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Neoss Individual Prosthetics are designed to be connected to Neoss Implants and intended for use as an aid in prosthetic rehabilitation. All digitally designed CAD/CAM customizations for the Neoss Individual Abutments are only intended to be sent to and manufactured by an FDA registered and Neoss approved milling facility. Digital designs for Individual Bars/Bridges are sent to Neoss.

Neoss Individual Prosthetics are endosseous dental implant abutments used to support single tooth restorations (Abutment) or multi-unit prosthetic restorations (Abutment, Bridge or Bar) on Neoss Implants on implant level or abutment level. Neoss Individual Prosthetics are generally produced with straight screw channels (SSC) to be used with Neo Abutment screws and Neo Screwdrivers. Neoss Individual Prosthetics also features the option to customize the angulation of the screw access channel. Compatible Neoss Implant System includes two implant/prosthetic interfaces, i.e. platforms, SP and NP. Neoss Implant System also includes one abutment/prosthetic interface. This platform is called Access with a platform diameter of 4.0 mm.

Neoss Individual Abutments are patient specific and are manufactured from Abutment Blanks. Blanks are hollow metal cylinders available in either Titanium (grade 4 ASTM F67 or Ti-6A1-4V alloy ASTM F136). The blank has a precision milled prefabricated Neoss® implant connection (NeoLoc®) for the SP and NP platforms. The top part of the blanks can be milled to a patient-specific shape. The design of the patient-specific shape of the abutment is performed by a licensed clinician or dental technician and then verified for compliance with the abutment design limits by Neoss or a Neoss approved milling facility. Following the verification of the design the CAD/CAM processing and production of the individual prosthetics is conducted by Neoss or a Neoss approved milling facility. The finished abutment is attached to a Neoss Implant with a screw and a screwdriver at a set torque that depends on the platform.

Neoss Individual Bridges are patient specific and are manufactured from bulk material in Titanium (Ti-6Al-4V alloy ASTM F136).The posts that attach to Neoss Implants, optionally with intermediate Neoss Access Abutments, have a pre-defined interface, SP, NP or Access, to assure compatibility. The design of the patient-specific shape of the bridges is performed by a licensed clinician or dental technician and then verified for compliance with the bridge design limits by Neoss. Following the approval of the design, CAD/CAM processing and production of the individual prosthetics is conducted by Neoss. The implant interface is manufactured to Neoss specification to facilitate compatibility with Neoss platforms SP, NP or Access. The finished bridge is attached to a Neoss Implant or Neoss Access abutment with a screw and a screwdriver at a set torque that depends on the platform.

Neoss Individual Bars are patient specific and are manufactured from bulk material in Titanium (Ti-6Al-4V alloy ASTM F136). The posts that attach to Neoss Implants, optionally with intermediate Neoss Access Abutments, have a pre-defined interface to assure compatibility. The bars are designed for use with full or partial removable dentures and can be made with pre-defined design features making them compatible with commercially available precision attachments. The design of the patient-specific shape of the bars is performed by a licensed clinician or dental technician and then verified for compliance with the bar design limits by Neoss. Following the approval of the design, CAD/CAM processing and production of the individual prosthetics is conducted by Neoss. The implant interface is manufactured to Neoss specification to facilitate compatibility with Neoss platforms SP, NP or Access. The finished bar is attached to a Neoss Implant or Neoss Access abutment with a screw and a screwdriver at a set torque that depends on the platform.

The provided text describes a 510(k) premarket notification for "Neoss Individual Prosthetics". This document focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than presenting a study to prove novel acceptance criteria for a new device type.

Therefore, many of the requested details about acceptance criteria, device performance from a new study, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data provenance are not applicable to this type of regulatory submission.

The document primarily provides a comparison of characteristics between the subject device and its predicates to argue for substantial equivalence.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable for this type of submission:

1. Table of acceptance criteria and the reported device performance

This document does not define new "acceptance criteria" for novel performance. Instead, it compares the characteristics of the subject device (Neoss Individual Prosthetics) to several predicate devices. The "performance" is implicitly demonstrated through conformance to established standards and the side-by-side comparison with predicate devices.

