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ST-Z5 surgical trays are intended to be used to enclose other medical devices that are to be sterilized by a health care provider. ST-Z5 surgical trays are intended to allow sterilization of the enclosed medical devices.

ST-Z5 surgical trays require the use of an FDA cleared wrap to maintain the sterility of the enclosed devices.

The trays are to be enclosed in a sterilization wrap that is FDA cleared for the indicated cycle, and moist heat (steam) sterilized using the following cycle:

Pre-vacuum steam: 132 ℃ (270 ℃) for 4 minutes with 20 minutes drying time.

ST-Z5 surgical trays are intended for sterilization of non-porous loads. ST-Z5 surgical trays are recommended not to be stacked during sterilization.

The subject device trays are reusable rigid containers, comprising a base (bottom), a removable inner tray, and a lid (cover). The subject device trays are to be used to organize and protect the instruments that are sterilized in the trays by the healthcare provider. The base, inner tray, and lid components are designed to be integrated into a single unit which contains and protects the interior contents during sterilization. The trays are perforated to allow for penetration of the sterilant, are to be used with moist heat (steam), and require the use of an FDA cleared wrap to maintain sterility. The subject device components are manufactured from injection molded polyphenylsulfone (PPSU), and holders of various geometries to position instruments in the trays are manufactured from silicone. The subject device includes two instrument trays that have the same size (same lid, base, and enclosed volume) and two inner tray configurations.

This document describes the validation of the ST-Z5 surgical trays for sterilization.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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Z5-TL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-TL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-TL implants are intended for delayed loading.

Z5-TL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for tissue level placement. The dental implants are provided in two endosseous body diameters (4 mm and 5 mm) and each diameter is provided in three endosseous lengths (8 mm, 10 mm, and 12 mm). The corresponding platform diameters are: 4.8 mm platform diameter for 4 mm body diameter, and 6 mm platform diameter for 5 mm body diameter. The dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The system also includes gingiva formers and a temporary abutment manufactured from polyetheretherketone (PEEK). Zirconia abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, zirconia Locator-type abutments are provided in straight and 15° angled designs.

The subject device is compatible with the following components cleared in K190243: a healing cap manufactured from PEEK; Locator-type abutments manufactured from zirconia; and occlusal (abutment) screws manufactured from zirconia and from Ti-6Al-4V alloy conforming to ASTM F136.

The subject device implants are provided sterilized by plasma gas. All other subject device components are to be sterilized by the end user by moist heat (steam).

The provided text describes a 510(k) premarket notification for a dental implant system (Z5-TL) and does not contain information about the acceptance criteria and study design you've requested for typical AI/ML device evaluations. This document focuses on demonstrating substantial equivalence to already-marketed predicate devices, primarily through non-clinical data.

Therefore, I cannot populate the table or provide answers to most of your questions as the information is not present in the provided text.

Here is what can be extracted based on the document:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or tabulated performance data for an AI/ML device are provided in this document. The performance data discussed relates to the mechanical properties and sterilization of the dental implant itself.

2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/ML device relying on a test set of data. The "performance data" section refers to non-clinical testing of the dental implant's physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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 MRMC study was mentioned or performed, as this is not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests, the "ground truth" would be established by validated test methods and physical measurements according to specified ISO and ASTM standards.

8. The sample size for the training set
Not applicable.

9. How the ground truth for the training set was established
Not applicable.

Summary of relevant performance data (non-clinical, from the document):

The performance data submitted was non-clinical and aimed to demonstrate substantial equivalence of the Z5-TL dental implant device.

• Sterilization Validation: According to ISO 14937 and ISO 17665-1 (referenced from predicate K132881).
• Sterile Product Shelf Life Testing: According to ISO 11607-1, ISO 11607-2, ASTM F1886/F1886M, and ASTM D3078 (referenced from predicate K132881).
• Biocompatibility of PEEK material: According to ISO 10993-3, ISO 10993-12, ISO 10993-10, ISO 19003-11, ISO 10993-18, and USP Class VI testing according to USP 37-NF32 (referenced from predicate K190243).
• Static compression and compression fatigue testing: Of the zirconia implants and abutments according to ISO 14801.
• Assessment of abutment screw loosening and removal torque testing: According to ISO 18130, after insertion and dynamic testing (ISO 14801), including microscopic examination, and comparison to reference devices K063286 and K072642.
• Assessment of wear particles: Associated with the Ti-6A1-V alloy abutment screw used with zirconia implant bodies and abutments after dynamic testing (ISO 14801), including light microscopy and SEM/EDX, and comparison to all-titanium constructs of reference devices K063286 and K072642 (leveraged from K190243).

