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ET System: The HIOSSEN Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
US/SS System: The OSSTEM Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

The ET US SS Prosthetic system is intended for use as an aid in prosthetic restoration. It is consisted of abutments, components and abutment screws.

The provided document is a 510(k) Premarket Notification from the FDA for a dental prosthetic system. It details the device, its intended use, and its substantial equivalence to predicate devices based on nonclinical testing. However, it does not contain acceptance criteria for device performance, nor does it describe a study proving the device meets specific performance criteria in terms of clinical effectiveness or accuracy.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is a different regulatory pathway than proving novel performance. Substantial equivalence is established by showing that the new device has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, that the different characteristics do not raise new questions of safety and effectiveness and that the device is as safe and effective as the predicate device.

Here's an analysis of the information available in the document, keeping in mind that it's a substantial equivalence filing rather than a performance validation study against acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document primarily identifies the device's characteristics (materials, dimensions, intended use) and compares them to predicate devices to establish substantial equivalence. It does not list quantitative acceptance criteria for clinical performance (e.g., accuracy, sensitivity, specificity, or success rates) or specific performance metrics that the device is intended to meet.

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

This information is not applicable in the context of the provided document. The submission explicitly states:

• "No clinical studies are submitted." (Page 22)
• The nonclinical testing primarily involves fatigue testing and biocompatibility evaluations, which are typically performed on samples of the device components rather than a "test set" of patient data. The sample sizes for these engineering tests are not specified in this summary.
• Data provenance for clinical data is not applicable as no clinical data was submitted.

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

This information is not applicable as no clinical studies with a test set requiring ground truth establishment by experts were submitted.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical studies with a test set requiring adjudication were submitted.

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 applicable. The device described is a physical dental prosthetic system (abutments, screws, caps), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect sizes are not relevant to this submission.

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

This information is not applicable for the same reason as point 5. The device is a physical prosthetic, not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable as no clinical studies requiring ground truth were submitted. The basis for safety and effectiveness is substantial equivalence to predicate devices, supported by nonclinical testing (fatigue, biocompatibility, sterilization validation).

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this device is not an AI/machine learning product and no clinical data or algorithms are being trained.

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

This information is not applicable as there is no training set mentioned in relation to this device.

Summary of the Study and "Acceptance Criteria" (as interpreted from the document's context):

The "study" described in the document is primarily focused on nonclinical testing and demonstrating substantial equivalence to predicate devices rather than fulfilling specific performance acceptance criteria for clinical outcomes.

Acceptance Criteria (Implicit from Substantial Equivalence):

From the context of a 510(k) submission, the "acceptance criteria" are implicitly met if the device can demonstrate that it is as safe and effective as a legally marketed predicate device. This is achieved by showing:

• Same Intended Use: The ET US SS Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations (crowns, bridges, over-dentures), which is identical to the indications for use of its identified predicate and reference predicate devices (e.g., K062030, K130662).
• Same Technological Characteristics OR Equivalent Safety/Effectiveness with Different Characteristics:
  • Material: Titanium Alloy, PEEK, Polymer (Polycarbonate, POM) – consistent with predicate devices.
  • Design & Function: Described as similar in various components (e.g., Quick Temporary Abutment, Solid Abutment, ComOcta Abutment, Healing Abutment, Ti Screw, O-ring Abutment, Multi Angled Abutment, Esthetic-low Temporary Cylinder). Where there are differences (e.g., new dimensions, slight shape changes, different connection structures for Multi Angled Abutments), the submission asserts that these differences "do not raise new questions of safety and effectiveness" and that the device maintains "same principles of operation, function, material, characteristic and intended use."
  • Biocompatibility: Stated to be the same as predicates, thus requiring no additional testing.
  • Sterilization: For Cover Screw and Healing Abutment, considered substantially equivalent to a predicate. Other components are non-sterile and require steam sterilization validation according to ISO 17665-1:2006. The results implicitly meet the standard.
  • Fatigue Testing: Performed according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with a worst-case scenario. The implied acceptance is that the device met the fatigue strength requirements comparable to the predicate devices or within safe limits for its intended use, ensuring structural integrity. Specific results or detailed criteria are not laid out, but the successful completion of these tests supports substantial equivalence.

