Search Results

Zirconia Implants:
The Neodent Implant System is intended to be surgically placed in the bone of upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusion loading. Multiple teeth applications can be rigidly splinted. The implants with length of 5 mm (short implants) may be used only with two-stage surgical procedures. The recommended healing time before loading is between 10 to 12 weeks.

Zi Transmucosal Cover Screw and Healing:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

Zi Transmucosal Provisional Coping:
The Neodent Implant System is intended for surgical procedures in maxilla or mandible, providing support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single- or multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Zi Transmucosal Abutment Replacement Screw:
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Zi Transmucosal Universal Base:
The Universal Ceramic Base Zi Transmucosal 5.0 is an abutment placed over Neodent Zi Transmucosal 5.0 Ceramic Implant System in order to provide support for custom-made prosthetic restorations, such as copings or crowns. It may be used for cement or screw-retained single unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Zirconia Base for Bridge:
The Zirconia Base for Bridge is an abutment placed over Neodent Zirconia Implants in order to provide support for custom-made prosthetic restorations. It may be used for cement or screw-retained multi-unit restorations. All digitally designed copings and/or crowns to be used with the Neodent Zirconia Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

Zirconia Base C:
The Zirconia Base C is an abutment placed over Neodent Zirconia Implants in order to provide support for customized prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are screw- or cement-retained in esthetic areas over implants installed in the maxilla or mandible. All copings and/or crowns digitally designed for use with the Titanium Base C are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

This premarket notification includes new ceramic devices into Neodent Implant System, which are compatible with Zirconia Implant System. The Zirconia Implants and Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System – Zirconia Implant System, according to predicate devices described above. This submission intends to expand the portfolio with new solutions and diameter, in order to provide more treatment options to the customers.

The Zirconia Implants are manufactured in Zirconia Y-TZP and are available in Bone Level (BL) or Tissue Level (TL or Transmucosal) configurations. The Zirconia Implants (BL) are available in a diameter of 5.0 mm and lengths in a range of 8 to 13 mm. The Zi Transmucosal Implants (TL) are available in a diameter of 5.0 mm and lengths in a range of 5 to 11.5 mm.

The Zi Transmucosal Healing and Cover Screw are temporary abutments manufactured in PEEK and used during the healing phase. They are compatible with the Zi Transmucosal Implants Ø5.0. The Zi Transmucosal Healing Abutment is available in the heights of 2 and 3.5mm.

The Zi Transmucosal Provisional Coping is a temporary abutment made of polycarbonate (PC) and has a double function: used for molding procedures or production of provisional restoration.

The Zi Transmucosal Abutment Replacement Screw is a prosthetic component manufactured in titanium alloy and used to fix the fix the Zi Transmucosal Base to the Zi Transmucosal Implant.

The Zi Transmucosal Universal Base is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zi Transmucosal Implant (TL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 0.3, 1.0 and 1.5 mm. The top-half prosthetic structure to be used with Zi Transmucosal Universal Base must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: IPS e.max CAD HT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 30°
Material: IPS e.max CAD LT, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm
Material: N!ce, Associated Material 510(k): K171773, Minimum wall thickness: 1.0 mm
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A

The Zi Base for Bridge is a two-piece abutment of base and top-half prosthetic structure to provide support for customized multi-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5 and 3.5 mm. The top-half prosthetic structure to be used with Zi Base for Bridge must be designed and milled in a Straumann Validated Milling center, using the following restoration materials and dimensions:
Material: Zirconia N!ce® LT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm, Maximum angulation: 30°
Material: Zirconia N!ce® HT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: Zirconia N!ce® XT, Associated Material 510(k): K222836, Minimum wall thickness: 0.4 mm
Material: PMMA N!ce, Associated Material 510(k): K071548, Minimum wall thickness: 0.7 mm
Material: Panavia—Kuraray Cement, Associated Material 510(k): K150704, Minimum wall thickness: N/A, Maximum angulation: N/A

