Search Results

Inion CPS™ 1.5 Baby Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures in the craniofacial skeleton (e.g., infant craniofacial surgery, craniosynostosis, congenital malformations, craniotomy flap fixation), mid-face and maxilla.

The Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures and to maintain the relative position of bone grafts or bone graft substitutes in the cranium, including craniotomy flap fixation.

Inion CPS™ and Inion CPS™ Baby implants are bioabsorbable plates, screws and mesh plates made of bioabsorbable co-polymers. Inion CPS™ 1.5/2.0/2.5 System implants are composed of L-lactic acid, D-lactic acid and Trimethylenecarbonate. Inion CPS™ 1.5 Baby System implants are composed of L-lactic acid, D-lactic acid and Poly-Glygolic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption of Inion CPS™ implants takes place within 2-4 years, and Inion CPS™ Baby implants within 2-3 years.

The systems consist of fixation plates, meshes and screws offered in different sizes and designed to be used with the Inion CPS™ bone drill bits, bone taps, self-drilling bone taps, countersinks, screw drivers, plate bending pliers and heating device. The instruments are nonsterile and reusable. They are intended to be cleaned and sterilized before initial use and after each use.

The implants are provided sterile by gamma irradiation. They are intended for single use and shall not be re-sterilized or re-used. Implants are non-pyrogenic and fully synthetic.

This FDA 510(k) clearance letter is for bioabsorbable fixation systems, not an AI/ML powered medical device. Therefore, many of the requested fields are not applicable. I will provide information from the document as it relates to the general acceptance criteria and the study that proves the device meets them, while noting when a specific AI/ML related field is not relevant to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: Not directly applicable as this is not an AI/ML device with a specific "test set" in the context of algorithm validation. The "testing" refers to various evaluations:
  • Biocompatibility/Non-pyrogenicity Testing: Representative samples of the subject devices were selected for rabbit pyrogen tests. The exact number of samples or rabbits is not specified but it generally follows standard laboratory protocols. The provenance is likely from laboratory testing.
  • Clinical Evaluation: The clinical evaluation relied on published clinical studies.
    • Inion CPS™ Baby 1.5 Bioabsorbable Fixation System: 11 publications including 240 patients.
    • Inion CPS™ 1.5/2.0/2.5 System: 39 publications including 1755 patients.
  • Data Provenance for Clinical Studies: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond being "published 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)

Not applicable. This device is a physical implant, not an AI/ML diagnostic tool that requires experts to establish ground truth for image interpretation or similar tasks. The "ground truth" for its performance is assessed through physical testing (material properties, pyrogenicity) and clinical outcomes reported in published literature.

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 establishing ground truth in AI/ML performance studies, where multiple human experts independently review cases and then resolve disagreements. This concept does not apply to the evaluation of a physical bioabsorbable fixation system.

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 specific to evaluating human reader performance with and without AI assistance for tasks like medical image interpretation. This device is a physical surgical implant and does not involve "human readers" in this context.

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

Not applicable. This device does not have an algorithm for standalone performance.

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

The "ground truth" (or basis for acceptance) for this device is established through:

• Physical Properties: Material composition, degradation profile, and strength retention are measured against pre-defined specifications.
• Biocompatibility and Non-pyrogenicity: Demonstrated through laboratory testing (e.g., rabbit pyrogen tests) against established biological safety standards (ISO 10993-1, USP chapters).
• Clinical Outcomes Data: Safe and effective use, performance rates, and complication rates are evidenced by published clinical literature and post-market follow-up data.

8. The sample size for the training set

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

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

Not applicable. This device is not an AI/ML model that requires a training set with established ground truth.

Ask a specific question about this device

Materialise Personalized Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and or guide surgical instruments in facial surgery.

CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications.

CMF Titanium Guides are intended for children, adolescents and adults.

CMF Titanium Guides are intended for single use only.

CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery.

Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures.

CMF Plastic Models are intended for infants, children, adolescents and adults.

CMF Plastic Models are intended for single use only.

CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery.

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery combines the use of 3D preoperative planning software with patient-matched guides and models to improve and simplify the performance of surgical interventions by transferring the pre-operative plan to surgery. Materialise Personalized Guides and Models for Craniomaxillofacial Surgery are used in the facial skeleton or in maxillofacial surgeries.