Acceptance Criteria (Implied by Predicate Comparison) and Reported Device Performance:

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. This is a 510(k) submission showing substantial equivalence, not a clinical trial or performance study requiring a test set of patient data with a specific sample size. The "testing data" refers to non-clinical performance and material characterization.
• The "Performance Testing" section mentions "engineering analysis and dimensional analysis" and "static and dynamic compression-bending testing according to ISO 14801." These are laboratory-based, non-clinical tests typically performed on a sample of manufactured devices (e.g., a batch or specific configurations), not on a "test set" of patient data. Specific sample sizes for these engineering tests are not provided in this summary.
• Data Provenance: The document does not specify the country of origin for the non-clinical testing data, nor whether it's retrospective or prospective. It's implied to be internal testing by Neoss Ltd, based in the UK.

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. As there is no "test set" for diagnostic performance or interpretation of patient data, there are no experts establishing ground truth in this context. The "ground truth" for the device's technical specifications is based on engineering principles and international standards.

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

• Not Applicable. No human interpretation of a "test set" is involved in this type of submission.

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 prosthetic (abutments, bridges, bars), not an AI diagnostic or assistive tool. Therefore, 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 dental prosthetic, not an algorithm.

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

• The "ground truth" for this device's performance is adherence to established international standards (ISO 10993-1, ISO 14801, ISO 17665-1) and comparison of technical specifications, materials, and intended use with previously cleared predicate devices. It's essentially engineering specifications and established regulatory benchmarks.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning algorithm. There is no "training set" in the context of an AI model.
• However, the design and manufacturing process involves digital CAD/CAM customizations. While not a "training set" in the AI sense, the designs are verified for compliance against design limits by Neoss or an approved milling facility. The accumulated knowledge and design rules used for this verification could be considered analogous to a "training" data in a very broad sense, but it's not a formal dataset for training an AI.

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

• Not Applicable. As there is no training set for an AI model, this question does not apply.
• For the CAD/CAM design process, the "ground truth" for the designs would be engineering specifications, anatomical considerations, and clinical requirements, validated by qualified personnel within Neoss or approved facilities.

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Neoss TiBase:

Neoss Abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.

The Neoss TiBase is compatible with the Sirona Dental System inCoris ZI Meso L. All digitally designed copings and/or crowns for use with the Neoss TiBase Abutments are to be designed and milled using the Sirona Dental CAD/CAM System.

Neoss CoCr Abutments:

Neoss abutments are designed to be connected to the Neoss Implants and intended for use as an aid in prosthetic rehabilitation.

Neoss TiBase and CoCr Abutments are endosseous dental implant abutments used to support single tooth or multi-unit prosthetic restorations. All subject abutments have a platform interface that is compatible with Neoss implant diameters Ø3.5-5.5 mm. All Neoss implant sizes have a 4.1 mm implant platform regardless of endosseous implant diameter. Neoss TiBase abutments are provided in two prosthetic platform sizes, N (narrow) and W (wide), to accommodate different emergence profiles. The Neoss TiBase Abutment are patient specific abutments intended for the coping/crown to be designed using the Sirona CAD/CAM System. The Neoss TiBase Abutment can be screw retained.

Neoss CoCr abutments are available in two designs (Mono and Multi), one prosthetic platform size and one height (15 mm). The indexed Mono abutment can be used for single tooth screw-retained or cement-retained restorations. The non-indexed Multi abutment is used for multi-unit screw-retained restorations.

Neoss Crystaloc screw in TiN/Au coated titanium is used with the Neoss TiBase and CoCr Abutments.

The provided document is a 510(k) Premarket Notification for the "Neoss TiBase and CoCr Abutments." This type of submission focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than conducting new clinical studies to prove safety and effectiveness. Therefore, the document does not contain information typically found in a study demonstrating a device meets acceptance criteria, such as a table of acceptance criteria with reported performance, sample sizes for test sets, number of experts for ground truth, adjudication methods, or MRMC comparative effectiveness studies.

Instead, the document details non-clinical performance data (engineering analysis, dimensional analysis, static and dynamic compression-bending testing) and material biocompatibility to support the claim of substantial equivalence.

