Search Results

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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MCI - Neuro Fixation System is indicated for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

The MCI – Neuro Fixation System is composed of plates (including burr hole covers), screws, and meshes. The bone plates and meshes are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6Al-4V (ASTM F136) and are available in different sizes and shapes, according to the site of the implantation and the extension of the fracture. The surface of plates, meshes and screws are colored-anodized.

MCI - Neuro Fixation System devices are for single use. The devices are provided non-sterile and must be properly sterilized before use, according to the recommendations provided in the Instructions for Use.

The devices must only be used by qualified surgeons mastering the surgical technique, having been trained and qualified in cranial surgery.

The provided text describes information about the MCI-Neuro Fixation System, a cranial fixation device. However, it does not contain the kind of detailed information about acceptance criteria, clinical study design, sample sizes, expert qualifications, or comparative effectiveness studies that your request asks for, especially concerning an AI/ML-driven device.

The document discusses:

• Regulatory Clearance (K212391): It's a 510(k) premarket notification for a Class II medical device.
• Device Description: The system consists of plates, screws, and meshes made from titanium.
• Predicate Device: K141911 - OPTIMUS NEURO SYSTEM.
• Performance Data: This section focuses on bench testing for physical and material properties (metallographic tests, cyclic polarization, cycle bend testing of plates, screw torsion yield test, pull-out testing, driving torque testing).
• Biocompatibility: Stated as supported by a reference device (K182758).
• Lack of Clinical Data: Explicitly states, "No clinical data were included in this submission."

Since this device is a physical fixation system and not an AI/ML driven diagnostic or prognostic tool, the concepts of human readers, AI assistance, ground truth establishment (beyond material specifications), training sets, and test sets in the context of diagnostic accuracy are not applicable to this document.

Therefore, I cannot provide a table of acceptance criteria and device performance, or details about clinical study design, sample sizes, expert qualifications, or adjudication methods as requested, because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence through material and mechanical bench testing.

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MCI - CMF System is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

The bone plates are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6AI-4V (ASTM F136) and are available in different sizes and shapes, according the site of the implantation and the extension of the fracture. The surface of plates and screws are colored-anodized. MCI - CMF System implant devices are for single use. The devices are provided non-sterile and must be properly cleaned, disinfected and sterilized before use, according the recommendations provided in the Instructions for Use.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called the "MCI - CMF System," which consists of bone plates and screws. This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through comparison of design, materials, indications for use, and a limited set of mechanical and biocompatibility tests.

There is no mention of an AI/algorithm-driven device, nor are there any acceptance criteria or studies related to AI model performance, accuracy, or human-in-the-loop studies involving expert readers.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves a device meets acceptance criteria in the context of an AI/algorithm. The provided text simply does not contain this information.

To elaborate on why I cannot answer based on the provided text:

• No AI/Algorithm: The "MCI - CMF System" is a physical medical implant (bone plates and screws). It is not software, an algorithm, or an AI system.
• No Diagnostic Claims: The device is for "selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin." These are surgical indications, not diagnostic. There's no AI that would be "reading" images or assisting in diagnosis.
• No Acceptance Criteria for AI Performance: Since it's a physical implant, the "performance" data refers to mechanical testing (e.g., bending fatigue of plates, pullout strength of screws) and biocompatibility, not AI metrics like sensitivity, specificity, AUC, or reader studies.
• No Test Set Details: There's no test set of patient data, as there's no AI to evaluate on such data.
• No Expert Ground Truth or Adjudication: These concepts are relevant for evaluating AI in diagnostic imaging or clinical decision support, which is not the function of this device.
• No MRMC or Standalone AI Study: These are types of studies specifically for AI performance evaluation.
• No Training Set Information: Again, training sets are for machine learning models, which are not described in this document.

The 510(k) summary concludes that the device is substantially equivalent based on engineering principles, material science, and the stated indications for use, compared to predicate devices already on the market.

