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The AnyRidge Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function: Smaller implants (less than ø6.0 mm) are dedicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Larger implants are dedicated for the molar region and are indicated for delayed loading.

The AnyRidge Internal Implant System is especially designed for use in dental implant surgery. It consists of machined titanium, screw-form, rootform endosseous dental implant. The AnyRidge Internal Implant System contains two types of fixtures, Normal ridge type and low ridge type, various abutments and instruments. This system is made from pure titanium and the surface treatment is done with R.B.M. The implants are used to replace missing teeth in various situations ranging from a single missing tooth to the completely edentulous individual. The wide ranges of size are provided to be in conformance with each patient, or to cover up in case of due to deficiency in implant operation. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained restoration for multi-mount options. This system has 4.0, 4.4, 4.9, 5.4, 5.9mm diameters for normal ridge and 6.4, 6.9, 7.4, 7.9, 8.4mm diameters for low ridge fixtures. In addition, this system has 7.7, 9.2, 10.7, 12.2, 14.20, 17.20mm lengths for normal ridge and 7.9, 9.4, 10.9, 12.4, 14.4mm lengths for low ridge fixtures.

The provided text describes a 510(k) premarket notification for the AnyRidge Internal Implant System, which is a dental implant system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data that would be typical for novel devices or AI/ML-driven diagnostics.

Therefore, the acceptance criteria and study information typically requested for AI/ML devices or novel medical devices with performance claims are largely not applicable in this context. The focus of this 510(k) is on demonstrating that the new device is as safe and effective as existing, legally marketed devices.

Here's a breakdown based on the provided document, addressing the requested points where applicable, and noting where information is not present:

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

For a 510(k) based on substantial equivalence for a dental implant system, the "acceptance criteria" are primarily related to meeting established standards and being comparable to predicate devices in terms of design, materials, intended use, and performance where tested (e.g., fatigue). There are no specific quantitative performance metrics (like sensitivity/specificity for a diagnostic AI) provided in this document as acceptance criteria.

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 provided: This type of information (test set sample size, provenance related to clinical data for performance evaluation in the AI/ML sense) is not relevant for a 510(k) submission for a dental implant based on substantial equivalence. The "test set" here refers to the physical device's non-clinical testing (fatigue). The non-clinical test data for fatigue testing doesn't specify a "sample size" in the context of clinical or diagnostic data, but rather the number of samples tested for the engineering evaluation. No information on data provenance relating to patient populations is 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 provided: The device is a physical dental implant. There's no "ground truth" to be established by experts in the context of a diagnostic AI/ML device. The "truth" for fatigue testing is whether the implant withstands certain loads according to the ISO standard.

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

• Not applicable / not provided: No adjudication method is described as there is no diagnostic or interpretive data requiring expert consensus.

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

• Not applicable: This device is a dental implant, not a diagnostic AI or imaging system, so MRMC studies are not relevant.

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

• Not applicable: This device is a physical medical device, not an algorithm.

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

• Not applicable (for AI/ML context): For the non-clinical fatigue testing, the "ground truth" is adherence to the ISO 14801 standard for dental implants. This involves objective engineering measurements of material strength and durability, not clinical outcomes or expert consensus on a diagnosis.

8. The sample size for the training set

• Not applicable: This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable: This device is not an AI/ML algorithm that requires a training set.

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The Ball Abutment Systems are used for implant retained mucosa-supported restorations, such as overdentures where the patient is fully edentulous in the arch to be restored. There are two types of Ball Abutment system, internal and external type, and the ball abutment technique is used on Ball Abutment System implants in the maxilla or mandible.

The abutments with the following diameters are available in sizes of 2.85mm, 3.10mm, 5.00mm, and 6.00mm. The male part for each diameter is available in gingival heights of 2.0mm, 4.0mm, and 6.0mm, and the ball head diameter is 2.25mm. There are a total of 15 different size ball abutment systems being offered by Megagen.

