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510(k) Data Aggregation
(264 days)
The Noris LONGY and LONGY-N implants are indicated for splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices with partially or fully edentulous upper jaws, and may be suitable for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The procedure can be accomplished in a one-stage or two-stage surgical operation.
The subject dental implant devices are single use devices, provided sterile by Gamma Radiation, made of Titanium alloy Ti-6Al-4V ELI (ASTM F136). The LONGY Implants and LONGY-N Implants bare internal hex connection, diameters of 3.75 and 4.0mm and lengths of 18, 20, 22 and 25 mm. The Noris LONGY and LONGY-N implants are indicated for splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices in patients with partially or fully edentulous upper jaws, and may be suitable for immediate loading when good primary stability is achieved. The procedure can be accomplished in a one-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
LONGY and LONGY-N dental implants are compatible with FDA cleared Noris Medical Ltd. Internal Hex platform abutments and superstructures only intended for multiple-unit loading, provided that they do not exceed an angulation of 30° (≤30).
The provided text is a 510(k) Premarket Notification from Noris Medical Ltd. for their LONGY Implant and LONGY-N Implant. It primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving a device meets specific acceptance criteria through a study involving AI or human reader performance.
Therefore, the document does not contain the information required to answer the prompt's request for acceptance criteria and a study proving device performance against those criteria, especially in the context of AI assistance or human reader improvement.
The document details the following:
- Device Name: LONGY Implant and LONGY-N Implant
- Regulation Number/Name: 21 CFR 872.3640 (Endosseous Dental Implant)
- Regulatory Class: Class II
- Product Code: DZE
- Indications for Use: Splinted restorations in the maxilla, utilizing a minimum of two implants to support fixed or removable prosthetic devices in patients with partially or fully edentulous upper jaws, suitable for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Can be accomplished in a one-stage or two-stage surgical operation.
- Predicate Devices: Neodent Implant System - GM Helix LG ® (K190958 - Primary), Noris Medical Ltd. - TUFF (K140440 - Reference), Neodent Implant System - Zygoma GM (K190718 - Reference), Noris Medical Ltd. - Zygomatic Implants (K151909 - Reference), Noris Medical Ltd. - MBI Dental Implant System (K153043 - Reference).
- Device Description: Single-use, sterile (Gamma Radiation), made of Titanium alloy Ti-6Al-4V ELI (ASTM F136), internal hex connection, diameters of 3.75 and 4.0mm, lengths of 18, 20, 22, and 25 mm.
- Performance Data: Fatigue tests per ISO 14801, biocompatibility, sterilization validation, shelf-life testing, mechanical testing, and MRI review. These tests are to demonstrate substantial equivalence, not to establish performance against specific clinical acceptance criteria in a user-performance or AI-assisted context.
Missing Information (as per the prompt's requirements):
- A table of acceptance criteria and the reported device performance: Not provided in the context of clinical endpoints or user performance. The performance data discussed (fatigue, biocompatibility, etc.) are for device safety and mechanical integrity, not for clinical diagnostic or treatment performance against specific numerical acceptance criteria.
- Sample size used for the test set and the data provenance: No test set is described for evaluating AI or human reader performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no AI/human reader study is described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This document is about a physical dental implant, not AI software.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the presented data (which is about implant mechanical and material properties).
- The sample size for the training set: Not applicable (no AI/machine learning model discussed).
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a dental implant, focusing on its physical and material properties to demonstrate substantial equivalence for market clearance. It does not contain information related to AI or human-in-the-loop studies, nor does it define acceptance criteria in the manner requested by the prompt for such studies.
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(463 days)
ICX-Implant System is indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. ICX- Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7.0 mm are indicated for delayed loading only.
ICX-Implant System CAD CAM abutments are intended for use with dental implants as a support for single unit or multiple unit prostheses in the maxilla of a partially or fully edentulous patient. All digitally designed abutments for use with ICX-Implant System CAD CAM abutments are intended to be manufactured at a medentis medical GmbH validated milling center.
The purpose of this submission is to obtain marketing clearance for an endosseous dental implant and abutment system. ICX-Implant System, from medentis medical GmbH. The ICX-Implant System includes a range of endosseous dental implants and prosthetic components. All implants have a selftapping apical thread with a tapered body and root-form designs with an internal hex implant/abutment connection. The implant body surface is blasted and acid-etched.
Abutments are available in multiple designs, including straight and angled abutments intended for single tooth and multi-unit restorations.
The provided text is a 510(k) summary for the "ICX-Implant System." This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to previously cleared devices rather than proving the device meets specific acceptance criteria through a standalone performance study.
Therefore, the document does not contain the detailed information required to fully answer all aspects of your request, especially regarding specific acceptance criteria for AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment for a test/training set in the context of an AI device.
