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The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging, is intended for use in the creation of a customized abutment for a cement-retained crown or bridge, or a customized screw-retained restoration.

The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Non-Engaging, is intended for use in the creation of customized multiple-unit restorations on implants (e.g., bars and bridges), when anti-rotation of the abutment is not necessary.

The purpose of an abutment with Cast-to capabilities is to satisfy customer needs of attaching cast framework prostheses to an abutment. The nonengaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The engaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast a single abutment for a cement-retained crown or bridge and frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System is designed for use with Zimmer 3.1mmD Dental Implant System to support cast framework prostheses. The engaging abutment/implant interface is an internal conical connection with a hex. The non-engaging abutment/implant interface is a connection that sits on top of the implant but does also has cylindrical features that sit passively within the implant.

The abutment is composed of Gold Alloy 6019 and secured to the implant with a separate Titanium alloy screw for retention.

The provided text is a 510(k) Premarket Notification for a medical device (Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed acceptance criteria table and a study proving the device meets those criteria in the way a clinical trial or performance study for a novel device would.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert consensus, and comparative effectiveness studies is not present in this document, as it is not typically required or included in a 510(k) submission for this type of device.

However, I can extract the information that is available and indicate where the requested information is not provided.

Acceptance Criteria and Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative targets and corresponding device performance data for the Zimmer Cast-to Gold Abutments in isolation. Instead, it relies on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical testing.

The acceptance criteria are implicitly met by showing that the device performs at least as well as the predicate device in relevant non-clinical tests, and that differences do not raise new questions of safety or effectiveness.

Study Details

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

   • Test Set Sample Size: Not specified. The non-clinical testing involved fatigue and compression tests on physical samples of the device. The exact number of samples used for these tests is not provided in this summary.
   • Data Provenance: Not specified, but likely from in-house or contracted laboratory testing based on the standards cited. The document does not mention country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable/Not specified. Ground truth as typically understood in AI/clinical studies (e.g., expert consensus on diagnoses) is not relevant for this type of mechanical engineering performance testing. The "ground truth" for the mechanical tests would be the established engineering standards and physical measurements.

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

   • Not applicable/Not specified. Adjudication methods are typically used in clinical imaging studies to resolve discrepancies in expert interpretations. This document describes mechanical testing.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • No. This is a mechanical device, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant.

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

   • No. This is a mechanical device. Standalone algorithm performance is not applicable.

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

   • The "ground truth" for the non-clinical tests would be the physical and mechanical properties measured against established engineering standards (ISO 14801:2007) and FDA guidance limits. For biocompatibility, the ground truth was based on previous testing of the predicate device's material (Gold Alloy 6019) in compliance with ISO 10993-1.

7. The sample size for the training set

   • Not applicable/Not specified. There is no mention of a "training set" as this is not an AI/machine learning device.

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

   • Not applicable. There is no training set for this type of mechanical device submission.

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Zimmer 3.1mmD Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer 3.1mmD Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical). The Zimmer 3.1mmD Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.

The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a singleor multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration.

The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cementretained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations.

The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired.

The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.

The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing.

The Retaining Screws are intended to be used for securing the temporary abutments, final abutments and impression transfers to the implant or implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions.

The Zimmer 3.1mmD Dental Implant System consists of 3.1mm threaded endosseous dental implants, as well as prosthetic components, and ancillary components for placement and restoration of these implants. The prosthetic components include 2.9mm Angled Abutment, 2.9mm Angled Abutment, Straight Hex, 2.9mm Contour Abutment, 2.9mm Contour Abutment, Straight Hex , 2.9mm Temporary Abutment, and 2.9mm Ball Abutment. The 2.9mm Angled, 2.9mm Contour, and 2.9mm Temporary Abutments are made to support single or multiple unit restorations. The 2.9mm Ball Abutments are made to support overdentures. The ancillary components for the Zimmer 3.1mmD Dental Implant System include 2.9mm Healing Collars and 2.9mm Healing Screws which are used during the healing process.

Zimmer 3.1mmD Dental Implant is an endosseous dental implant composed of titanium alloy. The implant body is designed for ease of implantation and with greater surface area for osseointegration. The implant surface is treated to facilitate osseointegration. In addition, the implant body is tapered with triple-lead threads. The Zimmer Dental 3.1mmD Dental Implant is currently offered in 3.1mm diameter in lengths of 8, 10, 11.5, 13, and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1: Tapered Screw-Vent Implant Dental Implant. The implant-abutment interface platform diameter will be offered in a size of 2.9mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants.