External type: The lower part of the Ball Abutment is composed of internal circle so that the external hex of fixture can be inserted. It can combine with screw to be fixed. The top part of the abutment is ball type, and the ball head diameter is 2.25mm, and it is designed to be able to connect with Dalbo Plus which is fixed on overdenture.

Internal type: This type of abutment is inserted and combined with fixture in order to support the overdenture. The sides of lower part of the abutment have been constructed with an 11° so that they can contact with upper part of the inner fixture. The top part of the abutment is designed as a ball type, and the ball head diameter is 2.25mm. This type of design enables to be connected with Dalbo Plus, overdenture.

The provided text describes a 510(k) premarket notification for a dental device, the "Ball Abutment System," and focuses on demonstrating its substantial equivalence to previously cleared predicate devices. It does not present a study with acceptance criteria and related performance metrics for the device itself.

Instead, the submission for the Ball Abutment System relies on an argument of substantial equivalence. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. This is a common pathway for medical device clearance in the US, particularly for Class II devices.

Therefore, many of the requested categories (acceptance criteria, sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of submission as the core of the submission is a comparison to established devices, not de novo performance testing against specific clinical endpoints.

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

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The submission does not define specific performance acceptance criteria for its own device. Instead, it asserts that the device is "substantially equivalent" to predicate devices, meaning it meets the safety and effectiveness profile of those existing, cleared devices.

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

• Not Applicable. There is no "test set" in the context of a performance study described in this submission. The submission is a comparison of the new device's design, materials, and intended use to existing predicate devices.

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

• Not Applicable. No ground truth establishment for a test set is described.

4. Adjudication Method for the Test Set:

• Not Applicable. No test set or corresponding 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:

• Not Applicable. This is a dental implant component, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and "human readers improve with AI" are irrelevant to this submission.

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

• Not Applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used:

• Not Applicable. The "ground truth" implicitly referred to is the established safety and effectiveness of the predicate devices through their prior clearances and market use. No new ground truth for a novel performance claim is present.

8. The Sample Size for the Training Set:

• Not Applicable. No training set for an algorithm is described.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable. No training set or corresponding ground truth establishment is described.

Summary of what IS provided regarding "proof" and "acceptance":

The "study" or "proof" for this device revolves around demonstrating substantial equivalence to predicate devices already on the market.

• Acceptance Criteria (Implicit for Substantial Equivalence): The implicit acceptance criteria are that the Ball Abutment System must have:
  • The same intended use as the predicate devices.
  • The same technological characteristics, or if different, those differences do not raise new questions of safety or effectiveness.
  • Be as safe and effective as the predicate devices.
• Study/Proof that the device meets criteria:
  • Basis: The submission is a "510(k) premarket notification" which is explicitly to demonstrate substantial equivalence.
  • Methodology: The manufacturer states they performed "Testing and other comparisons" to establish substantial equivalence. They claim the device is "substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance" to the predicate devices (Osstem Implant Co., Ltd, Altatec GmbH - K063861, K051636).
  • Materials: The device is manufactured from Ti-6Al-4V ELI and stainless steel, stated to meet ASTM and ISO standards, which would be consistent with materials used in predicate devices.
  • Device Characteristics: The submission notes that the Ball Abutment "has the same device characteristics as the predicate device. Its materials, dimensions, and intended use are similar to devices currently marketed worldwide."
  • Safety/Performance Validation: The document states, "The Ball Abutment has been subjected to extensive safety, performance, and product validations prior to release. Safety tests have been performed to ensure the devices comply to applicable industry and US regulations." (However, specific data from these "validations" or "safety tests" is not included in this summary excerpt).
  • Conclusion: The manufacturer concludes that the differences between their device and the predicates "do not raise any questions regarding its safety and effectiveness" and that the device "is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent."

In essence, for this 510(k) submission, the "acceptance criteria" are the legal and regulatory thresholds for demonstrating substantial equivalence, and the "study" is the comparison and testing (referenced but not detailed) that supports this claim of equivalence.

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The Rescue Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, These implants are bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.

Rescue Internal Implant System consists of machined titanium, screw-form, root-form endosseous dental implants. It is 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 can be used where smaller implants have failed.