Here's an analysis based on the information provided, addressing the questions as much as possible, or indicating when the information is not present:

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

This information is not present in the provided document. The 510(k) submission model relies on demonstrating equivalence to predicate devices, and while it mentions "sufficient strength of the final finished device for its intended use" based on testing according to ISO 14801, it does not explicitly state quantitative acceptance criteria or a dedicated table of device performance against such criteria. The performance data is summarized qualitatively to support the claim of substantial equivalence.

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

This information is not explicitly stated for the non-clinical testing. The document mentions "non-clinical testing data submitted, referenced, or relied upon," which included "static and dynamic compression-bending testing according to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants."

• Sample size: The specific number of abutments or test specimens used for the static and dynamic compression-bending tests is not provided in this summary.
• Data provenance: The document indicates the manufacturer is Neoss Ltd., located in Harrogate, UK. It's reasonable to infer the testing was conducted either internally by Neoss Ltd., or by a third-party lab on their behalf, likely within the UK or a region with equivalent testing standards. The data is non-clinical (laboratory testing), not patient data, so "retrospective or prospective" does not apply in the typical sense.

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 question is not applicable as the document describes non-clinical performance testing (mechanical and biocompatibility), not a study involving human experts establishing ground truth for diagnostic or clinical outcomes.

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

This question is not applicable as the document describes non-clinical performance testing. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints.

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

There is no MRMC comparative effectiveness study mentioned. This document pertains to dental implant abutments, a physical medical device, not an AI-powered diagnostic or assistive technology.

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

This question is not applicable. The device is an endosseous dental implant abutment, not a software algorithm or AI.

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

For the non-clinical performance data, the "ground truth" or standard for evaluation was:

• Engineering analysis and dimensional analysis: Based on design specifications and engineering principles.
• Static and dynamic compression-bending testing: "According to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants." This international standard defines the methodology and acceptance criteria for mechanical performance in a laboratory setting.
• Biocompatibility: "Confirmed by conformance to FDA recognized consensus material standards (titanium alloy conforming to ASTM F136, and cobalt chromium alloy conforming to ASTM F1537)." These ASTM standards define the requirements for implantable materials.

8. The sample size for the training set

This question is not applicable. The document describes a 510(k) submission for a physical medical device. There is no "training set" in the context of machine learning or AI development.

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

This question is not applicable for the reasons stated in point 8.

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An implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Neoss membranes are intended to be submerged and clinically implanted more than 30 days with an expected duration of implantation up of 6 months.

The Neoss Ti Reinforced Membrane a multi-layer non-resorbable dental membrane intended to be surgically placed beneath the muco-periosteum to aid in regenerative healing in 1) bone or 2) bone/periodontal ligament defects of the oral cavity. The Neoss Ti Reinforced Membrane is composed of two layers of PTFE membrane material enclosing a Titanium(Ti) mesh. The Neoss Ti Reinforced Membrane is a passive, non-load bearing material. The small pores of the PTFE membrane material, allows passage of fluid and vapor; as well as a controlled cellular ingrowth for stability and a barrier for soft tissue penetration. The Ti mesh is unalloyed surgical grade Titanium ISO 5832-2 Grade 2. The titanium mesh reinforcement is intended for space creating and shape-maintaining which minimizes movements and subsequent exposure while implanted. Neoss Ti Reinforced Membrane is provided pre-shaped in a variety of shapes and sizes detailed below. The device is supplied sterile and single use.

This document is a 510(k) Pre-Market Notification from the FDA regarding the "Neoss Ti Reinforced Membrane." It is a regulatory approval document and not a study report that details acceptance criteria and device performance in a clinical context.

Therefore, the requested information about acceptance criteria and a study proving device performance cannot be extracted from this document.

The document states:

• "Clinical Testing: Clinical data was not required to establish the substantial equivalence of the Neoss Ti Reinforced Membrane." This explicitly indicates that a clinical study, with its associated methodologies for acceptance criteria and performance measurement, was not performed or submitted as part of this specific FDA cleared.