The Abutments, Healing Collars, and Healing Screw are titanium alloy devices that are made to mate with the Zimmer 3.1mmD Dental Implant, which is also made of titanium alloy. The abutments are designed for use as a terminal or intermediate abutment prostheses.

The provided text is a 510(k) Premarket Notification for the Zimmer 3.1mmD Dental Implant System. It describes a medical device, not a diagnostic AI system, therefore most of the requested information regarding AI study design and performance metrics is not applicable.

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

Acceptance Criteria and Device Performance for Zimmer 3.1mmD Dental Implant System

The Zimmer 3.1mmD Dental Implant System is evaluated based on non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on mechanical performance and MRI compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that non-clinical testing indicates the new devices are "strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device(s)." It also confirms that the device "poses no additional restrictions on MRI beyond those that would otherwise occur for the patient."

While specific numerical acceptance criteria (e.g., minimum fatigue strength in MPa or compression load in N) and exact reported device performance values are not explicitly provided in this summary, the general acceptance criteria can be inferred from the nature of the tests and the conclusions drawn:

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: The document does not specify the sample size used for the fatigue, compression, or MRI compatibility tests. It only states "Non-clinical test data was used."
• Data Provenance: The tests were non-clinical, meaning they were likely conducted in a laboratory setting by Zimmer Dental Inc. The country of origin for the data is not specified, but the applicant information is for Zimmer Dental Inc. in Carlsbad, CA, USA. The data is prospective, as it involves testing of the new device.

3. Number of Experts and Qualifications for Ground Truth

• This is not applicable as the device is a dental implant system being evaluated through non-clinical mechanical and physical property testing, not an AI diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• This is not applicable, as the evaluation is based on objective measurements from mechanical and physical testing, not subjective expert judgment, which would require adjudication.

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

• This is not applicable. The document describes a medical device (dental implant and associated components), not a diagnostic AI system. Therefore, no MRMC study testing human reader improvement with or without AI assistance was performed.

6. Standalone (Algorithm Only) Performance Study

• This is not applicable. The device is a physical dental implant system, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements derived from standardized non-clinical performance tests conforming to FDA guidance and ASTM standards. Specifically:

• Mechanical Integrity: Measured by fatigue and compression testing results.
• MRI Compatibility: Measured by interactions with magnetic fields during MRI.

8. Sample Size for the Training Set

• This is not applicable. The product is a physical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

• This is not applicable, as there is no training set for an AI model.

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The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm, or 6.0mm Platform.

The Zimmer Zfx Titanium Abutment for the Biomet 3i Certain implant system is designed for use with Biomet 3i internal connection implants to support single or multi tooth restorations. The abutment/implant interface is an internal hexagonal connection.

The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.

The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.

The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention.

The new abutment will be offered in 3.4mm, 4.1mm, 5.0mm and 6.0mm implant platforms.

The document describes a 510(k) premarket notification for the "Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System." This submission focuses on establishing substantial equivalence to existing predicate devices through non-clinical testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table for all features. Instead, it describes compatibility and mechanical fatigue testing. The performance is demonstrated by the results of these tests, which support the claim of substantial equivalence.

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

• Test Set Sample Size: The document does not specify exact sample sizes for all tests. For "fatigue testing," it mentions "Zimmer Dental fabricated abutments assembled to OEM implants," but the number of samples is not provided.
• Data Provenance: The testing was conducted by Zimmer Dental. The data is from non-clinical laboratory testing performed by the company to support their 510(k) submission. It is prospective in terms of the device being tested, but based on established methods. The country of origin for the data is not explicitly stated but can be inferred to be the USA, given the submission location and company address.

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

• Number of experts: This information is not applicable. The "ground truth" for non-clinical testing is typically based on established engineering standards, material science principles, and FDA guidance documents, rather than expert consensus on a test set in the way it would be for a diagnostic AI device.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not applicable. As this is non-clinical testing of a physical device, there is no "adjudication" in the sense of reconciling expert opinions on observations. The performance is measured against predefined technical standards and predicate device data.

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

• MRMC study: No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often assisted by AI. The device in question is a dental implant abutment, meaning it's a physical medical device.

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

• Standalone performance: Not applicable. This device is a physical medical device (an abutment), not an algorithm or AI system. Therefore, standalone performance of an algorithm is not relevant.

