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The ISO Abutment is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The ISO Abutment is compatible with the following fixtures.

The ISO Abutment is to be placed into the dental implant to provide support for a prosthetic restoration. The ISO Abutment is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by 3rd party implant manufactures.

This 510(k) clearance letter details the regulatory approval for the ISO Abutment, an endosseous dental implant abutment. It establishes its substantial equivalence to a predicate device based on similar indications for use, technological characteristics, materials, design, and sterilization methods.

However, the provided document does not contain information related to software, artificial intelligence (AI), diagnostic accuracy studies, or clinical performance data typically associated with acceptance criteria tables, sample sizes for medical imaging datasets, expert adjudication, or MRMC studies. The device itself is a physical dental implant component, not an AI-powered diagnostic tool.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (as these would be mechanical and biocompatibility tests, not diagnostic accuracy metrics)
• Sample sizes used for the test set and data provenance (not applicable for this type of device)
• Number of experts used to establish ground truth and qualifications (not applicable)
• Adjudication method (not applicable)
• MRMC comparative effectiveness study (not applicable)
• Standalone (algorithm-only) performance (not applicable)
• Type of ground truth used (e.g., pathology, outcomes data - not applicable for this device beyond engineering/material testing)
• Sample size for the training set (not applicable)
• How the ground truth for the training set was established (not applicable)

The "Non-clinical Tests" section (Page 13) describes the types of studies performed for a physical device, which include:

• Sterilization validation testing (ISO 17665-1 & 2)
• Biocompatibility tests (ISO 10993-5, -10, -11, -3, -33) including:
  • Cytotoxicity
  • Oral mucosa irritation
  • Skin sensitization
  • Acute systemic toxicity
  • Subchronic systemic toxicity
  • Bacterial reverse mutation
• Reverse engineering analysis of OEM implant body, abutment, and fixation screw (for compatibility verification)
• TiN coating tests (F1044, F1147, F1160)
• Non-clinical worst-case MRI review (using scientific evidence and published literature) to assess magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119).

These tests establish the physical, mechanical, and biological safety and compatibility of the dental abutment, rather than the diagnostic performance of an AI system.

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Geo Abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit cement-retained prosthesis in the mandible or maxilla. Geo Abutments are compatible with the following implants. All digitally designed custom abutments for use with Geo Abutments are to be sent to a GeoMedi Co. Ltd. validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for Geo Abutment from GeoMedi Co., Ltd. a line of titanium base abutments (identified as Multibase) and machinable blank abutments (identified as CMFit) to interface with compatible dental implants from four (4) manufacturers, and a total of seven (7) implant-abutment connections. The compatible implant body diameters range from 3.0 mm to 8.0 mm. The subject device prosthetic platform diameters range from 4.0 mm to 4.6 mm. All patient-specific abutments prepared from subject device Geo Abutment are to be manufactured at a GeoMedi validated milling center.

Geo Multibase abutments are two-piece abutments in which the Geo Multibase Abutment comprises the first part of the two-piece abutment and a patient-specific zirconia superstructure comprises the second part; the assembly becoming a final finished medical device after cementation of the superstructure on the subject device abutment. They are provided in straight designs, and two (2) connection types: for single unit prostheses (engaging connection) and for bridge or multi-unit prostheses (non-engaging connection). They are not intended for angulation correction, as the design parameters for the superstructure are restricted to straight abutments only.

These abutments are made of titanium alloy (Ti-6Al-4V) with a titanium nitride (TiN) coating on the coronal portion of the external surface, not including the implant-abutment interface.

The Geo Multibase abutment and corresponding zirconia superstructure are provided to the clinician either with the superstructure cemented to the abutment by the dental laboratory or separately, for the clinician to bond together chairside, using the cement required in the labeling (3M ESPE RelyX Unicem bonding cement, cleared in K022476 as RelyX RMGIP).

All patient-specific custom zirconia superstructure fabrication is by prescription on the order of the clinician.

