regarding the non-clinical testing performed to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are derived from established international standards for dental implants and abutments. Since no specific performance metrics like sensitivity/specificity are reported for this type of device, the "reported device performance" is successful completion of the specified tests, thereby demonstrating substantial equivalence.

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

• Sample Size for Fatigue Test: Not explicitly stated as a number of devices, but the test was performed on "finished assembled implant/abutment systems of the worst-case scenario (smallest diameter with maximum angulation)." This implies a representative number of units for the specific configurations tested, as per the ISO standard.
• Data Provenance: The standard (ISO 14801:2007) is international. The testing itself would have been conducted by the manufacturer or a contracted lab. The document does not specify country of origin for the test results, but the submitter (DIO Corporation) is from the Republic of Korea. It is a prospective test, newly performed or leveraged for this submission.

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

• Not Applicable. This is a mechanical/material performance test, not a diagnostic or AI-driven assessment requiring expert ground truth for interpretation. The "ground truth" is determined by the physical outcome of the tests (e.g., whether the device fractured at a certain load, whether the sterilization parameters were met).

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

• Not Applicable. See point 3.

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 device is a physical dental implant abutment, not an AI diagnostic tool.

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

• Not Applicable. See point 5.

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

• For the fatigue test: The "ground truth" is the physical failure or non-failure of the device under specific, controlled dynamic loading conditions, as defined by the ISO standard.
• For sterilization: The "ground truth" is the measurable Sterilization Assurance Level (SAL), typically confirmed by biological indicators or other validated methods.
• For biocompatibility: The "ground truth" is the established safety profile of the material based on chemical composition and previous testing (ISO 10993).

8. The sample size for the training set

• Not Applicable. There is no training set as this is not an AI/machine learning device.

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

• Not Applicable. There is no training set.

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UCLA CCM Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

UCLA CCM Abutment is used for prosthetic restoration. It is used for cases with path and aesthetic and spatial constrainsts. After customization, be sure to use only dental non-precious metal for casting to make the prosthesis. When cast a prosthesis with UCLA CCM Abutment, the post height above the transmucosal collar of UCLA CCM Abutment has to be taller than 4mm. The subject device is not to be used with any angulation and are straight only. UCLA CCM Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. Both abutments types are compatible implant bodies (K182194, K161987, K122519, K170608 and K173975). UCLA CCM Abutments are made from CCM Alloy. UCLA CCM Abutment consists of UCLA CCM Abutment and abutment screw. It is provided non-sterile, this should be user steam sterilized before use.

This document is a 510(k) Premarket Notification for a dental device, specifically an endosseous dental implant abutment. It does not pertain to an AI/ML medical device, and therefore does not contain the information required to answer the questions about acceptance criteria and a study proving device performance in the context of AI/ML.

The document discusses:

• Device Name: UCLA CCM Abutment
• Regulation Number: 21 CFR 872.3630 (Endosseous Dental Implant Abutment)
• Regulatory Class: Class II
• Indications for Use: Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
• Predicate Devices: NP-Cast Abutment System (K121843), UV Active Implant System, CCM Cylinder (K182194), DIO CAD/CAM Abutment (K181037), and various UF implant systems.
• Non-clinical Testing: Refers to in-vitro testing for fatigue (though none was done as the design does not include angulation), sterilization validation, and biocompatibility, leveraging data from predicate devices.
• Clinical Testing: Explicitly states, "No clinical testing was performed for this submission."

Therefore, I cannot provide details on acceptance criteria and study data related to an AI/ML device's performance, as outlined in your request, because this document describes a physical medical device (dental abutment) and not an AI/ML algorithm.

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The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.

The UF(II) Anatomic abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. The anatomic abutment has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. It consist of straight abutment and angled of 5°, 18°, and are made from titanium alloy conforming to ASTM F136. The anatomic abutments are pre-manufactured (stock) abutments is provided non-sterile, this should be user steam sterilized before use.

The provided text describes the 510(k) summary for the UF(II) Anatomic abutment, focusing on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study design for device performance. Medical devices like this, classified as Class II, typically undergo performance testing to ensure safety and effectiveness.