7. The type of ground truth used

• Ground Truth: The "ground truth" for this submission relies on:
  • Established engineering specifications and measurements: For reverse engineering and dimensional compatibility.
  • FDA guidance documents and recognized standards: Such as the "Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments" for mechanical fatigue testing, and "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" for MRI safety.
  • Predicate device data: For comparison of fatigue test results.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The device design and manufacturing processes are developed based on engineering principles and knowledge, not through machine learning training.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for a physical medical device in this context.

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The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Straumann Bone Level implants with a Narrow CrossFit Connection (NC) Ø3.3mm or Regular Crossfit Connection (RC) Ø4.1mm or Ø4.8mm.

The Zimmer Zfx Titanium Abutment for the Straumann Bone Level implant system is designed for use with Straumann Bone Level implants to support single or multi tooth restorations. The abutment/implant interface is a conical connection with 4 grooves for insertion guidance.

The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.

The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.

The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention.

The new abutment will be offered in Narrow CrossFit (NC) Ø 3.3mm and Regular CrossFit (RC) Ø 4.1mm or Ø 4.8mm implant connection sizes.

The provided document is a 510(k) Pre-Market Notification for a dental abutment, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with a test set of data. Therefore, many of the requested elements for AI/machine learning device studies are not applicable to this document.

However, I can extract information related to the non-clinical testing performed to support the substantial equivalence claim.

Here's the breakdown based on the provided document:

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

The document does not explicitly define acceptance criteria in a quantitative table format for performance metrics like accuracy, sensitivity, or specificity, as would be expected for an AI/ML device. Instead, "acceptance criteria" are implied by demonstrating compatibility and equivalent mechanical performance to a predicate device through non-clinical testing.

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

• Sample Size for Test Set: The document does not specify a "test set" in the context of an AI/ML study, but for non-clinical testing:
  • Reverse Engineering: Based on "actual measurements taken from Straumann Bone Level implants, abutments and retaining screws." The exact number of units measured is not specified.
  • Fatigue Testing: The number of Zimmer fabricated abutments and OEM implants used for fatigue testing is not specified.
• Data Provenance: The data is internally generated from non-clinical laboratory testing performed by Zimmer Dental Inc. (USA) and references FDA guidance documents. This is prospective data collection for the purpose of regulatory submission.

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

Not applicable. This is not an AI/ML study involving human expert ground truth for classification or diagnosis. The "ground truth" for compatibility and mechanical performance was established through engineering analysis and physical testing against established standards and predicate device performance.

4. Adjudication method for the test set

Not applicable. No expert adjudication method was employed as it was not an AI/ML study requiring human interpretation or consensus for a "test set."

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 medical device submission for a physical dental abutment, not an AI/ML software. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a physical dental abutment, not an algorithm.

7. The type of ground truth used

For the non-clinical testing:

• Compatibility: "Ground truth" was established by reverse engineering measurements of existing, legally marketed Straumann Bone Level implant components and developing dimensional specifications, and by conducting tolerance and rotational analyses to ensure proper fit.
• Mechanical Fatigue: "Ground truth" was established by comparing the fatigue test results of the new device to the fatigue testing data of the predicate device (#3, Straumann Bone Level Anatomic Abutment), as well as adherence to FDA guidance standards for dental implant abutments.
• Sterilization: Validation against a minimum sterility assurance level (SAL) of 10⁻⁶, a recognized standard.
• MRI Safety: Adherence to FDA guidance for assessing passive implants in an MR environment.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set.

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

Not applicable. There is no training set for an AI/ML model.

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The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a straight or angled two piece abutment. The combination of the titanium base stock abutment and the abutment coping is designed for use as a terminal or intermediate abutment for cement or screw retained prostheses. The two-piece abutment is used for a single-unit or multi-unit (bridge) restoration. The Zimmer ZFx Abutment Coping shall be manufactured by an approved Zimmer Dental milling facility.

The Zimmer Zfx Titanium Base Abutment is a combination of a pre-manufactured (stock) abutment and the Zimmer Zfx Abutment Coping or Crown as part of a two piece abutment. The abutment is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment is used for single unit restorations in the anterior and posterior regions. The abutment base will be made available in 3.5, 4.5 and 5.7mm platforms. The Zimmer Zfx Titanium Base serves as a bonding base that allows for cementation of a patient-specific restoration. Copings, crowns and bridges can be used with the Zimmer Zfx Titanium Base.