The surgical planning is based on medical images of the patient that are segmented in order to create a 3D representation of the patient's anatomy. The surgical treatment of the patient is simulated based on instructions provided by the surgeon and the patient-matched devices are tailored to the treatment and the patient's needs. The patient-matched devices are manufactured from commercially pure Titanium, polyamide, or clear acrylic by means of additive manufacturing technologies. The patient-matched devices are provided non-sterile.

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery include CMF Titanium Guides and CMF Plastic Models.

The provided text is a 510(k) summary for the device "Materialise Personalized Guides and Models for Craniomaxillofacial Surgery." It details the device's indications for use, description, comparison to predicate and reference devices, and non-clinical performance data. However, it does not include information about AI/algorithm performance, acceptance criteria for such an algorithm, or a clinical study for proving the device meets those criteria. The document lists "non-clinical testing" and states that "no guide specific mechanical testing is performed but this is covered by mechanical analysis of CMF Titanium Plates."

Therefore, I cannot extract the information required for an AI device acceptance criteria and study from this document. The document primarily focuses on the substantial equivalence of the physical, patient-matched guides and models to existing devices, covering aspects like material compatibility, mechanical properties, biocompatibility, and sterilization.

To answer your request, the ideal information would be present in a document describing an AI/ML medical device, which would typically contain details regarding the algorithm's performance metrics (acceptance criteria), the dataset used for testing, ground truth establishment, and potential MRMC studies. This document does not describe such a device.

Ask a specific question about this device

The Medicon Epiplating System is indicated for the attachment of an external restoration prosthesis for restoration of a physical defect when other means of attachment are inadequate. The Epiplating system provides the bone anchorage for the prosthetic attachment. These devices are indicated for use in the maxillo-craniofacial region (including ear, nose and eye).

The Medicon Epiplating System is an implant system consisting of various plates used as the foundation for anchoring prostheses or epitheses in the craniofacial region. The system offers various implant sizes to fit the anatomical needs of a wide variety of patients. Components are manufactured from pure titanium (ASTM F67) or Ti6Al4V alloy (ASTM F136).

The provided text describes a 510(k) premarket notification for the "Medicon Epiplating System" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of its performance against specific acceptance criteria for an AI/ML-based device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided document.

The document is a regulatory submission for a physical medical device (an implant system), not an AI/ML software device. The "Performance Data" section discusses mechanical testing, sterilization validation, cleaning validation, and biocompatibility, which are standard for such devices, but not the type of performance metrics (e.g., sensitivity, specificity, AUC) typically associated with AI/ML solutions and their acceptance criteria.

Summary of what can be extracted based on the provided text:

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

• Not applicable/Not found. The document does not specify quantitative "acceptance criteria" in terms of clinical performance metrics that would be relevant for an AI/ML device (e.g., sensitivity, specificity). Instead, it refers to mechanical testing standards (ASTM F382) and biocompatibility standards (ISO 10993-1). The results are qualitative ("demonstrate substantial equivalence") rather than quantitative against specific clinical performance thresholds.

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

• Not applicable/Not found. This section is irrelevant for the type of device described. No "test set" of clinical data (images, patient records) is mentioned. "Performance data" refers to bench testing on the device itself.

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

• Not applicable/Not found. This information pertains to studies with human expert interpretation, typically in the context of AI/ML evaluation. This document describes a physical implant system.

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

• Not applicable/Not found. This is for clinical data interpretation, not for evaluating a physical implant.

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/Not found. This is specific to AI/ML devices that assist human readers.

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

• Not applicable/Not found. This is specific to AI/ML algorithm performance.

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

• Not applicable/Not found. For this physical device, "ground truth" would be related to material properties meeting standards, mechanical performance under specified loads, and biocompatibility, which are evaluated against established engineering and biological standards, not clinical ground truth derived from expert consensus or pathology.

8. The sample size for the training set:

• Not applicable/Not found. There is no AI/ML training set.

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

• Not applicable/Not found. There is no AI/ML training set.

