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Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity.

Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Ø1.2 diameter screw is for fixing non-resorbable membrane or non-resorbable titanium membrane (Osstem OssBuilder OB2 and OB3), cleared in K172354.

The specifications of the proposed device are as follow;

• Bone Screw
• Diameter (mm): Ø1.2
• Length (mm): 3.0, 4.0, 5.0

This document is a 510(k) clearance letter for a bone screw, not a study evaluating an AI/software as a medical device (SaMD). Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and studies proving device performance for an AI/SaMD.

The 510(k) summary focuses on demonstrating "substantial equivalence" of the new Bone Screw device to existing predicate devices based on:

• Indications for Use: The new device has the same intended use as the predicate.
• Technological Characteristics: Similarities in material (Titanium Alloy), manufacturing process (machined), design, and sterilization method (Gamma Irradiation).
• Performance Testing: Non-clinical tests (Driving Torque, Axial Pullout Strength, Torsional Strength) were conducted to show the new device performs comparably to the predicate, especially regarding a new smaller thread diameter.
• Biocompatibility and Shelf-life: Leveraged data from the predicate device due to material and packaging similarities.
• MR Compatibility: Assessed using scientific rationale and published literature, not a study with acceptance criteria.

Therefore, I cannot extract the requested information as it pertains to an AI/SaMD from this document.

If you have a document describing the performance study of an AI/SaMD, I would be happy to help you extract that information.

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USTOMED Bone Fixation/Bone Augmentation Systems – PIN is intended for fastening membranes during bone regenerative treatment.

USTOMED Bone Fixation/Bone Augmentation Systems – PIN consists of a titanium pin. The Pin can be used to fasten third-party non-absorbable PTFE and titanium-reinforced membranes up to a thickness of 1.0mm cleared by FDA for stabilization and support of bone grafts in dento-alveolar bony defect sites (product code JEY). After fulfilling its supportive function, which is typically achieved within three to nine months, the Pin must be removed, as it is not intended to remain in the body permanently.

The Pin are intended for single use and provided non-sterile for cleaning and sterilization by the user before use.

This 510(k) clearance letter pertains to a Class II medical device, the USTOMED Bone Fixation/Bone Augmentation Systems - PIN. The letter states that the device has been found substantially equivalent to a predicate device (NEOSS Ltd.'s Membrane Tack, K201561).

The information provided in this 510(k) summary focuses primarily on demonstrating substantial equivalence through a comparison of technological characteristics and performance testing to ensure the device meets established safety and performance standards. It does not describe a clinical study of diagnostic performance, but rather engineering and material tests typical for an implantable device with a mechanical function.

However, based on the provided text, we can describe the acceptance criteria and study that proves the device meets those criteria:

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 the exact sample sizes for each test mentioned (dimensional verification, reprocessing validation, mechanical testing, biocompatibility, cytotoxicity, materials chemical analysis). These are likely engineering and laboratory tests, not clinical trials with patient data. Therefore, "data provenance" in terms of country of origin of patient data or retrospective/prospective is not applicable to these types of tests. The data provenance would be laboratory testing conducted by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable to the types of tests described. These are not diagnostic accuracy studies requiring expert reads of images or clinical assessments to establish ground truth. The "ground truth" for these tests is established by the specifications and standards (e.g., ASTM F543-17, ISO 10993).

4. Adjudication Method for the Test Set

Not applicable. The tests described are laboratory and engineering tests with objective pass/fail criteria based on established standards, not subjective assessments requiring expert adjudication.

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

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data, often with and without AI assistance, to assess changes in diagnostic performance. This device is a bone fixation pin and therefore, this type of study is not relevant for its clearance.

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

Yes, in a sense. The "performance testing" described (dimensional verification, mechanical testing, biocompatibility, etc.) are all standalone tests of the device's physical and material properties, independent of human interaction during testing, beyond setting up the experiment. This device is not an AI algorithm, so the term "algorithm only" is not directly applicable.

