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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.

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

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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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 abulment support for fixed bridgework, this system is intended for delayed loading.

The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purposed of providing prosthetic support for dental restorations (Crown, bridge, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

The INNO SLA Submerged Implant System is a dental implant made of titanium(Grade 4) metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used. the claims, the material composition employed and performance characteristics. The differences between the subject device and the predicate device are shape and surface treatment. The INNO SLA Submerged Implant System has one-stage and two-stage surgery. The surface treatment method of the subject device is S.L.A(Sand-blasted Large grit Acid-etched).

The fixture diameters are 3.7. 4.2, 4.6, 5.1, and 6.0mm and the implant lengths are 7.0, 7.5, 8, 9.5. 10. 11.5. 12. and 14mm in this system. The available lengths for each diameter of the fixtures are the following:

• 03.7mm with lengths of 8mm, 10mm, 12mm, and 14mm
• 04.2mm with lengths of 8mm, 10mm, 12mm, and 14mm .
• 04.6mm with lengths of 8mm, 10mm, 12mm, and 14mm ●
• 5. 1mm with lengths of 7mm, 8mm, 12mm, 12mm, and 14mm .
• 06.0mm with lengths of 7mm, 7.5mm, 9.5mm, and 11.5mm .

The abutments are made of titanium alloy and plastic and it is intended for use to made temporary prosthesis. It consists of Abutment and Coping Screw. The Abutment diameters are 3.7 ~ 6.5mm, and lengths 7.9 ~ 17.7mm.

The provided text describes a 510(k) submission for the "INNO SLA Submerged Implant System" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria through performance data.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

• Nature of 510(k) Submission: A 510(k) submission primarily aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device (substantial equivalence), without requiring new studies to establish specific performance criteria like those often seen in AI/software device submissions. It often relies on comparisons of design, materials, indications for use, and possibly non-clinical bench testing.
• "No additional testing was performed for the subject device." This explicit statement means there isn't a performance study for the INNO SLA Submerged Implant System as requested.
• "Only the difference between the subject device and the predicate is the surface treatment method and the Fixture's external design." The submission argues that these differences do not raise new questions of safety or effectiveness.

Therefore, many of the requested fields related to a performance study will be marked as "Not Applicable" or "Not Provided" based on the content.

Acceptance Criteria and Device Performance

Since no specific performance study was conducted for the subject device to quantify its performance against pre-defined acceptance criteria, this table cannot be populated as requested in the context of typical AI/software device evaluation.

Study Details

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

   • Sample Size: Not applicable. No clinical or non-clinical performance study with a test set was performed for the subject device to demonstrate new performance metrics. The submission relies on demonstrating substantial equivalence to predicate devices that are already marketed.
   • Data Provenance: Not applicable.

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

   • Not applicable. No test set requiring expert ground truth was used for this submission. The submission is based on engineering and material comparisons, and the established safety and effectiveness of predicate devices.

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

   • Not applicable. No test set requiring ground truth adjudication was used.

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

   • Not applicable. This device is a dental implant, a physical medical device, not an AI software. Therefore, an MRMC study related to AI assistance is irrelevant.

5. 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 or software. Therefore, standalone algorithm performance is irrelevant.

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

   • Not applicable. The submission is for a physical dental implant and relies on established regulatory pathways for devices of similar design, materials, and intended use, rather than requiring ground truth for diagnostic or predictive performance.

7. The sample size for the training set:

   • Not applicable. This device is a physical dental implant, not a machine learning model.

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

   • Not applicable. This device is a physical dental implant, not a machine learning model.

Summary of the 510(k) Submission:

The provided text describes a 510(k) submission (K132247) for the INNO SLA Submerged Implant System. The submission itself explicitly states: "No additional testing was performed for the subject device."

Instead of conducting a new study to establish acceptance criteria and performance, the manufacturer, Cowellmedi Co., Ltd., is seeking clearance by demonstrating substantial equivalence to two predicate devices:

• Cowell Implant System by Cowellmedi Co., Ltd. (K100850)
• Implantium II by Dentium Co., Ltd. (K060501)

The grounds for substantial equivalence are based on:

• Identical intended use
• Identical material composition: CP Titanium, Gr.4 ASTM F67
• Similar design: Submerged
• Similar components and sterilization method (Gamma)
• Compliance with FDA's Class II special controls guidance document for root-form endosseous dental implants.

The noted differences between the subject device and the predicates are:

• Surface treatment method: INNO SLA uses SLA (Sand-blasted Large grit Acid-etched), while one predicate uses RBM (Resorbable Blast Medium) and the other uses SLA.
• Fixture's external design
• Specific implant diameters and lengths offered, which overlap significantly with the predicate devices' ranges.

The submission concludes that these differences do not raise new questions of safety or effectiveness, and therefore the device is substantially equivalent to the predicate devices. The FDA concurred with this assessment and cleared the device for market.

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The Cowell 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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is not intended for immediate loading.

The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

The Cowell Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The provided text describes a 510(k) summary for the Cowell Implant System, a dental implant. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.

The document states:

• "The Cowell Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics."
• "The Cowell Implant systems are similar in fundamental scientific technology to the predicate devices (K090825, K053353) in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutment."
• "concludes that the ball abutment is safe and effective and substantially equivalent to predicate devices as described herein."

This indicates that the device was approved based on its similarity to existing, approved devices and compliance with regulatory guidelines, rather than a standalone performance study with quantifiable acceptance criteria.

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The Atlas Implant System - Wide Plus is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. Also, there are no angled abutments intended to be used with this system. Smaller (e 4.5, e 5.5) implants are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger (o 6.0 to o 8.0) implants are dedicated for the molar region and not indicated for immediate loading.