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KLS Martin Individual Patient Solutions implant devices are intended for use in the stabilization, fixation, and reconstruction of the maxillofacial / midface and mandibular skeletal regions.

KLS Martin Individual Patient Solutions is comprised of patient-specific models and metallic bone plates used in conjunction with metallic bone screws for internal fixation of maxillofacial / midface and mandibular bones. The devices are manufactured based on medical imaging (CT scan) of the patient's anatomy with input from the physician during virtual planning and prior to finalization and production of the device. The physician only provides input for model manipulation and interactive feedback by viewing digital models of planned outputs that are modified by trained KLS Martin engineers during the planning session. For each design iteration, verification is performed by virtually fitting the generated implant over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.

Implants are provided non-sterile, range in thickness from 0.3 mm - 10 mm, and are manufactured using traditional (subtractive) methods from either CP Titanium (ASTM F67) or Ti-6Al-4V (ASTM F136) materials or additive methods from Ti-6Al-4V. These patient-specific devices are fixated with previously cleared KLS Martin screws.

The provided text describes the performance testing of the KLS Martin Individual Patient Solutions device, primarily focusing on non-clinical bench testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study establishing device performance against acceptance criteria in human subjects.

Therefore, many of the requested details regarding clinical study design (e.g., sample size for test set, expert adjudication, MRMC study, standalone performance, ground truth establishment for training/test sets) are not applicable as they relate to clinical studies that were explicitly stated as "not necessary for the substantial equivalence determination."

However, I can extract information related to the non-clinical performance testing and the implicit acceptance criteria derived from comparison to predicate devices and established standards.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The acceptance criteria are generally implied to be meeting or exceeding the performance and safety profiles of the predicate devices and relevant ASTM/ISO standards. The "reported device performance" is framed as demonstrating substantial equivalence rather than specific numerical metrics for a clinical outcome.

Study Information (Non-Clinical Focus)

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

   • Test Set Sample Size: Not explicitly stated in terms of number of unique devices for each mechanical test, but rather described as "bench testing" and "comparative performance testing." It implies sufficient samples were tested to meet standard requirements for ASTM F382 and other bench tests.
   • Data Provenance: The tests were conducted to demonstrate substantial equivalence to predicate devices (K163579, K944565), and some performance data (biocompatibility, sterilization, pyrogenicity) were "leveraged" from previous clearances of the predicate device since the materials and processes are identical. This implies the data originates from the manufacturer's internal testing or contract labs. The country of origin for the data is not specified but is presumably within the regulatory framework acceptable to the FDA. The testing is non-clinical bench testing, not retrospective or prospective human data.

2. 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 pertains to clinical studies involving expert review of diagnostic images or outcomes. The provided text describes non-clinical bench testing and software validation.

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

   • Not Applicable. This pertains to clinical studies involving human interpretation and ground truth establishment.

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:

   • Not Applicable. No clinical study (MRMC or otherwise) involving human readers or AI assistance was conducted or described for this device, as "Clinical testing was not necessary for the substantial equivalence determination." This device consists of patient-specific implants and the related planning system, not an AI for image interpretation.

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

   • Not Applicable. While software verification and validation were performed for the planning software, it's not an "algorithm" in the sense of an AI model for diagnosis. The software is a tool for design and planning, with human input from the physician and KLS Martin engineers. Therefore, a "standalone algorithm performance" as typically defined for AI/ML devices is not relevant here.

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

   • For Bench Testing: The "ground truth" for non-clinical performance testing is established by validated test methods (e.g., ASTM, ISO standards) and comparison to the known performance of the predicate devices. For software, the ground truth is its pre-defined specifications and user requirements.
   • Not Applicable for clinical "ground truth" types mentioned (expert consensus, pathology, outcomes data).

7. The sample size for the training set:

   • Not Applicable. This refers to machine learning models. The device involves patient-specific design based on CT scans, but not a generalizable AI model that requires a training set in the conventional sense. The software's design and functionality are established through traditional software development and validation, not machine learning training.

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

   • Not Applicable. (See point 7).