The design parameters for zirconia superstructures to be used with Geo Multibase abutments are:

• Minimum wall thickness – 0.5 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height of the superstructure – 0 mm (Geo Multibase abutments have minimum gingival height of 1.0 mm)
• Maximum gingival height – 5.0 mm
• Maximum angle – 0° (straight only)

All zirconia copings (superstructures) for use with the subject device Geo Multibase abutment will be made at a GeoMedi Co., Ltd. validated milling center under FDA quality system regulations, and the material will conform to ISO 13356, Implants for surgery – Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

Geo CMFit abutments are cylindrical titanium alloy abutments designed to be used for fabrication of a one-piece, all titanium patient-specific abutment by a CAD/CAM process. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. Geo CMFit abutments are available in engaging and non-engaging connections.

All patient-specific abutment fabrication is by prescription on the order of the clinician. The design parameters for all CMFit patient-specific abutments are:

• Minimum wall thickness – 0.65 mm
• Minimum cementable post height for single-unit restoration – 4.0 mm (minimum cementable post height for single-unit restoration is defined as the height above the restorative margin)
• Minimum gingival height – 0.5 mm
• Maximum gingival height – 5.0 mm
• Maximum angle – 30°

Manufacture of the Geo Abutment CMFIT patient-specific abutment is to be performed at an GeoMedi Co., Ltd. validated milling center.

The provided text is a 510(k) clearance letter for a dental implant abutment, not an AI/ML medical device where performance characteristics like sensitivity, specificity, or reader studies are typically discussed.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through:

• Indications for Use (IFU) comparison: Showing that the intended use of the Geo Abutment is the same as already cleared devices (supporting prosthetic devices in edentulous patients, compatible with various implants).
• Technological characteristics comparison: Detailing similarities in design, materials (titanium alloy, TiN coating, zirconia for superstructures), manufacturing processes (CAD/CAM, milling center), mechanical properties, and sterilization methods.
• Non-clinical performance data: This section lists types of tests conducted (e.g., mechanical testing per ISO 14801, shear/tension testing per ASTM F1044/F1147, sterilization validation per ISO 17665-1/2, biocompatibility per ISO 10993-5/12) to ensure the device meets safety and performance standards equivalent to the predicate. However, it does not provide acceptance criteria or specific numerical results from these tests. It only states that these tests were done to "demonstrate that the subject devices... have sufficient strength for the intended use" and "characterize the mechanical properties."

Therefore, based on the provided document, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This detailed information is typically part of the test reports submitted to the FDA, but not usually summarized in the publicly available 510(k) clearance letter or summary in this level of detail (i.e., the specific pass/fail thresholds and the measured values for each test). The document only states what was tested and the conclusion that it demonstrated "sufficient strength."
2. Sample sizes used for the test set and the data provenance: This information is not present in the 510(k) summary. These details would be in the specific test protocols and reports.
3. Number of experts used to establish the ground truth... and their qualifications: This is not applicable as this is a physical device, not an AI/ML diagnostic aid requiring human expert annotation for ground truth.
4. Adjudication method for the test set: Not applicable for this type of device.
5. MRMC comparative effectiveness study: Not applicable for a physical dental abutment. This is typically for AI/ML diagnostic devices.
6. Standalone (algorithm only without human-in-the-loop performance): Not applicable for a physical device.
7. The type of ground truth used: For a physical device like a dental abutment, "ground truth" relates to material properties, mechanical strength, dimensional accuracy, and biocompatibility, as demonstrated through engineering tests and material characterization, not clinical outcomes or expert consensus in an AI sense. The document refers to ISO and ASTM standards, which define the test methods and what constitutes acceptable performance (the "ground truth" for material and mechanical properties).
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.

In summary, the provided document demonstrates substantial equivalence for a physical dental device through comparison to predicate devices and adherence to established engineering and material standards, rather than through clinical study formats typically seen for AI/ML diagnostic tools.