The Zi Base C is a two-piece abutment of base and top-half prosthetic structure to provide support for customized single-unit restorations over Zirconia Implants (BL). The base is manufactured in Zirconia Y-ZTP and used with a patient-specific top-half prosthetic structure. The two-piece abutment has a cementable portion of 4mm and is available with gingival heights of 1.5, 2.5, 3.5 and 4.5 mm. The top-half prosthetic structure to be used with Zi Base C must be designed and milled in a Sirona InLab Validated Workflow, using the following restoration materials and dimensions:
Material: IPS e.max CAD, Associated Material 510(k): K132209, Minimum wall thickness: 0.9 mm, Maximum angulation: 20°
Material: IVOCLAR Multilink cement, Associated Material 510(k): K130436, Minimum wall thickness: N/A, Maximum angulation: N/A

All these abutments have an internal connection with the implants (ZiLock) and the prosthetic platform is identical for all subject devices described in this submission. They are intended for single use and provided sterile via Ethylene Oxide method, along with undergoing moist heat sterilization after end-user customization.

The provided FDA 510(k) clearance letter and its associated summary for the Neodent Implant System - Zirconia Implant System contain extensive information about the device, its intended use, and comparisons to predicate devices. However, it does not include specific acceptance criteria with numerical thresholds directly stated within the tables, nor does it detail a study that directly proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or image quality assessments.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests, implying that if the new device performs similarly to or better than previously cleared devices, it meets the necessary standards. The performance testing section describes the types of tests conducted (e.g., dynamic fatigue, torsion, insertion, pull-out, and software validation), but it does not present clear quantitative acceptance criteria or the specific performance results in a comparative table format.

Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain more to the performance evaluation of AI/software in interpreting medical images, which is not the primary focus of this dental implant submission.

Here's an attempt to answer the questions based on the available information, noting where information is not explicitly provided in the document:

Acceptance Criteria and Device Performance Study for Neodent Implant System - Zirconia Implant System

The FDA 510(k) summary for the Neodent Implant System - Zirconia Implant System focuses on demonstrating substantial equivalence to predicate devices through a combination of bench testing, software validation, MRI compatibility, biocompatibility, and sterilization validation. It does not present specific quantitative acceptance criteria or performance metrics directly from a comparative study in the way one might expect for an AI/software-based medical device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating that the proposed devices perform at a level substantially equivalent to legally marketed predicate devices under standardized testing conditions.

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

As mentioned, explicit numerical acceptance criteria and reported device performance in a comparative table (e.g., for diagnostic accuracy) are not provided in this 510(k) summary. The summary indicates that tests were conducted according to relevant ISO standards and FDA guidance, and the results demonstrated that the subject devices exhibit a level of performance substantial equivalent to the predicate and reference devices.

Below is a conceptual table based on the types of tests mentioned, noting that specific numerical acceptance criteria and performance data are not detailed in the provided text.

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NeoConvert Solution: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Direct Screw to MUA: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. All digitally designed personalized copings to be used with the Direct to Multi Unit Abutment Screw are intended to be sent to Straumann for manufacture at a validated milling center.

GM Attachment TiN 30°: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The GM Attachment TiN 30° may be used with single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

This premarket notification includes the following additions to the Neodent Implant System: NeoConvert Solution, Direct Screw to MUA, GM Attachment TiN 30°. The Neodent Multi-Unit Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Neodent Abutments with these new solutions for multi-unit restorations, to provide more treatment options to customers. The NeoConvert Solution is a technique comprised by some abutments (not subject of this submission) used for converting removable temporary prosthesis into a screw-retained fixed temporary prosthesis. The Direct Screw to MUA is a prosthetic component designed to fix planned and digitally designed multi-unit milled restorations directly onto mini or micro abutments, eliminating the need for using the passive seating cylinder to restore chewing function. The GM Attachment TiN 30° is a prosthetic component used to stabilize implant-mucosa-supported removable full prosthesis (retained on the implant and supported on the mucosa), on implants installed in the maxilla or mandible. Although all these three new solutions are compatible with the same implants and components of Neodent Implant System and used for multiple unit rehabilitation, they are not used in conjunction with each other.

The provided text describes a 510(k) premarket notification for the "Neodent Implant System," focusing on the NeoConvert Solution, Direct Screw to MUA, and GM Attachment TiN 30°. This document details the device's technical characteristics, intended use, and its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device submission. The document is a traditional 510(k) submission for dental implants and abutments, which are physical medical devices, not AI/ML software. Therefore, the specific requirements for an AI/ML device study (such as sample sizes for test and training sets, expert qualifications for ground truth, MRMC studies, or standalone performance) are not applicable or present in this document.