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CranioMaxillofacial Fixation (CMF) System - CMF Visionare is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

The subject device is a fixation system consisting of plates and screws in a variety of shapes and sizes. All plates are made of commercially pure titanium conforming to ASTM F67, and all screws are made of Ti-6Al-4V alloy conforming to ASTM F136. The subject device includes the following groups: 1.5 System Plate, 2.0 System Plates, 2.4 System Plates, Orthognathic Plates, Blocking Screws (for intermaxillary fixation, 2.0 mm diameter), and screws for use with the various plates ranging in diameter from 1.5 mm to 2.7 mm.

It looks like the provided text is a 510(k) Summary for a CranioMaxillofacial Fixation (CMF) System, which is a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the input request asking for:

1. A table of acceptance criteria and reported device performance
2. Sample sizes for test set and data provenance
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth
8. Sample size for training set
9. How ground truth for training set was established

cannot be fully answered from the provided text. The document describes non-clinical data (mechanical testing, dimensional analysis, biocompatibility) to show equivalence, not clinical study results with acceptance criteria.

Here's what can be extracted and inferred from the text:

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

There isn't a table of "acceptance criteria" for clinical performance. The "performance data" reported in the document is non-clinical, demonstrating mechanical and material properties. The acceptance criterion for the 510(k) submission itself is "substantial equivalence" to predicate devices.

Non-clinical Performance Data Reported:

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 as the submission relies on non-clinical engineering and laboratory testing, not a clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided as there was no clinical test set requiring expert ground truth for performance evaluation.

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

This information is not applicable/not provided for the same reason as 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/not provided. The device is not an AI-assisted diagnostic tool; it's a physical fixation system. No clinical comparative effectiveness study is mentioned, particularly an MRMC study.

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

This information is not applicable/not provided. The device is not an algorithm.

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

For the non-clinical tests, the "ground truth" implicitly refers to established engineering standards (ASTM, ISO) for mechanical properties, material composition, and sterilization. For the comparison to predicate devices, the "ground truth" is the design and performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable/not provided as the device is not an AI/ML algorithm requiring a training set.

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

This information is not applicable/not provided for the same reason as above.

Summary of what the document focuses on instead:

The document describes a substantial equivalence claim for the CranioMaxillofacial Fixation (CMF) System - CMF Visionare. This means the manufacturer is asserting their device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. This is primarily established through:

• Comparison of Indications for Use: The indications for use are reported as "identical" to the primary predicate device (K102641), with the only difference being the device names.
• Comparison of Technological Characteristics: Detailed tables (Tables 1-6) are provided comparing the subject device's plates (1.5 System, 2.0 System, 2.4 System, Orthognathic) and screws (Blocking, other screws) to those of the primary predicate device and several reference devices. These comparisons cover plate designs, dimensions (thickness, overall sizes, hole configurations), screw dimensions (diameter, threaded length), and material composition.
• Non-clinical Performance Data:
  • Sterilization validation: Conformed to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 14937.
  • Biocompatibility testing: Conformed to ISO 10993-5 and ISO 10993-12 (cytotoxicity testing).
  • Dimensional analysis: Engineering analysis of cross-sectional dimensions and bending moments of inertia "compared favorably" to predicate/reference devices.
  • Mechanical testing: Performed according to ASTM F382 (single cycle bending fatigue) and ASTM F543 (torsional properties, driving torque, axial pullout, self-tapping performance). The implication is that these tests demonstrate performance comparable to predicate devices.
• Material Equivalence: All subject device plates are CP titanium, and all screws are Ti-6Al-4V alloy, which are stated to be substantially equivalent to the materials of the primary predicate and most reference devices. A minor difference in screw alloy (Ti-6Al-7Nb) for some reference devices is identified but deemed not to affect intended use or raise new safety/effectiveness questions.

In essence, the study presented is a design and performance comparison against existing, cleared devices and recognized standards, rather than a clinical trial with specific performance acceptance criteria.