The Atlas Implant System - Wide Plus is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

This is a 510(k) premarket notification for a medical device called the "Atlas Implant System - Wide Plus," which is an endosseous dental implant. The document states that the device is "substantially equivalent" to predicate devices already on the market, meaning no new clinical studies are typically required to demonstrate safety and effectiveness for substantial equivalence.

Therefore, the provided document does not contain any information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way you've described (e.g., performance metrics like sensitivity, specificity, or clinical outcomes from a trial).

Here's why and what information can be extracted/inferred:

Reason for lack of information:

• Substantial Equivalence (510(k)): The 510(k) pathway for medical device clearance in the US primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing design, materials, indications for use, and performance characteristics (often mechanical or biocompatibility testing), but does not typically require prospective clinical trials with performance metrics like those seen in software or diagnostic device submissions.
• Device Type: Endosseous dental implants are mechanical devices. Their "performance" is generally assessed through mechanical properties (strength, fatigue), biocompatibility, and integration with bone, rather than diagnostic accuracy or predictive power that would have metrics like sensitivity/specificity.

Based on the provided text, the following points apply:

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

   • Not available. The document does not specify quantitative acceptance criteria or detailed performance results in the context of comparative effectiveness or diagnostic accuracy. The "performance characteristics" mentioned are likely related to mechanical and material properties compared to predicates, but these are not disclosed in detail.

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/Not available. Since no clinical study or test set for performance evaluation (e.g., diagnostic accuracy) is mentioned, this information is not provided.

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/Not available. No ground truth establishment related to a test set is discussed.

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

   • Not applicable/Not available. No test set or adjudication method 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:

   • No. This is a hardware device (dental implant), not an AI/software device. Therefore, an MRMC study with human readers and AI assistance is not relevant or reported.

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

   • No. This is a hardware device, not an algorithm.

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

   • Not applicable/Not available. No ground truth definition for a performance study is provided. For this type of device, "ground truth" might refer to successful osseointegration or long-term clinical success, but no study is detailed.

8. The sample size for the training set:

   • Not applicable/Not available. As this is not an AI/machine learning device, there is no training set in that context.

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

   • Not applicable/Not available. No training set is described.

In summary: The provided 510(k) summary for the "Atlas Implant System - Wide Plus" demonstrates its substantial equivalence to predicate devices based on design, materials (TI6A1-4V ELI alloy), indications for use, and performance characteristics (which are not detailed but are assumed to be mechanical and biocompatibility data typical for such devices). It does not present a clinical study with acceptance criteria and results in the manner typically expected for diagnostic or AI-powered devices.

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The Atlas Implant System - Mini Plus is intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

The Atlas Implant System - Mini Plus is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The provided text describes the "Atlas Implant System - Mini Plus" dental implant. The performance data section states:

"All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, mechanical testing of the implants demonstrated that the Atlas Implant System - Mini Plus possess mechanical strength at least equivalent to the predicate devices."

This sentence indicates that the acceptance criteria for the device's performance are based on mechanical strength at least equivalent to the predicate devices, as determined by mechanical testing consistent with the referenced FDA guidance document. The study proving this involved mechanical testing of the Atlas Implant System - Mini Plus.

However, the provided document does not contain the specific details required for the table or other requested information. It functions as a summary of a 510(k) submission, confirming substantial equivalence, but it does not include the raw data, specific test results, detailed acceptance limits, or methodological specifics of the performance study beyond the type of test (mechanical) and the comparison to predicate devices.

Therefore, many of the requested fields cannot be accurately populated from the provided text.

Here's how much of the information can be extracted or inferred based on common 510(k) practices for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. Mechanical testing for dental implants typically involves a statistically relevant number of samples to ensure robust results, but the exact number is not included in this summary.
• Data Provenance: Not specified, but likely from laboratory testing conducted by or for the manufacturer (Cowellmedi Co., Ltd.). Origin country (South Korea) could be inferred for where the manufacturer is located, but not explicitly for the test data itself. Retrospective or prospective is not applicable for this type of mechanical testing.

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

• This question is not applicable as the "ground truth" for mechanical testing is based on objective physical measurements and engineering standards, not expert clinical assessment.

4. Adjudication method for the test set

• This question is not applicable for mechanical testing. Adjudication is used for subjective assessments, typically in clinical studies or image interpretations.

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 question is not applicable. The device is a physical dental implant, not an AI or imaging diagnostic tool.

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

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

7. The type of ground truth used

• For mechanical testing, the "ground truth" is established by objective physical measurements against predefined engineering standards and comparison with established performance of predicate devices, following the FDA guidance. It is not based on expert consensus, pathology, or outcomes data in the usual sense for this type of performance evaluation.

8. The sample size for the training set

• This question is not applicable as the device is a physical dental implant, not a machine learning model requiring a training set.

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

• This question is not applicable for the same reason as above.

Summary of what can be definitively stated from the text:

• Acceptance Criteria: Mechanical strength at least equivalent to predicate devices.
• Study Type: Mechanical testing of implants.
• Proof: The mechanical testing demonstrated the device possesses mechanical strength at least equivalent to the predicate devices.
• Predicate Devices: Intermezzo™ Implant System (K051018), IMTEC Sendax MDI and MDI Plus (K031106), Maximus™ OS Implant (K041938).
• Guidance Followed: FDA guidance document "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004."

The document focuses on establishing substantial equivalence to legally marketed predicate devices, which is common for 510(k) submissions. It confirms that the necessary performance data (in this case, mechanical testing) was provided and met the standards for equivalence, but it does not detail the specifics of that data as would be found in a full study report.

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