The "Performance Testing" section (pages 15-16) describes bench testing (dynamic fatigue, torsion, SEM images), MRI compatibility testing, biocompatibility testing, sterilization validation, and shelf-life testing for the physical dental implant components. These are standard performance tests for this type of physical device, not AI/ML algorithm validation.

Therefore, I cannot provide a table of acceptance criteria and a study proving the device meets acceptance criteria as typically outlined for an AI/ML medical device, as this information is not present in the provided document. The document focuses on demonstrating substantial equivalence of a physical dental device to predicate devices through engineering and material testing.

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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage surgical procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with physiological occlusal loading. Multiple teeth applications can be rigidly splinted.

The CR Abutment is an abutment placed over Neodent Zirconia Implants in order to provide support for prosthetic restorations, such as copings or crowns. It may be used for single-unit restorations that are cement-retained in esthetical areas over implants installed in maxilla or mandible.

• Intended for single use;
• Provided sterile via Ethylene Oxide;
• . All devices of Zirconia Implant System are manufactured of Y-TZP (Yttrium-stabilized zirconium dioxide);
• . The CR Abutment for Zirconia system is supplied along with a titanium alloy screw (ASTM F136);
• ZiLock prosthetic interface with internal indexer;
• Apically tapered implant with trapezoidal thread profile;
• Implant provided with sand-blasted, acid etched surface finish;
• . The subject Implants are compatible with the Zirconia Bases (already cleared per market per K201491) and CR Abutments (subject of this submission);
• . The subject CR Abutments are compatible with the Zirconia Implants 4.3 mm (already cleared per market per K201491) and Zirconia Implants 3.75 mm (subject of this submission).

This document describes the Neodent Implant System - Zirconia Implant System (K210336), which includes Zirconia Implants and CR Abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly refer to "acceptance criteria" in the traditional sense of numerical thresholds for a study endpoint. Instead, the performance data presented aims to demonstrate equivalence to predicate devices through various tests.

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The DSP Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

DSP Implant System is composed of the External Hex (HE) implant line is composed of implants and related prosthetic components available in multiple designs. DSP implants are made of commercially pure titanium (ASTM F67). DSP prosthetic components are made of commercially pure titanium or cobalt-molybdenum alloy (ASTM F1537). DSP implant system screws (abutment and prosthetic screws) are made of titanium alloy (ASTM F136). The HE implant line is named after the External Hex implant-to-abutment interface. It is subdivided in External Hex SLIM (HE SLIM), External Hex BIOFIT), External Hex SOULFIT (HE SOULFIT), External Hex PROPFIT (HE PROPFIT) and External Hex WAYFIT). The HE implants are bone-level implants. The subject device abutments components mate exclusively with the subject implants of the same line.

This is a 510(k) summary for the DSP Implant System, a dental implant device. It establishes substantial equivalence to various predicate devices rather than providing performance data against specific acceptance criteria for the new device. Therefore, it does not present a typical study design with acceptance criteria and results in the way a clinical trial or device performance study would.

However, based on the provided text, we can infer the approach taken by the manufacturer to demonstrate substantial equivalence, which serves as their "proof" that the device meets regulatory requirements.

Here's an interpretation of the requested information based on the 510(k) summary:

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

Since this is a 510(k) submission focusing on substantial equivalence, there isn't a table of discrete acceptance criteria and reported device performance in terms of clinical outcomes or specific quantitative measures as one might find in a standalone performance study. Instead, the "acceptance criteria" are implied by the characteristics of the legally marketed predicate devices, and the "reported device performance" is the demonstration that the subject device shares these characteristics or has equivalent performance as validated through non-clinical testing.

The acceptance is based on demonstrating that the DSP Implant System is substantially equivalent to the predicate devices in terms of:

• Intended Use: The indications for use statement of the subject device is equivalent to the primary predicate device K101207, and within the scope of reference devices.
• Technological Characteristics: The subject device's design features, materials (CPTi Gr4, CoCr, POM, Ti6Al4V-ELI), sterilization methods (irradiation), and surface treatments (grit-blasted and acid-etched, machined collar) are compared to the predicate and reference devices. Minor differences are justified as not raising new questions of safety or effectiveness.
• Performance: Non-clinical testing demonstrates that the device performs comparably to the predicate devices in relevant areas for dental implants.