Conclusion on Performance: The document states that the non-clinical data demonstrated that the device has "sufficient strength for their intended use" and supports substantial equivalence to the predicate devices. No clinical data was included in the submission.

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Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.

Z5-BL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for bone level placement. The subject device includes dental implants provided in one body diameter of 3.6 mm in lengths of 8 mm, 10 mm. The subject device also includes a gingiva former, straight abutments for single-unit cemented restorations, and a 15° angled abutment also for single-unit cemented restorations.

The subject device is compatible with components cleared previously in K190243, including a healing cap, straight abutments for multi-unit cemented restorations, Locator-type abutments for retention of overdentures, and occlusal (abutment) screws.

The subject device dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The subject device abutments are manufactured from Y-TZP zirconia conforming to ISO 13356, or from polyetheretherketone (PEEK).

The subject device implants are provided sterilized by plasma gas. All other components are to be sterilized by the end-user by moist heat (steam).

The provided text describes a 510(k) premarket notification for a dental implant system (Z5-BL). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The information primarily focuses on non-clinical performance data and a comparison of technological characteristics, rather than reporting on a study demonstrating the device meets specific acceptance criteria in terms of clinical performance or human-AI effectiveness.

Therefore, many of the requested details, such as acceptance criteria for clinical performance, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable or not present in the provided document.

Here's a breakdown of the available information based on your request:

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

The document does not specify quantitative clinical acceptance criteria for the Z5-BL device. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical performance data and technological characteristics.

The "performance data" section lists the types of non-clinical tests performed and their respective standards. The implied acceptance criterion for these tests is conformance to the referenced international or national standards, which is then used to support the claim of substantial equivalence.

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

• Not applicable. This submission did not include clinical data or a "test set" in the context of clinical performance evaluation or AI model validation. The performance data listed are non-clinical, mechanical, and material tests.

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

• Not applicable. No clinical test set or ground truth established by experts is mentioned.

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

• Not applicable. No clinical 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 document describes a dental implant and does not involve AI or human reader improvement studies.

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

• Not applicable. This document describes a dental implant and does not involve an algorithm.

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

• For the non-clinical performance data, the "ground truth" is established by adherence to the respective international and national standards (e.g., ISO, ASTM, USP) for material properties, sterility, biocompatibility, and mechanical performance. These standards define the accepted methods and criteria for evaluating device properties.

8. The sample size for the training set:

• Not applicable. No training set for an AI model is mentioned.

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

• Not applicable. No training set for an AI model is mentioned.

In summary, this 510(k) submission for the Z5-BL dental implant relies on demonstrating substantial equivalence through comprehensive non-clinical testing according to established standards. It explicitly states, "No clinical data were included in this submission" (page 5). Therefore, the requested information pertaining to clinical studies, AI performance, ground truth, and expert evaluation for a test or training set is not present.

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Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.

Z5-BL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for bone level placement. The dental implants are provided in body diameters of 4 mm and 5 mm, and each diameter is provided in 8, 10, and 12 mm lengths. The dental implants are manufactured from Y - TZP zirconia conforming to ISO 13356. The system also includes a healing cap, gingiva formers, and a temporary abutment manufactured from polyetheretherketone (PEEK). Zircoma abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, Zirconia Locator-type abutments are provided in straight and 15° angled designs. Occlusal (abutment) screws are provided in Ti-6Al-4V alloy conforming to ASTM F136 and in zirconia.

The subject device implants and Healing Cap are provided sterilized by plasma gas. All other components are to be sterilized by the end-user by moist heat (steam).

The provided text is a 510(k) summary for the Z5-BL dental implant. It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance data. However, it does not contain information about acceptance criteria and studies proving the device meets those criteria in the context of AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, or MRMC studies).

