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The INNO SLA Mini Plus® Implant System is divided into two types:

• Cemented Type
  The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors to serve as temporary support prosthetic devices during stage of permanent endosseous dental implant, such as artificial teeth, in order to restore masticating function in partially edentulous patients.

• Ball Type
  The Ball type is designed for use in dental implant surgery. The Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. The use of the Ball type implants is not to exeed one hundred and eighty (180) days.

The Cemented Type and Ball Type implant bodies are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The INNO SLA Mini Plus® Implant System has two types, cement type and ball type. The INNO SLA Mini Plus® Implant System is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is made of commercially pure titanium and has S.L.A. surface treatment.

The provided text is a 510(k) summary for the INNO SLA Mini Plus® Implant System, which establishes substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on a clinical study for performance. Therefore, much of the requested information regarding acceptance criteria, study details, and expert involvement is not present in the provided document.

However, I can extract the non-clinical performance data and related information as presented.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of acceptance criteria with corresponding device performance metrics from a formal study. Instead, it describes various non-clinical tests conducted or leveraged to demonstrate substantial equivalence to predicate devices. These tests primarily focus on material properties, manufacturing processes, and safety aspects.

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

This information is not provided in the document. The document describes non-clinical tests, and for those, the "sample size" would refer to the number of units tested. This detail is not present. Data provenance (country of origin, retrospective/prospective) is also not applicable or not disclosed for these non-clinical tests.

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

This information is not provided. This document focuses on demonstrating substantial equivalence to existing devices through non-clinical testing and comparison of characteristics, not through a clinical study requiring expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods are typically relevant for clinical studies involving multiple readers or assessors, which is not described here.

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

This information is not provided. The device is an endosseous dental implant system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable.

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

This information is not applicable. The device is a physical dental implant system, not an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical tests described:

• Biocompatibility/Chemical Analysis: The ground truth would be established by industry standards and regulatory requirements for safe material interaction with biological systems.
• Sterilization Validation: Ground truth is established by meeting the sterility assurance level (SAL) defined by ISO standards.
• Shelf Life: Ground truth is established by assessing material degradation over time under specific conditions.
• Endotoxin Testing: Ground truth is established by meeting specified pyrogen limits.
• MRI Safety: Ground truth is established by referenced scientific literature and adherence to ASTM standards and FDA guidance for MR safety, which define acceptable parameters for magnetic field interaction, heating, and artifact generation.

8. The Sample Size for the Training Set

This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device. The non-clinical tests would have involved a sample size of the physical device components, but these details are not disclosed.

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

This information is not applicable/not provided for the same reason as point 8.

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INNO SLA Submerged Hybrid Ti-Base System is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations. All digitally designed zirconia superstructures for use with the INNO SLA Submerged Hybrid Ti-Base System are intended to be sent to a Cowellmedi validated milling center for manufacture.

INNO SLA Submerged Hybrid Ti-Base System consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment). These two pieces together form the final abutment. Ti-base Abutment System is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The zirconia material is InCoris Zi, cleared under K123664, and the cement is RelyX Unicem 2Automiz, cleared under K100756. Zirconia CAD/CAM abutment or superstructure that composes the final prosthetics is intended to be designed and milled, according to the prosthetic planning and patient clinical situation. It is compatible with the following systems: INNO SLA Submerged Implant System(K132242) by Cowellmedi Co., Ltd. The system offers the following three types of Ti-Base with a screw that fix the abutment into the fixture. Hybrid S Ti-Base, Hybrid L Ti-Base, Hybrid A Ti-Base.

The provided text is a 510(k) Summary for the INNO SLA Submerged Hybrid Ti-Base System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data from a clinical or extensive non-clinical study that would typically be conducted for a de novo device or a device requiring premarket approval (PMA).

Therefore, the information required to fully answer your request (acceptance criteria, specific study results proving the device meets criteria, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not present in this 510(k) summary.

