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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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KLS Mini Osteosynthesis System (K943347): The KLS Mini Osteosynthesis System is indicated for 1) Fractures, 3) Reconstruction procedures of the craniomaxillofial skeletal system.
KLS Chin Plate System (K943348): The KLS Chin Plate System is indicated for 1) Fractures, 3) Reconstruction procedures of the craniomaxillofacial skeletal system.
KLS-Martin Micro Osteosynthesis System (1.0MM) (K944561): The KLS-Martin Micro Osteosynthesis System (1.0MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractures. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS-Martin Micro Osteosynthesis System (1.5MM) (K944565): The KLS-Martin Micro Osteosynthesis System (1.5MM) is used in oral-maxillo-cranio-facial surgery to stabilize fractures. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS Martin Centre-Drive Drill-Free Screw (K971297): The KLS Martin Centre-Drive Drill-Free Screws are in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bone fragments. The addition of the self drilling feature is the only difference between the submitted device and the predicate device referenced.
KLS-Martin Temporary Condylar Implant (K990667): The KLS-Martin Temporary Condylar Implant is only intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMF or treatment of temporomandibular joint disease (TMD).
KLS-Martin Mandibular/Reconstruction System II (K032442): The KLS-Martin Mandibular/Reconstruction System II is intended for use in the stabilization of mandibular fractures and mandibular reconstruction.
KLS-Martin Ortho Anchorage System (K033483): The KLS-Martin Ortho Anchorage System is intended to be surgically placed in the mouth for use an an anchor for orthodontic procedures.
KLS-Martin Ortho Anchorage System (Plates) (K040891): The KLS-Martin Ortho Anchorage System (Plates) are implants intended to be surgically placed in the mouth for use as an anchor for orthodontic procedures in patients.
KLS Martin Rigid Fixation - Sterile (K060177): The KLS Martin Rigid Fixation - Sterile is in sterile packaging, osteosynthesis products with the following indications for use:
K051236: The RESORB-X® SF Sonotrode is only intended for use for insertion of the RESORB-X® SF pins.
K032442: The KLS Martin Mandibular/Reconstruction System II is intended for use in the stabilization of mandibular fractures and mandibular reconstruction.
K971297: The KLS Martin Centre-Drive Drill-Free screws are in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates which are contoured to fit the bony surface and stabilize the bone fragments. The addition of the self drilling feature is the only difference between the predicate device reference
K944565: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
K944561: The KLS-Martin Micro Osteosynthesis System is used in oral-maxillo-cranio-facial surgery to stabilize fractured bone segments. The bone segments are attached to the plate with screws to prevent movement of the segments.
KLS Martin Drill-Free MMF Screw (K042573): The KLS Martin Drill-Free MMF Screws is intended for use in maxilonandibular fixation of fractures of the maxilla, mandible, or both.
Drill Free MMF Screw (K083432): The Drill Free MMF Screw is intended for use in maxillomandibular fixation of fractures of the maxilla, mandible, or both.
KLS Martin L1 MMF System (K173320): The KLS Martin L1 MMF System is intended for temporary stabilization of maxillary fractures. It is designed to maintain proper occlusion during intraoperative bone healing (app. 6-8 weeks). It is indicated for the temporary treatment of maxillomandibular fixation (MMF) in adults or adolescents who have permanent teeth present (ages 12 and older).