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Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the cranial bones that require gradual distraction.

Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of cranial bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.

This document is a 510(k) premarket notification for the "Internal Distraction - Sterile" device. The acceptance criteria and supporting studies are based on demonstrating substantial equivalence to a predicate device, the "Zurich Distraction System (K010139)".

Here's a breakdown of the requested information:

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

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

The document primarily relies on non-clinical performance data (bench testing) and comparison to the predicate device.

• Biocompatibility: No new testing was performed; it relied on the predicate device's clearance.
• Pyrogenicity: The sample size for Bacterial Endotoxins testing is not specified.
• Mechanical Performance: The sample size for axial load, bending torsion, axial-torsion, and transverse shear testing is not specified. This was bench testing, not clinical data, so provenance like "country of origin" or "retrospective/prospective" is not applicable in the typical sense for patient data.

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. The study is a 510(k) submission based on non-clinical bench testing and demonstration of substantial equivalence to a predicate device. There was no test set requiring expert ground truth for clinical cases.

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

Not applicable. No clinical test set or adjudication for diagnostic ground truth was performed or required.

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 medical implant (internal distraction system), not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted.

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

Not applicable. This is a medical device, not an algorithm, so the concept of standalone performance does not apply.

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

Not applicable in the context of clinical ground truth for diagnostic accuracy. The "ground truth" for this submission is based on:

• Predicate Device Equivalence: The safety and effectiveness profile of the legally marketed predicate device (Zurich Distraction System, K010139).
• Engineering Standards: Compliance with recognized standards for biocompatibility (ISO 10993-1), pyrogenicity (ANSI/AAMI ST72:2011, USP , EP 2.6.14), and mechanical performance through bench testing against design requirements.

8. The sample size for the training set

Not applicable. This is a medical device clearance, not an AI model. There is no concept of a "training set" for the device itself.

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

Not applicable. See point 8.

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Internal Distraction - Sterile includes devices intended as bone stabilizers and lengthening (and or transport) devices for correction of congenital deficiencies or post traumatic defects of the mandible (including ramus, body, alveolar ridge, palate, symphysis) and mid-face bones that require gradual distraction.

Internal Distraction - Sterile consists of sterile internal distraction devices intended for the correction of the mandible and mid-face bones that are comprised of several different designs and components intended for bone stabilization and elongation through distraction osteogenesis. It is composed of multiple sizes and shapes of distractor footplates and either fixed or detachable activator arms. The devices are positioned internally with a connected activation arm extending through the soft tissue for external activation. Some devices, due to their anatomical positioning, are directly activated using a patient activation driver, eliminating the need for attaching an activation arm to the device. The distractor footplates are fixated to the bone on either side of the osteotomy using previously cleared bone screws (K943347, K944561, K944565, K971297, K060177). Distraction is achieved by rotating the distractor threaded drive screws with the patient driver, often with an activation arm, which causes a separation of the distractor footplates and induces the body to grow bone and expand soft tissue as a response. Various lengths of distractor drive screws are available to achieve the desired distraction length. Upon completion of distraction and consolidation of the bone, the screws are removed from the footplates and the distractor is explanted.

This document describes a 510(k) premarket notification for the "Internal Distraction - Sterile" device. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily by indicating that the new device is a sterile version of existing non-sterile devices.

Based on the provided document, here's a breakdown of the requested information:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical study. Instead, it describes general design requirements and performance evaluations for mechanical properties and biocompatibility. The "reported device performance" indicates that these requirements were met.

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

• Sample size for the test set: Not applicable (N/A). This submission did not involve a clinical study with a "test set" of patients. The performance data presented is from non-clinical bench testing and biocompatibility assessments of the device materials.
• Data provenance: N/A. The data provenance described is related to bench testing, not patient data.

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)

• Number of experts: N/A. No clinical test set with ground truth established by experts was used.

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

• Adjudication method: N/A. No clinical test set to adjudicate was utilized.