A 510(k) submission primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, or if there are differences, that these differences do not raise new questions of safety and effectiveness. The "Performance Data (Non-Clinical)" section lists the types of tests performed (sterilization, biocompatibility, fatigue, MR environment review) and states that the "test results support that the subject device is substantially equivalent to the predicate devices." However, it does not provide the actual acceptance criteria or the specific numerical performance results against those criteria.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in terms of pass/fail thresholds for each test. The implicit acceptance criterion for a 510(k) is that the device is "substantially equivalent" to the predicate.
• Reported Device Performance: Only general statements are made:
  • "Sterilization validating testing has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization." (Result: Implied adequate sterilization)
  • "Biocompatibility testing has been performed in accordance with ISO 10993-3, 5, 6, 10, 11, and 23." (Result: Implied biocompatible)
  • "Fatigue test in accordance with ISO 14801" (Result: "the result supports that the [subject device is] substantially equivalent to the predicate device in the market.")
  • "MR Environment Condition... Non-clinical worst-case MRI review was performed... based on the entire system including all variations... Rationale addressed parameters per the FDA Guidance... including magnetically induced displacement force and torque." (Result: Implied suitable for MR environment, likely "MR Conditional" or "MR Safe" based on the referenced guidance, though not explicitly stated.)

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

• Not specified. This document describes non-clinical engineering and materials testing, not a clinical study involving human patient data.

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

• Not applicable. This pertains to an AI/ML device where expert review establishes ground truth for image interpretation or diagnosis. This document is about a dental implant abutment system.

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

• Not applicable. This applies to expert review of data for AI/ML performance evaluation.

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

• No. This is not an AI/ML device for diagnostic assistance.

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

• Not applicable. This is not an AI/ML diagnostic software.

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

• Not applicable in the AI/ML sense. For the engineering tests, the "ground truth" would be established by the specifications of the relevant ISO standards (e.g., ISO 14801 for dental implant fatigue, ISO 10993 for biocompatibility) and comparison to the predicate device's performance (though the specific predicate's performance is not numerated here).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

In summary: The provided 510(k) summary for the INNO SLA Submerged Hybrid Ti-Base System details the types of non-clinical tests performed to demonstrate substantial equivalence to predicate devices (URIS Base, Preat Abutment, BioHorizons CAD/CAM Abutments). It does not provide the specific numerical acceptance criteria or quantitative performance results, as is typical for a 510(k) submission which relies heavily on comparison to existing legally marketed devices rather than requiring de novo clinical performance validation against novel acceptance criteria. The questions posed align more with the evaluation of AI/ML or diagnostic software devices, which this dental hardware device is not.

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Meta G UCLA Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The Meta G UCLA Abutment is used for prosthetic restoration. The Meta G UCLA Abutment consists of Meta G UCLA Abutment and abutment screws. The Meta G UCLA Abutment is made of CCM (ASTM F1537) and POM (ASTM F1855). The casting material to make prosthesis is also CCM. When cast a prosthesis with the Meta G UCLA Abutment, the post height above the transmucosal collar of the Meta G UCLA Abutment has to be taller than 4mm and maximum 7mm.

The Meta G UCLA Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. No angulation is to be incorporated into the cast final device and abutments should not be used on implants placed at an angle.

It is provided non-sterile, this should be user steam sterilized before use. The Meta G UCLA abutment is compatible with our own implant system.

• INNO SLA Submerged Implant System(K132242) by Cowellmedi Co., Ltd.
• INNO SLA Submerged Narrow Implant System (K231395) by Cowellmedi Co., Ltd.

The design envelope for the Meta G UCLA Abutment is as follows.

<Design limits - Meta G UCLA Abutment> Minimum Diameter: 4.5 mm (0.18 in) Minimum Thickness : 0.8mm Maximum Total Cuff Height : 4mm Minimum Total Cuff Height : 1mm Maximum Cuff Height of Casting CCM part : 3mm Minimum Cuff Height of Casting CCM part : 0mm Post height: minimum of 4mm and maximum of 7mm

<Design limits - Meta G UCLA Abutment (Narrow)> Minimum Diameter: 4.5 mm (0.18 in) Minimum Thickness : 0.93mm Maximum Total Cuff Height : 4mm Minimum Total Cuff Height : 1mm Maximum Cuff Height of Casting CCM part : 3mm Minimum Cuff Height of Casting CCM part : 0mm Post height: minimum of 4mm and maximum of 7mm

The provided document is a 510(k) summary for a medical device (Meta G UCLA Abutment) seeking clearance from the FDA. It does not describe a study proving the device meets acceptance criteria for an AI/ML powered device. Instead, it details the device's technical specifications, indications for use, and a comparison to predicate devices to demonstrate "substantial equivalence."

Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving an AI/ML device meets them, as this document is not about an AI/ML device or its performance evaluation in that context. This document focuses on the mechanical and material properties of a dental abutment and its equivalence to previously cleared devices.

Here's why and what information is available (though not directly answering your prompt):

• Type of Device: The Meta G UCLA Abutment is an "Endosseous Dental Implant Abutment." This is a mechanical medical device, not an AI/ML powered one.
• Performance Data (Non-Clinical) - Section 7: This section outlines the tests performed to demonstrate the safety and equivalence of the mechanical device:
  • Sterilization validation testing: In accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization.
  • Biocompatibility testing: In accordance with ISO 10993-3, 5, 10, 11.
  • Biocompatibility of the abutment screw: Leveraged from a previously cleared submission (K201323).
  • MR Environment Condition: A non-clinical worst-case MRI review was performed using scientific rationale and published literature to assess magnetically induced displacement force and torque.

These are standard regulatory requirements for this type of mechanical implant component, not acceptance criteria for an AI/ML algorithm's analytical performance (e.g., sensitivity, specificity, AUC).

If you have a document pertaining to an AI/ML powered device, I would be happy to analyze it according to your requested criteria.

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INNO SLA Submerged Narrow Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols:

• The intended use for the 3.3mm, 3.5mm diameter INNO Sub Narrow Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors.

• Immediate placement in extraction situations with a partially or completely healed alveolar ridge.

• It is intended for delayed loading.

The INNO SLA Submerged Implant System offers the following components.

1 INNO SLA Submerged Narrow Fixture (Narrow) Ø 3.3 x 8.00, 10.00, 12.00, 14.00 mm Ø 3.5 x 8.00, 10.00, 12.00, 14.00 mm
2 Cover Screw (Narrow) Ø 2.84 x 5.0 mm Ø 3.23 x 6.0 mm Ø 3.62 x 7.0 mm
3 Healing Abutment (Narrow) Type 1 Ø3.5 x 6.7, 7.2, 9.2, 10.2, 11.2 mm
4 Healing Abutment (Narrow) Type 2 Ø 4.5 x 7, 9, 10, 11, 12, 14 mm
5 Cemented Abutment (Narrow) Ø 4.5 x 7.85, 8.85, 9.85, 10.85, 11.85, 12.85, 13.85, 14.85mm Ø 4.5 x 9.35, 10.35, 11.35, 12.35, 13.35 mm Ø 4.5 x 7.65, 8.65, 9.65, 10.65, 11.65, 13.65, 14.65 mm Ø 4.5 x 9.15, 10.15, 11.15, 12.15, 13.15 mm
6 Angulated Abutment (Narrow) Ø 4.5 x 11.85, 12.85, 13.85, 14.85 mm (15°, 25°)
7 Multi S Abutment Ø 4.5 x 5, 5.8, 6mm
8 Multi A Abutment Ø 4.5 x 6.42, 7.42, 8.42, 6.96, 7.96mm (15°,30°) – Hex type Ø 4.5 x 6.23, 7.22, 8.22, 6.76, 7.76mm (15,30°) – Non Hex type
9 Multi Hybrid Ti-Base Cylinder Ø 4.5 x 4.5mm
10 Abutment Screw (Narrow) Ø 2.25 x 10.2 mm Ø 1.95 x 8.7 mm
Ø 1.95 x 9.3 mm
12 Multi Cylinder Screw Ø 2.25 x 5 mm
13 Straight Abutment Ø 3.5 x 13.5, 14, 15, 16, 17 mm
14 Temporary Abutment Ø 4.5 x 10 mm
15 Multi Titanium Cylinder Ø 4.5 x 9 mm

The provided document is a 510(k) premarket notification for a medical device (INNO SLA Submerged Narrow Implant System). This type of document focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on proving clinical effectiveness or meeting specific performance acceptance criteria through a dedicated study.