7. The Type of Ground Truth Used

The ground truth for these performance tests is based on engineering specifications, material science standards (e.g., ISO 10993, ASTM F543-17), and documented reprocessing protocols. For example, for dimensional verification, the ground truth is the specified dimensions from the device design. For mechanical testing, the ground truth is the expected mechanical properties as defined by the ASTM standard for a similar device. For biocompatibility, the ground truth is the absence of adverse biological reactions as defined by ISO standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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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The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.

The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
MATERIALS: Only materials approved for medical purposes are used in the manufacture of products: Pure Titanium Grade 4 according to standard ISO 5832-2 and ASTM F67-13.

I am sorry, but the provided text is a 510(k) K233419 FDA clearance letter and related summary for a dental device called "GBR System". This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing and comparison of technological characteristics.

It does not contain information about acceptance criteria for a study proving device performance, nor details about a study that would meet such criteria. Therefore, I cannot extract the requested information from this document.

The document discusses:

• Non-clinical tests: Biocompatibility, Insertion Torque, Fracture Torque, Pull-out tests, sterilization validation, and MRI compatibility. These are primarily engineering and material characterization tests, not clinical studies with acceptance criteria for device performance in patients.
• Comparison to predicate devices: This is done to establish substantial equivalence, not to prove that the device meets specific performance acceptance criteria from a clinical study.

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The MP Pins without thread, flat head are indicated for the fixation of apical membrane ends at the local bone in order to avoid micromobility of the membrane. They allow for the fixation of resorbable and non-resorbable membranes.

Pin with a flat head for the fixation of resorbable and non-resorbable membranes.

This is a 510(k) summary for a medical device (MP Pin without thread, flat head) which is seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving efficacy in the way a pharmaceutical might.

Therefore, the requested information, which is typically associated with clinical trials, statistical performance metrics, and AI/software device studies, is largely not applicable or present in this document.

Here's an breakdown based on the provided text, addressing why some information is absent:

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

The document does not specify formal "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, accuracy) that an AI or diagnostic device would undergo. Instead, substantial equivalence is based on:

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

This information is not applicable as this submission is for a mechanical medical device (a pin) and does not involve AI or software that would typically have a "test set" of patient data. The "performance data" refers to standard mechanical and biological testing.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable for the reasons stated above.

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 as this device is a physical medical pin and does not involve AI assistance for human readers.

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

This information is not applicable as this device is a physical medical pin and does not involve an algorithm.

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

For the biocompatibility testing, the "ground truth" would be the standard biological response according to ISO 10993-5, where the absence of cytotoxicity is the desired outcome. For sterilization, the "ground truth" is compliance with the specified ISO standards for sterility. For mechanical and dimensional evaluation, the "ground truth" relates to engineering specifications and comparison to the predicate device's design, assessed through internal validation.

8. The sample size for the training set

This information is not applicable as this submission is for a mechanical medical device and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable for the reasons stated above.

In summary: The provided document is a 510(k) summary for a physical medical device. The "study" proving it meets acceptance criteria consists of standard engineering, biocompatibility, and sterilization testing, not clinical trials or AI performance evaluations as would be implied by many of the questions. The acceptance criteria are primarily focused on demonstrating substantial equivalence to a predicate device in terms of intended use, materials, fundamental operation, and safety.

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The KLS Martin Drill-Free MMF Screw is indicated for temporary stabilization of mandibular and maxillary fractures to maintain proper occlusion during surgery in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.

The KLS Martin Drill-Free MMF Screw are bone-borne, self-drilling screws for maxillomandibular fixation (MMF). The screws are intended to provide stabilization of mandibular and maxillary fractures as well as maintain proper occlusion during intraoneralive bone fixation. These screws may be applied prior to or after exposure of the Drill Free MMF Screw is manufactured from stainless steel (ASTM F138) with a head designed with a hole to allow passing and securing ligature wire during the procedure and is available in threaded lengths of 2.0 x 8.0 mm - 2.0 x 12.0mm. Implants are available both sterile and non-sterile.