Information that is mentioned in the document (but not directly addressing the AI/ML specific questions):

• Device Type: Medicon Epiplating System, an implant system.
• Purpose: Attachment of an external restoration prosthesis for physical defects in the maxillo-craniofacial region (ear, nose, eye).
• Regulatory Mechanism: 510(k) premarket notification.
• Substantial Equivalence: Demonstrated through comparison of technological characteristics (design, intended use, material composition, function) to predicate devices.
• Performance Data (for this device type):
  • Mechanical Testing: Performed in accordance with ASTM F382 (proof of load, bending strength, bending stiffness, structural bending stiffness).
  • Sterilization Validation: Pre-vacuum (steam) sterilization in accordance with ANSI/AAMI/ISO 17665-1:2006/(R)2013.
  • Cleaning Validation: Manual and machine cleaning validation in accordance with AAMI TIR30:2011.
  • Biocompatibility: Based on previously cleared devices with identical material and manufacturing methods, tested according to ISO 10993-1.

The document entirely pertains to a physical medical device and does not involve AI/ML technology, which is why the specific questions about AI/ML acceptance criteria and study design cannot be answered from the provided text.

Ask a specific question about this device

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.

Ask a specific question about this device

Universal CMF System Intended use The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. Indications for use 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. MP Lefort I Plates Intended Use The Stryker Leibinger Universal CMF and Universal 2.0 Mini Plating Systems are Craniomaxillofacial (CMF) plate and screw systems intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Indications for Use The MP LeFort I Plates as part of the predicate subgroup Universal 2.0 Mini Plating System are implants indicated for osteotomy, stabilization, and rigid fixation of LeFort I fractures of the maxillofacial skeleton. Stryker Upper-Face AXS Screws And Mid-Face AXS Screws Indications for Use The Stryker Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. Stryker MP, Mandible, HMMF And MMF AXS Screws -Universal CMF System: Intended Use The Universal CMF System is intended for stabilization and rigid fixation of the craniomaxillofacial (CMF) skeleton. Indications for Use 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 Universal SMARTLock Hybrid MMF System: Intended Use The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing. Indications for Use 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. -Stryker MMF Screw Intended use 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. Indications for use 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. Stryker Universal Orbital Floor System Intended Use The Stryker Universal Floor System is intended to be used in the reconstruction of the floor and/or medial wall of the orbit. Indications for Use The Stryker Universal Orbital Floor System is indicated for the reconstructive treatment of orbital floor and/or medial wall trauma or bone excision in patients 15 years of age and older. Stryker Universal Smartlock Hybrid MMF System Intended use The Stryker Universal SMARTLock Hybrid MMF System is intended to be used for temporary stabilization of mandibular and maxillary fractures in order to maintain proper occlusion during fracture healing. Indications for use 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. Stryker MMF Screw Intended use 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. Indications for use 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.

This Bundled. Traditional 510(k) is for a single change the MR status that affects multiple devices and can be assessed during one review. There are no changes to the predicate devices themselves, just the addition to allow MR Conditional use of the implants in scope after MRI compatibility testing was completed. Associated labeling for each Predicate Device is also updated to reflect the MR conditional use of the implants.

Ask a specific question about this device

The tmCMF Solution is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT-based system. The input data file is processed by the tmCMF Solution, and the result is an output data file that may then be provided as digital models or used as input to a manufacturing portion of the system that produces physical outputs, including anatomical models, surgical guides, dental splints, and implants for use in maxillofacial, midface, and mandibular surgery. Implants are intended for bone fixation and reconstruction. restoration of bone defects, and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton, midface, mandible, and chin in adolescents (greater than 12 to 21 years of age) and adults. The tmCMF Solution is also intended as a preoperative software tool for simulating/ evaluating virtual surgical treatment options.

TechMah CMF (tmCMF) Solution is a family of personalized product solutions for Reconstructive, Orthognathic, Trauma, and Augmentation procedures in the mandible and midface (including orbital floor, medial and lateral orbital walls). The solution is comprised of Surgeon Review Tool (SRT) software and maxillofacial and mandibular surgical instruments (surgical guides, anatomical models, and dental splints) and implants. The surgical instruments and implants are patient-specific devices and are designed utilizing CT and dental scan patient image data.

Surgical guides are patient-specific devices or templates based on pre-operative software planning designed to fit a specific patient. These guides are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the marking/drilling of bone for plate fixation screws and the position of the osteotomy marking/cutting slots. Guides can be used in conjunction with anatomical models to verify anatomical positioning and fit. Surgical guides can be used with either tmCMF Solution patient-specific implants or compatible off-the-shelf DePuy Synthes implants.