Based on the information provided, here's a breakdown of the acceptance criteria and the studies conducted:

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

The document mentions several tests performed according to specific ISO standards and FDA guidance. The "acceptance criteria" are implied by adherence to these standards and demonstration of "substantial equivalence." The "reported device performance" is framed as successful completion of these tests, indicating the device meets the requirements of the standards.

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 does not explicitly state the sample sizes used for the non-clinical tests (sterilization, fatigue). It refers to standard testing protocols outlined in the cited ISO standards and FDA guidance documents. These standards typically specify the number of samples required for robust testing.

• Sterilization Validation: Sample size not specified, but implied to be sufficient for achieving SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2.
• Fatigue Test: Sample size not specified, but implied to be sufficient for testing according to ISO 14801:2007, often involving multiple samples tested to failure or a specified number of cycles. The test was conducted on "the subject device."
• Biocompatibility: No new samples were tested for biocompatibility; it was leveraged from a previous submission (K122519).

Data Provenance: The document does not specify the country of origin of the data for the non-clinical tests, nor whether the studies were retrospective or prospective. These are lab-based tests, not clinical studies involving human patients. The submitter is DIO Corporation, located in the Republic of Korea, so the testing was likely conducted in that region or by a contract lab.

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)

This question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical performance tests like sterilization and fatigue are objective measurements against established engineering and biological standards (e.g., microbial kill rate, force sustained before failure). These tests do not typically involve human expert interpretation or consensus for establishing "ground truth" in the way a clinical diagnostic accuracy study would.

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

This question is not applicable. Adjudication methods are used in clinical studies where human interpretation or a "gold standard" reference is subject to variability or requires reconciliation among multiple experts. The non-clinical tests described are objective, laboratory-based physical and biological assessments.

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

This question is not applicable. The device described, the UF(II) Anatomic abutment, is a dental implant component (an abutment). It is a passive mechanical device and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

This question is not applicable, as the device is mechanical and not an algorithm or AI system.

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

As discussed in point 3, the concept of "ground truth" derived from expert consensus, pathology, or outcomes data is not directly applicable to the non-clinical performance tests mentioned in the document.

For:

• Sterilization Validation: The "ground truth" is an objective measurement of microbial reduction (e.g., spore log reduction) or sterility against a defined standard.
• Fatigue Test: The "ground truth" is the objective mechanical performance (e.g., cycles to failure, maximum load sustained) measured by engineering equipment against the requirements of ISO 14801.
• Biocompatibility: The "ground truth" is derived from established biological responses to materials as per ISO 10993-1 (e.g., cytotoxicity, sensitization, irritation).

8. The sample size for the training set

This question is not applicable, as this is a mechanical device, not a machine learning model requiring a training set.

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

This question is not applicable for the same reason as point 8.

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DIO CAD/CAM Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Patient specific abutment is intended for use with the UF Implant Systems provided in the chart. All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.

The DIO CAD/CAM Abutment includes two CAD/CAM abutment designs, Hybrid Link Abutment and Patient-Specific Abutment.

1. Hybrid Link abutment: Hybrid Link abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The hybrid link abutment is composed of two-piece abutment that is a hybrid link at the bottom and a coping (CAD/CAM patient specific superstructure) at the top. The hybrid link abutments are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136. The diameters of Hybrid Link Abutment are 4.0/4.5/5.5mm. Hybrid Link abutment is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the Hybrid Link Abutment.

2. Patient-Specific Abutment: Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician. The diameters of patient-specific Abutment are 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 and two connection designs (Hex, Non-hex). Patient-specific abutments are supplied with an abutment screw previous cleared device as K122519 and K161987 and provided non-sterile.

The document provided is a 510(k) Premarket Notification from the FDA for a dental implant abutment. It does not describe a study involving an AI/ML device, nor does it provide acceptance criteria or performance metrics in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices through material properties, design specifications, and non-clinical testing for dental implant abutments.

Therefore, I cannot provide the requested information regarding acceptance criteria and device performance from this document. The sections you asked for, such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, are not applicable to the content of this 510(k) summary for a physical medical device.

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