Reported Device Performance (from the perspective of 510(k) substantial equivalence):

The document reports the device's performance by demonstrating its similarities to predicate devices across various characteristics:

• Materials: Predominantly Titanium Alloy (ASTM F 136), Titanium (ASTM F 67), and various polymers (PEEK, Polycarbonate, PolyOxy Methylene). These are well-established materials in dental prosthetics, matching those of the predicate devices.
• Dimensions: Various diameters and heights are listed for each component, often including new dimensions that are added to existing product lines. The claim is that these new dimensions do not alter the fundamental safety or effectiveness and maintain the "same principles of operation, function, material, characteristic and intended use" as the predicate devices.
• Functional Principles: Described for each component (e.g., "Used to make temporary prosthesis," "Used in producing ordinary cement-retained prosthetics," "Connect an abutment with fixture by screw"). These are consistently aligned with the predicate device functions.
• Nonclinical Test Results:
  • Biocompatibility: Implicitly deemed acceptable due to using the same materials, manufacturing processes, surface treatments, and sterilization methods as legally marketed predicate devices.
  • Sterilization Validation: Cover Screw and Healing Abutment results are "considered to be substantial equivalent" to a specific predicate, indicating adequate sterilization protocols. Other non-sterile devices underwent steam sterilization validation to ISO 17665-1:2006, implying successful validation.
  • Fatigue Testing: Performed on a "worst-case scenario" sample, suggesting that the device's mechanical durability was assessed and found satisfactory based on the relevant guidance document, thereby supporting its structural integrity and equivalence.

In conclusion, the document demonstrates that the ET US SS Prosthetic System meets the "acceptance criteria" for a 510(k) submission by establishing its substantial equivalence to predicate devices through a comparison of technological characteristics and successful nonclinical testing for biocompatibility, sterilization, and fatigue. No clinical performance criteria or studies are presented.

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Hiossen Prosthetic system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

The Hiossen Prosthetic system is intended for use as an aid in prosthetic restoration. It consists of Abutments, overdenture components and Abutment Screws. The Hiossen Prosthetic 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.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) summary for a dental prosthetic system, and it primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria.

Here's what is missing from the document based on your request:

• A table of acceptance criteria and reported device performance: The document mentions safety, performance, and product validations but does not provide a table with specific criteria and results.
• Sample size and data provenance for a test set: This information is not present.
• Number and qualifications of experts for ground truth: This is not discussed.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: The document explicitly states "No clinical studies are submitted."
• Standalone algorithm performance study: This is not a software device, and no such study is described.
• Type of ground truth used: Not applicable given the nature of the device and the lack of clinical studies.
• Sample size and ground truth establishment for the training set: Not applicable and not mentioned, as this is a hardware device approval, not an AI/software device.

The document states: "Proposed devices in this submission are substantially equivalent to the predicate devices Therefore we didn't consider conducting additional test but biocompatibility test and retention test of O-Ring are conducted because material of O-Ring is changed." This indicates that the primary method of demonstrating safety and effectiveness was through comparison to existing cleared devices, with limited specific testing mentioned for material changes.

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The Axon-Bus Prosthetic System is to be used exclusively for exoprosthetic fittings of the upper limbs.

The Axon-Bus Prosthetic System is to be used exclusively for upper limb exoprosthetic fitting. The Axon-Bus Prosthetic System is suitable for unilateral amputations starting with the transradial/transhumeral amputation level or, in case of dysmelia, for forearm or upper arm fittings. The Axon-Bus prosthetic system was developed for everyday use and must not be used for unusual activities. The prosthesis is intended exclusively for use on one patient. Fitting a patient with the Axon-Bus prosthetic system may only be carried out by a prosthetist who has been authorized by Ottobock after completion of a corresponding training course.