Anatomical models are patient-specific models that are based on pre-operative anatomy and surqical planning specific to a patient. These models are used to assist a surgeon in transferring the pre-operative plan to the surgery by representing pre-operative, intra-operative, and post-operative anatomical models as quidance. Anatomical models can be used to check quide fit and facilitate the pre-bending of a non-patient-specific off-the-shelf plate.

Dental splints are patient-specific devices or templates based on pre-operative software planning designed to fit a specific patient. These templates are used to assist a surgeon in transferring the pre-operative plan to the surgery by guiding the dental alignment of bone and teeth.

Implants are patient-specific devices that are based on pre-operative software planning designed to fit a specific patient. These implants are integral components for CMF (craniomaxillofacial) procedures, facilitating bone repositioning, fixation, reconstruction, and the restoration of bone defects. They are designed according to the pre-operative surgical plan to ensure continuity in regions where bone is absent and to provide structural integrity to the maxillofacial skeletal components, midface, mandible, and chin. This could include stabilizing fractured or intraoperatively cut bone, fixating harvested graft segments, or augmenting bone defects. Implants can be used in conjunction with surgical guides and anatomical models to assist with anatomical positioning and fit.

The Surgeon Review Tool (SRT) software is used by surgeons for the review of surgical plans, surgical instruments, and implant designs. The SRT software is accessed through a web interface.

tmCMF Solution supports the following maxillofacial, midface (including orbital floor, lateral and medial orbital wall), and mandibular surgical procedures:

• . Reconstructive
• Orthognathic
• Trauma
• Augmentation ●

The provided text describes the tmCMF Solution device and its substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria or the study details proving the device meets those criteria, particularly for performance metrics like accuracy, sensitivity, or specificity for the software components.

The "Benchtop Performance" section mentions that "Testing demonstrated that the tmCMF Solution and substantial equivalence with the predicate device" and lists several "Performance verification" items, but these are high-level statements rather than detailed acceptance criteria and reported performance values. For example, "Testing demonstrated that the surgical guide and implants meets the predetermined acceptance criteria" indicates that acceptance criteria exist but doesn't provide them or the specific performance results.

Therefore, I cannot fulfill all parts of your request with the given input. I will extract the information that is present and indicate where information is missing.

Here's a summary of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided with specific numerical acceptance criteria or reported performance values in the document. The document generally states that "Testing demonstrated that... meets the predetermined acceptance criteria" for various aspects.

Note: The document only states that the device "meets" or is "compliant" with predetermined acceptance criteria, without providing the specific quantitative or qualitative criteria themselves, nor the specific performance values (e.g., accuracy percentages, error margins).

2. Sample Size for the Test Set and Data Provenance

This information is not provided in the document. The document refers to "testing" but does not specify the sample size for any test set or the provenance (country of origin, retrospective/prospective) of data used for performance validation.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document.

4. Adjudication Method

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not provided in the document. The document focuses on the device's technical specifications and substantial equivalence to predicate devices, not on comparative effectiveness with human readers.

6. Standalone (Algorithm Only) Performance Study

The document does not explicitly present a standalone performance study with specific metrics (e.g., accuracy, sensitivity, specificity) for the imaging or segmentation algorithms. It mentions tmCMF Solution is "a software system and image segmentation system," and that "Software Verification and Validation Testing was conducted," but focuses on compliance with software standards (IEC 62304) and general system functionality rather than detailed standalone performance metrics against ground truth for clinical tasks.

7. Type of Ground Truth Used

The specific type of ground truth (e.g., expert consensus, pathology, outcomes data) used for the software's performance assessment is not explicitly stated in the document. It generally refers to "predetermined acceptance criteria" for various verification items.

8. Sample Size for the Training Set

This information is not provided in the document.

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

This information is not provided in the document.

Ask a specific question about this device

METICULY Patient-specific titanium maxillofacial mesh implant is intended for bone fixation and reconstruction, restoration of bone defects and intended to provide continuity in regions where the bone is missing and/or to augment the bone by means of an onlay device in the maxillofacial skeleton and midface.