Rescue Internal Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue Internal Implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, and the instruments.

This document is a 510(k) Premarket Notification Summary for the Rescue Internal Implant System, which is a dental implant device. It does not contain information about acceptance criteria or a study proving the device meets performance criteria in the way a medical device utilizing an algorithm or AI would.

The document primarily focuses on establishing "substantial equivalence" of the new Rescue Internal Implant System components to previously cleared predicate devices (Rescue Internal Implant System K063216 and BIOCON Dental Implants K010185 and K050712). Substantial equivalence in this context means that the device is as safe and effective as a legally marketed device.

Here's why the requested information cannot be extracted from this document:

• Type of Device: This is a physical, endosseous dental implant system, not a software or AI-driven diagnostic or treatment device. The performance of such devices is typically assessed through aspects like material biocompatibility, mechanical strength, and clinical outcomes over time, rather than metrics like sensitivity, specificity, or predictive accuracy.
• Regulatory Pathway: A 510(k) submission primarily demonstrates substantial equivalence to a predicate device. It doesn't typically require a clinical study demonstrating performance against specific acceptance criteria for algorithm performance.
• Lack of Performance Data: The document states, "FDA has not established a performance standard applicable to endosseous implants. The materials in the Rescue Internal Implant System meet applicable standards." This indicates that the regulatory pathway for this physical device does not require a study with performance metrics as would be expected for a device using an algorithm. The "standards" referred to are likely material and manufacturing standards, not performance metrics related to diagnostic accuracy.

Therefore, I cannot provide the requested information because the provided text describes a physical medical device (dental implant) approved through the 510(k) pathway by demonstrating substantial equivalence, and not a device that would typically have acceptance criteria and a study design focused on algorithm performance, such as sensitivity/specificity, sample sizes for test/training sets, expert ground truth, or MRMC studies.

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The EZ Plus Implant Systems are intended to be surgically placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. Large angle abutments (e.g. 25°) on small diameter implants of the EZ Plus internal connection system are intended for the anterior region of the mouth and not intended for use in the posterior region of the mouth due to limited strength of the implant.

The EZ Plus Implant system consists of machined titanium, screw-form, root-form endosseous dental implant. The system is used as two stage, root-form dental implants, associated with abutment systems, which provide the clinician with the screw (for UCLA abutments) and cement (for solid abutments) retained restoration for multi-mount options. Fixtures, the prosthetics, and the surgical instruments are produced and packaged separately. All included devices in the system are covered by this submission.

This submission describes the EZ Plus Implant System, an endosseous dental implant. The document is a 510(k) summary for premarket notification, indicating a pathway for market clearance based on substantial equivalence to a predicate device, rather than a de novo approval requiring extensive clinical efficacy studies with predefined acceptance criteria.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this type of regulatory submission.

The 510(k) submission primarily focuses on demonstrating that the new device (EZ Plus Implant System) is as safe and effective as a legally marketed predicate device (EXFEEL IMPLANT SYSTEM). This is typically achieved through comparative data on design, materials, sterilization, indications for use, and mechanical testing, rather than clinical performance metrics relative to predefined acceptance criteria in the context of device performance.

Here's the relevant information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The submission does not define specific clinical acceptance criteria for performance metrics (e.g., success rates, failure rates) for the EZ Plus Implant System. Its clearance is based on substantial equivalence to a predicate device.

Instead, the submission includes a comparative table to demonstrate equivalence:

• External Type Implant: 3.3, 4.0, 5.0mm | 3.5, 4.1, 4.8mm (Internal)
  3.30, 3.75, 4.0, 5.0mm (External) |
  | Implant Lengths | - Internal Type Implant: 8.0, 10.0, 11.0, 13.0, 15.0, 18.0mm
• External Type Implant: 8.0, 10.0, 11.0, 13.0, 15.0, 18.0mm | - Internal Type Implant: 7.0, 8.5, 10.0, 11.5, 13.0mm
• External Type Implant: 8.5, 10.0, 11.5, 13.0, 15.0, 18.0mm |
  | Attachments | Various abutments and components | Various abutments and components |
  | Product Code | DZE | DZE |

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

Not applicable. This is a 510(k) submission, not a clinical trial report with a defined test set of patient data for performance evaluation. The "test" mentioned refers to laboratory testing for functionality and conformance to design requirements, not clinical data.
The document states, "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." No details regarding the sample size or provenance of data from this laboratory testing are provided in the summary.