To answer your question, if this were an AI/ML device document, the "acceptance criteria" and "reported device performance" would typically be found in sections describing performance metrics like:

• Sensitivity, Specificity, Accuracy
• Area Under the Receiver Operating Characteristic (ROC) Curve (AUC)
• Positive Predictive Value (PPV), Negative Predictive Value (NPV)
• F-score or Dice coefficient (for segmentation tasks)
• Comparison to a "clinical standard of care" or "expert performance."

And the "study that proves the device meets the acceptance criteria" would be a clinical validation study (often a retrospective or prospective reader study or a standalone algorithm performance study) with clearly defined ground truth, reader qualifications, and statistical analysis. None of these elements are present because the device is a physical dental abutment.

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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.

This submission adds various abutments to the DESS and OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.

The subject device abutment designs include Cover Screws, Healing Abutments, Temporary Abutments, Ti Base Abutments, AURUM Base Abutments (Ti Base abutments with a screw channel design that allows easier instrument access to the abutment screw), CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight and angled), DESSLoc Abutments (Locator-type abutments), and abutment screws.

This document is a 510(k) summary for the DESS Dental Smart Solutions, a line of endosseous dental implant abutments. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device itself is a physical medical device (dental implant abutments and associated components), not a software or AI-driven system. Therefore, the questions related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, and ground truth establishment for AI would not be directly applicable to this product as described.

The document focuses on establishing substantial equivalence to previously cleared predicate devices through:

• Identical Intended Use: The device is intended for "functional and esthetic rehabilitation of the edentulous mandible or maxilla" by providing support for prosthetic restorations, which is the same as the predicate devices.
• Similar Technological Characteristics: The device utilizes similar designs, materials (Ti-6Al-4V, Co-Cr-Mo alloy), manufacturing processes, and sterilization methods as its predicates.
• Performance Data: Non-clinical testing (mechanical testing per ISO 14801, MR environment assessment) and comparison to existing data from predicate devices are used to demonstrate safety and effectiveness.

Therefore, many of the requested elements for describing AI acceptance criteria and studies are not present or applicable in this document.

However, I can extract information relevant to the device's performance assessment and criteria for its type of submission.

Here's an attempt to answer the questions based solely on the provided text, acknowledging that the nature of the device (a physical implant component) means many AI-specific questions will be answered as "Not Applicable" (N/A):

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

The document does not explicitly state quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" metrics for this specific 510(k) submission. Instead, it relies on demonstrating substantial equivalence to existing predicate devices.

The underlying "acceptance criteria" for demonstrating substantial equivalence for this device type are primarily through:

• Mechanical Testing (ISO 14801): This is a critical performance standard for dental implants and abutments. The document states that mechanical testing was "conducted according to ISO 14801 to support the performance." The acceptance criteria would be successful completion of these tests, demonstrating the device's mechanical strength and fatigue resistance are comparable to or better than predicate devices. The reported performance is simply that the tests supported the performance.
• Material Conformance: Materials must conform to specific ASTM standards (e.g., ASTM F136 for Ti-6Al-4V, ASTM F1537 for Co-Cr-Mo). The reported performance is that the materials conform to these standards.
• Biocompatibility: While not detailed in this excerpt, the mention of "biocompatibility" in relation to predicates implies conformance to relevant biocompatibility standards (e.g., ISO 10993 series). The reported performance is that it is compatible.
• Sterilization Validation: Demonstrated sterility assurance level (SAL) of 10⁻⁶ via validated methods (moist heat or gamma irradiation). The reported performance is that validation was performed and met this SAL.
• Dimensional Compatibility: The abutments must fit the corresponding OEM implants correctly. The reported performance is that reverse engineering dimensional analysis confirmed compatibility.

Due to the nature of the document being a 510(k) summary focusing on substantial equivalence rather than a full study report, specific numerical performance results for the device tests are not provided in this text.