System Components:

• Michelangelo Hand (terminal device)
• AxonFlexion Adapter (passive flexion)
• AxonRotation Adapter (passive rotation)
• AxonArm (passive elbow joint with mechanical and/or electrical lock)
• AxonEnergy Integral (battery)
• AxonCharge (charger)
• AxonMaster (control unit)
• Electrode (detecting EMG Input signals)
• AxonSoft (adjustment software)
• AxonSkin (prosthetic glove)

The provided text describes the Axon-Bus Prosthetic System and its performance testing, but it does not include a study proving that the device meets specific acceptance criteria in the format requested. The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to various performance standards.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging where specific details for the requested format are missing:

The document states, "Extensive testing was performed (e.g. software testing and electrical safety tests including EMC). Also biocompatibility testing according to ISO 10993-1 was performed on all patient contacting materials. No clinical studies were performed. Since all samples tested met the acceptance criteria, substantial equivalence has been demonstrated through these tests." and "All tests that has been conducted on the Axon-Bus Prosthetic System to ensure that the device meets design specifications, operates as it is intended, and ensures that safety functions and features operate as they are intended were passed."

This indicates that internal performance testing against design specifications served as the "study" to prove acceptance criteria. However, the specific quantitative acceptance criteria for each "Performance Attribute" are not explicitly listed, only "Passed" as the test result.

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

The document also lists various standards adhered to (e.g., ISO 22523, IEC 60601-1, ISO 10993-1, etc.). The acceptance criteria for these would be compliance with the requirements of each standard. For example, for biocompatibility:

• Biocompatibility (patient contacting materials): Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10.
• Reported Device Performance for Biocompatibility: All patient contacting materials tested according to biocompatibility requirements of ISO 10993 and stated that "Titan (grade 1) is tested according to biocompatibility requirements of ISO 10993", "used Silicone Pad is certified according to USP Class VI. In addition, all used materials (ASA, Silicone Pad and Bonding Agent) are tested according to biocompatibility requirements of ISO 10993." (implicitly "Passed")

2. Sample sized 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 explicitly stated. The document mentions "all samples tested met the acceptance criteria," but does not specify the number of units or components tested.
• Data Provenance: The testing was "internal testing regarding performance characteristics," implying it was conducted by the manufacturer, Otto Bock HealthCare Products GmbH in Austria. The nature of this testing (retrospective/prospective) and specific country of origin for any "data" beyond internal testing are not detailed. "No clinical studies were performed."

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

• This information is not provided as the testing described is primarily engineering/performance-based, not involving "ground truth" derived from expert interpretation in the clinical sense.

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

• This information is not applicable/provided for the type of engineering performance testing conducted.

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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical studies were performed." The device is a prosthetic system, not an AI-assisted diagnostic tool typically evaluated with MRMC studies.

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

• This question is not directly applicable as the device is a physical prosthetic system with embedded software, not a standalone algorithm. The "AxonSoft" (adjustment software) and "AxonMaster" (control unit) are integral parts of the system with human-in-the-loop interaction by the user and prosthetist. Internal testing ensured the device "operates as it is intended, and ensures that safety functions and features operate as they are intended," which implies standalone function within its control scheme.

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

• The "ground truth" for the internal performance testing was based on engineering design specifications and compliance with recognized international standards (e.g., ISO, IEC). It was not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• This information is not applicable/provided as the device is not described as utilizing machine learning or AI that requires a "training set" in the conventional sense. The "AxonSoft" is adjustment software, not explicitly an AI model trained on data.

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

• This information is not applicable/provided for the reasons stated in point 8.

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ET Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The ET Prosthetic System is device made of titanium and titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. It's surfaces are partially TiN coated and uncoated. The ET Prosthetic 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 ET Prosthetic System is substantially equivalent in design, function and intended use to the Prosthetic System(K110308) and ET/SS Implant System (K120847)of Osstem Implant Co., Ltd. These proposed abutments are compatible with the HIOSSEN Implant fixture only. HTIII SA Fixture (K101096).