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

• MRMC study done: No. This is a medical device (bone plate/distractor) submission, not an AI/software as a medical device (SaMD) submission. An MRMC study would not be relevant in this context.
• Effect size: N/A.

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

• Standalone done: No. This submission is for a physical medical device.

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

• Type of ground truth: N/A. For the mechanical and biocompatibility testing, the "ground truth" is defined by established engineering and biological standards and specifications (e.g., design requirements, ANSI/AAMI ST72:2011, USP , EP 2.6.14 for endotoxins). No clinical ground truth (like expert consensus or pathology) was used as there was no clinical study.

8. The sample size for the training set

• Sample size for the training set: N/A. There was no "training set" in the context of an algorithm or AI. The design and manufacturing processes for the device are well-established based on existing predicate devices.

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

• How ground truth was established for the training set: N/A. This concept is not applicable to the type of device and submission described.

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The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

The Stryker Universal Neuro 3 System is designed for a wide selection of solutions for cranial fixation. It consists of an implant module (a storage module that contains various versions and shapes of plates and screws) for the respective anatomical and indicated areas. The low profile plates of the Stryker Universal Neuro 3 System provide rigid fixation of cranial flaps with decreased palpability. There is a comprehensive selection of burr hole covers, straight plates, gap plates, 3D-plates, shunt plates, and box plates to provide many fixation options. The malleable plates can be easily contoured by hand without instruments. The pre-shaped skull-base plates provide covers for standard craniectomies, obviating the need to cut or trim mesh.

The Stryker Universal Neuro 3 System is intended for reconstruction, stabilization, and/or rigid fixation of non-load-bearing bony areas subsequent to craniotomy, craniectomy, and cranial fractures in adults and adolescents (age 12 and higher).

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

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

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

The document does not specify exact "sample sizes" in terms of number of devices tested for each performance criterion. Instead, it refers to testing of "all plates," "the screws," and "all Neuro 3 screws, plates and meshes." This implies that a sufficient number of samples were tested to demonstrate compliance with the referenced ASTM and ISO standards for the representative product configurations.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the tests were conducted according to recognized international (ISO) and US (ASTM) standards, suggesting the testing was performed in a controlled laboratory environment to demonstrate compliance. Given the context of a 510(k) submission, this testing would be prospective and specifically conducted for regulatory approval.

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 to this type of device and study. The testing for the Stryker Universal Neuro 3 System involves mechanical and material property evaluations against established engineering standards (ASTM, ISO), not clinical assessment requiring expert interpretation of data or images. Therefore, there is no "ground truth" to be established by experts in a clinical sense.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above. Adjudication methods are typically used in studies involving subjective interpretation, such as clinical trials or image-based diagnostic assessments.

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

There was no MRMC comparative effectiveness study done. This device is a passive implant (craniofacial plates, burr hole covers, and screws) and does not involve AI or human "readers" in its function or evaluation for regulatory submission.

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

There was no standalone (algorithm only) performance study done. This device is a physical medical implant and does not involve any algorithms or software for its primary function.

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

The "ground truth" for this device's performance evaluation is based on established engineering standards and material specifications. For example:

• Biocompatibility: Conformance to ISO 10993 series.
• Mechanical Properties: Conformance to ASTM F 382-99 for bending stability (Lerch test) and ASTM F 543 for screw performance (torque, depth, angle, pull-out safety, retention force).
• Material Composition: Commercially Pure Titanium (Grade II, IV) and Titanium Alloy (Grade V), which are well-defined materials with known properties.

These standards and specifications serve as the objective "ground truth" against which the device's performance is measured.

8. The sample size for the training set

There is no training set for this device. As a passive mechanical implant, it does not involve machine learning or AI models that require training data.

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

This question is not applicable as there is no training set or ground truth established for a training set for this device.

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OsteoMed OSA Rigid Internal Fixation System is intended for a variety of pan facial indications. Specifically, the system is intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and mandible. Implants are single use only.