This document is a 510(k) Premarket Notification summary from the FDA for a medical device called the "KLS Martin Drill-Free MMF Screw". It is specifically a clearance letter and a summary of the device and its equivalence to a predicate device.

Based on the provided text, the device is a mechanical implant (a screw for bone fixation), not a software-based AI/ML medical device. Therefore, the questions related to AI/ML acceptance criteria, ground truth establishment, training data, MRMC studies, and effect sizes are not applicable to this documentation.

The document describes the non-clinical performance data used to demonstrate substantial equivalence for this mechanical device.

Here's an analysis of the provided information, focusing on the mechanical device's testing:

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

The document states that comparisons were made to a primary predicate device (KLS Martin Drill Free MMF Screw (K083432)) and reference devices. It describes the type of tests performed, but does not provide specific numerical acceptance criteria or the reported device performance metrics in a tabular format within this summary.

Types of Tests Mentioned:

• Comparative head-to-head static and dynamic bench testing: Conducted on the subject device and the primary predicate device to determine equivalent performance.
• Comparative screw testing: Performed to evaluate:
  • Torsional strength
  • Drive torque
  • Pullout strength
• Biological safety risk assessments: In compliance with ISO 10993-1:2018.
• LAL endotoxin testing: To address the presence of bacterial endotoxins and meet pyrogen limit specifications in accordance with ANSI/AAMI ST72:2019.
• Gamma sterilization process validation: In accordance with ISO 11137-1:2015 and ISO 11137-2:2015 using the VDmax25 method, and also ISO 11737-1:2018 and ISO 11737-2:2019.
• Packaging validations: Performed for the PETG blister pack with 1073B Tyvek cover in accordance with ISO 11607-1 and ASTM D7386.

Reported Device Performance (General Statement):
"Mechanical test results demonstrate that KLS Martin MMF Screw's performance is substantially equivalent to the primary predicate device."
"Biological safety risk assessments... concluded the devices are biocompatible and appropriate for their intended use."
"LAL endotoxin testing... meet pyrogen limit specifications."

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

The document does not specify the sample sizes used for the bench testing (e.g., number of screws tested for torsional strength, number of packaging units for validation). The provenance is "Non-Clinical Performance Data," implying lab testing rather than patient data. Country of origin for data is not mentioned, but the applicant and correspondent are KLS-Martin L.P. in Jacksonville, Florida, United States. These are bench tests, not clinical studies.

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. Ground truth for mechanical performance is established through physical measurements and adherence to engineering standards (e.g., ASTM, ISO). There are no "experts" in the sense of clinicians establishing ground truth from medical images for this type of device.

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

This question is not applicable as this is a mechanical device, not an AI/ML system requiring human annotation 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.

This question is not applicable. This is a mechanical device, not an AI-assisted diagnostic tool. No MRMC study was performed or required.

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

This question is not applicable. This is a mechanical device.

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

For this mechanical device, the "ground truth" for performance is based on established engineering standards and physical measurements (e.g., force, torque, material properties) as defined by ASTM and ISO standards, and comparison to the predicate device's measured performance. Biosafety is determined by established biological test methods (e.g., LAL, biocompatibility assays).

8. The sample size for the training set.

This question is not applicable. This is a physical device, not an AI model that requires a training set.

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

This question is not applicable. As above, there is no AI training set for this device.

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-Stryker Universal SMARTLock Hybrid MMF System: The Stryker Universal SMARTLock Hybrid MMF System is indicated for the treatment of mandibular and maxillary fractures in adults and adolescents (age 12 and higher) in whom permanent teeth have erupted.
-Universal CMF System: Craniomaxillofacial Implants The Universal CMF System is Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Mandible Implants The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.
-Stryker MMF screw: The Stryker MMF Screw is intended for use as a bone screw in the temporary maxillomandibular fixation to provide indirect stabilization of fractures of the maxilla, mandible or both, where there is sufficient occlusion.