Implicit Acceptance Criteria and Reported Device Performance (based on substantial equivalence justification):

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

• Sample Size for Test Set: Not applicable for a typical clinical or performance study as presented in this 510(k). The "testing" referred to is non-clinical bench testing (sterilization, biocompatibility, pyrogenicity, material analysis). These tests typically use a representative sample size specified by the relevant standard (e.g., a certain number of devices for sterility testing). The document does not specify these individual sample sizes.
• Data Provenance: The data is non-clinical (bench testing) and generated by the manufacturer to support device characteristics. The 510(k) is submitted by a Brazilian manufacturer (D.S.P. Industrial Eireli) and prepared by a Brazilian regulatory affairs specialist (PR Servicos Regulatorios Administrarivos Ltda). The location of the actual testing labs is not specified. The studies are not clinical, so concepts like "retrospective" or "prospective" do not apply.

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 is a non-clinical submission. Ground truth, in the sense of expert opinion on clinical data, is not established. The "ground truth" for the non-clinical tests is established by the specifications of the referenced international and national standards (ISO, ASTM, USP, AAMI/ANSI).

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

• Not applicable. Adjudication methods are typically for evaluation of conflicting expert opinions or clinical outcomes, which is not the nature of this non-clinical 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. This is a submission for a dental implant system (hardware), not an AI/software device. An MRMC study is not relevant.

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

• No. This is a physical medical device. Not an algorithm.

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

• For the non-clinical performance data, the "ground truth" is defined by the requirements and test methodologies of the referenced industry standards (e.g., ISO 11137 for sterilization, ISO 10993-5 for biocompatibility, AAMI/ANSI ST72 and USP for pyrogenicity, SEM/EDS for material analysis). The demonstration is that the device conforms to these standards and shares equivalent characteristics with legally marketed predicate devices.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

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

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

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Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball).

HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm.

HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm.

CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm).

lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136).

The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).

The provided document is a 510(k) Summary for a dental implant system. It outlines the device description, intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence. Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of AI/ML-based medical devices.

The "Performance Data" section explicitly states: "No clinical data were included in this submission." Instead, it lists non-clinical data for physical and material properties of the dental implants, such as sterilization validation, shelf life testing, biocompatibility, and mechanical performance (fatigue and torsional loading).

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC comparative effectiveness studies, as these types of studies are not described in this 510(k) submission for a traditional medical device (dental implants), which are not a software device or AI/ML-based device.

If you are looking for information on acceptance criteria and study data for AI/ML-based medical devices, you would need to consult a different type of FDA submission, specifically for software as a medical device (SaMD) or AI-enabled medical devices, where such performance data would be critical for demonstrating safety and effectiveness.

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• HE (External Hex) implants, stock abutments and stock copings (originally cleared per K101207)
• Titamax CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 ● and extended per K123022, K133696 and K150199)
• Titamax CM (Cone Morse) EX implants, stock abutments and stock copings (originally cleared per K101945 and extended per K123022, K133696 and K150199)
• Alvim CM (Cone Morse) implants, stock abutments and stock copings (originally cleared per K101945 and ● extended per K123022, K133696 and K150199)
• CM (Cone Morse) Drive implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696, K150182 and K150199)
• GM (Grand Morse) Titamax implants, stock abutments and stock copings (originally cleared per K163194)
• GM (Grand Morse) Drive implants, stock abutments and stock copings (originally cleared per K163194) ●
• . GM (Grand Morse) Helix implants, stock abutments and stock copings (originally cleared per K163194)

The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

• Titamax WS implants, abutments and copings (originally cleared per K123022)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth to restore chewing function. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.

The Titamax WS implants are indicated for a delayed loading protocol.

• Facility implants, stock abutments and stock copings (originally cleared per K123022 and extended per K133696 and K150199)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth to restore chewing function. The Neodent Implant System may be used for single or multiple unit restorations. Multiple tooth applications may be rigidly splinted.

