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The Z7 Zirconia Implant System is intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The ø3.7 mm reduced diameter implants are recommended for central and lateral incisors only.

The Z7 Zirconia Implant System is an integrated system of endosseous dental implants (Z7 Zirconia Implant One Piece) and PEEK prosthetic parts. The Z7 Zirconia Implant One Piece are yttria stabilized tetragonal zirconia (Y-TZP) dental implants composed of a One Piece, monotype implant with an integrated abutment. The implant is manufactured via a ceramic injection molding with the macro and micro surface characteristics of the implant directly structured in the mold. The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone. The implants come in corresponding diameters of 3.7 and 4.3 mm.

The provided text describes the Z7 Zirconia Implant System, a dental implant device, and its compliance with FDA requirements for substantial equivalence to a predicate device. However, the information you've requested regarding acceptance criteria and study details in the context of an AI/ML device is not present in this document.

The document is a 510(k) clearance letter for a medical device manufactured from Zirconia (an endosseous dental implant), not an AI/ML-driven medical device. Therefore, it does not contain information about:

• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
• Sample size for test sets in an AI context
• Data provenance for AI training/testing
• Number/qualifications of AI ground truth experts
• Adjudication methods for AI ground truth
• MRMC studies for AI assistance
• Standalone AI algorithm performance
• Type of ground truth used for AI
• Training set sample size for AI
• Ground truth establishment for AI training

The performance testing summarized in the document (Page 7) is related to the physical and material properties of the dental implant itself:

• Material Performance Testing: Per ISO 13356:2015 for Yttria-stabilized tetragonal zirconia (Y-TZP).
• Fatigue Testing: Per ISO 14801:2016 for dynamic loading of endosseous dental implants.
• Implant Surface Roughness and Chemical Analysis Validation: Through 3D Scanning Electron Microscope (SEM) Imaging and Energy Dispersive Spectrometry (EDS Analysis).
• Biocompatibility: According to ISO 10993-1 and ISO 10993-5 (cytotoxicity).
• Endotoxin Testing: Following USP<85> and USP<161>.
• Sterilization Validation: Per ISO 11135:2014 (Ethylene Oxide) and ISO 17665 (Moist Heat) for sterility assurance level (SAL) of 10^-6.
• Shelf-Life Validation: Accelerated aging followed by real-time aging.

For these physical device tests, all results are reported as "PASS" and "Device met all predetermined acceptance criteria" or "Substantially equivalent fatigue strength to reference device."

To reiterate, this document does not contain the information you are looking for regarding AI/ML device acceptance criteria and study details.

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SDS2.2 dental implants are intended as artificial replacements to be placed in the human upper or lower jaw to provide anchor points for the prosthetic restoration. They are indicated for transgingival healing. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

SDS2.2 standard implant posts and SDS2.2 standard screws are industrially manufactured prosthetic components. They are connected to the SDS2.2 dental implant and enable the fixation of prosthetic restorations.

SDS2.2 dental implants are a two-piece implant system to fit a synthetic root replacement into the human jaw. The implants are made of Y-TZP (yttria-stabilized tetragonal zirconia poly-crystal) zirconium dioxide ceramics in accordance with ISO 13356. The SDS2.2 dental implant system with its included components is used to fix the prosthetic restoration and is suitable for patients with an intolerance to metal. The implants have a self-tapping Dynamic Thread® in the implant for good primary stability. Its bone-condensing section has a 2.5x thread depth. The upper section of the implant has a micro-thread. The outer surface of the SDS2.2 implants is abrasive blasted for good osseointegration, the implant shoulder is machined. SDS2.2 implants are provided in different length/ diameter combinations and with 2 different shoulder designs (standard shoulder and oval shoulder). The implants are provided sterile in sterile packaging and are intended for single use. The sterile packaging also includes the SDS2.2 cover screw made of PEEK (Polyetheretherketone), which can be used to protect the implant interface during the healing phase up to 180 days. SDS2.2 standard implant posts are made of Y-TZP and are attached to SDS 2.2 dental implants by cementation. During cementation, the implant posts are screw retained with the SDS2.2 standard PEEK screw to ensure implant post is fixed at final position. The SDS2.2 standard PEEK screw is removed before the cement is completely cured. After attachment to the SDS2.2 implant, standard implant posts enable cementation of prosthetic restorations. SDS2.2 standard implant posts are available in different designs. The SDS2.2 standard implant posts and SDS2.2 standard PEEK screws are provided non-sterile.

The document is a 510(k) premarket notification for the SDS2.2 dental implant system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices. The information provided heavily emphasizes physical and mechanical properties, material composition, manufacturing processes, and sterilization validation rather than AI/ML algorithm performance.

Therefore, many of the requested bullet points for describing AI/ML device acceptance criteria and study details cannot be directly answered from this document. The document describes a traditional medical device (dental implant) and its non-clinical testing for safety and effectiveness.

Here's an analysis based on the provided document, addressing what can be inferred and stating what cannot:

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

The document doesn't present acceptance criteria in a formal table with values for an AI/ML algorithm's performance metrics (e.g., sensitivity, specificity, AUC). Instead, it discusses the device meeting "existing requirements and acceptance criteria" based on various regulatory standards and non-clinical tests.

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

• Test Set Sample Size: Not applicable. This document describes testing for a physical medical device (dental implant), not an AI/ML algorithm. The "test set" in this context refers to physical implants subjected to various lab tests (e.g., fatigue testing, material analysis). The sample sizes for these specific physical tests are not provided in this summary document.
• Data Provenance: Not applicable for AI/ML dataset. The "data" refers to the results of bench testing and physical-chemical characterization of the implant. There is no mention of country of origin or retrospective/prospective human data.

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

Not applicable. Ground truth, in the context of AI/ML, refers to human annotations or confirmed diagnoses used to train and evaluate an algorithm. For a dental implant, "ground truth" is established through engineering and material science standards and confirmed by accredited lab testing, not by expert physicians interpreting images or data for AI.

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

Not applicable. Adjudication methods are typically used in clinical studies involving multiple human readers to resolve discrepancies in annotations or diagnoses for AI/ML ground truth. This is not relevant to the physical testing of a dental implant.

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. An MRMC study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks. This document describes a physical medical device and its non-clinical performance, not an AI/ML diagnostic aid.

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

No. This concept is specific to AI/ML algorithm testing. The device is a physical implant; its "performance" is inherently "standalone" in mechanical terms, but it's not an algorithm.

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

The "ground truth" for evaluating this device's performance is based on established engineering and material standards for dental implants (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility) and the successful outcome of physical bench tests and material analyses. It's not based on clinical imaging, pathology, or outcomes data in the sense used for AI/ML.

8. The sample size for the training set:

Not applicable. There is no AI/ML training set discussed in this document.

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

Not applicable. There is no AI/ML training set discussed in this document.

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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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