The Zimmer Zfx Abutment Coping is a zirconia mesostructure component that would be cemented onto the Zimmer Zfx Titanium Base Abutment to form the two-piece abutment. These componenents will be manufactured from zirconia or IPS e.Max. The maximum angulation that is allowed is 20°. The two piece abutment would then be able to be used as a terminal or intermediate abutment for cement or screw retained prostheses that is for a single or multi-unit (bridge) restoration. The Zimmer Zfx Abutment Coping would require a separate crown to be cemented onto the coping or direct veneering to be applied.

The provided text is a 510(k) Pre-Market Notification for the Zimmer Zfx Titanium Base Abutment. This document is a regulatory submission to the FDA, not a study report. Therefore, it does not contain a typical "acceptance criteria" table or a detailed "study" proving the device meets specific performance criteria in the way an academic or clinical study would.

Instead, the submission aims to demonstrate substantial equivalence to existing legally marketed predicate devices. This means showing that the new device is as safe and effective as devices already on the market, rather than meeting novel performance metrics.

Here's an analysis based on the information provided, addressing your points where possible and noting where information is not applicable to this type of document:

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

This document does not present a formal "acceptance criteria" table with specific quantitative performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/algorithm-based medical device study.

Instead, the "performance" is demonstrated by showing "substantial equivalence" through:

• Identical intended use, materials, and abutment/implant interface design when compared to predicate devices.
• Non-clinical mechanical testing demonstrating equivalence in mechanical strength.

The table in Section 7 ("Technological Characteristics") compares features of the new device to predicate devices, showing similarities in:

• Indications for Use
• Implant Interface (Internal Hex)
• Abutment Platform Diameter (3.5mm, 4.5mm, 5.7mm)
• Material (Titanium 6Al-4V for base, Zirconia for coping/crown)
• Compatibility with CAD/CAM and Traditional patient-specific restorations

The implied acceptance criteria are that the new device's characteristics and mechanical performance should be no worse than the predicate devices. The reported "performance" is that it meets or exceeds these aspects.

2. Sample size 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. The "tests" mentioned are non-clinical mechanical tests, not clinical trials with human subjects. Thus, there's no "test set" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a submission for a dental abutment, not an AI or diagnostic device that requires expert-established ground truth from images or patient data. The "ground truth" for mechanical testing would be engineering specifications and ASTM/ISO standards, assessed by engineers, not medical experts establishing diagnostic ground truth.

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

Not applicable. As above, this is mechanical testing of a physical device, not an AI or diagnostic device that involves human perception or interpretation requiring adjudication.

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. No MRMC study was conducted or is relevant.

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

Not applicable. This device does not involve an algorithm.

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

For the non-clinical mechanical testing, the "ground truth" would be established by relevant engineering standards (e.g., ISO, ASTM for dental implants and abutments) and direct physical measurements of mechanical strength (e.g., fatigue strength, fracture resistance) evaluated against established benchmarks for similar devices, particularly the predicate devices. The text states:

• "The first test consisted of the Titanium base portion of the new device assembled in an abutment test setup. A hemispherical test cap, representing a final restoration, was cemented directly to the Titanium base portion of the device. The results demonstrated that the Titanium base portion of the new device is equivalent to the currently marketed Zimmer Hex Lock Abutment (K011028)."
• "The second test evaluated the new device as a two-piece abutment system... The results demonstrated that the two-piece abutment system is substantially equivalent to the currently marketed Zimmer Pre-Angled Ti Abutment (K011028)."

The ground truth here is the established mechanical performance of identical or very similar legally marketed devices.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI or machine learning model 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 a physical device.

Summary of Acceptance Criteria and Proving Device Meets Them for this 510(k) Submission:

• Acceptance Criteria (Implied - Substantial Equivalence):

  • Indications for Use: Must be substantially similar to predicate devices.
  • Technological Characteristics: Must have similar design features, materials, and dimensions to predicate devices.
  • Safety & Effectiveness: Non-clinical mechanical testing must demonstrate performance (e.g., mechanical strength) equivalent to or better than predicate devices.
  • No new questions of safety or effectiveness.