The Facility implants of the Neodent Implant System are indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

• Zygomatic implants, stock abutments and stock copings (originally cleared per K141777)
  The Zygomatic implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Zygomatic implants of the Neodent Implant System are indicated for surgical installation in the zygoma region in cases of severe jaw resorption in order to restore patient esthetics and chewing function. Zygomatic implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration.

• CM (Cone Morse) Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K150367 and extended per K153624)
• o GM (Grand Morse) Exact Titanium Base Abutment component of two-piece patient-specific abutment (originally cleared per K163194)

The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Titanium Base is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base Abutment are intended to be sent to Straumann for manufacture at a validated milling center.

• CM (Cone Morse) Titanium Base for CEREC Abutment component of two-piece patient-specific abutment (originally cleared per K160964)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Titanium Base for CEREC Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. They are used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

All digitally designed copings and/or crowns for use with the Neodent Titanium Base for CEREC Abutment are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.

• CM Preface Abutment component of patient-specific abutment (originally cleared per K150367)
  The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Preface Abutment is a titanium abutment to be used in fabricating a full custom abutment placed onto Neodent dental implants to provide support for customized prosthetic restorations. The Preface Abutments is indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.

All digitally designed restorations for use with the Neodent Preface Abutment are intended to be sent to Straumann for manufacture at a validated milling center.

• GM (Grand Morse) ProPEEK Abutments (originally cleared per K163194) ●
• CM (Cone Morse) ProPEEK Abutments (originally cleared per K170080)

The implants, abutments and copings of the Neodent Implant System are intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Pro PEEK Abutment is indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months.

• Neodent Implant for Orthodontic Anchor (originally cleared per K102769) ●
  The Neodent Implant for Orthodontic Anchor is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures.

• . The Neodent Graft Screw (originally cleared per K103084)
  The Neodent Graft Screw is an implantable device used for fixation of bone blocks for the regeneration of bone in the oral cavity. The product is intended for temporary use only.

Not Found

The provided text is a 510(k) Premarket Notification from the FDA regarding the MRI compatibility of various Neodent Implant System devices. It primarily focuses on defining the indications for use for different components of the implant system and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/Medical Device.

The document is a regulatory approval letter and descriptive indications for use, not a study report or technical performance assessment. Therefore, I cannot extract the requested information from this text.

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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Revolution Compact with a 6 mm length is intended for delayed loading only.

The subject device includes six product lines (Revolution Compact, Micro-Mini Revolution, Strong SW HE, TryOn, Strong SW HI). Five of the product lines have an external hex implant/abutment connection (HE) and one has an internal hex implant/abutment connection (HI). Each product line includes implants with an acid-etched surface and abutments in multiple designs (healing, provisional, cemented, UCLA, overdenture, conical and mini).

Revolution implants (Revolution Compact, Micro-Mini Revolution) are cylindrical implants with apical cutting flutes and are placed with the Revolution Assembler mount. Strong SW HI are cvlindrical implants with apical cutting flutes and micro-threads on the collar. Strong SW HE has and external connection and Strong SW HI has an internal connection. TryOn implants with apical cutting flutes and a machined collar. Subject Device components are made of commercially pure titanium, titanium alloy or cobalt-chromium alloy. All subject device abutments have 0° angulation.

This document is a 510(k) summary for the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use and technological characteristics, rather than presenting a performance study with acceptance criteria in the typical sense for a medical device with an AI/ML component.

Therefore, many of the requested details about acceptance criteria, study design, and AI performance metrics are not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria for a performance study in the way a clinical trial or AI validation study would. Instead, it demonstrates "substantial equivalence" of the S.I.N. Dental Implant System to existing predicate devices based on:

• Indications for Use: The subject device's indications align with those of multiple predicate devices.
• Technological Characteristics: Comparison of design (prosthesis attachment, restoration, implant/abutment interface, dimensions) and material composition (implant, surface, abutment, abutment screw) to predicate devices.
• Non-clinical Testing Data: This includes validation of sterilization, biocompatibility, endotoxin testing, and shelf-life testing. These are regulatory compliance criteria, not performance metrics related to diagnostic or predictive accuracy.