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

• Sample Size for Mechanical Testing: The document states "mechanical testing conducted according to ISO 14801." For such tests, ISO 14801 typically specifies minimum sample sizes (e.g., 10-11 samples for static strength, typically more for fatigue). The exact number of samples used for this specific submission is not explicitly stated, but it would have followed the standard's requirements.
• Data Provenance: The mechanical testing and material analyses are assumed to be "non-clinical data submitted or referenced" by the manufacturer, Terrats Medical SL, based in Barcelona, Spain. The "reverse engineering dimensional analysis" was done by Terrats Medical SL or through contractual agreement. This is prospective testing performed to support the 510(k). The document itself does not specify the country of origin for the underlying OEM implant data used for reverse engineering, although the OEM companies are listed (e.g., Astra Tech AB, BioHorizons).

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

N/A. This is a physical device. Ground truth, in the context of AI, refers to validated labels for data used to train and test an algorithm. For a physical device, performance is evaluated through engineering and biocompatibility testing against defined standards. There are no "experts" establishing ground truth in the AI sense. Testing would be performed by qualified engineers and technicians.

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

N/A. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) to resolve discrepancies. This document describes non-clinical performance testing of 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

N/A. This product is a dental implant abutment, not an AI software intended to assist human readers.

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

N/A. This is a physical device, not an algorithm.

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

N/A. For engineering tests of physical devices, the "ground truth" is typically derived from established engineering principles, international standards (e.g., ISO 14801 for mechanical properties, ASTM for materials), and the physical properties of the materials and designs themselves. There isn't "expert consensus" or "pathology" in the AI or clinical trials sense.

8. The sample size for the training set

N/A. This is a physical device; there's no "training set" in the machine learning sense. The device is manufactured based on established engineering designs and material specifications.

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

N/A. No training set for AI. For device manufacturing, the "ground truth" for design and production parameters comes from established engineering best practices, prior successful device designs (predicate devices), and adherence to quality systems regulations (21 CFR Part 820).

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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile.

The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws.

The provided text is a 510(k) summary for the DESS Dental Smart Solutions, an endosseous dental implant abutment. It details the device, its intended use, and its substantial equivalence to previously cleared predicate and reference devices. However, this document does not contain the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The 510(k) submission for this dental abutment focuses on establishing substantial equivalence based on:

• Design and Material: The subject device components are identical in design, material (Ti-6Al-4V alloy, DLC coating), and technological characteristics to previously cleared devices.
• Manufacturing: The manufacturing process is consistent with previously cleared devices.
• Biocompatibility: Referenced from previous K-clearances.
• Sterilization: The main change in this submission is expanding the system to provide products sterile to the end-user via gamma irradiation, which was validated by referencing a previous K-clearance (K212538).
• MR Environment Testing: Non-clinical analysis was performed to evaluate the subject devices in the MR environment, referencing published literature and FDA guidance.
• Shelf Life Testing: Referenced from a previous K-clearance (K212538) for samples after accelerated aging.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI/ML device meets them based on the provided text, as this document is not about an AI/ML medical device. It's about dental implant abutments and establishes substantial equivalence through non-clinical performance data and comparison to predicate devices, not through AI/ML performance metrics.

To provide the information you requested, I would need a document detailing the validation of an AI/ML medical device, which would include definitions of acceptance criteria (e.g., accuracy, sensitivity, specificity), details of training and test datasets, ground truth establishment, and potentially clinical effectiveness studies if applicable.

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SIMDA Abutments are 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.

SIMDA Abutment is made of titanium alloy (Ti-6Al-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration. It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant.

This FDA 510(k) summary describes a dental device, the SIMDA Abutment. However, it does not include information that directly addresses the specific questions you've asked about acceptance criteria and a study proving a device meets them, particularly for an AI/ML powered device.

Here's why and what information is provided:

The document is a premarket notification for a Class II medical device, specifically dental implant abutments. These are physical components used in dental restorations, not an AI/ML powered diagnostic or therapeutic device. Therefore, the concepts of "acceptance criteria for an AI model," "test set," "ground truth," "MRMC studies," "effect size of human readers with AI assistance," or "standalone algorithm performance" are not applicable to this submission.

The "studies" mentioned are non-clinical (mechanical, biological) tests demonstrating the physical safety and performance of the abutments and their compatibility with existing dental implant systems.