The document does describe non-clinical performance data for the dental implant system itself (e.g., sterilization, biocompatibility, mechanical testing) to show its safety and effectiveness, but not for an AI component.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Missing: The document does not define "acceptance criteria" in the context of an AI/algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, it discusses the substantial equivalence of the ICX-Implant System and its components to predicate devices based on technological characteristics, materials, and indications for use.
- The "Performance Data" section (Page 7) lists non-clinical tests performed, such as:
- Validation of gamma irradiation sterilization to a sterility assurance level (SAL) of 10⁻⁶.
- Bacterial endotoxin testing:
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(361 days)
Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient's chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Noris Medical Zygomatic Dental Implant System is intended to be implanted in the upper jaw arch to provide support for fixed or removable prosthetic devices in patients with partially or fully edentulous maxillae.
The Noris Medical Dental Implants System includes Multi Unit and Vari Connect abutments with various gingival heights and angles (17°, 30°, 45°, 52°, 60°), and Vari Connect Extenders. The system also includes abutment fixation screws. The abutments are intended to be used with specific Noris Medical Dental implants (K151909 and K140440). The Multi-Unit system provides a solution for screw-retained prostheses, while the Vari-Connect system is for removable prostheses. The components are manufactured from Titanium alloy.
The provided text describes a 510(k) submission for the Noris Medical Dental Implants System. While it discusses the device's equivalence to predicate devices and presents clinical data, it does not explicitly state acceptance criteria or a specific study proving the device meets those criteria in the format requested.
Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of:
- Intended Use: Similar to predicate devices.
- Technological Characteristics: Similar to predicate devices (e.g., material, design, connection type).
- Performance Testing: Biocompatibility, sterilization, and mechanical fatigue tests were performed, but specific acceptance criteria for these tests within the context of a "device performance" summary are not detailed.
- Clinical Data (Real-World Evidence): Retrospective studies on both a predicate device and the subject device are presented to support clinical performance, but these are comparative rather than against pre-defined acceptance criteria for a new device.
Therefore, many of the requested fields cannot be directly extracted from the provided text because the study presented is a comparative effectiveness study (comparing the Noris Medical device to predicate devices and real-world evidence, which serves as a benchmark rather than a fixed acceptance criterion).
However, I can extract information related to the clinical data presented, which serves as the closest equivalent to a "study" proving performance in this context of a 510(k) submission.
Here's an attempt to answer the questions based on the available information, noting where information is not present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of explicit acceptance criteria with numerical targets. Instead, it relies on demonstrating "substantial equivalence" and reporting success rates from retrospective clinical studies, comparing them to predicate device performance.
| Acceptance Criteria (Inferred/Benchmark from Predicate) | Reported Device Performance (Noris Medical MU Abutment) |
|---|---|
| Clinical Success Rate: Comparable/Non-inferior to predicate device (Nobel Biocare's 95.3% patient success, 95.9% implant/abutment success at 2 years, and 93.5% survival rate for 60° Zygomatic implant/abutment within 6-48 months) | Clinical Success Rate: 100% (No failures) for 88 Multi Unit abutments (follow-up period 6-47 months) |
| Adverse Events/Complications: Comparable to predicate device | No adverse events nor inflammation reported. |
| Stability/Micro Movements: No micro movements (Implicit from success definition) | No micro movements observed. |
| Bleeding/Soft Tissue Downgrowth: No bleeding or soft tissue downgrowth (Implicit from success definition) | No bleeding or soft tissue downgrowth observed. |
| Pain: No pain (Implicit from success definition) | No pain observed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Subject Device (Noris Medical Multi Unit):
- Sample Size: 33 patients, encompassing 88 Multi Unit abutments.
- Data Provenance: Retrospective study. Country of origin not explicitly stated but the company is "Noris Medical Ltd. 8 Hataasia street, Nesher 3688808, Israel," suggesting the data could be from Israel or a region where Noris Medical devices are used. The implants were placed between 2013 and 2020.
- Predicate Device (Nobel Biocare Multi Unit):
- Sample Size: 44 completely edentulous maxillary rehabilitations (77 Multi unit abutments).
- Data Provenance: Retrospective study, "Real-world evidence... from the literature" (Ref. 1: J. Clin. Med. 2021, 10, 3600). The specific country of origin for this study is not detailed beyond the journal citation, but the reference indicates "Armando L, Miguel de Araújo Nobre, Ana Ferro, Carlos Moura Guede, Ricardo Almeida and Mariana Nunes," suggesting a potential origin in Portugal or similar European context.