Reported Device Performance (in terms of substantial equivalence):

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not applicable. This document does not describe a performance study involving a "test set" of patient data for evaluating diagnostic or predictive accuracy. The testing mentioned is for non-clinical aspects (sterilization, biocompatibility, etc.), which would involve material samples or batches.
• Data Provenance: Not applicable in the context of patient data. The "data" refers to non-clinical testing results.

3. Number of Experts for Ground Truth and Their Qualifications

• Not applicable. This document pertains to the substantial equivalence of a physical dental implant system and does not involve AI/ML or a ground truth established by experts for diagnostic performance.

4. Adjudication Method

• Not applicable. There is no "adjudication method" described as it relates to expert consensus for a test set.

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

• No. This document explicitly states: "No clinical data were included in this submission." An MRMC study would fall under clinical effectiveness.

6. Standalone (Algorithm Only) Performance Study

• No. The device is a physical dental implant system, not a software algorithm.

7. Type of Ground Truth Used

• Not applicable. Not relevant for this type of device submission. The "truth" here relates to the physical and material properties meeting regulatory standards and being substantially equivalent to legally marketed devices, verified through laboratory testing and predicate comparisons.

8. Sample Size for the Training Set

• Not applicable. There is no "training set" as this device is not an AI/ML product.

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

• Not applicable. There is no "ground truth for a training set" as this device is not an AI/ML product.

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The Pro PEEK Abutments are indicated to be used on Neodent implants to provide temporary support for prosthesis structure for up to 6 months. They can be used in one or two stage procedures and also immediate load when there is good primary stability.

CM Pro PEEK abutments are temporary intermediary prosthetic components to be installed onto CM Implants to support the provisional prosthesis up to 6 months. They are composed of a customizable cylindrical body with an internal channel for the screw access and of a base for anti-rotational implant connection. The customizable portion is manufactured in PEEK (high performance polymer – specific for dental use) and the implant-to-abutment interface is made of titanium alloy. They have a coupled screw for fixing them to the Implant. They present a hexagonal indexing at the apical end of the Morse taper connection to provide anti-rotational feature to the implant-to-abutment connection, and facilitates proper alignment of the prosthesis to the implant. They are available in diameters of 4.5 and 6.0 mm and in lengths of 0.8, 1.5, 2.5, 3.5, 4.5 and 5.5 mm. The customization of the PEEK chimney must be done into the mouth of patient or chairside. Chairside customization means that the device preparation must be done in a controlled environment in the operating room, in the context of the prosthetic placement, in a surgical site's aseptic environment using sterilized tools. The dentist can wear the PEEK chimney with the aid of suitable techniques, high speed handpiece and cooling, according to the patient interocclusal space, respecting the minimum of 5mm of height. No customization is allowed for the diameter/ wall thickness of the abutment, as well as no angulation. No CAD/CAM design and fabrication is allowed for the CM Pro PEEK Abutments. Only hand-milling may be used for abutment modification. The CM Pro PEEK abutments can be used before the installation of the final prosthesis to maintain, stabilize and shape the soft tissue (gum) during the healing phase.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the "test set" in terms of number of devices for biocompatibility, mechanical, or sterilization testing. It mentions "samples" were submitted for testing.

The data provenance is from laboratory testing performed by or for JJGC Indústria e Comércio de Materiais Dentários SA, a company based in Curitiba, Parana, BRAZIL. The clinical data was not submitted or relied upon, so the testing is likely retrospective in the sense that it's laboratory data, not data gathered from human trials.

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

This information is not applicable as the studies conducted are laboratory-based performance tests (biocompatibility, mechanical, sterilization validation) and do not involve human interpretation or subjective assessment that would require expert ground truth establishment in the way it's typically understood for AI/diagnostic devices. The acceptance criteria are based on established international standards (ISO, ASTM) and FDA guidance documents.

4. Adjudication Method for the Test Set

This is not applicable for the type of laboratory performance studies described. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of medical images or clinical outcomes, which did not occur here.