The document explicitly states: "No clinical data were included in this submission." This means there is no performance data related to human-in-the-loop studies, standalone AI performance, or any studies that would involve establishing ground truth from expert consensus or pathology for evaluating AI model performance.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria from the provided text, as it describes a traditional medical device submission for dental implants, not an AI/ML-driven device.

To answer your specific questions in the context of an AI/ML device, I would need a different type of document that describes performance data related to an AI/ML algorithm.

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Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Z5m(t) is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). It has a tapered implant body, a double thread design in the coronal third of the implant and a self-tapping apex. The Z5m(t) endosseous surface is laser modified, identical to the Z5m surface cleared under K120793. Z5m(t) and Z5m utilize the same prosthetic components. Z5m(t) is designed for single or multiple tooth restorations and provided in two diameters (4.0, and 5.0 mm), each in three lengths (8. 10, and 12 mm). The Z5m(t) implant system is suitable for patients with metal allergies and the chronic diseases resulting from them.

This document is a 510(k) Pre-market Notification for a dental implant system called Z5m(t). It does not describe an AI medical device or a study proving that an AI device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, AI performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and standalone AI performance cannot be extracted from this document.

However, I can extract the general "performance data" that was submitted for this non-AI device:

Performance Data for Z5m(t) Dental Implant System (Non-AI device)

This device is not an AI/ML device, so much of the requested information (AI performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies) is not applicable. The document describes performance data for the dental implant itself, focusing on physical and biological aspects, not a diagnostic or prognostic AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device (dental implant) and not an AI algorithm, the "acceptance criteria" are related to product standards and validation rather than diagnostic performance metrics. Similarly, "reported device performance" refers to the validation results against these standards.

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: Not applicable in the context of typical AI/ML test sets. The tests mentioned (sterilization, biocompatibility, mechanical) involve specific numbers of device units or biological assays per standard, but are not usually referred to as "test sets" in the AI sense.
• Data Provenance: Not applicable in the context of this type of device submission. The data would be generated in laboratories according to international standards (ISO).

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 not an AI device that requires expert-established ground truth for diagnostic accuracy.

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

Not applicable. This is not an AI device that requires expert adjudication for a ground truth dataset.

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 not an AI device, and no human reader comparative effectiveness studies are mentioned.

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 (expert consensus, pathology, outcomes data, etc)

Not applicable. For this device, "ground truth" would be established by physical and biological measurements against regulatory and industry standards (e.g., a device is sterile if it meets the SAL, it is biocompatible if it passes ISO 10993 tests, it is mechanically sound if it passes ISO 14801 fatigue tests).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI algorithm. No training set is used.

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

Not applicable. This is a physical device, not an AI algorithm. No training set or ground truth for a training set is relevant.

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Z5c implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5c implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them. Z5c implants are intended for delayed loading.

Z5c is a two-piece, root-form, threaded implant and abutment system made from yttria-stabilized zirconia (Y-TZP). The Z5c implant endosseous surface is grit blasted and laser modified. The Z5c implant and corresponding abutment are bonded together using a self-adhesive resin cement. The Z5c implant system is designed for single or multiple tooth restorations. Z5c implants are provided in two endosseous diameters (4.0 and 5.0 mm) and each diameter is provided in three lengths (8, 10, and 12 mm). Z5c abutments are provided in two designs, straight and angled 15°.

The Z5c dental implant device underwent non-clinical and clinical testing to demonstrate substantial equivalence to predicate devices, thus meeting acceptance criteria for market authorization.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance (Test Set):

The document does not explicitly state a specific sample size for a "test set" in the context of an AI/algorithm-driven device evaluation. Instead, the evaluation for this dental implant relies on:

• Non-clinical testing data: This includes engineering analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801. The number of samples for each test type is not specified in the summary.
• Clinical data: A summary of clinical placement, loading, follow-up data, and multiple clinical case reports were submitted. The total number of patients or implants included in this clinical data is not specified.
• Data Provenance: Not explicitly stated, however, the manufacturer is Z-Systems AG, Switzerland. Given the context of a 510(k) submission to the FDA, it is likely that the data were collected in accordance with international standards, but specific countries of origin for the clinical data are not mentioned. The data is presented as if it is retrospective compilation (summary of placement, follow-up, and case reports) rather than a prospective, controlled trial for this specific submission.