Here's a breakdown of the relevant information provided, framed as closely as possible to your request, but acknowledging the device type:

Device: SIMDA Abutments (K232271)
Device Type: Endosseous Dental Implant Abutment (physical medical device, not AI/ML powered)

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

The document sets design limits and then demonstrates conformity through non-clinical testing. The "acceptance criteria" here are rather design specifications and performance standards for dental abutments.

2. Sample sized 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. For physical tests (fatigue, biocompatibility, sterilization), sample sizes would typically be determined by the relevant ISO standards.

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. "Ground truth" in the context of AI/ML is not relevant here. The "truth" is established by physical measurement, adherence to material standards, and documented mechanical performance.

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

• Not applicable. Adjudication methods are typically for subjective assessments, whereas these are objective physical 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

• Not applicable. This is a physical dental device, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical dental device.

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

• For physical tests, the "ground truth" is defined by the ISO standards and FDA guidance documents to which the device is tested. This includes established methods for fatigue testing, biocompatibility evaluation, and sterilization efficacy. For compatibility, it's about precise dimensional matching and mechanical fit to existing OEM implant systems.

8. The sample size for the training set

• Not applicable. This is a physical dental device, not an AI/ML powered device that requires a "training set."

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

• Not applicable. See point 8.

In summary, this document is for a traditional medical device (dental abutments), and thus the questions formulated for an AI/ML device do not directly apply. The acceptance criteria are based on established engineering and materials standards, and performance is demonstrated through non-clinical laboratory testing rather than clinical or observational studies on diagnostic performance.

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INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:

• The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.

• Immediate placement in extraction situations with a partially or completely healed alveolar ridge.

• It is intended for delayed loading.

The INNO SLA Submerged Implant System offers the following components.

1 INNO SLA Submerged Narrow Fixture (Narrow) Ø 3.3 x 8.00, 10.00, 12.00, 14.00 mm Ø 3.5 x 8.00, 10.00, 12.00, 14.00 mm
2 Cover Screw (Narrow) Ø 2.84 x 5.0 mm Ø 3.23 x 6.0 mm Ø 3.62 x 7.0 mm
3 Healing Abutment (Narrow) Type 1 Ø3.5 x 6.7, 7.2, 9.2, 10.2, 11.2 mm
4 Healing Abutment (Narrow) Type 2 Ø 4.5 x 7, 9, 10, 11, 12, 14 mm
5 Cemented Abutment (Narrow) Ø 4.5 x 7.85, 8.85, 9.85, 10.85, 11.85, 12.85, 13.85, 14.85mm Ø 4.5 x 9.35, 10.35, 11.35, 12.35, 13.35 mm Ø 4.5 x 7.65, 8.65, 9.65, 10.65, 11.65, 13.65, 14.65 mm Ø 4.5 x 9.15, 10.15, 11.15, 12.15, 13.15 mm
6 Angulated Abutment (Narrow) Ø 4.5 x 11.85, 12.85, 13.85, 14.85 mm (15°, 25°)
7 Multi S Abutment Ø 4.5 x 5, 5.8, 6mm
8 Multi A Abutment Ø 4.5 x 6.42, 7.42, 8.42, 6.96, 7.96mm (15°,30°) – Hex type Ø 4.5 x 6.23, 7.22, 8.22, 6.76, 7.76mm (15,30°) – Non Hex type
9 Multi Hybrid Ti-Base Cylinder Ø 4.5 x 4.5mm
10 Abutment Screw (Narrow) Ø 2.25 x 10.2 mm Ø 1.95 x 8.7 mm
Ø 1.95 x 9.3 mm
12 Multi Cylinder Screw Ø 2.25 x 5 mm
13 Straight Abutment Ø 3.5 x 13.5, 14, 15, 16, 17 mm
14 Temporary Abutment Ø 4.5 x 10 mm
15 Multi Titanium Cylinder Ø 4.5 x 9 mm

The provided document is a 510(k) premarket notification for a medical device (INNO SLA Submerged Narrow Implant System). This type of document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving clinical effectiveness or meeting specific performance acceptance criteria through a dedicated study.