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

No, an MRMC comparative effectiveness study was not done. The study involved laboratory performance testing of the device itself, not a comparison of human readers with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (dental abutment), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests consists of:

• Compliance with international standards: ISO 10993 series for biocompatibility, ISO 14801 and FDA Guidance for Mechanical Strength, ISO 11135 and ISO 10993-7 for Sterilization, and ASTM F1980, ISO 11737, US Pharmacopeia, ASTM E499/E499M, ASTM F1929, and ASTM F88/F88M for Shelf Life.
• Predicate device characteristics: The subject device's performance is compared against the established performance and characteristics of legally marketed predicate devices to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical dental abutment, not an AI model that requires a training set.

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

This information is not applicable as there is no training set for a physical device.

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Rodo Abutment System is intended to be used in conjunction with compatible implant systems in the maxillary or mandibular arch to provide support for crowns, bridges or overdentures.

The Rodo Abutment System includes the Rodo Abutment, Smileloc Sleeve, Silicone Seal, Titanium Coping, Temporary Cap, abutment screws, and Smileloc Activator (or Smileloc Remover). The Smileloc Sleeve is used to lock and unlock the Titanium Coping for final restoration to or from the abutment. This makes the prosthesis removable.

Rodo Abutment is provided in five series designs (100 F. 200 P. 300 S. 400 M. 500 D) with the 200 P and 500 D series having angled abutments (17°, 30°), for a total of nine designs. The 200 P and 500 D series are designed for multi-unit restorations only, the 300 S series is designed for limited occlusal space, and the 400 M series is designed for large interproximal spaces. Abutments are available in sizes ranging from 0 3.0 mm depending on the compatible implant system in use. Designs are available with engaging and non-engaging implant-abutment interfaces.

The provided document is a 510(k) summary for the Rodo Abutment System, a dental device. It outlines the device's indications for use, its classification, and a comparison to predicate devices, but does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in terms of algorithm-based metrics (like sensitivity, specificity, or AUC) as would be typical for an AI/ML device.

The closest information available that might relate to "acceptance criteria" for a medical device (not specifically an AI/ML device) typically involves demonstrating substantial equivalence to a legally marketed predicate device through various tests and comparisons.

Here's an analysis based on the provided document, addressing the requested points:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a physical dental abutment system and not an AI/ML device, there are no specific performance metrics like sensitivity, specificity, or accuracy mentioned as "acceptance criteria" for an algorithm. Instead, the "performance" is demonstrated through various non-clinical and clinical tests to show safety and effectiveness and substantial equivalence to predicate devices.

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

• Sample Size (Clinical Trial): 34 subjects were enrolled, 32 subjects received Rodo Abutments and restorations. Out of these, 3 subjects received 4 abutments each as part of full arch treatment, resulting in a total of 41 Rodo Abutments placed and restored.
• Data Provenance: The document states, "A prospective multi-center clinical trial... was conducted under an Investigational Device Exemption study according to FDA guidelines." This indicates it's prospective data. The document does not explicitly state the country of origin, but given the FDA submission context, it's presumed to be a US-based study or at least data acceptable for US regulatory purposes.

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

This information is not provided in the document. For a physical device like a dental abutment, "ground truth" might refer to clinical outcomes assessed by trained dental professionals, but the study description does not detail the number or qualifications of experts involved in assessing device performance or generating the "ground truth" of safety and effectiveness outcomes beyond the medical staff conducting the trial.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically relevant for studies where multiple readers interpret data and discrepancies need to be resolved, which is common in imaging studies for AI/ML devices. For a clinical trial of a physical implant, such a method for "test set" adjudication is not typically described in this manner.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating diagnostic performance, often of AI/ML systems or diagnostic tests, comparing multiple readers' interpretations of cases. The Rodo Abutment System is a physical dental device.

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

No, a standalone algorithm performance study was not done. The Rodo Abutment System is a physical dental device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" for evaluating the Rodo Abutment System's safety and effectiveness was based on clinical outcomes data from human subjects who received the device. This included:

• Observation of adverse events (e.g., abutment screw loosening, crown separation, non-device related events).
• The overall clinical assessment that the system "provides an appropriate method of attaching prosthetic restorations to dental implant abutments" and "if necessary, it allows repeated removal of the restoration."

For non-clinical tests, the "ground truth" was based on engineering standards and direct measurement/testing results (e.g., SAL for sterility, acceptable ranges for biocompatibility, mechanical strength, corrosion resistance).