• Study Proving Acceptance:

  • Non-Clinical Mechanical Testing:
    • Device Tested: Zimmer Zfx Titanium Base Abutment (both as a single component and as a two-piece system with a zirconia mesostructure).
    • Methodology: Two distinct mechanical tests were conducted:
      1. One for the Titanium base portion with a cemented hemispherical test cap.
      2. One for the two-piece abutment system (Titanium base + 20-degree angulated Zirconia mesostructure).
    • Comparison: The results were compared to the already marketed predicate devices: Zimmer Hex Lock Abutment (K011028) for the base portion and Zimmer Pre-Angled Ti Abutment (K011028) for the two-piece system.
    • Results: The tests demonstrated that the new device (both components and the system) is equivalent or substantially equivalent in mechanical strength to its respective predicate devices.
  • MRI Compatibility Evaluation: Zimmer Dental implant systems were evaluated for interactions with magnetic fields during MRI, in accordance with FDA guidance. (No specific results provided, but implying compliance).
  • Clinical Testing: Not performed. The justification was that the device is not significantly different from the predicate device and shares the same design features, technological characteristics, and indications for use.

In essence, for a 510(k) submission like this, the "study" demonstrating that the device meets "acceptance criteria" is a comparative analysis and non-clinical mechanical testing to prove it is as safe and effective as a device already approved for market (a predicate device), rather than meeting novel, pre-defined performance thresholds for a new capability.

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The Zimmer Zfx Titanium Abutment for NobelActive Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelActive and NobelReplace Conical Connection implants with a Narrow Platform (NP) Ø 3.5mm or Regular Platform (RP) Ø 3.9mm

The Zimmer Zfx Titanium Abutment for the NobelActive Implant system is designed for use with NobelActive and NobelReplace Conical Connection endosseous dental implants to support single or multi tooth restorations. The abutment/implant interface is an internal conical connection with a hexagonal interlock.

The Zimmer Zfx Titanium Abutment for NobelActive Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.

The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.

The abutment is composed of Titanium alloy (Ti6Al4V), and is secured to the implant with a separate Titanium alloy screw for retention.

The new abutments will all be available with a choice of 3.5mm and 3.9mm implant platform diameters.

This is a premarket notification for a dental abutment, a mechanical component, not an AI/ML device, therefore, the requested information regarding acceptance criteria and studies are not applicable in the context of AI/ML.

Here's why and what information is available about the non-clinical testing:

Device Type: The device is a "Zimmer Zfx Titanium Abutment for NobelActive Implant System," which is an endosseous dental implant abutment. This is a physical, mechanical medical device.

Absence of AI/ML Specifics: The document describes the materials, design, indications for use, and non-clinical testing (mechanical and compatibility) for this physical component. There is no mention of artificial intelligence, machine learning, or any software-based diagnostic or predictive capabilities. Therefore, criteria such as "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML (e.g., sensitivity, specificity, AUC) are not relevant here.

However, I can extract information related to the non-clinical testing performed to determine substantial equivalence as described in the document:

The non-clinical testing aimed to support the decision of substantial equivalence to predicate devices, focusing on fit, function, and safety of the mechanical component.

1. Table of Acceptance Criteria and Reported Device Performance (as pertains to non-clinical testing for a mechanical device):

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

• Mechanical Fatigue Testing: The document states "fatigue testing was completed using Zimmer fabricated abutments assembled to OEM implants." No specific sample size (N) for the number of abutments or implants tested is provided in this summary.
• Data Provenance: The testing was conducted by Zimmer Dental Inc. in support of their 510(k) submission. It is internal testing performed by the manufacturer. It is retrospective in the sense that it was done to support a pre-market submission, not ongoing clinical data collection.
• MRI Compatibility: Implied to be laboratory testing rather than patient data.

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

• Not applicable as this is a mechanical device evaluation, not an expert-driven diagnostic assessment. Ground truth is based on engineering specifications and physical test results against established standards.

4. Adjudication method for the test set:

• Not applicable for a mechanical device. The "adjudication" is through physical testing results and engineering analysis.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is not an AI/ML diagnostic tool and thus does not involve "human readers" or "AI assistance."

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

• Compatibility & Dimensional Fit: Engineering drawings, physical measurements of predicate devices, and established dimensional tolerances.
• Mechanical Fatigue Testing: Industry standards (FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments) and performance data from legally marketed predicate devices.
• Sterilization: Regulatory standards for Sterility Assurance Level (SAL) of 10^-6.
• MRI Compatibility: FDA guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set. The "design input" could be considered analogous, which would include the engineering specifications and reverse-engineered dimensions from predicate devices.

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

• Not applicable. No training set is used for this type of device. The design specifications were derived from reverse engineering existing compatible systems and industry standards.