KLS Mini Osteosynthesis System (K943347): The KLS Mini Osteosynthesis System consists of titanium non-locking plates ranging in thickness from 0.6mm - 2.5mm and titanium screws ranging in diameter from 1.5mm - 2.3mm.
KLS Chin Plate System (K943348): The KLS Chin Plate System consists of titanium plates ranging in thickness of 0.6mm and titanium screws ranging in diameter from 1.5mm - 2.3mm.
KLS-Martin Micro Osteosynthesis System (1.0mm) (K944561): The KLS-Martin Micro Osteosynthesis System is designed to aid in the alignment and stabilization of the skeletal system after a facial fracture or surgery. The bone plates, bone plates, bone screws and accessories of various shapes and sizes for use in oral-maxillo-cranio-facial surgery. The bone plates are manufactured from CP Titanium and range in thickness from 0.3mm - 0.6mm. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.0mm - 1.2mm.
KLS-Martin Micro Osteosynthesis System (1.5mm) (K944565): The KLS-Martin Micro Osteosynthesis System is designed to aid in the alignment and stabilization of the skeletal system after a facial fracture or surgery. The bone plates and screws of various shapes and sizes for use in oralmaxillo-cranio-facial surgery. The bone plates are manufactured from CP Titanium and range in thickness from 0.3mm - 0.6mm. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.5mm - 1.8mm.
KLS Martin Centre-Drive Drill-Free Screw (K971297): The KLS Martin Centre-Drive Drill-Free Screws are designed to eliminate the need for pre-drilled pilot holes. They are self-tapping with one step insertion. They are intended for use in rigid internal fixation of the oral-maxillo-cranio-facial bones. The bone screws are used to anchor plates where are contoured to fit the bone fragments. The bone fragments. The bone screws are manufactured from Titanium Alloy and range in diameter from 1.0mm - 2.0mm.
KLS-Martin Temporary Condylar Implant (K990667): The KLS-Martin Temporary Condylar Implant is a solid condylar head which attaches with fastening screws to a KLS-Martin Fracture/ Reconstruction Plate. The implant is available for left and right placement. The KLS-Martin Temporary Condy intended for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to benign tumors requiring the removal of the mandibular condyle. This device is not for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD).
KLS-Martin Mandibular/Reconstruction System II (K032442): The KLS-Martin Mandibular/Reconstruction System II includes several different designs of titanium plates and screws intended for use in the stabilization and fixation of mandibular fractures and reconstruction. The plates are manufactured from either CP Titanium or Titanium Alloy and range in thickness from 1.0mm - 3.0mm. The screws are manufactured from either CP Titanium Alloy and range in diameter from 2.0mm - 3.2mm.
KLS-Martin Ortho Anchorage System (K033483): The KLS-Martin Ortho Anchorage System consists of a titanium screw designed to aid in dental movement by providing a rigid skeletal fixation point. The screw is intended to be surgically placed in the mouth for orthodontic procedures. The screws are manufactured from either CP Titanium or Titanium Alloy.
KLS-Martin Ortho Anchorage System (Plates) (K040891): The KLS-Martin Ortho Anchorage System (Plates) consists of titanium non-locking plates to aid in dental movement by providing a rigid skeletal fixation point. The plates are manufactured from either CP Titanium Alloy and are fixated with titanium screws and are utilized as an anchor for orthodontic procedures in the palatal, maxilla or mandible region.
KLS-Martin Drill-Free MMF Screw (K042573): The KLS-Martin Drill-Free MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture. The KLS-Martin Drill-Free MMF Screw is in maxillomandibular fixation to provide stabilization of fractures of the maxilla, or both. The screws are manufactured from either CP Titanium Alloy and are provided in 2.0mm diameter with lengths ranging from 8mm - 12mm.
KLS Martin Rigid Fixation - Sterile (K060177): The KLS Martin Rigid Fixation - Sterile includes titanium plates of various shapes and thickness, titanium screws of various length and diameter, stainless steel twist drills of various length and stainless steel sonotrode tips that are provided in sterile packaging. The KLS Martin Rigid Fixation - Sterile is intended to provide KLS Martin's previously cleared osteosynthesis products in sterile packaging.
Drill Free MMF Screw (K083432): The Drill Free MMF Screw provides temporary occlusal and fracture stabilization. These screws may be applied prior to or after exposure of the fracture. The Drill Free MMF Screw is in maxillomandibular fixation to provide stabilization of fractures of the maxilla, mandible, or both. The screws are manufactured from Stainless Steel and are provided in 2.0mm diameter with lengths ranging from 8mm - 12mm.
KLS Martin L1 MMF System (K173320): The KLS Martin L1 MMF System is a bone-borne maxillomandibular fixation (MMF) system consisting of metalic archbars with sliding locking plates that attach to the dental arches with screws. The system is intended to provide temporary stabilization of mandibular and maxillary fractures as well as maintain properative bone fixation and postoperative bone healing (app. 6-8 weeks). The patient is brought into occlusion by wiring around the archbar wire hooks. The L1 MMF system plates are manufactured from CP Titanium (ASTM F67), are available in either a 7-hole siding plate configuration with two different lengths, and are 0.5mm in plate thickness. The L1 MMF system sliding locking plates are fixated with either 2.0 x 6 mm selfdrilling locking screws manufactured from Ti-6Al-4V (ASTM F136). Implants are available both sterile. The system also includes the necessary instruments to facilitate placement of the implants.

The document describes the KLS Martin Oral-Max Implants - MR Conditional, a bundled submission of various osteosynthesis systems and screws intended for use in craniomaxillofacial surgery. The purpose of this submission is to support the conditional safety and labeling modification of these devices in the magnetic resonance (MR) environment.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are implied by the non-clinical tests conducted to support MR Conditional safety, aligning with relevant ASTM standards and FDA guidance. The reported device performance is that the devices can be safely scanned under specified conditions.

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

The testing involved computational modeling and simulation (CM&S). The "test set" in this context refers to the simulated scenarios and device configurations.

• Sample Size for Test Set: "the entire portfolio of KLS Martin maxillofacial implants" was simulated. This implies that all devices grouped under "KLS Martin Oral-Max Implants - MR Conditional" were included in the simulations. The document also mentions "various in-vivo device positions and landmarks," "worst-case single and multiple devices," and simulations in "10 cm increments." This suggests a comprehensive set of simulated scenarios rather than a traditional physical sample size.
• Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective" in the same way clinical data is. The data is generated through computational modeling and simulation using MED Institute's FDA-qualified Medical Device Development Tool (MDDT) and the Duke virtual human anatomy. This is a form of prospective simulation data.

