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CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the cranial and/or craniofacial skeleton (frontal bone including the brow ridge). This device is indicated for both adult and pediatric use (for children 7 years of age and above). CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:

• trauma and vascular pathologies, either associated or non-associated to cranial decompression;
• removal of tumours;
• reabsorption of autologous bone;
• rejection of other prosthetic materials;
• congenital malformations.

CustomizedBone Service patient specific implants for the reconstruction of cranial/craniofacial defects are made of porous biomimetic hydroxyapatite with a chemical composition and structure that resembles the mineral component of human bones. This biomaterial is highly porous with trabecular structure and is composed of pores with the following characteristics:

• macro-pores,
• interconnecting pores,
• micro-pores.
  This material is biocompatible.
  The implants are designed and produced by Fin-Ceramica Faenza according to the surgeon's specifications and based on the patient's CT scan data, obtained through a standardized protocol. During the pre-operative planning phase, the final implant design. All the implants are accompanied by the patient's identification code.

The provided text describes a 510(k) premarket notification for a medical device called "CustomizedBone Service." It focuses on demonstrating substantial equivalence to a legally marketed predicate device. The information provided is primarily related to the device's design, material, intended use, and a minor change in fixation method.

Crucially, the document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of typical AI/ML medical device performance studies. The document describes a traditional medical device submission, not an AI/ML-driven device.

Therefore, I cannot extract the information required to populate the fields related to acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training data, or ground truth for training data as these concepts are not discussed in the provided text.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section mentions tests for "Stability verification of CustomizedBone Service stabilized with Cranial LOOP (L)" and "Usability of an alternative method of fixation." However, these are mechanical/usability tests for a physical implant, not performance metrics for an AI/ML algorithm.

In summary, the provided content is insufficient to answer the prompt because it describes a hardware medical device (cranioplasty plate) and not an AI/ML-driven device requiring the specified performance evaluations.

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The Longeviti ClearFit OTS cranial implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.

The Longeviti ClearFit OTS (off-the shelf) cranial implants are ultrasound penetrable fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate (PMMA) materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.

The provided text is a 510(k) summary for the Longeviti ClearFit OTS Cranial Implant. It describes the device, its intended use, and its classification. However, it does not contain information about acceptance criteria for a study demonstrating device performance, nor details of a study that proves the device meets such criteria. Specifically, it lacks:

• A table of acceptance criteria and reported device performance.
• Details on sample size, data provenance, number and qualifications of experts, or adjudication methods for a test set.
• Information on MRMC studies, standalone algorithm performance, or the type of ground truth used.
• Information regarding the training set's size or how its ground truth was established.

The document primarily focuses on the regulatory aspects of the device, establishing substantial equivalence to a predicate device, and outlining general controls and FDA regulations. It mentions that there are "no technological differences to the material (PMMA) and no differences to the materials of manufacturing. There are no differences to the packaging or sterilization process" compared to its predicate device (Longeviti ClearFit OTS Cranial Implant, K212058). This suggests that the substantial equivalence determination is based on the similarity of the device to previously cleared devices, rather than new performance data from a specific study demonstrating new acceptance criteria.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on the provided text. The text does not contain that information.

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The PEEK Patient Specific Cranial Craniofacial Implant (PSCI) is intended to replace bony voids in the cranial and/or craniofacial skeleton, excluding maxillofacial and /or oral regions.

The PEEK Patient Specific Cranial/Craniofacial Implants are designed individually for each patient to correct defects in cranial/facial bone, and fabricated using the patient' s CT imaging data. The implants are made of PEEK material which is medical grade material. The PSCI consists of PEEK bone plate, and it is fixated to native bone using previously cleared Bioplate Fixation System manufactured by Bioplate, Inc. The PSCI is provided in non-sterile and must be sterilized before use in Health Care Facility.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) premarket notification letter and a 510(k) summary for a medical device (PEEK Patient Specific Cranial/Craniofacial Implant).