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The Zimmer Dental Tapered Screw-Vent®T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are a self-tapping, screw type endosseous dental implant designed for bone level placement and can be used in a single or two stage protocol. The implant is composed of titanium alloy with hydroxylapatite (HA) coating, and has a tapered body with an external triple lead thread design. Identical to predicate #1, the new device has the same implant to abutment internal hex friction-fit connection. The new device will have coronal microgrooves that extend to the collar within 0.64mm of the top of the implant identical to predicate #2.

The new implant will be offered in two surface finish configurations at the coronal end: full MTX texturing to the top of the implant and partial MTX texturing to 0.5mm from the top of the implant leaving a machined collar. Both coronal configurations are identical to the currently marketed predicate #2 device (K101977, K111889).

The Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated family is composed of tapered implants with a choice of diameters and lengths. Both implant configurations, machined and fully textured collar, will be available in diameters of 3.7mm, 4.1mm, 4.7mm, and 6.0mm and in five lengths: 8, 10, 11.5, 13, and 16mm. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. The drilling sequences and drills that will be utilized to place the new device are pre-existing sequences and drills that are listed in the previous 510(k) K011028.

The provided document describes a pre-market notification (510(k)) for dental implants. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as would be typical for AI/Software as a Medical Device (SaMD).

Instead, this K133339 submission focuses on demonstrating substantial equivalence of a new dental implant (Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated) to existing predicate devices already on the market.

Therefore, many of the requested criteria in your prompt are not applicable to this type of medical device submission.

Here's an analysis based on the information available:

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

The document does not specify performance-based acceptance criteria (e.g., accuracy, sensitivity, etc.) because it is for a physical dental implant, not AI/SaMD. The "acceptance criteria" here are related to demonstrating substantial equivalence in terms of design, materials, indications for use, and mechanical performance compared to predicate devices.

The non-clinical testing sections hint at the performance criteria:

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

For the non-clinical mechanical testing (fatigue and compression), the document does not specify the sample size used. It only states that "Non-clinical test data was used to support the decision of substantial equivalence." Details like the number of implants tested or the specific test conditions (e.g., cycles for fatigue) are not provided in this summary.

Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for this type of mechanical device testing.

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

This is not applicable. The "ground truth" for mechanical testing of implants involves engineering specifications and performance standards, not expert clinical interpretation.

4. Adjudication method for the test set

Not applicable for mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical dental implant, not an AI/SaMD. No MRMC study was conducted.

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

Not applicable. This is a physical dental implant, not an algorithm.

7. The type of ground truth used

For the mechanical tests (fatigue and compression), the "ground truth" would be established by specified engineering standards and regulatory guidance documents (e.g., FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments). For MRI safety, it relates to the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/SaMD.

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

Not applicable. There is no training set as this is not an AI/SaMD.

In summary:

This 510(k) submission primarily relies on demonstrating substantial equivalence to already legally marketed devices through:

• Design comparison: Showing the new device has the same fundamental technology, materials, and intended use as predicate devices. The key differences (coronal microgrooves, surface finish configurations) were shown to be identical to different aspects of existing predicate devices.
• Non-clinical testing: Mechanical tests (fatigue and compression) and MRI compatibility were performed to ensure the new device meets established performance standards and is safe. The document states these tests "demonstrated improvements over the predicate device" in mechanical strength, suggesting the new design's modifications did not negatively impact performance and might have enhanced it.
• No clinical testing: The submission explicitly states, "No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence." This is common for devices demonstrating substantial equivalence where the risks are well understood and adequately addressed by non-clinical means.

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The Zimmer Trabecular Metal Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The 3.7mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.
The 4.1mmD Zimmer Trabecular Metal Implants should be splinted to additional implants when used in the molar region.
The 4.1mmD x 8mmL Zimmer Trabecular Metal Implant should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

Trabecular Metal Implant is an endosseous dental implant composed of titanium alloy and Trabecular Metal (tantalum). The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with triple-lead threads.

The Trabecular Metal Implant family is currently offered in 4.1. 4.7, and 6.0mm diameters in lengths of 8. 10. 11.5. 13. and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1 : Trabecular Metal Dental Implant. An additional Trabecular Metal implant with a new diameter of 3.7mmD will be offered in lengths of 10, 11.5, 13 and 16mmL. The implant-abutment interface platform diameter will be offered in a size of 3.5mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.