Here's an analysis of the provided text regarding the acceptance criteria and study for the OSSTEM ET Prosthetic System:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of typical AI/ML studies involving patient data. The nonclinical testing revolves around fatigue testing of the physical device.

For the nonclinical fatigue testing:

• Sample size for test set: Not explicitly stated, however, the phrase "worst case scenario" implies a focused, rather than large-scale, selection of samples for mechanical testing.
• Data provenance: Not applicable in the context of patient data. The tests were performed on the physical dental abutment devices.

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

Not applicable. The ground truth for the nonclinical fatigue testing is defined by the established international and national standards (ISO 14801 and FDA guidance) for mechanical performance of dental implants and abutments. This is a physical engineering standard, not an interpretation of medical images by human experts.

4. Adjudication Method for the Test Set

Not applicable. This is not a study where human disagreement would require adjudication. The compliance is determined by adherence to a defined mechanical testing protocol and performance metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical studies are submitted." An MRMC study is a type of clinical study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way that is relevant to a medical device and not just software. The core of the evidence is standalone nonclinical (mechanical) testing of the ET Prosthetic System. This is an "algorithm only" in the sense that the device's inherent mechanical properties were evaluated without human intervention in the device's functional performance during the test.

7. The Type of Ground Truth Used

The ground truth used for the nonclinical testing is compliance with established international and FDA standards for fatigue testing of endosseous dental implants and abutments (ISO 14801 and specific FDA Guidance Document).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set of data. It is a physical dental prosthetic system.

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

Not applicable, as there is no training set for this type of device.

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Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The Prosthetic System is device made of titanium, titanium alloy, Gold alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutments, Protect caps and Abutment Screws. Its surfaces are partially Tin coated and uncoated.

The provided document describes a 510(k) submission for a medical device, the "Prosthetic System," which is a dental abutment. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined performance metrics.

Therefore, the requested information elements related to acceptance criteria, diagnostic performance, sample sizes, expert involvement, and ground truth for a study proving device performance are largely not applicable (N/A) in the context of this 510(k) submission.

Here's a breakdown based on the information available:

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

• Acceptance Criteria: Not explicitly stated as diagnostic performance metrics. Instead, the acceptance criteria are based on demonstrating substantial equivalence to predicate devices in terms of:
  • Material composition
  • Intended use
  • Design
  • Technological characteristics
  • Performance characteristics
  • Safety (biocompatibility)
  • Mechanical fatigue testing according to relevant standards.
• Reported Device Performance:

  Performance Aspect	Description
  Substantial Equivalence	The device is deemed substantially equivalent to the HU/HS/HG Prosthetic System (K081575) and HS/HG Prosthetic System (K100245) of Osstem Implant Co., Ltd. for the intended use and technological characteristics.
  Fatigue Testing	Conducted for Custom Abutment and Multi Angled Abutment according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801. Results are reported to be in compliance.
  Biocompatibility	Performed to ensure compliance with applicable international and US regulations. Results implied compliance.
  Other Safety/Performance	The Prosthetic System has been "subjected to safety, performance, and product validations prior to release," with an overall conclusion that it is "safe and effective."

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

• N/A. No diagnostic performance test set is described as this is not a diagnostic device and the submission focuses on mechanical and material equivalence, not clinical diagnostic accuracy. The fatigue testing would involve a certain number of samples, but the specific sample size is not detailed in this summary. The tests were likely conducted in a lab environment.

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)

• N/A. Not applicable as there is no diagnostic test set or ground truth established by experts in the context of diagnostic accuracy. The "ground truth" for the fatigue test would be the standard's pass/fail criteria, derived from engineering principles and industry consensus, not expert medical opinion.

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

• N/A. Not applicable as there is no diagnostic test set requiring expert adjudication.

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

• N/A. This is a dental prosthetic system (abutment), not a software or AI-enabled diagnostic device. No MRMC study was performed.

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

• N/A. This is a physical prosthetic device, not an algorithm, so standalone performance in the context of AI/software is not relevant.

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

• N/A for diagnostic ground truth. For the fatigue testing, the "ground truth" would be the engineering specifications and pass/fail criteria defined by ISO 14801 and FDA guidance documents. For biocompatibility, it would be the compliance with relevant international and US regulations.