Therefore, the document does not contain any information regarding:

• Acceptance criteria in the traditional sense of a clinical or performance study with numerical targets for metrics like sensitivity, specificity, accuracy, etc.
• The study that proves the device meets acceptance criteria (as no such study with performance metrics is presented).
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Ground truth type for a performance study.
• Sample size for the training set.
• How the ground truth for the training set was established.

Instead, the document focuses on demonstrating substantial equivalence through:

1. Performance Data (Non-Clinical):

The performance testing listed focuses on engineering and material characteristics, leveraging previous clearances and established standards.

• Gamma radiation sterilization and shelf-life: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Steam sterilization of abutments: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K201323.
• Five-year shelf life and packaging: Leveraged from Cowellmedi Co., Ltd's previous clearance K132242.
• SLA surface treatment: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Fatigue test in accordance with ISO 14801: This is an engineering test to ensure the mechanical integrity of the implant system. The document states: "We have performed the fatigue test to make sure the differences do not raise and the test result of the test supported substantial equivalence." However, no specific numerical acceptance criteria or results are provided in the summary.
• Biocompatibility endpoints: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Non-clinical worst-case MRI review: Performed using scientific rationale and published literature to evaluate displacement force and torque.

2. Substantial Equivalence Discussion and Comparison Chart:

This section directly compares the subject device (INNO SLA Submerged Narrow Implant System) with various predicate and reference devices, highlighting similarities in:

• Intended Use
• Material (Titanium Grade 4 or Ti-6Al-4V ELI)
• Principle of Operation
• Design
• Surface Treatment (SLA, TiN Coating)
• Sterility (Gamma Sterilization, Non-sterile with terminal sterilization via moist heat/autoclave, End User Sterilization)
• Shelf Life (5 years)

The document asserts that slight differences, such as in abutment size options or diameter ranges, do not affect substantial equivalence or raise concerns about safety or performance.

In summary, for a traditional clinical or AI/ML performance study as requested, all fields would be "Not Applicable" or "Not Provided" based on the content of this 510(k) summary. The "acceptance criteria" here are implicitly that the device performs equivalently to the listed predicates based on the non-clinical tests and functional comparisons detailed.

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SuperLine® implants are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. SuperLine® implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Single tooth cases on 7 mm length implants are indicated for delayed loading.

The purpose of this submission is to add dental implants to the SuperLine components cleared in K160965. This submission includes two series of implants: SuperLine FXSxxxxB Series and SuperLine FXSxxxx Series.

The FXSxxxB Series has a machined collar height that ranges from 0.03 mm (on the 3.6 mm body diameter implant) to 0.6 mm (on the 5.0 mm body diameter implant). All FXSxxxxB Series implants have an endosseous length of 7 mm, and threaded lengths ranging from of 6.98 mm to 6.4 mm. Other than the endosseous length of 7 mm, the subject device FXSxxxB implants are identical in design and sizes to SuperLine implants cleared in K160965.

The FXSxxxx Series has machined collar 1.5 mm in height for all implant body diameter sizes. For body diameters 4.0 mm to 5.8 mm, the collar has a reverse taper. All FXSxxxx Series implants have an endosseous length of 7 mm, and a threaded length of 5.5 mm. The FXSxxxx series implant design has not been cleared previously by FDA for any body diameter or length.

All subject device implants are manufactured from the same unalloyed titanium conforming to ASTM F67 and have the same surface treatment (S.L.A., Al2O3 blasted and acid etched) as the dental implants cleared in K160965.

All subject device implants are compatible with previously-cleared abutments and prosthetic components from Dentium Co., Ltd., including those cleared in K192436, K141457, and K041368.

The provided document is a 510(k) summary for a medical device (SuperLine dental implants) and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document discusses substantial equivalence to predicate devices based on non-clinical data and design comparisons.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study demonstrating device performance against those criteria.