This document describes a 510(k) premarket notification for a medical device, the Zimmer Trabecular Metal Implant. For medical devices, "acceptance criteria" and "device performance" are typically related to the physical and mechanical properties of the device, and the "study" proving these are usually non-clinical (laboratory) tests. Clinical studies (with human subjects) are often not required for 510(k) clearances, especially if substantial equivalence to a predicate device can be demonstrated through non-clinical testing.

Here's the breakdown of the requested information based on the provided text, focusing on the absence of typical "AI/software algorithm" acceptance criteria and studies, as this is a dental implant:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative table format as might be seen for software performance metrics (e.g., sensitivity, specificity thresholds). Instead, it refers to performance standards for mechanical properties.

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

• Sample Size for Test Set: Not explicitly stated. Non-clinical mechanical testing typically uses a certain number of samples, but the exact count is not provided in this summary.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no mention of country of origin for data as it's not patient data, nor is there a retrospective or prospective nature to the data.

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

This is not applicable for non-clinical mechanical testing of a dental implant. "Ground truth" in this context refers to established engineering standards and guidelines for mechanical performance, not expert medical consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical imaging studies. This document describes mechanical testing.

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

No. An MRMC study is a clinical study comparing human reader performance, often with and without AI assistance. This document explicitly states: "No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence."

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

No. This device is a physical dental implant, not a software algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for non-clinical testing is based on established engineering principles, industry standards (e.g., ISO standards for dental implants), and FDA guidance documents (specifically, the Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments). The device's ability to resist fatigue, compression, and maintain torque strength constitutes the "truth" against these predefined benchmarks.

8. The Sample Size for the Training Set

No. This is not applicable to the development and testing of a physical medical device like a dental implant. "Training set" refers to data used to train machine learning models.

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

Not applicable. As noted above, this relates to machine learning models, not physical device engineering.

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The Zimmer Zfx Abutment for Nobel Replace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedy abutinent our be access with a Narrow Platform (NP) Ø 3.5 mm, Regular Platform (RP) Ø 4.3 mm, Wide Platform (WP) Ø 5.0 mm or 6.0 Platform (6.0) Ø 6.0 mm.

The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles. They frequently incorporate the modifications typically done at a dental laboratory or "chair-size" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, the Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.

The Zimmer Zfx Abutment for NobelReplace Implant System is a dental implant abutment with a fixed competitor compatible interface. It is designed for use with NobelReplace endosseous dental implants to support single or multi tooth restorations. The abutment-implant interface is an internal tri-lobe. The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.

The abutment is composed of Titanium alloy (Ti6AI4V) and it is secured to the implant with a separate Titanium allov screw for retention.

The new abutment will be available with a choice of 3.5mm, 4.3mm, 5.0mm, and 6.0mm platform diameters. The maximum abutment anqulation will be 20°. The new abutment will interface with Nobel Replace implants with an internal tri-lobe connection.

This document describes the Zimmer Zfx Abutment for NobelReplace Implant System, a dental implant abutment. The submission is a Traditional 510(k) Premarket Notification (K120873) seeking to demonstrate substantial equivalence to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document implicitly defines acceptance criteria through the comparison of the new device to established predicate devices and the performance of non-clinical mechanical fatigue testing. The primary acceptance criterion appears to be demonstrating substantial equivalence to the predicate devices regarding material, general design features, and mechanical suitability.

The device performance is reported as meeting these criteria, as stated in the conclusion: "Based on our analysis, the device is substantially equivalent to the predicate."

Here's the table of acceptance criteria and reported device performance, derived from the comparison to predicate devices and testing described:

Study Information:

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

   • Test Set Sample Size: The document does not specify the exact sample size for the mechanical fatigue testing. It states that "all sizes" of the implant/abutment assembly were tested. The reference to "actual measurements taken off NobelReplace implants, abutments and retaining screws" suggests a physical sampling of these predicate devices for reverse engineering.
   • Data Provenance: The testing was non-clinical. The information does not specify the country of origin for the components used in testing, but the company is US-based (Carlsbad, CA). The data is prospective in relation to the new device's design and verification.

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

   • Number of Experts: Not applicable. The "ground truth" for the test set (e.g., dimensional specifications, mechanical performance) was established through engineering analysis, reverse engineering, and mechanical testing, not through expert consensus on medical images or clinical outcomes.
   • Qualifications of Experts: The work was performed by Zimmer Dental Inc.'s engineering and regulatory teams, as implied by the non-clinical testing and internal documentation. Specific qualifications of individuals are not provided.