The METICUL Y Patient-specific titanium maxillofacial mesh implant is a device designed individually for each patient and intended for use in selective trauma of the maxillofacial skeleton, maxillofacial surgery, and reconstructive procedures. It is specifically designed with a focus on applications of non-bending related scenarios. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion) and is intended to be used with titanium screws. All additive manufacturing and other post-processing steps are only to take place under Meticuly manufacturing control. The device is not intended to substitute for bone reconstruction in clinical situations where bone is needed for support and stability of the maxillofacial skeleton under functional loading conditions. It is intended for adults only (at least 22 years of age). The surgeon approves the design of the mesh implant prior to fabrication of the implant device by the sponsor. The proposed FaciMesh models are intended to treat the maxillofacial region, while the OrbiMesh models treat the Orbital region. The device is not intended for reconstruction of the orbital roof defects or for any frontal bone defects, such as the supra-orbital ridge. Additionally, the FDA-cleared commercially available titanium screws that can be used with the subject devices include the TITANIUM MINIPLATE SYSTEM (K951690) and MICRO TITANIUM PLATE SYSTEM (K951688).

The METICULY Patient-specific titanium maxillofacial mesh implant underwent various performance tests to demonstrate its substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance:

The document broadly mentions compliance with various ASTM and ISO standards for material properties, manufacturing quality, biological evaluation, sterilization, and packaging. While specific quantitative acceptance criteria are not explicitly listed in a single table alongside reported values within the provided text, the conclusion states that "Verification and validation testing confirms that the product specifications have been met, demonstrating that the device will perform as intended. There were no unexpected results which indicate the suitable material used and manufacturing process compared to the standards for medical devices." This implies that the device met the requirements outlined in the referenced standards.

Here's a breakdown of the performance aspects and the reported methods/outcomes:

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

The document does not specify the sample sizes for the various performance tests conducted (e.g., number of powder samples, printed devices for fatigue testing, implants for biocompatibility).

The data provenance is also not explicitly stated beyond the tests being conducted by the manufacturer to support the 510(k) submission. It doesn't mention country of origin for data or if it was retrospective or prospective.

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

This information is not provided in the document. The studies described are primarily engineering and laboratory-based performance tests for the device itself (materials, manufacturing, sterility), not clinical studies requiring expert ground truth for interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable as the described tests are laboratory-based device performance evaluations, not clinical studies requiring expert adjudication of results.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not done or reported in this document. The submission focuses on the chemical, physical, and mechanical properties of the device and its manufacturing process, not on its diagnostic or treatment efficacy as interpreted by human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This information is not applicable. The device is a physical implant, not an algorithm or software that performs a diagnostic or treatment function on its own. While the design process involves digital input (CAD data from CT scans), the "performance" described is of the physical mesh implant, not a standalone algorithm.

7. Type of Ground Truth Used:

For the performance tests, the "ground truth" is largely established by recognized industry standards (ASTM, ISO, USP-NF). For instance:

• Material properties: Measured values compared against specified ranges in ASTM F3001-14.
• Biocompatibility: Results of biological tests (cytotoxicity, irritation, sensitization, etc.) are compared against established biological endpoints defined by ISO 10993 series and USP-NF.
• Sterilization: Achievement of a defined Sterility Assurance Level (SAL) and compliance with microbial limits as per ISO/ANSI/USP standards.
• Manufacturing accuracy: Comparison of the physical implant to the digital design and CT scan data inputs, with acceptable tolerances implied by "consistently matches."

No pathology, expert consensus on patient outcomes, or outcomes data is mentioned as ground truth for these device performance tests.

8. Sample Size for the Training Set:

This information is not applicable as the document describes a physical medical device, not an AI/ML algorithm that requires a training set. The device design process involves patient-specific CT data, but this is an input for individual device fabrication, not a training set in the context of AI/ML.

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

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device

The Stryker Facial iD System is intended for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).

Specific Indications for Use:

• Orbital reconstructive/ trauma surgery

The Stryker Facial iD System (Subject Device) is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orbital reconstructive and/or trauma surgery. The Subject Device is not intended for use in the orbital roof and can only be used if no exposure of the intracranial compartment is presented, and not intended for cranial use.

The Subject Device implants are additively manufactured patient-specific implants, and the patient-specific design of the implants allows certain features to be configured to meet the individual needs of each patient. The Subject Device implants are provided with a Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Additionally, the Subject Device is compatible with a separately provided Model. Customized Surgical Guides, Templates and Anatomical Models.

Here's a breakdown of the acceptance criteria and study information for the Stryker Facial iD System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal table of "acceptance criteria" with quantitative targets for each test, followed by the measured "device performance." Instead, it describes various performance tests and states that the "acceptance criteria were met" or that the device "met all pre-defined acceptance criteria."