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)
- The document does not specify the number or qualifications of experts used to establish the ground truth for either the Noris Medical or Nobel Biocare retrospective studies. Clinical outcomes (success/failure) were reported, likely by the treating clinicians or study investigators, but expert adjudication details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not specify any adjudication method for the clinical outcomes reported in either retrospective 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
- No, an MRMC comparative effectiveness study was not done. The studies presented are clinical outcome studies on dental implants and abutments, not diagnostic imaging studies involving human readers and AI. This question is not applicable to the type of device and studies described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm-only) performance study was not done. This product is a physical dental implant system, not a software algorithm. This question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For both the Noris Medical and Nobel Biocare clinical studies, the "ground truth" was based on clinical outcomes data (prosthetic success, abutment success, complications, absence of micro movements, bleeding, soft tissue downgrowth, pain) observed over a follow-up period by clinicians.
8. The sample size for the training set
- The document describes studies for substantial equivalence and clinical performance evaluation, not machine learning model training. Therefore, a "training set" in that context is not applicable or described. The clinical studies mentioned are test sets for device performance.
9. How the ground truth for the training set was established
- As a "training set" is not applicable in this context, the method for establishing its ground truth is also not applicable.
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(469 days)
Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball).
HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm.
HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm.
CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm).
lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136).
The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).
The provided document is a 510(k) Summary for a dental implant system. It outlines the device description, intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence. Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of AI/ML-based medical devices.
The "Performance Data" section explicitly states: "No clinical data were included in this submission." Instead, it lists non-clinical data for physical and material properties of the dental implants, such as sterilization validation, shelf life testing, biocompatibility, and mechanical performance (fatigue and torsional loading).
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC comparative effectiveness studies, as these types of studies are not described in this 510(k) submission for a traditional medical device (dental implants), which are not a software device or AI/ML-based device.
If you are looking for information on acceptance criteria and study data for AI/ML-based medical devices, you would need to consult a different type of FDA submission, specifically for software as a medical device (SaMD) or AI-enabled medical devices, where such performance data would be critical for demonstrating safety and effectiveness.
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(389 days)
TAV Medical Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The Implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
TAV Medical Dental Implant System is a two piece dental implant system for one stage or two stage surgical implantation of dental implant provided with cover screw and supported by a compatible abutment systems and surgical instruments. The implant is fabricated from a medical grade titanium alloy 6Al 4V ELI, according to ASTM F136. TAV Medical implant includes a body portion and a collar. The body portion is configured to extend into and Osseo integrate with the alveolar bone. The top surface of the collar lies flush with the crest of the jawbone bone. TAV Medical abutment lies on the top surface and extends through the soft tissue, which lies above the alveolar bone. The abutment supports the final prostheses. TAV Medical implants include the following brands: Silhouette, Sirius, and iCone. TAV Medical Abutments are intended for used as an adapter between the implant and the crown. The abutments are characterized by four distinct geometrically features: Height/length, angle, diameter and internal/external hex lock or conical connection. Anodized Color coding is used for categorical consideration only. TAV Medical abutments, as other available in the market of dental prosthetics are dental components composed either of titanium (Ti 6AL 4V ELI), PEEK and Yttrium Stabilized Zirconia (ZrO2). All the abutments fixation screws are composed of Ti 6AL 4V ELI. The abutments are supplied non-sterile to be sterilized by the physician before use according to the accompanied instruction for use. Abutment device refers to the fixture that is assembled on the implant. The crown is then built on the abutment. The prosthetic parts are divided into 3 main categories: Cemented retained restorations, Screw retained restorations, and Overdenture retained. Various abutment types are available: Titanium Abutments, Temporary Esthetic PEEK Abutments, Ball attachment, Locker overdenture, and Healing caps.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TAV Medical Dental Implant System:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the format typically used for AI/ML device performance. Instead, it details that the device underwent various non-clinical tests to demonstrate equivalence to predicate devices and adherence to established standards. The acceptance criteria for each test (e.g., biocompatibility according to ISO 10993-1, SAL of 10^-6 for sterilization, satisfactory results for mechanical and biological tests where material differences exist) are implicitly linked to the relevant standards or the statement of "satisfactory results" or "meets design specifications."