The Subject Device screws are screw versions modified with the Stryker AXS Screw technology, where the abbreviation "AXS" stands for axial stability. This submission is adding the AXS Screw technology to the Subject Device. The Subject Device screws have modified geometry and features which will be implemented as AXS Screws in each of the existing Predicate/Reference Device systems. This includes screws with a length range of 4-20 mm and a diameter range from 2.0-2.7 mm. The materials (titanium and stainless steel) are the same as for the corresponding Predicate/Reference Devices. There are no other changes to the Predicate/Reference Device systems, only the implementation of the AXS Screw technology to each existing product line. The Subject Device screws will have the same clinical application, treat the same craniomaxillofacial anatomical locations, and are for the same patient population as the corresponding Predicate/Reference Devices.

The provided FDA 510(k) clearance letter pertains to Stryker MP, Mandible, HMMF and MMF AXS Screws, which are intraosseous fixation screws. This submission is for a medical device (screws), not an AI/software as a medical device (SaMD). Therefore, the questions related to AI device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document.

The clearance is based on demonstrating substantial equivalence to predicate devices, primarily through engineering performance bench testing.

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

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

The document states that "The Subject Device met all pre-defined acceptance criteria, and the results of the V&V tests support the substantial equivalence of the Subject Device to the Predicate/Reference Devices." However, the specific numerical acceptance criteria for each test are not detailed in this summary document. The document lists the types of performance bench tests conducted:

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

This information is not provided in the summary document. The document refers to "Verification and Validation (V&V) testing" and "test reports" being included within the full submission, but the summary itself does not detail specific sample sizes for these bench tests or the provenance of any data beyond the general statement that testing was performed.

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. This is a medical device (screws) and does not involve AI or software requiring expert review for ground truth establishment. The "acceptance criteria" are engineering performance metrics.

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

Not Applicable. This is a medical device (screws) and does not involve subjective human interpretation or adjudication for its performance evaluation in the way an AI diagnostic tool would. Performance is based on objective engineering tests.

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 (screws) and does not involve AI or 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 (screws) and does not involve an algorithm.

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

For mechanical performance tests, the "ground truth" or reference standard would be the physical properties and behavior of the devices as measured by standardized testing methods (e.g., ASTM F543) and compared against pre-defined engineering specifications and the performance of the predicate device.

8. The sample size for the training set

Not Applicable. This is a medical device (screws) and does not involve a training set as would be used for AI/machine learning.

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

Not Applicable. This is a medical device (screws) and does not involve a training set.

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The device is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.

SAVE GBR is manufactured by Ti-6Al-4V ELI. The SAVE GBR is composed of GBR Screw and Bone Tack and these screws and tacks are used to fix barrier membranes in bone regeneration procedures.

The diameter of the GBR screw is 1.4 and length is 3.9, 4.38, 5.9, 6.38, 7.9 and 8.38mm. The diameter of the Bone Tack is 2.5 and length is 2.6 and 4.1mm.

These screws and tacks are implanted for a maximum duration of 6 months. The SAVE GBR is provided sterile.

The subject device is compatible with the OssBuilder membrane cleared in K172354.

The provided document is a 510(k) premarket notification for the "SAVE GBR" device, which is an intraosseous fixation screw or wire used in guided bone/tissue regeneration in the oral cavity. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, accuracy, or human reader improvement with AI) is not applicable to this type of regulatory submission.

The document describes non-clinical testing performed to demonstrate the safety and effectiveness of the device compared to its predicates. The "acceptance criteria" here are typically compliance with relevant international standards and equivalence to predicate devices in terms of material, design, and performance characteristics.

Here’s a breakdown of the information that can be extracted from the provided text, addressing the points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The FDA 510(k) process for this device type doesn't establish numerical "performance" criteria in the way a diagnostic AI device might have sensitivity/specificity targets. Instead, "acceptance criteria" are compliance with standards and demonstration of equivalence to legally marketed predicates. The "reported device performance" reflects how the device met these engineering and material standards.