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The IU Implant System is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

The IU Implant System is an integrated system of endosseous dental implants with corresponding various abutments (cover screw, two piece abutment, solid abutment, abutment screw, ball abutment, retained abutment, temporary abutment, and multi abutment). The IU Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. There are two types of Fixtures, triangular screw threads design and square screw threads design. The IU Implant System includes the each fixtures is available in various diameters (lengths) 3.6 mm (8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 4.1 mm, 4.6 mm, 5.1 mm, 5.6 mm, 6.1 mm (7.5 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) of triangular screw threads design and 4.3 mm, 4.8 mm, 5.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm) & 6.3 mm (7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm) of square screw threads design according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy and it is intended for use to make permanent prostheses and/or temporary prosthesis. The abutments are provided non-sterile and should be sterilized before use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IU Implant System, extracted from the 510(k) summary:

The provided document (K172345) is a 510(k) Summary for a new medical device, the IU Implant System. In 510(k) submissions, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to establish new safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating equivalence to established standards and predicate devices, largely through non-clinical testing.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IU Implant System are implicitly set by the standards and characteristics of the identified predicate and reference devices, as well as relevant ISO standards. The "performance" being demonstrated is that the subject device meets these established benchmarks, thereby showing substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance

Study Details

Given this is a 510(k) submission, the "study" that proves the device meets the acceptance criteria is primarily a non-clinical comparative testing and documentation of material/design equivalence to predicate devices and recognized standards.

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

• Test Set Sample Size: Not explicitly stated in terms of a "test set" as one might refer to it in a clinical study. The non-clinical tests (biocompatibility, sterilization, shelf-life) would typically involve a sample of the manufactured device components. The exact number of samples for each specific test (e.g., cytotoxicity, sensitization, mechanical flexural strength) is not detailed in this summary.
• Data Provenance: The biocompatibility testing was conducted according to International Standard ISO 7405:2008 and ISO 10993-1:2009/AC:2010. Sterilization testing followed ISO 11137-1/2/3 and ISO 17665-1/2. Shelf-life testing followed ASTM F1980. Risk analysis followed ISO 14971. This indicates testing against internationally recognized standards. The country of origin of the data generation isn't specified beyond the device manufacturer being WARANTEC Co., Ltd. from Korea. This is a retrospective analysis of non-clinical design and safety data against known standards and predicate devices.

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

• This is not applicable in the context of this 510(k) submission. "Ground truth" in this scenario is established by adherence to recognized international standards (ISO, ASTM) and demonstrative equivalence to predicate devices, rather than expert consensus on a test set (e.g., interpretation of medical images). The experts involved would be those who conducted the laboratory tests and certified compliance with the standards (e.g., microbiologists, material scientists, toxicologists), but their number and specific qualifications are not detailed in this summary.

3. Adjudication method for the test set:

• Not applicable. There is no "adjudication method" in the sense of reconciling divergent expert opinions on test data. Compliance with each standard (e.g., passing a cytotoxicity test, achieving a certain SAL) is a binary outcome based on pre-defined criteria within the standard itself.

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, an MRMC comparative effectiveness study was not done. This device is an endosseous dental implant system, not an AI-powered diagnostic or assistive tool for human readers. This type of study is irrelevant for this device.

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

• No, this is not an AI algorithm. This question is not applicable.

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

• The "ground truth" for this P(re-market) N(otification) is
  • Compliance with recognized international standards for biocompatibility (ISO 10993, ISO 7405), sterilization (ISO 11137, ISO 17665), shelf-life (ASTM F1980), and risk management (ISO 14971).
  • Substantial equivalence to predicate devices in terms of intended use, materials, design, and manufacturing processes, which implicitly means the predicate devices' established safety and effectiveness serve as the benchmark.

7. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a 510(k) submission for this type of device. The information refers to the manufacturing and testing of physical medical devices and their components, not machine learning models.

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

• Not applicable. As stated, there is no training set for this type of device.