The "Performance Testing" section mentions tests conducted according to ISO and ASTM standards (e.g., burst strength, bend testing, biocompatibility). However, these are engineering and material property tests to ensure the device meets specified quality and safety characteristics, not clinical performance acceptance criteria. The document lists the standards applied, but does not provide the specific acceptance criteria values or the reported performance values of the Neoss Ti Reinforced Membrane against those criteria. It only states that these tests were done "in order to confirm the strength, integrity and functionality of the device."

The document focuses on establishing "substantial equivalence" to predicate devices based on indications for use, technological characteristics, and material composition, rather than presenting a standalone study with defined acceptance criteria and performance results in a table.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set or data provenance (as no clinical test set was described).
3. Number of experts or their qualifications (as no ground truth establishment for a clinical test set was described).
4. Adjudication method (as no clinical test set was described).
5. MRMC comparative effectiveness study (as no human reader study was described).
6. Standalone performance (as it refers to clinical performance, which was not assessed in a study described here).
7. Type of ground truth used (as no clinical ground truth was established).
8. Sample size for the training set (as this is not a machine learning device).
9. How ground truth for the training set was established (as this is not a machine learning device).

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The Neoss Tapered Implant is for single-stage or two-stage surgical procedure and cement or screw retained restorations. The Neoss Tapered Implant is intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

The Neoss Tapered Implant is a threaded, internal abutment connection, root-form titanium dental implant. The Neoss Tapered Implant consists of a number of implants with a diameter of Ø3.5 to Ø5.5 mm and lengths between 7.0 – 17.0 mm; all sizes have the same internal abutment connection dimension independent of implant diameter. The internal connection is equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. The Neoss ProActive Tapered Implant System is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices, which can restore chewing function and aesthetic appearance. Supplied sterile. The Neoss Implant System has specific design characteristics for mating Neoss components such as implants, abutments and prosthetic components. Combining components that are not configured or dimensioned for correct mating can lead to mechanical failure of components, damage to tissue, or unsatisfactory esthetic results. Abutment screws made in gold alloy, titanium or Ti with TiN/Au are available. Screw driver connection is compatible with screwdrivers supplied by Neoss. The abutment screws are supplied non-sterile.

Here's an analysis of the provided text regarding the Neoss Tapered Implant (K113376) and its acceptance criteria and supporting studies.

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, it does not contain the detailed, standalone study results and acceptance criteria typically found in a full scientific publication or comprehensive device validation report.

Based on the information given, here's what can be extracted and what is not available:

Acceptance Criteria and Reported Device Performance

Critique on "Acceptance Criteria": The document doesn't explicitly state numerical acceptance criteria (e.g., "minimum fatigue limit of X N"). Instead, it references the predicate device's performance and general "requirements" as the benchmark. The "reported device performance" for the Neoss Tapered Implant is often a statement of equivalence or enhanced performance compared to previous designs or the predicate, rather than a raw data point against a predefined threshold. The core of this 510(k) is the argument of substantial equivalence, not necessarily meeting new, specific acceptance thresholds for this novel device.

Study Details

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

   • Fatigue Tests: Not specified how many implants were tested. The reference is to "Performed fatigue tests of ProActive implants (K083561)". For the new Tapered Implant, the conclusion of equivalence is based on design similarity, implying reliance on the predicate's testing rather than extensive new fatigue testing for the Tapered Implant itself.
   • Clinical Feedback: Refers to "only one fracture related complaint" for the ProActive Implant (K083561), not specifically for the new Tapered Implant. This is retrospective data from post-market surveillance.
   • Primary Stability: No specific sample size is mentioned for the in vitro tests (insertion, displacement, theoretical implant-bone contact analysis).
   • Osseointegration (Animal Testing): "In animal testing..." No specific sample size or animal model details are provided. This would be prospective animal data.
   • Data Provenance: Not explicitly stated for all tests. Clinical feedback is retrospective. Animal testing and in vitro primary stability tests would likely be prospective, but no country of origin is mentioned.

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

   • This information is not provided in the 510(k) summary. The document focuses on physical and biological testing, not on subjective expert evaluation for "ground truth" in the way an AI/CAD study would.