The OsteoMed OSA Rigid Internal Fixation System is comprised of various plates and screws. Plates, .8mm through 1.0mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm and 2.0mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 1.9mm and 2.4mm diameter. Depth gauges, screwdrivers, countersinks, pilot drills, and preparation instruments will also be a part of the system.

This 510(k) summary describes a physical medical device (OsteoMed OSA Rigid Internal Fixation System) and not an AI/ML powered software device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training set is not applicable to this document. The submission focuses on demonstrating substantial equivalence to predicate devices based on similarities in intended use, material, design, and operational principles.

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This device is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.

This submission describes self drilling bone screws intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand, secondary to trauma or for reconstruction. The Self Drilling Screw is available in 1.2 and 1.7 mm diameters with lengths ranging from 4-7 mm and in a 2.0 mm diameter with lengths ranging from 5-8 mm.

The provided document is a 510(k) summary for the Leibinger® Self-Drilling Screw and the FDA's response letter indicating substantial equivalence. This type of submission is for medical devices and focuses on demonstrating equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria through a standalone study.

Therefore, the information typically requested for AI/device performance studies (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document. The document highlights the device's intended use, materials, design, and operational principle to establish similarity with predicate devices.

Here's why the requested information isn't available and what the document does provide:

• Acceptance Criteria & Reported Performance: This document does not describe specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present a study comparing the device's performance against such criteria. The "performance" being evaluated here is primarily whether the new device is substantially equivalent to existing legally marketed devices based on its characteristics.
• Study Details (Sample Size, Data Provenance, Ground Truth, Adjudication, MRMC, Standalone): These are all elements of a clinical or technical performance study, which is not described. The 510(k) pathway often relies on bench testing, material characterization, and comparison to predicate devices rather than de novo clinical performance trials, especially for low-to-moderate risk devices like bone screws, if substantial equivalence can be shown.
• Training Set Information: This product is a physical medical device (a screw), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

Based on the provided text, here is what can be extracted, acknowledging that most of the requested fields are not applicable to this type of regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as numerical performance metrics. The underlying "acceptance criteria" for a 510(k) submission are met if the FDA determines the device is substantially equivalent to a predicate device. This is based on similarities in intended use, materials, design, and operational principles, and that it doesn't raise different questions of safety and effectiveness.
• Reported Device Performance: The document states that "Equivalence for this device is based on similarities in intended use, material, design and operational principle" to the KLS Martin Centre-Drive Drill-Free™ Screw [K944565] and the Leibinger® Luhr Small Bone Screws [K963739, K963740 and K963741]. This is the "performance" shown: it is sufficiently similar to devices already on the market.

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

• Not Applicable. This document does not describe a "test set" in the context of performance evaluation for an AI or diagnostic device. The evaluation is based on device specifications and comparison to predicates.

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

• Not Applicable. No ground truth establishment by experts is described for a performance study.

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

• Not Applicable. No adjudication method is described.

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

• Not Applicable. This is a physical bone screw, not an AI-assisted diagnostic device.

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

• Not Applicable. This is a physical bone screw, not an algorithm.

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

• Not Applicable. There is no "ground truth" established for performance evaluation in a clinical study detailed in this document. The "truth" in this context is the FDA's regulatory determination of substantial equivalence based on the provided technical information and comparison to predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI algorithm.

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

• Not Applicable. This is a physical medical device, not an AI algorithm.

Summary of what the document does provide:

• Device Name: Leibinger® Self-Drilling Screw
• Intended Use: Internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.
• Device Description: Available in 1.2, 1.7, and 2.0 mm diameters with various lengths. Manufactured from titanium alloy. Self-drilling, one-step insertion.
• Predicate Devices: KLS Martin Centre-Drive Drill-Free™ Screw [K944565] and Leibinger® Luhr Small Bone Screws [K963739, K963740, K963741].
• Basis for Equivalence: Similarities in intended use, material, design, and operational principle.
• Regulatory Outcome: FDA found the device "substantially equivalent" to predicate devices, allowing it to be marketed.

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