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical and non-clinical data collected serve as validation for the device's design and manufacturing rather than training an algorithm.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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Titanium Base Abutment is a titanium base placed onto Neodent dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement-retained single or multi-unit restorations, or screw-retained single restorations.

PreFace Abutment is a titanium abutment to be used in fabricating a full custom abutment and placed onto Neodent dental implants to provide support for customized prosthetic restorations. PreFace Abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations.

The purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper abutment interface, mating abutments, abutment screws, and other associated components. This submission includes the Titanium Base Abutment, provided in two prosthetic platform diameters (3.5 and 4.5 mm), each in five gingival heights (0.8, 1.5, 2.5, 3.5 and 4.5 mm). Titanium Base is an abutment to be used as a base when fabricating a zirconia superstructure. This submission also includes the PreFace Abutment in two overall (milling) diameters of 11.5 and 15.8 mm. The PreFace Abutment with overall (milling) diameter of 15.8 mm is only used to mill an angled abutment.

PreFace is an abutment to be used in fabricating a full custom abutment in titanium alloy. After milling the minimum wall thickness for the PreFace must be no less than 0.4 mm, and the emergence profile diameter must be at least 3.3 mm. The maximum limit for angulation is 30°, and the maximum gingival height is 6 mm from the implant platform. In the case of an angled abutment, the cementable height from the emergence profile (prosthetic height) must not exceed 6 mm. The total height of the abutment (above the implant-abutment connection platform) must be no greater than 14.2 mm and no shorter than 4 mm. The range for the abutment body diameter (above the implant-abutment connection platform) is 3.3 mm. The implant interface must remain intact and cannot be modified.

The subject abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The subject abutments are compatible with Neodent dental implants having the Morse taper interface cleared in K101945, K123022 and K133592.

The provided text is a 510(k) Summary for the Neodent Implant System. It describes a medical device approval and focuses on demonstrating substantial equivalence to existing predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics, ground truth, or expert consensus.

Therefore, many of the requested elements regarding acceptance criteria, study design, expert qualifications, and ground truth are not present in this type of regulatory document.

However, I can extract information related to performance data and comparison to predicate devices, which serve as a form of "acceptance criteria" in the context of substantial equivalence.

Here's an attempt to answer your request based on the provided document:

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

In the context of a 510(k) submission, "acceptance criteria" are typically demonstrating substantial equivalence to legally marketed predicate devices through comparison of technological characteristics and performance data. The reported "performance" is that the new device is at least as good as, or substantially equivalent to, the predicates.

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

• Sample Size for Test Set: Not specified in the document. The performance data mentioned are "non-clinical" (biocompatibility, engineering analysis, dimensional analysis, mechanical testing, sterilization testing). For mechanical testing (ISO 14801), sample sizes are not detailed, but such standards typically require a specific number of samples for statistically valid testing.
• Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification from a Brazilian manufacturer (JJGC Indústria e Comércio de Materiais Dentários SA) to the U.S. FDA, meaning the testing data would typically be generated by or for the manufacturer. The data is non-clinical, likely from laboratory testing. It is not clinical data (no "retrospective or prospective" clinical studies are mentioned).

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 information is not applicable and not provided in the document. The document describes a medical device (dental implant abutments) that undergoes non-clinical engineering and material testing, not diagnostic performance evaluation requiring ground truth established by experts.

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

• This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies or performance evaluations where there's subjectivity and disagreement among reviewers (e.g., in imaging interpretation). The tests described are objective, non-clinical tests (e.g., mechanical fatigue, sterilization parameters).

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices that assist human interpretation, which is not the nature of the dental implant abutments described.

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

• No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device. The "performance data" refers to the physical and material properties of the abutments.

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

• This information is not applicable and not provided in the document as it pertains to non-clinical engineering and material testing. The "ground truth" for mechanical testing, for example, would be the physical measurement of failure points or fatigue limits compared against a standard. For biocompatibility, it's compliance with ISO standards.

8. The sample size for the training set

• This information is not applicable and not provided in the document. There is no AI or algorithm involved that would require a "training set."

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

• This information is not applicable and not provided in the document as there is no training set mentioned.

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