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. Ground truth for clinical performance is not established or discussed in this 510(k) summary as it is not a clinical efficacy study.

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

Not applicable.

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

Not applicable. This 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:

Not applicable. This device is a physical dental implant.

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

Not applicable. Ground truth in the context of clinical outcomes or diagnostic accuracy is not established or discussed. The "ground truth" here would be adherence to engineering specifications and performance in mechanical tests.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" in the context of this device's regulatory submission.

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

Not applicable.

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The Rescue Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose 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.

Rescue Internal Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue Internal Implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, and the instruments.

The provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria for the "Rescue Internal Dental Implant System."

Instead, the document is a 510(k) Premarket Notification Summary for the device, which aims to establish substantial equivalence to a predicate device. This type of submission generally focuses on comparing the new device's design, materials, and indications for use to an already legally marketed device, rather than presenting new performance data against specific acceptance criteria.

The relevant sections of the document explicitly state:

• "FDA has not established a performance standard applicable to endosseous... The materials in the Rescue Internal Implant System meet applicable implants." (Section 8, page 1) This indicates that there are no specific FDA-mandated performance standards or acceptance criteria for this type of device that would necessitate a study to meet them.
• "The noted difference in the design and material does not effectively change the performance of the device." (Section 11, page 1) This statement, along with the comparison table, emphasizes that the justification for market clearance is based on the new device being substantially equivalent to a predicate, implying that its performance is presumed to be similar without requiring new performance studies against specific criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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The Rescue® Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose 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.

Rescue® Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue® implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, which provide the clinician with screw and cement retained restoration for multi-mount, screw retained restoration for octa abutment, and cement retained restoration for solid abutment restorative options. The devices covered by this submission are Rescue® Implant Fixtures, Retained Restoration Abutment System.

The provided 510(k) summary for the Mega'Gen Co., Ltd. Rescue® Implant System does not contain acceptance criteria or a study that evaluates device performance against such criteria in the manner typically expected for AI/ML-based diagnostic devices.

This document describes a dental implant system, which is a physical medical device. The "performance" section refers to "Laboratory testing was conducted to determine device functionality and conformance to design input requirements," but it does not specify what those requirements were, what the test outcomes were, or any quantitative acceptance criteria.

The submission focuses on establishing substantial equivalence to predicate devices (BICON Implant Systems). This is a common pathway for physical medical devices where the manufacturer demonstrates that their new device is as safe and effective as a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and manufacturing processes, rather than conducting a clinical study with detailed performance metrics against a defined ground truth.

Therefore, I cannot fulfill the request to provide the requested information for acceptance criteria and a study proving device performance as the provided document does not contain this type of data for this specific device.

Here's why the requested information isn't present in the context of this 510(k) for a dental implant system:

• Type of Device: Dental implants are physical devices, not AI/ML-based diagnostic tools. Their performance is typically assessed through mechanical testing, biocompatibility testing, and comparison of design features to established standards and predicate devices, rather than through metrics like sensitivity, specificity, or AUC based on AI model outputs.
• Submission Type: A 510(k) submission for this type of device aims to demonstrate "substantial equivalence" to a predicate device. This often means showing similar design, materials, and intended use, rather than conducting new clinical trials to prove efficacy against specific performance criteria as might be required for a novel diagnostic.
• "Performance" Section: The single line "Performance Laboratory testing was conducted to determine device functionality and conformance to design input requirements" is very generic and doesn't provide specific criteria or results.

If this were a submission for an AI/ML diagnostic device, the requested information would be crucial and would typically be found in detailed performance studies.