3. Number of Experts and Qualifications (Test Set Ground Truth):

Not applicable in the context of this traditional medical device submission. Ground truth for dental implants is typically established through objective measures (e.g., successful osseointegration, absence of complications, mechanical integrity) validated by clinical outcomes and engineering specifications, rather than expert consensus on image interpretation.

4. Adjudication Method (Test Set):

Not applicable. The evaluation is based on engineering tests and clinical outcomes, not interpretations requiring adjudication.

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

Not applicable. This is not an AI-assisted diagnostic device. The evaluation focuses on the physical and biological performance of the implant.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical medical device (dental implant), not an algorithm.

7. Type of Ground Truth Used:

• Engineering Specifications: Compliance with ISO 14801 for mechanical properties (fatigue strength).
• Clinical Outcomes/Performance: Successful placement, loading, and follow-up data indicating the implant's ability to replace missing teeth without significant complications. This would implicitly involve aspects like osseointegration, stability, and lack of adverse events.
• Material Science: Demonstrating the yttria-stabilized zirconia (Y-TZP) material meets relevant standards and is suitable for implantation.

8. Sample Size for Training Set:

Not applicable. This is a physical medical device. There is no AI model or algorithm requiring a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable (as above).

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Zsmlb: Z mlb implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Z5mlb implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Z

The purpose of this submission is to expand the Z-Look3 Evo SLM implant line (K 120793) to include two implant designs indicated for denture attachment. The Z5mlb and Z5mlc are onepiece, root-form, threaded implants made from yttria-stabilized zirconia (Y -TZP). Zsmlb and 25mlc implants are designed for full or partial denture restorations. Z5mlb implants are provided in two diameters (3.6 and 4.0 mm) and two endosseous lengths (8 and 10 mm). Zsmlc implants are provided in one diameter (4.0 mm) and one endosseous length (10 mm).

The provided text describes the Z5mlb and Z5mlc dental implants and their substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics in terms of effectiveness or accuracy.

Therefore, I cannot provide the requested table or answer most of the questions because the necessary data is absent from the provided 510(k) summary. This document primarily focuses on establishing substantial equivalence based on intended use, design principles, and material similarities to already marketed devices, rather than presenting a performance study with acceptance criteria.

Here's what I can extract based on the limitations of the provided text:

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

• Not available. The document does not specify any quantitative acceptance criteria for device performance (e.g., success rates, functional scores) and therefore does not report device performance against such criteria. The submission is a 510(k) for substantial equivalence, which relies on demonstrating similarity to predicate devices rather than proving performance against novel metrics.

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

• Not applicable. No test set for performance evaluation is described in the provided document.

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

• Not applicable. No test set or ground truth establishment process for performance evaluation is described.

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

• Not applicable. No test set or adjudication method for performance evaluation is described.

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

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

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

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

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

• Not applicable. No test set or ground truth establishment process for performance evaluation is described. The "ground truth" for a physical implant's safety and efficacy is typically established through a combination of preclinical testing (mechanical, biocompatibility) and clinical data (which is not detailed in this 510(k) summary beyond the general claim of substantial equivalence).

8. The sample size for the training set:

• Not applicable. This device is a physical dental implant, not an AI model requiring a training set.

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

• Not applicable. This device is a physical dental implant, not an AI model requiring a training set.

Summary of available information:

The provided document is a 510(k) summary for dental implants (Z5mlb and Z5mlc). It asserts substantial equivalence to several predicate devices based on:

• Same intended use: Surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Also suitable for patients with metal allergies.
• Same operating principle: Implantation of a root-form, threaded implant.
• Same basic design: One-piece, root-form, threaded implants made from yttria-stabilized zirconia (Y-TZP).
• Same or very similar materials: Y-TZP.
• Similar packaging and sterilization processes.
• Similar physical dimensions: The subject device (Z5mlb: 3.6 & 4.0 mm diameter, 8 & 10 mm length; Z5mlc: 4.0 mm diameter, 10 mm length) falls within the range of predicate devices.

The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical trials with defined acceptance criteria and performance studies. The "study" referenced in the prompt implicitly refers to the comparison done for substantial equivalence. The "proof" is the FDA's concurrence that the device is substantially equivalent, implying it meets safety and efficacy standards equivalent to the predicate devices.

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Z-Look3 Evo SLM implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z-Look3 Evo SLM implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.