3. Adjudication method for the test set:

   • Adjudication method: Not applicable in the traditional sense (e.g., 2+1, 3+1 for clinical assessments). The "adjudication" of the non-clinical test results would have been an internal review and comparison by Zimmer Dental's engineering and regulatory personnel against established standards (e.g., FDA guidance, internal specifications, predicate device data).

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:

   • MRMC Study: No. This device is a dental abutment, a manufactured physical component, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI-related effectiveness are not relevant or discussed.

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

   • Standalone Performance: Not applicable. As noted above, this is a physical medical device, not an algorithm or AI system.

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

   • Ground Truth Type:
     • For dimensional and interface compatibility: The "ground truth" was derived from physical measurements (reverse engineering) of the actual NobelReplace predicate implants and abutments. This provides a factual basis for interface design.
     • For mechanical fatigue: The "ground truth" involved mechanical test data generated from the predicate NobelReplace device, established according to FDA guidance (Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments). The new device's performance was then compared to this established predicate data.

7. The sample size for the training set:

   • Training Set Sample Size: Not applicable. This is a physical device, not a machine learning model.

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

   • Ground Truth for Training Set: Not applicable. This is a physical device, not a machine learning model.

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The Zfx Dental CAD System is intended to allow the user to acquire patient specific data via a scan or digital file and define the shapes of dental prosthetic devices such as dental abutments, crowns, bridges, copings, in-lays, on-lays, and veneers through the use of a 3D-CAD tool. Zfx Dental CAD System creates an output file of the restorations designed by the user that can be manufactured using a CAM system.

The Zfx Dental CAD system is software that is used to design dental restorative prosthetic devices from digital optical impressions. The software receives topographical characteristics of dental impressions or stone models from a compatible scanning system. The design created in the software is complied into a format enabling manufacturing of a patient specific component at Zimmer Dental. The CAD software is pre-installed on a Windows compatible computer system.

Here's an analysis of the acceptance criteria and study information for the Zfx Dental CAD System, based on the provided text:

Important Note: The provided document is a 510(k) summary, which often focuses on substantial equivalence to predicate devices rather than formal acceptance criteria and detailed clinical study results for a new medical device claiming performance improvements. As such, some of the requested information (like specific quantifiable acceptance criteria, effect sizes, and detailed ground truth acquisition for training data) is not present in this type of submission.

Acceptance Criteria and Device Performance

Study Information

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

   • The document does not specify a distinct "test set" sample size in terms of number of patient cases or designs.
   • The testing described is verification and validation, implying an internal product development and testing process, rather than a clinical trial with a patient-specific test set.
   • Data provenance is not specified regarding country of origin or whether it was retrospective/prospective.

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

   • This information is not provided. Since no clinical testing was performed, and the testing was focused on software and manufacturing capabilities, the concept of "ground truth" as established by medical experts for diagnostic accuracy doesn't directly apply in the way it would for an AI-diagnostic device. The "ground truth" for the device's function would be its adherence to design specifications and manufacturing capabilities.

3. Adjudication method for the test set:

   • Not applicable as this was not a clinical study involving human interpretation of medical images or data requiring adjudication. The verification and validation process would involve internal engineering and quality assurance checks against design requirements.

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 MRMC comparative effectiveness study was done.
   • This device is a CAD system for designing dental prosthetics, not an AI-powered diagnostic or interpretation tool for human readers. Its function is to facilitate design, not to assist in human diagnostic decisions.

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

   • Yes, in essence, the "standalone" performance is the device's function. The Zfx Dental CAD System is software that takes digital input and allows a user to design restorations. The verification and validation testing assesses the software's ability to perform these functions accurately (i.e., accept files, allow design, output files for manufacturing). It does not involve a human in a diagnostic loop that would be compared to an AI algorithm.

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

   • For the verification and validation, the "ground truth" would be the design specifications and manufacturing requirements established by Zimmer Dental for patient-specific restorations. The system's output (digital designs) and the subsequent manufactured physical restorations would be compared against these established specifications for accuracy and adherence.

7. The sample size for the training set:

   • This information is not provided. The Zfx Dental CAD System is described as CAD software for design, not as a machine learning model that undergoes a training phase with a distinct training set of data. Its functionality likely relies on algorithms based on geometric principles and dental design rules, rather than statistical learning from a large training dataset.

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

   • Not applicable as the device is not described as a machine learning system requiring a labeled training set with established ground truth in the typical sense. The "ground truth" for developing such software would be established by engineering requirements, dental prosthetic design principles, and industry standards.

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