3. Adjudication method for the test set:

   • Not applicable / Not provided. Since this is focused on physical device performance and animal studies, "adjudication" in the context of expert consensus for ground truth determination is not relevant here.

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:

   • No, this was not done. This is a dental implant, not an imaging device with AI assistance for human readers. This type of study is completely irrelevant to the device being described.

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

   • Not applicable / No. The device is a physical dental implant. There is no algorithm involved in its direct function.

6. The type of ground truth used:

   • Fatigue Testing: Mechanical failure (fracture) or meeting engineering specifications.
   • Primary Stability: Measured mechanical parameters (insertion torque, displacement, theoretical contact area).
   • Osseointegration: Histomorphometric analysis (e.g., bone-to-implant contact percentages, push-out/pull-out strength) from animal studies.
   • Clinical Feedback: Real-world adverse event reporting (fractures).

7. The sample size for the training set:

   • Not applicable / Not provided. There is no "training set" in the context of a machine learning or AI algorithm for this physical device.

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

   • Not applicable / Not provided. As there's no AI/ML component, there's no training set or ground truth establishment relevant to that. The "ground truth" for the physical device's performance is established by direct measurement during testing.

Summary of Device and Study:

The K113376 submission for the Neoss Tapered Implant relies heavily on demonstrating substantial equivalence to its predicate, the Neoss ProActive Implant (K083561). The study evidence presented is:

• Reliance on Predicate Fatigue Data: The Tapered Implant's structural integrity is primarily justified by the predicate's "well in line with requirements" fatigue tests and clinical feedback (one fracture complaint for the predicate), combined with an assertion of "design in critical areas shows enough similarity" between the two implant types.
• In Vitro Primary Stability Testing: The Tapered Implant showed "enhanced primary stability" in in vitro tests compared to a "straight Neoss implant" (presumably an earlier or different Neoss design, but not explicitly stated if it's the predicate ProActive). No specific numerical results are provided.
• Animal Testing for Surface Characteristics: General statements about grit-blasted and acid-etched surfaces (which are properties of the implant, not necessarily new research specific to the Tapered Implant) demonstrating increased osseointegration and bone-to-implant contact compared to other surface treatments.

The documentation is a regulatory summary; it is not a detailed scientific report of new studies specific to the Neoss Tapered Implant with comprehensive data, but rather a justification of its equivalence and safety based on existing knowledge and some comparative in vitro testing.

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The Neoss Implant System Ø3,25 is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss Implant System Ø3,25 are intended for immediate loading on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar. The Neoss Implant Ø3,25 abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.

The Neoss Implant System Ø3,25 assortment consists of a number of implants with a diameter of Ø3,25 mm and lengths between 9,0 - 17.0 mm having the same internal abutment designs as previously cleared per K083561 & K043195 & K071838, but a smaller diameter and includes a selection of abutments. Identical to K043195 & K083561, the Neoss Implant System Ø3,25 remains a threaded, internal abutment connection, root-form titanium dental implant. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Smaller associated bone cutting instruments are also available. The Neoss Implant System Ø3,25 available surface treatment will be identical to either the Neoss Bimodal or Neoss ProActive Implant. Supplied sterile.

The provided text describes a 510(k) premarket notification for a dental implant system (Neoss Implant System Ø3,25). This submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a study proving a device meets specific performance acceptance criteria through clinical trials or detailed non-clinical performance benchmarks. Therefore, most of the requested information regarding acceptance criteria, specific study details, ground truth establishment, expert adjudication, MRMC studies, or training sets is not applicable or not available in the provided document.

However, I can extract information related to the device's technological characteristics and the general approach to demonstrating safety and effectiveness based on the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for performance metrics. Instead, "compliance to device specifications and recognized standards" and "all functions were verified to operate as designed" are mentioned in the context of performance and fatigue testing. The performance is then discussed in terms of "substantial equivalence" to predicate devices.

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

Not applicable. This document describes a 510(k) submission for a modified dental implant, which primarily relies on demonstrating substantial equivalence to existing predicate devices through engineering analysis and limited non-clinical testing rather than new clinical trials with patient test sets.

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

Not applicable. The substantial equivalence argument does not involve establishing ground truth from expert consensus on a test set in the way a diagnostic AI device would.