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Intermezzo ™ Plus are designed for use in dental implant surgery and are intended to be used in a manner in which the implants integrate with the bone (osseointegration). The system is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures.

Intermezzo ™ Plus Implant System is an integrated system of endosseous dental implants which are intended for use in partially or fully edentulous mandibles and maxillae in support of overdentures.

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the way typically seen for AI/ML-based medical devices with performance metrics like sensitivity, specificity, or AUC.

Instead, this document is a 510(k) Summary for a dental implant system (Intermezzo™ Plus), which is a physical medical device. For such devices, "acceptance criteria" are usually related to manufacturing quality, material properties, mechanical performance, and demonstrated equivalence to a predicate device. The "study" typically refers to laboratory testing and comparison to an already approved device.

Based on the provided text, here's what can be extracted and inferred:

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

The document implicitly defines "acceptance" as demonstrating substantial equivalence to a predicate device (Intermezzo™ Implant Systems, K051018) in terms of indications for use, fundamental scientific technology, materials, size, and safety/effectiveness.

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

• Sample size for test set: Not specified in the provided text. The "test" in this context refers to laboratory testing of the physical implant device, not a test set of data for an algorithm.
• Data provenance: Not explicitly stated for specific test raw data. The manufacturer is Mega'Gen Co., Ltd., located in Gyeongsan, Gyeongbuk, South Korea. The testing would presumably have been conducted there or by a contracted lab.

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):

• This information is not applicable to this type of device and submission. "Ground truth" established by experts in this manner (e.g., for diagnostic imaging) is not a component of a 510(k) for a dental implant. The "ground truth" for a physical device like this is objective measurements from laboratory tests and conformance to material standards, typically verified by engineers and quality control personnel.

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

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of medical data, particularly in AI algorithm validation. This document describes a physical medical device.

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 is not applicable. MRMC studies are used for evaluating the impact of AI on human reader performance in diagnostic tasks. This document is for a dental implant.

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

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

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

• For this physical device, the "ground truth" (or basis for verification) isn't established by expert consensus on medical images or pathology in the typical sense. Instead, it would be based on:
  • Engineering specifications and standards: Material properties, dimensions, mechanical strength, biocompatibility, sterility.
  • Performance metrics derived from laboratory testing: For example, fatigue testing, torque resistance, surface roughness, integration with bone (though this is more of an in-vivo outcome, the design facilitates it).
  • Demonstrated equivalence to a legally marketed predicate device: This is the primary "ground truth" for a 510(k) submission like this, meaning it performs as safely and effectively as the existing device.

8. The sample size for the training set:

• This is not applicable. There is no "training set" in the context of a physical dental implant device.

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

• This is not applicable as there is no training set.

Summary of the "Study" mentioned:

The document states:

• "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (Section 13-8)
• The comparison data in Section 13-13 provides evidence for "substantial equivalence" to the predicate device (Intermezzo™ Implant Systems, K051018). This comparison serves as a key part of the "study" demonstrating the device meets the regulatory acceptance criteria for 510(k) clearance. The comparison focuses on:
  • Indications for Use
  • Material (C.P Titanium Gr.3)
  • Sterility and Sterilization Method (Gamma)
  • Dimensions (Implant Diameters and Lengths)
  • Fundamental technology (threaded, root form)

In essence, the "study" for this dental implant is primarily laboratory-based physical testing and a detailed comparison against an already approved predicate device to demonstrate that it is equally safe and effective.

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The ExFeel Dental Implant Systems are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure

The ExFeel® Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. ExFeel® implant Fixture Systems consist of one-stage, rootform dental implants, associated with abutment systems, which provide the clinician with screw and cement retained restoration for multi-mount, screw retained restoration for octa abutment, and cement retained restoration for solid abutment restorative options. The devices covered by this submission are ExFeel® Implant Fixtures, Retained Restoration Abutment System.

The provided text is a 510(k) summary for the "ExFeel® IMPLANT SYSTEMS." It details the device's characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through clinical or analytical validation with human subjects or AI algorithms.