It details:

• The device's identification and intended use
• Comparison to a predicate device
• Non-clinical testing for biocompatibility and performance (compression, fitting, fixation)
• A statement that no clinical tests were performed.

Therefore, there is no mention of acceptance criteria based on device performance in a clinical study, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training sets. This information would typically be found in a clinical study report, which is not present here.

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The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is designed individually for each patient and intended to correct defects / replace bony voids in the cranial skeleton.

The MedCAD® AccuShape® Titanium Patient-Specific Cranial Implant is a preformed non-alterable cranioplasty plate that cannot be altered or reshaped at the time of surgery and is designed to be implanted in a patient to repair a skull defect.
The subject device is composed of commercially pure (CP) Grade 2 titanium per ASTM F67. The manufacturing process is subtractive manufacturing (CNC milled) from models created and developed from patient specific CT Scan Data. The software used in this process is identical to the software used in the predicate device (K110684). The device is designed to have, as requested by the physician, drainage holes over the defect void area, fixation holes over an onlay area, and retractions and other features that fall within the approved design envelope. All designs must be approved by the physician prior to manufacture.

The provided document describes the MedCAD AccuShape Titanium Patient-Specific Cranial Implant and its substantial equivalence to a predicate device (MedCAD AccuShape PEEK Patient Specific Cranial Implant) based on non-clinical performance testing.

It is important to note that this document does not describe an AI/ML-driven device or study parameters typical for such devices (e.g., ground truth establishment for a training set, human reader studies, or expert consensus on clinical data). The device described is a physical cranial implant, and the study referenced in the document is a series of non-clinical performance tests designed to assess the physical and mechanical properties of the implant, not its diagnostic or predictive accuracy in an AI context.

Therefore, many of the requested bullet points, particularly those pertaining to AI/ML device evaluation (like sample size for test/training sets of data, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to the information provided in this document.

However, I can extract information relevant to the device's acceptance criteria and the non-clinical performance testing performed for this physical device.

Here's an interpretation of the "acceptance criteria" and "study" as presented for a physical medical device, rather than an AI/ML diagnostic:

Device: MedCAD AccuShape Titanium Patient-Specific Cranial Implant (K220357)

Purpose of the "Study" (Non-Clinical Performance Testing): To demonstrate the substantial equivalence of the MedCAD AccuShape Titanium Patient-Specific Cranial Implant to its predicate device (MedCAD AccuShape PEEK Patient Specific Cranial Implant, K110684) by evaluating its physical and mechanical properties.

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

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

• Sample Size for Test Set:
  • Evaluation of Fit Testing: "3 large defect predicate historical cases (K110684)" were used to generate "worst case CT data". The number of manufactured implants tested is implied to be at least 3 (one for each case). The phrase "All samples" in the result suggests a specific number of manufactured implants were produced and tested, but the exact number isn't quantified beyond the 3 cases used for input data.
  • Comparative Strength: "Identical subject and predicate devices" were used, implying at least one (and likely more for statistical significance, though not stated) of each type (titanium and PEEK) for comparative testing.
  • Screw Fixation: Not explicitly stated, but implies multiple tests to determine "at least as strong as" criteria.
  • MR Compatibility: At least one device (or representative sample) would be tested.
• Data Provenance: The "worst case CT data" for the Evaluation of Fit testing came from "3 large defect predicate historical cases (K110684)". This suggests a retrospective use of previously acquired clinical data (CT scans) from actual patients. The country of origin is not specified but is implicitly USA, given this is an FDA submission.

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

• This concept is not directly applicable in the context of this device's non-clinical testing. The "ground truth" (or reference standard) is based on engineering specifications, material properties, and established test methodologies (e.g., ASTM standards, previous FDA-cleared device performance).
• For the "Evaluation of Fit Testing," "qualified inspectors" performed the evaluation. Their qualifications (e.g., years of experience, specific certifications) are not detailed beyond "qualified".

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

• Not applicable. Adjudication methods are typically used in clinical studies involving multiple human readers interpreting medical images, where discrepancies need to be resolved. This document describes physical, non-clinical tests.