4. Adjudication Method 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 is a medical device (dental implant), not an AI diagnostic tool that would involve human readers.

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

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

7. The Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for the device's performance is implicitly defined by its ability to function safely and effectively as a dental implant, comparable to its predicate devices, based on engineering tests and intended use.

8. The Sample Size for the Training Set

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

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

Not applicable.

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The Neoss Access Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.

Neoss Access Abutments represent a two piece abutment system and are designed to be connected to the Neoss implants, to receive another abutment or framework and intended for use as an aid in multiple-unit prosthetic rehabilitation such as dental bridge restorations.

The internal connection of the Neoss Access Abutment provides a solution with a minimum height of the complete prosthesis of 5 mm and allows an overall implant alignment of up to 60 degrees without restraining the fabrication of a multiple-unit screw-retained restoration.

The angulated 10°, 20° and 30° abutments are intended for multi-unit cases in order to improve the position of the screw access hole.

Restorations can be based on Neolinks being incorporated into gold or ceramic frameworks, or solid titanium and ceramics frameworks. The frameworks are then tightened with prosthetic screws onto the Neoss Access Abutments.

The Neoss Access Abutments are dental abutments.

Here's an analysis of the provided text regarding acceptance criteria and the study:

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

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

• Sample Size: Not explicitly stated. The document mentions "performed testing" but does not detail the number of units tested.
• Data Provenance: Not explicitly stated. Given that the manufacturer is Neoss Ltd (UK) and the submission is to the FDA (USA), the testing was likely conducted in a controlled laboratory environment, but the location of the lab or the origin of any materials used is not specified. It is a prospective test specifically for regulatory submission.

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

• Number of Experts: Not applicable. This device is a physical dental abutment, and its performance is assessed against engineering and material requirements, not against human expert interpretation of data.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. Performance testing of a physical device against engineering standards typically involves direct measurement and comparison to predefined thresholds, not a multi-expert adjudication 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:

• MRMC Study: No. This is a physical medical device (dental abutment), not an AI/software device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.

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

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

7. The type of ground truth used:

• Ground Truth: The "ground truth" for this device's performance is established by the "recommended requirements" outlined in the "Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004." These requirements specify the mechanical, material, and biocompatibility properties the abutment must meet.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The design and manufacturing processes are likely informed by engineering principles, material science, and previous product development, but not a data-driven training set.

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

• Ground Truth for Training Set: Not applicable. (See point 8).

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The Neoss ProActive Implant is for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neoss ProActive Implant is intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

The Neoss ProActive is an modified version of the Neoss Bimodal Implant (K043195), Identical to K043195, the ProActive Implant is a threaded, internal abutment connection, root-form titanium dental implant. The ProActive assortment consists of a number of implants with a diameter of Ø3,5 to Ø5,5 mm and lengths between 7,0 - 19.0 mm having the same internal abutment dimension independent of implant diameter. The internal connection being equipped with interlocking elements for an insertion tool and the non-rotational locking of the abutment. Supplied sterile.

The provided 510(k) summary for the Neoss ProActive Implant does not contain the detailed information requested regarding acceptance criteria and a study proving device performance as typically understood for AI/ML-based medical devices.

This submission is for a dental implant, which is a physical device, not a software or AI/ML diagnostic tool. Therefore, the traditional metrics of sensitivity, specificity, accuracy, and detailed ground truth generation processes that would be relevant for devices making diagnostic claims are not applicable or present in this type of submission.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Neoss Bimodal Implant K043195) due to a modification in the surface finish process. The performance is assessed through comparisons of physical characteristics and biological responses in animal models, rather than a clinical study with a human test set and expert adjudication.

Here's a breakdown of what is and is not available based on the provided text:

1. Table of acceptance criteria and reported device performance:

Note: These are based on biological responses in animal testing and general performance verification, not metrics like sensitivity or specificity.

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

• The document mentions "animal testing" but does not specify the sample size, type of animals, or country of origin for these tests. This is a pre-clinical, non-human study.
• The study is retrospective in the sense that it's comparing a modified device to a previous one, but the specific animal tests themselves would be prospective experiments.