Here's a summary of the non-clinical testing performed and the reported performance, as extracted from the text:
| Test/Characteristic | Acceptance Criteria (Implicit from Standards/Statements) | Reported Device Performance |
|---|---|---|
| Premarket Equivalence | Substantial equivalence to predicate devices in: Indications for Use, technological characteristics, mode of operation, performance specifications. Minor differences justified by testing and reference devices. | TAV Medical Dental Implant System is stated to be substantially equivalent to predicate devices (MIS Dental Implant System, Hahn Tapered Implant System, Noris Medical Dental Implant System, SGS Dental Implants System, AB DENTAL Devices Ltd., Implant Direct, Ditron Dental Ltd.) in all device features, indications for use, materials, dimensions (with minor differences justified by other predicate devices or testing), prosthetic connection, device features, and sterilization method. Minor differences in implant diameter, packaging, healing cap dimensions, and abutment materials (Zirconia) and duration of use (PEEK abutments) were addressed by referencing other predicate devices or conducting specific mechanical/biological tests with "satisfactory results." |
| Material Biocompatibility | Conformance to ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-11 (systemic toxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-18 (chemical characterization). FDA guidance "Use of International Standard ISO 10993-1" also followed. | "TAV Medical Dental Implant System products were tested and evaluated for materials biocompatibility... in order to demonstrate the biocompatibility of the system." (Implies successful demonstration). |
| Sterilization Validation | ANSI/AAMI/ISO 11137 parts 1 and 2 standards. Sterility Assurance Level (SAL) of 10^-6. All testing requirements met. | "Test results have demonstrated that the SAL of 10^-6 was achieved and all testing requirements were met." |
| Pyrogenicity | Acceptance criteria as required by USP and . | "Tested using LAL method with satisfactory results that met the acceptance criteria." |
| Shelf Life | Successful accelerated aging validation, followed by real-time shelf-life validation for 5 years. | "Accelerated aging have been applied on the final packaging followed by a real time shelf life aging validation for 5 years shelf life." (Implies successful validation for 5 years). |
| Human Factors Study | Safe handling of the sterile single unit packaging, meeting study criteria. | "The study's criteria were met and passed successfully. Positive feedbacks received from the users participated in the study." |
| Performance Testing | Meets design specifications and performs as intended, similar to predicate devices. Includes: Implant to abutment compatibility, Static and Dynamic fatigue testing (ISO 14801:2007), Corrosion testing (ASTM F746-04), Surface finish analysis, Zirconia Material testing (ISO 13356:2008). | "Descriptive information, laboratory bench testing, and biocompatibility testing are provided to demonstrate Tav Medical Dental Implant System meets its design specifications, performs as intended... The non-clinical testing results showed that the proposed dental implant system meet the device requirements and is considered equivalent to its predicate device." Specific tests mentioned performed with "satisfactory results" where material differences existed (e.g., Zirconia locker). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or imaging data, as this is a medical device (dental implant system) and not an AI/ML diagnostic software. The "test set" refers to the physical devices and materials undergoing various engineering, biological, and material tests. The specific number of implants, abutments, or material samples used for each test is not detailed.
- Data Provenance: Not applicable in the context of clinical/imaging data provenance, as no such data was used. All testing appears to be non-clinical (bench testing, biocompatibility, sterilization validation).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. Ground truth in this context refers to the defined parameters and expected outcomes of the physical and chemical tests performed on the dental implants. This is established by engineering standards, material specifications, and regulatory guidelines, rather than expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiological reads). Here, the performance is measured against objective, measurable criteria from established scientific and engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers with vs. without AI Assistance
Not applicable. This is not an AI/ML medical device, so no MRMC studies involving human readers or AI assistance were performed or are relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML medical device.
7. The Type of Ground Truth Used
The "ground truth" for the TAV Medical Dental Implant System is based on:
- Mechanical and Material Standards: Compliance with ISO (e.g., ISO 14801 for fatigue testing, ISO 13356 for Zirconia materials) and ASTM (e.g., ASTM F746 for corrosion) standards.
- Biocompatibility Standards: Conformance to ISO 10993 series and FDA guidance on biocompatibility.
- Sterilization and Packaging Standards: Compliance with ANSI/AAMI/ISO 11137 and ISO 11607-2.
- Design Specifications: The device met its own established design specifications, which are implicitly derived from the intended use and comparison to predicate devices.
- Predicate Device Equivalence: The performance results were considered "satisfactory" if they demonstrated equivalence to the safely and effectively marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML medical device.
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(201 days)
The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The IBS Implant System II is consists of dental fixtures, screws and multiunit abutment cylinders.
The provided document is a 510(k) summary for the IBS Implant System II, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and non-clinical testing. It does not describe an acceptance criteria study with the requested details (number of experts, sample size for test/training set, ground truth methods, MRMC study, or standalone performance).
Instead, the document details a comparison of the new device to existing devices (predicates) regarding various technical specifications and non-clinical test results.
Since the document does not contain the information for acceptance criteria and a study proving device meets it as requested, I cannot complete the table or answer the specific questions.
No information for the requested table and study details is available in the provided text. The document focuses on demonstrating substantial equivalence through comparison with predicate devices and non-clinical tests (biocompatibility, endotoxin, sterilization validation, shelf-life validation, fatigue). These are not presented as a study with specific acceptance criteria that the device performed against in the way an AI/software performance study would be evaluated.
Therefore, the requested table of acceptance criteria and reported device performance cannot be generated. Similarly, specific details about sample size (training/test), data provenance, expert involvement, adjudication, MRMC, or standalone performance are not provided as these types of studies are typically associated with performance claims for diagnostic or prognostic devices, not for substantial equivalence of an endosseous dental implant based on physical and material properties.
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