Therefore, the document does not contain any information regarding:

• Acceptance criteria in the traditional sense of a clinical or performance study with numerical targets for metrics like sensitivity, specificity, accuracy, etc.
• The study that proves the device meets acceptance criteria (as no such study with performance metrics is presented).
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Ground truth type for a performance study.
• Sample size for the training set.
• How the ground truth for the training set was established.

Instead, the document focuses on demonstrating substantial equivalence through:

1. Performance Data (Non-Clinical):

The performance testing listed focuses on engineering and material characteristics, leveraging previous clearances and established standards.

• Gamma radiation sterilization and shelf-life: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Steam sterilization of abutments: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K201323.
• Five-year shelf life and packaging: Leveraged from Cowellmedi Co., Ltd's previous clearance K132242.
• SLA surface treatment: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Fatigue test in accordance with ISO 14801: This is an engineering test to ensure the mechanical integrity of the implant system. The document states: "We have performed the fatigue test to make sure the differences do not raise and the test result of the test supported substantial equivalence." However, no specific numerical acceptance criteria or results are provided in the summary.
• Biocompatibility endpoints: Leveraged from Cowellmedi Co., Ltd.'s previous clearance K132242.
• Non-clinical worst-case MRI review: Performed using scientific rationale and published literature to evaluate displacement force and torque.

2. Substantial Equivalence Discussion and Comparison Chart:

This section directly compares the subject device (INNO SLA Submerged Narrow Implant System) with various predicate and reference devices, highlighting similarities in:

• Intended Use
• Material (Titanium Grade 4 or Ti-6Al-4V ELI)
• Principle of Operation
• Design
• Surface Treatment (SLA, TiN Coating)
• Sterility (Gamma Sterilization, Non-sterile with terminal sterilization via moist heat/autoclave, End User Sterilization)
• Shelf Life (5 years)

The document asserts that slight differences, such as in abutment size options or diameter ranges, do not affect substantial equivalence or raise concerns about safety or performance.

In summary, for a traditional clinical or AI/ML performance study as requested, all fields would be "Not Applicable" or "Not Provided" based on the content of this 510(k) summary. The "acceptance criteria" here are implicitly that the device performs equivalently to the listed predicates based on the non-clinical tests and functional comparisons detailed.

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InnoGenic™ Non-resorbable membrane is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "InnoGenic™ Non-resorbable Membrane". This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment related to an AI/ML powered medical device.

The document states that the device is a "temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites." It is a Class II device (Bone Grafting Material, 21 CFR 872.3930).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided text.

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The INNO SLA Submerged Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The INNO SLA Submerged Implant System offers Healing Abutment (Type A and Type B), Angulated Abutment, Temporary Abutment, Sonator S Abutment, Sonator A Abutment, and Screws. These components are used with the fixtures and cover screws cleared under K132242.

The provided text is a 510(k) summary for the INNO SLA Submerged Implant System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/ML-driven device performance study. The device described, the "INNO SLA Submerged Implant System," is a physical dental implant system and not an AI/ML-based medical device. Therefore, the questions related to AI/ML device performance (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this document.

The document does mention "Non-Clinical Testing" which includes:

• Surface Modification: Leveraging specifications and processes from a predicate device (K132242) for TiN coating.
• Cytotoxicity Testing: Performed on representative abutments with TiN coating according to ANSI/AAMI/ISO 10993-5 and ISO 10993-12. This type of testing ensures the material is not harmful to cells.
• Mechanical performance testing: Conducted according to ISO 14801. This test establishes the fatigue limit to ensure structural integrity and sufficient strength for intended use. The "worst-case scenario" was chosen based on FDA Guidance.
• End-user sterility validation: Conducted according to ISO 17665-1 and ISO 17665-2 for a prior clearance (K132242) and leveraged for the subject devices.

These tests are standard for physical medical devices and confirm material compatibility, mechanical robustness, and effective sterilization, which are relevant "acceptance criteria" for such devices. The document explicitly states that the mechanical performance test demonstrated "sufficient strength for their intended use and are substantially equivalent to predicate devices with regard to mechanical performance."

In summary, the requested information regarding AI/ML device performance cannot be extracted from this document because it pertains to a physical dental implant system, not an AI/ML system.

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