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

• Not applicable. This device is a physical implant, not an AI/ML diagnostic tool, and no human reader study was performed.

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

• Not applicable. This is not an AI algorithm. The manufacturing software is mentioned (same as predicate device), but its performance in terms of design output is assessed through the physical device tests (e.g., Evaluation of Fit), not as a standalone AI model.

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

• The "ground truth" for these tests is based on:
  • Engineering Specifications/Standards: e.g., ASTM F2503-20 for MR compatibility.
  • Predicate Device Performance: For comparative strength, the performance of the legally marketed predicate device (K110684 PEEK implant) served as the benchmark.
  • Established Biomechanical Principles: For screw fixation, comparison to "axial pullout forces measured in prior testing of FDA-cleared neuro screws in an established cortical bone model" serves as the reference.
  • 3D Digital Models/Physical Prototypes: For "Evaluation of Fit," the 3D digital model of the implant and representative anatomical models served as the reference for fit.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML system that requires a "training set" of data in the machine learning sense. The manufacturing process uses patient-specific CT scan data as input for design, but this is not a training set for an AI model.

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

• Not applicable, as there is no AI/ML training set in this context.

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Meticuly patient-specific tianium mesh implant is a device that is designed individually for each patient. This device is intended for use in selective trauma of the craniofacial skeleton (e.g., frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer), cranial and craniofacial surgery, and reconstructive procedures.

Meticuly's Patient-specific Titanium Mesh Implant is a device designed individually to replace each patient's bony voids in the cranial and/or craniofacial skeleton comprises of frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer. This patient-specific device is intended to be used with titanium screws. The subject device has been validated and tested with titanium screws with the diameter of 1.4 mm - 1.8 mm (K141452 : Jeil Medical's LeForte Neuro system screws). The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The surgeon approves the design of the mesh implant prior to fabrication of the implant device.

The provided text describes the Meticuly Patient-Specific Titanium Mesh Implant and its substantial equivalence determination by the FDA. However, it does not contain the specific information requested regarding an AI/ML powered device, specifically:

• It does not describe acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, or F1-score, which are typical for AI/ML devices.
• It does not specify sample sizes for test or training sets in terms of patient numbers or image counts, nor data provenance (country of origin, retrospective/prospective).
• It does not mention the number or qualifications of experts used for ground truth, any adjudication methods, or MRMC comparative effectiveness studies.
• It does not refer to standalone performance for an algorithm or the type of ground truth (e.g., pathology, outcomes data).

Instead, the document details the performance testing for a physical medical device (a patient-specific titanium mesh implant). The performance tests focus on material properties, manufacturing quality, biocompatibility, sterilization, packaging, and mechanical properties. The "comparative device modeling with Finite Element Analysis (FEA)", "comparative mechanical testing with modified compression test", and "comparative roughness testing" are all hardware-related validation activities, not AI/ML algorithm validation.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study details for an AI-powered device based on the provided text, as the text describes a physical implant and its regulatory submission, not an AI/ML device.

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The Longeviti ClearFit™ OTS Cranial Implants are manufactured to correct and/or restore bony voids and/or defects of the cranium.

The Longeviti ClearFit™ OTS (off-the shelf) cranial implants are fixed size prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implants are manufactured from polymethyl methacrylate materials. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners.

The provided text is a 510(k) summary for the Longeviti ClearFit OTS Cranial Implants. It focuses on demonstrating substantial equivalence to a predicate device, not on proving that a specific new device (such as an AI/ML powered device) meets acceptance criteria for classification tasks (e.g., detecting disease, segmenting organs).

Therefore, the document does not contain the information needed to answer questions 1-9 in the requested format, as those questions typically apply to studies evaluating the performance of AI/ML algorithms, especially in diagnostic or clinical decision support contexts.