Summary of the "Study" (Non-Clinical Evidence):

The "study" presented is a collection of non-clinical tests and comparisons to establish substantial equivalence. It confirms:

• The IU Implant System has the same intended use as the primary predicate device (Luna Dental Implant System / SHINHUNG MST Co., Ltd. / K123155).
• Its technological characteristics (design, dimensions, material, surface treatment, connection, sterilization method) are similar to or identical to the predicate and reference devices.
• It meets all relevant biocompatibility standards (ISO 7405, ISO 10993-1) through specific lab tests (Cytotoxicity, Sensitization, Oral irritation, Systemic Toxicity, Genotoxicity, Implantation, Endotoxin).
• Its sterilization process achieves the required sterility assurance level (SAL 10^-6) validated by ISO standards.
• It has demonstrated shelf-life stability through accelerated aging testing (ASTM F1980).
• A risk analysis was conducted according to ISO 14971, finding all risks acceptable.

Key Point from the Submission: "No clinical data were included in this submission." This explicitly states that the substantial equivalence determination relies entirely on non-clinical data and comparison to legally marketed predicate devices, as is common for many Class II medical devices in the 510(k) process.

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Dentium Ti-Base abutments are intended for use on Dentium endosseous dental implants in the edentulous or partially edentulous maxilla or mandible, as an aid in prosthetic rehabilitation.

All digitally designed abutments for use with Dentium Ti-Base abutments are intended to be sent to a Dentium-validated milling center for manufacture.

Dentium Ti-Base is a patient specific abutment fabricated by Dentium and composed of unalloyed titanium and zirconia ceramic. The Ti-Base has a titanium pre-manufactured precision abutment/implant interface and ceramic superstructure bonded to the post of the titanium base. Ti-Base is used for support of CAD/CAM fabricated zirconia superstructures or for support of hybrid crowns or bridges. Hybrid crowns or bridges and zirconia superstructures are manufactured by a Dentium validated milling center.

Ti-Base Abutments are available in two prosthetic diameters (4.5 and 5.5 mm) and four gingival heights (0.5, 1.0, 1.5, and 2.0 mm). Each of the abutments is available indexed and non-indexed. All subject device abutments are compatible with Dentium and Dentium Superline dental implants.

The provided text describes a 510(k) premarket notification for the Dentium Ti-Base dental abutment, establishing its substantial equivalence to previously marketed predicate devices. This type of submission relies on non-clinical performance data rather than extensive clinical studies with specific acceptance criteria as might be seen for novel devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated for any of the non-clinical tests. For ISO 14801, typical sample sizes are small (e.g., n=5 or n=10 per test condition), but this is not specified.
• Data Provenance: The studies are non-clinical (laboratory/mechanical testing). The manufacturer is Dentium Co., Ltd. in the Republic of Korea. Therefore, the data originates from the manufacturer's testing or a contracted testing facility. All data is presumably prospective as it was generated to support the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• This information is not applicable as the studies are non-clinical performance tests for a device seeking substantial equivalence, not a diagnostic algorithm requiring expert-established ground truth. The "ground truth" for these tests is defined by the standards (ISO 17665-2, ISO 10993-5, ISO 14801).

4. Adjudication Method for the Test Set

• This information is not applicable as the studies are non-clinical performance tests and do not involve human adjudication for a "test set" in the context of diagnostic assessment.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical dental abutment, not a diagnostic AI system that would assist human readers.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. The device is a physical medical device. The "digitally designed abutments" mentioned refer to CAD/CAM processes used in manufacturing, but this is a manufacturing method, not an AI algorithm requiring standalone performance evaluation in the medical sense.

7. Type of Ground Truth Used

• The "ground truth" applied here is primarily established international standards for medical device testing (e.g., ISO 17665-2 for sterilization, ISO 10993-5 for cytotoxicity, ISO 14801 for mechanical strength). For substantial equivalence, the performance is compared against the characteristics of legally marketed predicate devices.

8. Sample Size for the Training Set

• This information is not applicable. The device is a physical product, not an AI/ML algorithm that is "trained" on a dataset. The manufacturing process might involve CAD/CAM software, but this is distinct from an AI training set.

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

• This information is not applicable as there is no "training set" in the context of an AI/ML algorithm.

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