8. The sample size for the training set

• N/A. There is no "training set" in the context of an AI/machine learning model for this physical medical device.

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

• N/A. Not applicable, as there is no training set for an AI/machine learning model.

In summary: The provided 510(k) summary is for a physical medical device (dental abutment) and focuses on demonstrating substantial equivalence to existing predicate devices through material, design, and limited performance (fatigue, biocompatibility) testing, rather than a clinical study evaluating diagnostic accuracy against specific performance criteria. Therefore, most of the requested information regarding AI/diagnostic performance studies is not applicable.

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HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The HS/HG Prosthetic System is device made of titanium alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutment, Protect Cap and Abutment Screw. Its surfaces are partially Tin coated and uncoated.

The provided text describes a 510(k) summary for the HS/HG Prosthetic System, a dental device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a new device.

Therefore, the document does not contain information on:

• A table of acceptance criteria and reported device performance for specific thresholds.
• Sample sizes used for a test set or data provenance for a performance study.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study, effect size.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, etc.) for performance evaluation.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the submission focuses on:

Study and Evidence Presented:

1. Substantial Equivalence Matrix: The submission directly compares the HS/HG Prosthetic System to two predicate devices:

   • HU/HS/HG Prosthetic System (K081575)
   • Ziocera & Convertible System (K081786)
     The comparison covers manufacturer, 510(k) number, intended use, packaging, sterilization, and shelf life, demonstrating similarity across these characteristics.

2. Safety, Performance, and Product Validations (General Statement): The document states: "The HS/HG Prosthetic System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." However, specific details of these validations (e.g., acceptance criteria, test results) are not provided in the summary.

3. Fatigue Testing:

   • Test Performed: Fatigue testing was conducted according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment."
   • Worst-Case Scenario: The testing was done using a "worst case scenario."
   • Result: "The fatigue test result were Similar to previously cleared predicate device." This indicates a comparative approach rather than meeting specific pre-defined numerical acceptance criteria for fatigue.

Conclusion:

The main conclusion presented is that the HS/HG Prosthetic System is substantially equivalent to the predicate devices based on the information provided, including similar material, indication for use, design, technological characteristics, and comparable fatigue test results. This type of submission relies on demonstrating similarity to a previously cleared device, rather than establishing de novo performance against a new set of criteria.

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HU/HS/HG Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

The HU/HS/HG Prosthetic System is device made of titanium, titanium alloy, POM and PC intended for use as an aid in prosthetic restoration. It consists of Abutment, Protect Cap and Abutment Screw. Its surfaces are partially Tin coated and uncoated.

The provided text describes a 510(k) premarket notification for the OSSTEM HU/HS/HG Prosthetic System, a dental device. This type of submission relies on demonstrating substantial equivalence to existing legally marketed devices (predicates) rather than providing new clinical study data with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for AI/CADe devices.

Instead, the document focuses on:

• Device Description: The HU/HS/HG Prosthetic System is made of titanium, titanium alloy, POM, and PC, intended for prosthetic restoration with dental implants.
• Predicate Devices: The device is compared to several existing OSSTEM Implant Co., Ltd. systems (US System K062030, SS System K062051, GS System K063861, US/SS/GS System K073247).
• Claim of Substantial Equivalence: The manufacturer asserts that the new system is substantially equivalent in design, function, intended use, materials, and performance characteristics to the predicate devices.
• Safety and Performance Validation: It mentions that safety tests, including biocompatibility, were performed to ensure compliance with international and US regulations.

There is no discussion of an AI/CADe device, performance metrics like sensitivity/specificity, or a study to "prove the device meets acceptance criteria" in the way one would for diagnostic software. This is a clearance for a physical dental prosthesis system, not an AI-powered diagnostic tool.

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The CAMLOG Logfit™ Prosthetic System is intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the naxillary and/or mandibular arch.