I'll synthesize the information into a table format based on the tests performed and the outcomes mentioned:

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

• Mechanical Bench Testing: The document states that "All tests have been performed with the corresponding worst-case design considering the entire design envelope and all design features." It does not specify a numerical sample size (e.g., number of implants tested).
  • Data Provenance: Not explicitly stated, but it's in vitro bench testing.
• Biocompatibility Testing: Not specified.
  • Data Provenance: Not explicitly stated, but it's in vitro laboratory testing.
• Cleaning & Sterilization: Not specified.
  • Data Provenance: Not explicitly stated, but it's in vitro laboratory testing.
• End-User Testing: Not specified.
  • Data Provenance: Not explicitly stated, but it implies internal testing or simulation scenarios.

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

This information is not provided in the document. The studies described are primarily laboratory and bench testing, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are technical performance tests (mechanical, biocompatibility, sterilization) and not clinical studies requiring human interpretation and adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document states "Clinical testing was not required as a basis for substantial equivalence." The studies focused on technical performance and comparison to predicate and reference devices.

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

This concept is not directly applicable to the Stryker Facial iD System as described. The "system" involves the design and manufacturing of patient-specific implants. While there's likely software involved in generating the designs from CT scans (similar to the predicate KLS Martin IPS software), the document focuses on the implant's performance rather than the standalone performance of a diagnostic algorithm or AI for interpretation. The device itself is an implant, not an AI software intended for standalone diagnostic use.

7. The Type of Ground Truth Used

• Mechanical Bench Testing: The ground truth is established by the performance characteristics of the Reference Device (K221855), against which the Subject Device's mechanical stability was compared for "substantial equivalence."
• Biocompatibility Testing: The ground truth is established by the international standards (ISO 10993-1, DIN EN ISO 10993-5, DIN EN ISO 10993-12) for biocompatibility.
• Cleaning & Sterilization: The ground truth is established by international standards (DIN EN ISO 17665-1, ISO 17665-2, ISO 14937) for sterilization and sterility assurance levels.
• End-User Testing: The ground truth is the "intended performance" under specified use conditions.

8. The Sample Size for the Training Set

This information is not applicable. The Stryker Facial iD System is a patient-specific implant system, not an AI model that requires a "training set" in the context of machine learning. The design of each implant is based on individual patient CT data.

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

This information is not applicable for the reasons stated above (not an AI model with a training set). The patient-specific designs are generated from individual patient CT scans based on established engineering principles and medical design specifications, informed by the capabilities proven by the predicate and reference devices.

Ask a specific question about this device

The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions in adolescents (greater than 12 to 21 years of age) and adults.

The MedCAD AccuPlate® 3DTi Patient-Specific Plating System is a metal bone plate used in conjunction with commercially available, non-locking metal bone screws for the fixation to bone in orbital, midface / maxillofacial, and non-continuity mandibular operations. The design and dimensions of each plate within the envelope specification is based upon the patient's anatomical data (CT scan, CBCT scan, or MRI), and the intended anatomy to be fixated as determined from input provided by the surgeon. The subject device is not intended to be bent or modified in surgery. If for any reason the surgeon chooses not to use the subject device in surgery, they may use any of the commercially available plates to complete the surgery. The subject device is additively manufactured from Ti-6AL-4V Extra Low Interstitial (ELI) titanium alloy, provided non-sterile, must be sterilized prior to use, and is intended for single use only. Plates are fastened to bone using commercially available non-locking bone screws with diameters ranging from 1.5mm to 2.7mm and lengths ranging from 3.5mm to 22mm.

Here's a summary of the acceptance criteria and study information for the MedCAD® AccuPlate® 3DTi Patient-Specific Plating System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance letter mentions the following non-clinical performance tests. The acceptance criteria are implied to be "equivalent" to identified reference devices.

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

The document does not explicitly state the sample sizes (number of devices or tests) for the non-clinical performance tests (bending, pushout, fit and form validation). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective, as these are non-clinical (mechanical and material) performance tests rather than clinical studies with patient data.

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

This information is not explicitly provided in the document. For non-clinical performance tests, "ground truth" is typically established by engineering standards and validated testing procedures, not by human experts in the same way as clinical image interpretation. The "Fit and Form Validation" mentions alignment with an "approved surgical plan," which would involve surgical expertise in its creation, but the number and qualifications of individuals involved in approving these plans or assessing the fit are not detailed.