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

• This is not applicable as the "ground truth" for a physical dental implant's performance would be established through mechanical testing, material characterization, and biological response in animal models, not expert clinical interpretation of images or other data.

4. Adjudication method for the test set:

• Not applicable for this type of 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:

• Not applicable. This is a physical dental implant, not an AI/ML diagnostic tool.

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

• Not applicable. This is a physical dental implant.

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

• The closest concept to "ground truth" here would be the biological outcomes observed in animal models (e.g., strength of osseointegration, bone-to-implant contact) and engineering/material properties verified during performance testing.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set. The "development" of the device involves engineering design and pre-clinical testing.

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

• Not applicable.

In summary: The provided 510(k) pertains to a hardware modification (surface finish) of an existing dental implant. The safety and effectiveness data provided are based on pre-clinical animal testing and engineering verification, not clinical studies with human participants or the detailed performance metrics typically associated with AI/ML-based diagnostic devices.

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The Neoss various Titanium Abutments are designed to be connected to the Neoss implants and intended for use as an aid in prosthetic rehabilitation.

The Neoss Titanium Prepable Abutment 15°and 20° is designed to be modified and secured directly to the implant using an abutment screw and supplied non-sterile. The Neoss Express Abutment requires no modification and allows for abutment level impression taking. The Neoss Locator Abutment system, made by commercially pure titanium, designed to secured directly to the implant using an abutment screw and supplied non-sterile.

The provided document is a 510(k) summary for the Neoss various Titanium Abutments. It details the device's identification, equivalence to predicate devices, description, intended use, technological characteristics, and a discussion of performance testing.

However, the document does not contain the acceptance criteria or a detailed study proving the device meets specific acceptance criteria in the format typically used for AI/ML medical devices. Instead, it refers to general guidelines for dental implant systems and states that the device "fills the recommended requirements."

Therefore, I cannot populate the requested table and answer the study-specific questions as the information is not present in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through design similarities and adherence to general mechanical testing guidelines, rather than presenting specific quantitative performance metrics against defined
acceptance criteria from a clinical or analytical performance study.

Here's a breakdown of what could be provided based on the document and what is missing:

Summary regarding the "study that proves the device meets acceptance criteria":

The document refers to "Mechanical testing requested for Dental Implant Systems" described in the "Guidance for industry and FDA staff, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant Abutments, dated May 12, 2004." It states that the device "has, where applicable, been tested in accordance to the Guideline... and the test results show that the abutment fills the recommended requirements."

This statement indicates that a study (mechanical testing) was conducted in accordance with an FDA guidance document, and the results demonstrated compliance with the requirements outlined in that guidance. However, the specific details of that study (e.g., number of units tested, precise tests performed, quantitative results, and the exact "recommended requirements" or acceptance criteria from the guidance document) are not provided in this 510(k) summary. The conclusion of substantial equivalence is based on these tests and design similarities to predicate devices.

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The Neo Implants - Neo Implant System are for single-stage and two-stage surgical procedures and cement or screw retained restorations. The Neo Implants - Neo Implant System are intended for immediate placement and function on single tooth and /or multiple tooth applications recognizing sufficient bone stability and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

Implant fixture: miplant is a threaded, internal abutment connection, root-form titanium dental implant. The Neo implant assortment consists of a number of implants with a diameter of mynant. The Neo miplangths between 7.0 -- 19.0 mm having the same internal abutment dimension independent of implant diameter. The internal connection being equiped with interlocking elements for an insertion tool and the non-rotational locking of the abutitient. Supplied sterile.

Temporary part related to the fixture - Cover screw; Made in titanium for implantation. Supplied sterile.

Temporary part related to the fixture - Healing abutment; Made in titanium or PFEK for implantation. Supplied sterile.

Abutments: The Neo Abutment system is a set of modifiable gold alloy or commercially pure titanium abutments (Neolink), which are secured directly to the implant using an abutment screw. For easy wax-up a set of pre-shaped plastic copings can be used to fit to the abutment. Supplied non-sterile.

Prepable Ti abutments: Prepable titanium abutments of straight or angle (20 degrees or less) design made to be adjusted by clinician or dental technician. Crown or bridge cemented on prepped abutment. Supplied non-sterile.