Instead, this document focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) based on design, materials, intended use, and laboratory testing for functionality and conformance to design input requirements. This is a common approach for medical devices cleared through the 510(k) pathway, where a direct comparison to a predicate device often fulfills the regulatory requirement for demonstrating safety and effectiveness without requiring extensive new clinical trials.

Therefore, I cannot provide the requested information because it is not present in the given text. The text explicitly states:

• "13-8. Performance Laboratory testing was conducted to determine device functionality and conformance to design input requirements" - This indicates engineering/bench testing, not clinical performance acceptance criteria against human data or AI performance.
• "13-12. Basis for Substantial Equivalence The Exfeel Implants are substantially to ITI Dental Implant(K002374), Nobel Biocare Branemark Dental Implant(K993595) in intended use, material and design." - This highlights the primary method of demonstrating safety and effectiveness.

To explicitly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not available. The document refers to "laboratory testing... to determine device functionality and conformance to design input requirements," but it does not specify what those criteria were or detail the results in a performance table.
2. Sample size used for the test set and the data provenance: Not applicable, as there is no human test set or data described. The "test set" here would refer to the physical implants subjected to laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical or image-based AI studies is not relevant to this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Intermezzo TM Implant Systems are intended to load immediately in partially or fully edentulous mandibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.

Intermezzo ™ Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Intermezzo ™ Implant System consists of Intermezzo ™ Implant Fixtures, Intermezzo Cap, and Implant System Surgery Tray. Implant Fixture Systems consist of one-stage, root-form dental implants, associated with protective cap, which provide the clinician to maintain the patients' gingival contour. The system also includes surgical and restorative instrumentation: lance drills, twist drills, unification drills, and handpiece drivers and hand drivers to provide the clinician to choose only those components required for each clinical situation. The devices covered by this submission are Intermezzo ™ Implant Fixtures, Intermezzo Protective Cap, and Intermezzo Implant System Surgery Tray.

The provided text is a 510(k) summary for a dental implant system (Intermezzo™ Implant Systems). It does not describe an AI/ML device or a study assessing its performance against acceptance criteria in the way envisioned by your request.

The core of this document is to demonstrate "substantial equivalence" of the Intermezzo™ Implant Systems to already legally marketed predicate devices, not to prove its performance against specific acceptance criteria through a clinical study for an AI algorithm.

Therefore, I cannot populate the requested information regarding acceptance criteria and a study that proves the device meets them, specifically for an AI/ML context, because this document describes a traditional medical device (dental implants), not an AI-powered one.

Here's how the provided information relates to your template, highlighting the absence of AI/ML-specific details:

1. Table of acceptance criteria and the reported device performance

• Cannot be provided. The document states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." However, it does not specify what those design input requirements (acceptance criteria) were or the results of this testing. The focus is on demonstrating "substantial equivalence" to predicate devices, not meeting novel performance criteria.

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

• Cannot be provided. No test set or data provenance is mentioned in the context of performance evaluation, as this is a traditional medical device submission based on substantial equivalence and laboratory testing, not a clinical study to assess a diagnostic or predictive algorithm.

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)

• Cannot be provided. Ground truth, in the context of AI/ML, refers to definitively established outcomes or labels for a dataset. This concept is not applicable to a submission for a dental implant system.

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

• Cannot be provided. Adjudication methods are relevant for subjective interpretations in clinical trials or for establishing ground truth in AI/ML studies. This document does not describe such a process.

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

• Cannot be provided. No MRMC study was done, as this is not an AI-assisted device.

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

• Cannot be provided. This is not an algorithm.

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

• Cannot be provided. The concept of "ground truth" as it applies to AI/ML clinical validation is not relevant to this device's submission.

8. The sample size for the training set

• Cannot be provided. There is no AI model, therefore no training set.

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

• Cannot be provided. Not applicable due to the absence of an AI model/training set.

In summary: The provided document is a 510(k) summary for a "Class II" dental implant system, demonstrating substantial equivalence to pre-existing predicate devices. It focuses on device description, intended use, materials, and manufacturing, rather than clinical performance data against specific acceptance criteria for an AI/ML algorithm.

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