The following questions are not applicable to this 510(k) submission as it concerns a physical medical device (implants) and not a diagnostic or AI-driven system that would typically undergo such evaluations.

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 document describes non-clinical (biocompatibility, mechanical, sterilization) testing of a physical implant device, not a diagnostic algorithm tested on a dataset of patient cases.

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 a diagnostic algorithm is not relevant here. The ground truth for device safety and performance relies on validated laboratory methods and engineering standards.

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

• Not Applicable. This pertains to expert review of diagnostic cases, which is not relevant for this physical 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. MRMC studies are for diagnostic interpretation improvement with AI. This document is for a physical implantable device.

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

• Not Applicable. This refers to the performance of an algorithm; it is not relevant for this physical device.

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

• The "ground truth" for this device's regulatory clearance is compliance with recognized international standards (e.g., ISO, ASTM for materials, sterilization, mechanical properties) and demonstration of substantial equivalence to legally marketed predicate devices through comparative testing and analysis. This is based on objective measurements and verified material properties, not clinical expert consensus on diagnostic images or patient outcomes.

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI algorithm for this device. Testing involves samples of the physical device for non-clinical evaluations.

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

• Not Applicable. No training set; ground truth is established by engineering and materials science standards.

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The Micro Screw System, Micro Screw System Basic are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures, especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field. Note: Micro Screws are not intended to remain in the body permanently. After they have fulfilled their supportive function such as is the case after healing of a transplant, or healing of a fracture, for example, they need to be removed completely.

The Micro Screw System, Micro Screw System Basic are used for the safe fixation and stabilisation of cortical bone grafts. These systems contain osteosynthesis screws made of surgical stainless steel with diameters of 1.0 mm and 1.2 mm.

This is a 510(k) premarket notification for a medical device called the "Micro Screw System, Micro Screw System Basic". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, the structure of the response will be different as the document does not contain information about a study designed to meet specific performance acceptance criteria in the typical sense for an AI/ML device. Instead, the "study" is a set of non-clinical bench tests comparing the new device to a predicate device to show equivalence.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (micro screws), the "acceptance criteria" are primarily established by recognized standards and requirements for substantial equivalence to a predicate device, rather than explicit numerical performance targets like sensitivity/specificity for an AI system. The "reported device performance" are the results of bench tests demonstrating compliance with these standards and comparability to the predicate.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the mechanical performance tests (e.g., how many screws were tested for torsional properties). It mentions "Several performance tests have been performed."
• Data Provenance: The tests are "Non-Clinical Bench Testing" conducted by the manufacturer, Hager & Meisinger GmbH. The country of origin for the data is Germany (where the company is based), but the standards used are international (ASTM, ISO, AAMI, DIN EN). This is retrospective data, as it describes tests already performed.

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

This information is not applicable in the context of this 510(k) submission for a physical device. Ground truth for mechanical properties is established through standardized physical measurements and material science, not human expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, particularly for AI/ML performance evaluation, not for physical device bench testing.

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

Not applicable. This is not an AI/ML device, and an MRMC study is relevant for evaluating the impact of AI on human reader performance, which isn't the scope of this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily:

• Physical Measurements: Directly measured properties like torque, angle, and pullout force.
• Material Standards Compliance: Verification against established chemical and mechanical specifications for surgical stainless steel (e.g., composition, strength).
• Biological Standards Compliance: Verification against established ISO standards for biocompatibility, typically involving in-vitro tests (e.g., cytotoxicity) and risk assessments.
• Predicate Device Data: Performance characteristics of the previously cleared predicate device (K080430, STOMA Bone Block Screw) serve as a de facto "ground truth" for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the sense of machine learning.

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

Not applicable. There is no training set.

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Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment. These membrane fastening means are in direct body contact, intended for temporary use only. Membrane fastening means are submerged and clinically implanted more than 30 days with an expected duration of three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.