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

Not applicable in the traditional sense for this type of non-clinical, simulation-based study. The "ground truth" for the RF-induced heating simulations is derived from the established physics and engineering principles embedded in the FDA-qualified MDDT and the Duke virtual human anatomy model. The expertise lies in the development and validation of these computational tools and the interpretation of the simulation results by experts in MR safety and medical device engineering at MED Institute and the submitting company. The document does not specify the number or qualifications of individual experts validating the computational model, but implies that the MDDT itself is "FDA-qualified," indicating a level of expert review and agreement on its methodology.

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

Not applicable. Adjudication methods like "2+1" or "3+1" are typically used for consensus building among human expert readers for clinical studies, especially when establishing ground truth from image interpretation. This study is based on physical property testing and computational simulations, not human interpretation of clinical data.

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 not a study involving human readers or AI-assisted diagnostic performance. It focuses on the physical safety of implants in an MR environment.

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

The RF-induced heating assessment involved "Computational modeling and simulation (CM&S) ... using MED Institute's FDA-qualified Medical Device Development Tool (MDDT) and in a clinically relevant position within the Duke virtual human anatomy." This is a standalone algorithm/model-based assessment without a human-in-the-loop for the performance evaluation itself. Human experts design the simulations, configure the models, and interpret the results, but the "performance" (temperature rise, SAR calculations) is computed by the algorithm.

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

For the non-clinical tests:

• Magnetically induced displacement force, torque, and image artifacts: The "ground truth" is based on the physical properties of the materials and device designs, measured or calculated according to established ASTM standards (F2052-21, F2213-17, F2119-07).
• RF-induced heating: The "ground truth" for the simulations is derived from the established electromagnetic physics and thermal dynamics principles implemented in the FDA-qualified Medical Device Development Tool (MDDT) and applied to the Duke virtual human anatomy model. The MDDT's qualification process by the FDA implicitly establishes the reliability of its results as a form of "ground truth" for simulation-based assessments.

8. The sample size for the training set

Not applicable. This is a non-clinical study for MR safety assessment, not a machine learning model requiring a training set in the typical sense. The "training" for the MDDT is its initial validation and qualification against known physical phenomena and experimental data, which is a separate process from this submission.

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

Not applicable, as there is no training set for a machine learning model in this context. The "ground truth" for qualifying the simulation tool (MDDT) would have been established through extensive validation against experimental measurements and recognized physical theories.

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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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The Biomet Microfixation OmniMax MMF System is indication of mandibular and maxillary fractures to maintain proper occlusion during surgery and for post-operative fracture healing in adults and adolescents (age 12 and older) in whom permanent teeth have erupted.

The Biomet Microfixation OmniMax MMF System is composed of metallic plates (arch bars) and locking screws that provide temporary stabilization of mandibular and maxillary bone during fracture healing and/or temporarily maintain a stable occlusion during surgery. Mandibular and Maxillary Fixation (MMF) is achieved through application of fixation plates and locking screws to bone; wire or elastics are then secured around hooks.

The OmniMax MMF system includes a fixation plate (also known as an arch bar) that has an in-plane bend to provide an initial approximation of mandibular and maxillary anatomy. The plate also features slots for locking screw fixation. These slots allow for a maximum of 12 fixation points in the bone as well as screw placement variation within the slot to avoid tooth roots. The OmniMax locking screws are 2.0mm in diameter and vary in length from 7mm to 11mm. The screw head also features a low-profile design to minimize irritation and palpability.

The document provides information about the Biomet Microfixation OmniMax MMF System, specifically for its 510(k) submission, K202969. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with diagnostic AI/ML device submissions (e.g., performance metrics like sensitivity, specificity, AUC).

Instead, the non-clinical performance data section focuses on validation testing for the cleaning process and biocompatibility assessment as the primary acceptance criteria for this specific submission, which seems to be an update or modification rather than a completely new device that requires extensive clinical performance evaluation.

Here's a breakdown of the information available based on your request, highlighting what is present and what is explicitly stated as not necessary or not evaluated:

Acceptance Criteria and Device Performance

Study Details (Based on the provided document)

Since the submission primarily focuses on updates to the cleaning process and biocompatibility, and explicitly states that clinical testing was not necessary for substantial equivalence, many of the typical elements of a clinical performance study (like those involving AI/ML devices) are not applicable or not provided in this document.

1. Sample size used for the test set and the data provenance: This information is not provided as there wasn't a clinical performance study in the traditional sense for diagnostic accuracy. The "test set" here refers to the materials and controls used for cleaning validation and biocompatibility testing. The document does not specify their origins.

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 as it's not relevant for cleaning validation or biocompatibility assessments.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided as it's not relevant for cleaning validation or biocompatibility assessments.

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: This is not applicable. This device is a bone plate and screw system, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable. This is not an algorithm-based device.

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

   • For Cleaning Validation: The ground truth is established by the ability to meet the acceptance criteria derived from FDA guidance documents and industry standards for sterility/cleaning.
   • For Biocompatibility: The ground truth is established by meeting acceptance criteria based on ISO 10993-1 standards and predicate device performance, often involving laboratory tests for material safety and biological responses.

7. The sample size for the training set: This information is not provided as there was no AI/ML training set.

8. How the ground truth for the training set was established: This information is not applicable as there was no AI/ML training set.

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