Z-Look3 Evo SLM is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). The Z-Look3 Evo SLM surface is grit blasted with medical grade Al20 and laser modified. Implants are available in three diameters (3.6, 4.0 and 5.0 mm) and four lengths (8, 10, 11.5 and13 mm). Z-Look3 Evo SLM implants are designed for single or multiple tooth restorations. Z-Look3 Evo SLM implants are a modification to Z-Look3 implants. The laser modified surface has been added to increase surface roughness and, therefore, the surface area available for contact with bone.

This document is a 510(k) summary for the Z-Look3 Evo SLM dental implant. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a clinical study with acceptance criteria and a device performance evaluation in the way requested.

Therefore, many of the requested sections regarding the study and acceptance criteria cannot be extracted from the provided text.

Here is what can be inferred:

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

This information is not explicitly provided in the document. The submission aims to establish substantial equivalence through design principles, materials, technological characteristics, and intended use, rather than reporting performance against specific, quantifiable acceptance criteria from a clinical study within this summary.

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

Not applicable. The document does not describe a clinical study with a test set.

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. The document does not describe a clinical study with a ground truth established by experts.

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

Not applicable. The document does not describe a clinical study.

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 (dental implant) submission, not an AI/software device.

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

Not applicable. This is a medical device (dental implant) submission, not an AI/software device.

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

Not applicable. The document does not describe a clinical study with a ground truth.

8. The sample size for the training set

Not applicable. The document does not describe a clinical study with a training set.

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

Not applicable. The document does not describe a clinical study with a training set.

Summary of available information from the document related to device characteristics:

• Intended Use: Implantation into the upper and lower jaw for attachment of prosthodontic appliances to replace missing teeth. Also suitable for patients with metal allergies.
• Device Description: One-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). Surface is grit blasted with medical grade Al2O3 and laser modified.
• Dimensions: Available in three diameters (3.6, 4.0, 5.0 mm) and four lengths (8, 10, 11.5, 13 mm).
• Equivalence Basis: Substantial equivalence to predicate devices (Z-Look3 Dental Implant System, Nobel Biocare Zirconia Implant, Oral Iceberg S.L. CeraRoot Implant System, Contour Healer Temporary Abutment, Zimmer Dental Inc. Plastic Temporary Abutment) based on:
  • Same intended use.
  • Similar design principles.
  • Same operating principle.
  • Same basic design.
  • Same or very similar materials.
  • Similar physical dimensions.
  • Similar packaging and sterilization methods.
  • Differences in technological characteristics (laser modified surface) do not raise new safety/efficacy issues.

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Z-Look3 Dental Implants are suitable for all indications of endosseous implants in the upper and lower jaw, for the functional and aesthetic oral rehabilitation of edentulous and partially edentulous patients. The Z-Look3 Dental Implants with modifiable abutments are restored with fixed / cemented crowns and bridges. A special indication of the Z-Look3 Dental Implant System is for patients with metal allergies and chronic illnesses due to metal allergies.

Contraindications for the Z-Look3 Dental Implant Ø 3.25 mm:

• Restoration of posterior teeth in the upper or lower jaw
• Single-tooth restoration of canines and central incisors in the upper jaw

The Z-Look3 Dental Implant is a one-piece, self tapping, threaded, root form endosseous dental implant. Z-Look3 Dental Implants are offered in three diameters (3.25 mm, 4.0 mm, 5.0 mm) and four lengths (10 mm, 11.5 mm, 13.0 mm, 14.0 mm).

The provided text is a 510(k) summary for the Z-Look3 Dental Implant System. It describes the device, its intended use, and its equivalence to marketed devices. However, it does not contain information about acceptance criteria, specific studies proving the device meets those criteria, or details regarding performance evaluation studies such as sample sizes, ground truth establishment, or expert involvement.

The document states that the Z-Look3 Dental Implant System is "substantially equivalent in indications and design principles to predicate devices," implying that its performance is implicitly accepted based on the established safety and effectiveness of its predicates.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, or details about training sets.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or the effect size of AI assistance.
6. Results from standalone (algorithm only) performance studies.
7. The type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The document primarily focuses on administrative information, device description, materials, and a declaration of substantial equivalence to predicate devices for regulatory clearance.

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