Membrane Tacks and Membrane Screws are regenerative membrane fastening devices available in 3mm length. The Membrane Tack is used in conjunction with a Tack Positioning Instrument, while the Membrane Screw is applied with the Neoss Implant Inserter. Regenerative membranes are designed to prevent ingrowth of gingival soft tissue into bony defects, in order to facilitate the bone formation during the repair process of the defect. Membrane Tacks and Screws are made of titanium while related instruments are made in stainless steel. The Membrane fastening devices are single-use only while the instruments are for multiple use.

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves a device meets the acceptance criteria in the context of AI or machine learning models.

The document is a 510(k) premarket notification for "Membrane Screws and Membrane Tacks," which are physical medical devices used in bone regenerative treatment. The content focuses on demonstrating substantial equivalence to predicate devices based on material composition, dimensions, intended use, and general performance characteristics (sterilization, shelf life, biocompatibility, instrument cleaning, and insertion/removal forces).

Therefore, I cannot provide the requested information, which includes details about:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size and data provenance for test sets.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC studies and effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.).
• Training set sample size and ground truth establishment.

The document explicitly states that "Clinical data is not required to establish substantial equivalence in this submission," further indicating a lack of clinical study data relevant to AI/ML performance evaluation.

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Bone Screw is used to stabilize and fixate bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. Bone Tack is indicated for use to stabilize and support bone graft and/or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.

Bone Screw is using as anchor to fix the bone plate, membrane that cover bone material or block bone for bone regeneration or remodeling. Ø1.4 diameter screw is for fixing membrane or bone plate, and Ø2.0 diameter screw is for fixing block bone. Bone Tack is a stabilizer that can stably fix the membrane in GBR.

The provided document is an FDA 510(k) Premarket Notification summary for a Bone Screw and Bone Tack device. It generally discusses the device's substantial equivalence to predicate devices based on non-clinical testing. However, it explicitly states that no clinical studies were submitted and therefore does not contain information about acceptance criteria or a study proving the device meets them through clinical performance.

Therefore, I cannot provide details for most of your requested points, as they pertain to clinical or comparative effectiveness studies that were not performed or reported in this document.

Here's what can be extracted based on the information provided, and what cannot:

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

• Cannot be provided. The document does not specify acceptance criteria for clinical performance or any reported device performance that would meet such criteria. It focuses on demonstrating substantial equivalence through comparison to predicate devices and non-clinical testing.

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

• Cannot be provided. No clinical test set was used or reported in this submission. The non-clinical testing details do not specify sample sizes in a way that aligns with "test set" for performance evaluation.

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. No clinical test set or ground truth establishment by experts is mentioned.

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

• Cannot be provided. No clinical test set or adjudication method 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

• Cannot be provided. No MRMC study was done, and the device is a medical implant, not an AI diagnostic tool.

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

• Cannot be provided. The device is a medical implant, not an algorithm.

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

• Cannot be provided. No clinical ground truth was established as no clinical studies were performed.

8. The sample size for the training set

• Cannot be provided. No training set for an algorithm was used.

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

• Cannot be provided. No training set or ground truth for it was established.

Summary of what the document does provide regarding testing:

The manufacturer performed non-clinical testing to support the substantial equivalence claim. These include:

• Biocompatibility evaluation: Considered following FDA Guidance Document Use of International Standard ISO 10993-1 and ISO 10993 suite of standards. This leveraged information from reference device K172354.
• Sterilization Validation and Shelf-life: Considered following ISO 11137 and ISO 11607 suites of standards. Endotoxin batch testing is in place per the FDA Guidance Document Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile.
• Mechanical Properties: Evaluated following ASTM F543 with a "worst-case scenario."

The document explicitly states: "No clinical studies are submitted." (Page 7, Section 8)

Therefore, based solely on the provided text, no information is available about clinical acceptance criteria or studies proving device performance against such criteria. The submission relies on substantial equivalence to predicate devices and non-clinical testing.

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