4. Adjudication Method for the Test Set

Not applicable for these types of non-clinical, objective performance tests. Adjudication methods like 2+1 or 3+1 are typically used for subjective clinical interpretations by multiple readers (e.g., radiologists) in diagnostic accuracy studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was mentioned. The MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is a patient-specific surgical implant, not an AI-assisted diagnostic tool.

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

This concept is not directly applicable. The device itself is an implant. However, the "patient specific design process" for creating the implant is an "algorithm only" type of process in that it uses patient anatomical data to generate the device design. The "Fit and Form Validation" likely assessed the output of this design process against the intended surgical plan. The document states that the design process "was shown to produce devices that aligned with the approved surgical plan," indicating successful standalone performance of the design software.

7. The Type of Ground Truth Used

• Biocompatibility: Established by adherence to ISO 10993 standards and FDA guidance.
• Sterilization Validation: Established by adherence to ISO 17665 standards and FDA guidance, with a specific SAL target.
• Static and Dynamic Bending: Established by ASTM F382 standard, with comparison to a reference device's known performance.
• Axial Screw Pushout: Established by ASTM F543 standard, with comparison to a reference device's known performance.
• Fit and Form Validation: Established by alignment with an "approved surgical plan." This likely involves a comparison of the 3D-printed plate geometry with the virtual surgical plan derived from patient imaging data, which can be considered "design ground truth."

8. The Sample Size for the Training Set

The document does not describe the development or training of an AI algorithm in the traditional sense, so there is no mention of a training set sample size. The "patient-specific design software" is mentioned as being the same as a reference device (K192282), implying it's a previously validated system rather than a newly trained AI model.

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

As no training set for an AI algorithm is described, this information is not applicable.

Ask a specific question about this device

The ACR Screw System is indicated for use as a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth for use in patients 12 years of age and older. It is used temporarily and is removed after orthodontic treatment is complete. The screws are intended for single use only.

The ACR Screw System is indicated for use as a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment is complete. The average temporary implantation period for the anchorage screw is six months. Screws are intended for single use only.

Screws are essentially C-type screw head design and size. Screw diameters and lengths are offered in the following range: thread diameter (1.75 mm) and overall length (11.10 – 15.10 mm). The screw tip has a self-drilling feature for insertion and removal. It is manufactured from a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13). These devices are supplied sterilized by gamma irradiation. This device is individually packaged in a polyethylene bag.

The provided document is a 510(k) premarket notification for the ACR Screw System, an orthodontic anchorage screw. It describes the device, its indications for use, and its substantial equivalence to predicate devices, primarily through non-clinical testing. However, it does not contain a study that quantitatively proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or similar measures typically associated with diagnostic or AI-driven devices.

The document focuses on demonstrating physical and material equivalence, as well as safety and basic functionality. Therefore, I cannot fully answer your request for acceptance criteria and a study proving device performance in the way you've outlined for AI/diagnostic devices.

Here's an attempt to extract relevant information given the limitations of the provided text:

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

The document details performance testing related to mechanical properties, biocompatibility, sterilization, bacterial endotoxin, and shelf-life. However, explicit quantitative acceptance criteria and detailed reported performance values for each are not presented in a comparative table within the document. Instead, it states that tests "met predetermined acceptance criteria" or "all test requirements were met."

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

The document does not specify sample sizes for mechanical, sterilization, bacterial endotoxin, or shelf-life testing. The data provenance is implied to be from internal testing by BioMaterials Korea, Inc. or their contracted labs, primarily from South Korea, as indicated by the manufacturer's and consultant's addresses. All tests are non-clinical (laboratory/bench).

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

This is not applicable to the non-clinical testing described. Ground truth for these types of tests is established by standardized testing protocols and measurement instruments, not human expert consensus.

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

Not applicable, as this is for non-clinical testing.

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

Not applicable. This device is a physical orthodontic screw, not an AI or diagnostic imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This device is a physical product.

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

The ground truth for the non-clinical tests (mechanical properties, biocompatibility, sterilization, etc.) is established by adherence to international standards and validated laboratory test methods (e.g., ISO and ASTM standards for material properties, sterility, and packaging integrity).

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

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

Not applicable.

Ask a specific question about this device