Bar abutment; straight titanium or gold abutment cylinder to which a bar can be bonded (i.e welded or soldered) or cast on to. Supplied non-sterile.

Ball abutment; conventional design (ball head diameter 2,25 mm) used with standard attachments. Supplied non-sterile.

Abutment screw made in gold alloy or titanium. Screw driver connection compatible with screwdrivers supplied by Neoss. Supplied non-sterile.

Round bur; The round bur with diameter Ø1,8-2 with is ISO 1797-1 hand piece connection and shaft.

Twist drills: Two flute twist drill with ISO 1797-1 hand piece connection and shaft. Depth marking corresponding to the implant lengths in the Neoss implant system, hence 7, 9, 11, 13, 15 and 17. Diameter from Ø2.2 to Ø5,1 in appropriate steps to match the Neoss implants.

Screwtap: Screwtap for the different implant diameters existing in the Neo Implant system (Ø3,5 to Ø5,5) with ISO 1797-1 hand piece connection and shaft.

Countersink: Countersink, (05,5) with ISO 1797-1 hand piece connection and shaft. The tool has a centring tap in relation to the prepared hole.

Material of bone cutting instruments is medical grade stainless steel currently being used for similar components.

The provided text describes the Neoss Ltd Neo Implant System and its submission for 510(k) premarket notification. It asserts substantial equivalence to predicate devices but does not contain information about specific acceptance criteria or a study that rigorously proves the device meets such criteria.

Instead, the submission relies on the concept of substantial equivalence to existing legally marketed devices. This means that the manufacturer argues their new device is as safe and effective as a predicate device already on the market, rather than conducting a new, comprehensive clinical study to prove performance against pre-defined acceptance criteria.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, ground truth establishment, MRMC study, standalone performance) cannot be answered from the provided document.

Here's a breakdown of what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance criteria" here implicitly refer to the demonstration of substantial equivalence to predicate devices.

• Reported Device Performance: Not reported in terms of clinical outcomes or specific quantitative metrics against acceptance criteria. The performance is implied to be equivalent to the predicate devices.
  The document mentions:

  • Mechanical Testing: "Mechanical testing requested for Screw-type Endosseous Implants are described in the Guideline 'Information Necessary for Pre Market Notification Submission for Screw-Type Endosseous Implants', dated December 9, 1996."
  • Conclusion regarding further testing: "Neo implant and abutment designs are within the scope of the Guideline... why we have come to the conclusion that further testing will not race new issues of safety and efficacy." and "Neo bone cutting instruments, are in terms of design, material, dimensions, and intended us in all relevant aspect identical to predicative devices why we have come to the aonclusion that further testing will not race new issues of safety and efficacy."

  This indicates that the manufacturer believes their device meets the expectations of the guideline and is sufficiently similar to predicates that further testing for safety and efficacy to establish new acceptance criteria is not needed.

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: Not applicable/Not provided. No clinical test set or data provenance is detailed, as the submission relies on substantial equivalence rather than a new clinical study with a test set.

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. No test set requiring expert-established ground truth is mentioned.

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

• Not applicable/Not provided. No test set requiring adjudication is mentioned.

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 study was done, as this is a dental implant system, not an AI-assisted diagnostic device.

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

• Not applicable. This is a medical device (dental implant), not an algorithm or AI system.

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

• Not applicable/Not provided. No new ground truth was established for a performance study. The "ground truth" for the submission is the established safety and efficacy of the predicate devices.

8. The sample size for the training set

• Not applicable/Not provided. This is a medical device, not a machine learning model.

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

• Not applicable/Not provided. This is a medical device, not a machine learning model.

In summary: The provided document is a 510(k) summary for a dental implant system. The regulatory pathway of "substantial equivalence" as utilized here means that the manufacturer is demonstrating that their device is as safe and effective as pre-existing, legally marketed predicate devices, rather than conducting new clinical trials to meet specific, quantified acceptance criteria. Therefore, most of the questions pertaining to clinical study design, data sets, expert review, and ground truth are not addressed in this type of submission.

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