The CAMLOG Logfit Prosthetic System includes dental implant abutments and screws intended to be used to support cement retained crowns and bridges in conjunction with Camlog dental implants in the maxillary and/or mandibular arch. The system also includes impression caps, analogs and plastic, burn-out copings, (Class I exempt, not a part of this submission), intended to facilitate the preparation of prosthetic restorations.

This document does not contain an acceptance criteria table or a study description of the device's performance. The provided text is a 510(k) summary for the CAMLOG Logfit™ Prosthetic System, which focuses on administrative information, device description, intended use, and equivalence to predicate devices, culminating in the FDA's clearance letter.

Therefore, I cannot provide the requested information.

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Intended to be placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.

Examples:

Support andhors for temporary restorations during the healing and osseointegration process of permanent implants.

Immediate loading temporary abutments for repairing failing tooth and implant suported restorations.

Transitional supports for immediate replacement of missing teeth.

Provide assistance in case planning, implant position alignments, and interim anchor foundations.

The Dentatus Mini Transitional Implants (MTTM) are titanium or titanium-alloy threaded posts, 1.8 mm to 2.5 mm in diameter and from 14 to 22 mm. in length. There are variations; they are threaded at the bottom-self-tapping, and the "head" is of slightly varying shapes.

The provided text is a 510(k) summary for the Dentatus MTI Modular Transitional Implants. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

This type of submission does not typically include a detailed study with acceptance criteria and device performance results as it focuses on demonstrating substantial equivalence, not conducting new clinical trials for effectiveness against specific performance metrics.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, along with specific details about sample size, ground truth, expert qualifications, adjudication, MRMC studies, and training set information, is not present in the provided document.

Instead, the document focuses on:

• Substantial Equivalence: Comparing the device to pre-amendment devices and several currently marketed devices (e.g., Sendax MDI implant K-972351, Bofors Nobelpharma K-820013, etc.) based on shape, form, composition, usability, and materials.
• Literature Review: Summarizing existing literature on endosseous implants and their transitional use to support the safety and effectiveness of the underlying technology and materials (titanium and titanium alloy). This literature review mentions:
  • Possible adverse effects listed by the US classification panel.
  • A quote from Matukas stating "Little or no hard data could be found on the medical risks associated with [dental] implants."
  • A review of the literature by Smith and Zarb proposing criteria for implant success (but these criteria are not detailed or applied to the Dentatus device in this summary).
  • The "Proceedings of the Consensus Development Conference on Dental Implants" (NIH, 1988) providing a comprehensive summary of scientific data.
  • Zarb's 10-year Toronto study concluding the "predictable and reliable" nature of the Branemark implant technique.
  • Gottherer and Singer's report on effective means for preliminary stabilization of full denture patients.
• Material Specifications: Stating that all metals meet ASTM specifications (ASTM F-136 for titanium (ELI) alloy and ASTM F 67-95 for pure titanium), which demonstrates material quality but not device performance against functional acceptance criteria.

In summary, this document does not contain the specific study design and results typically associated with proving a device meets predefined acceptance criteria for performance. It relies on established equivalence to predicate devices and the long history of clinical use and literature supporting the materials and general technology.

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This looks like a summary of a 510(k) submission for a medical device called "Dentatus MTI™ Anchor Post," which is an endodontic splint.

However, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. The document focuses on:

• Classification and identification of the device.
• A brief literature review asserting the safety and effectiveness of endodontic splints in general, not specifically the Dentatus MTI™ Anchor Post through a dedicated study.
• Substantial equivalence claims to pre-amendment devices and previously cleared devices, which is a regulatory pathway that often bypasses the need for new, extensive clinical studies if a device is sufficiently similar to existing ones.
• Technology details confirming it uses established materials and manufacturing methods.

Therefore, I cannot populate the table or answer your specific questions with the information provided. The document explicitly states: "Endodontic splints made of titanium or titanium alloy have V. been proved safe and effective through the years," implying reliance on general historical use and existing literature rather than a new study for this specific device.

If you have a different document that details acceptance criteria and performance studies for the Dentatus MTI™ Anchor Post, please provide that.

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