The document discusses:

• Device Description: Off-the-shelf polymethyl methacrylate (PMMA) cranial implants.
• Intended Use: Correct and/or restore bony voids and/or defects of the cranium.
• Comparison to Predicate: The key difference highlighted is that the subject device is a fixed-size implant, while the predicate is a patient-specific implant. However, the document emphasizes that they use the same materials and manufacturing processes.
• Performance Testing: References several ASTM standards for tensile, flexural, and impact properties of plastics, stating that these tests were "passed" and are applicable due to similar materials and manufacturing.

It does not describe:

• Acceptance criteria for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC).
• A "study" in the sense of a clinical trial or algorithm performance evaluation using a test set of data with ground truth.
• Sample sizes for AI training or test sets.
• Expert involvement for ground truth establishment or MRMC studies.
• Any AI/ML components.

Therefore, it is impossible to populate the requested table and answer the study-related questions based on the provided text, as this document pertains to a physical medical device (cranial implant) and not an AI/ML powered device.

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The Longeviti ClearFit Cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defect of the cranium.

Not Found

This document is a 510(k) clearance letter for the Longeviti ClearFit Cranial Implant. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. The "Indications for Use" section describes the intended use of the device but does not include any performance metrics or acceptance criteria.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set details) from the provided text.

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The Longeviti ClearFit™ cranial Implant is designed and manufactured individually for each adult patient to correct bony voids and/or defects of the cranium.

The Longeviti ClearFit Implant is patient specific, implantable prosthetic cranioplasty plates intended to correct and/or restore bony voids and/or defects of the cranium. The implant is manufactured from polymethyl methacrylate materials and are designed using the patient's CT scan data. The devices are provided sterile and can be fixated to cranial bone using commercially available fasteners. An identical backup implant may be supplied as a courtesy to the surgeon, according to custom, but is not required. The typical maximum single plate size does not exceed a total surface area of 411 cm2 and should have a nominal thickness of 4mm, not to exceed 5mm, to ensure physical integrity. Perfusion holes (also known as drainage holes) are available upon surgeon request at the time of ordering. Perfusion holes are 2mm in diameter and spaced at least 10mm apart.

I am sorry, but the provided text does not contain the information required to answer your request regarding the acceptance criteria and study proving device performance for an AI/CADe device. The document is a 510(k) premarket notification letter and summary for a cranial implant (Longeviti ClearFit Cranial Implant), which is a physical medical device, not an AI or CADe product.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance (for an AI/CADe).
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. Information about MRMC comparative effectiveness studies or effect sizes for human readers.
6. Stand-alone performance data for an algorithm.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document explicitly states: "No new performance testing was required to determine substantial equivalence because the manufacturing and materials are identical to those described in K191210. The only additional testing for this submission was the addition of the acoustic property testing to support the labeling change." This indicates that the device's performance was not evaluated through the types of studies typically conducted for AI/CADe systems.

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The Longeviti ClearFit™ Cranial Implant is designed and manufactured individually for each patient to correct bony voids and/or defects of the cranium.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Longeviti PMMA Static Cranial Implant, indicating substantial equivalence to a predicate device. It defines the device’s indications for use but does not contain any information regarding acceptance criteria, study details, or device performance metrics.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This information is typically found in the 510(k) submission summary or a separate clinical study report, which is not part of this document.

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Neuro:

• Neurosurgery
• Nasoethmoidal fractures
• Infraorbital area fractures
• Frontal sinus wall Fractures
• Infant craniofacial surgery
  Dental:
• Maxillofacial surgery

The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system, manufactured from commercially pure titanium, and is intended for use in:

• Oral, maxillofacial surgery: trauma; surgical correction of dentofacial deformities; reconstructive surgery; and maxillofacial surgery
• Neurosurgery: osteosynthesis of the cranial bones.

Dental: The DePuy Synthes Single Vector Distractor with Detachable Feet is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or posttraumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating fonns of clefts of the lip and palate, and congenital mandbular hypoplasia, such as Hemifacial Microsomia, Treacher Collins Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
The DePuy Synthes Single Vector Distractor with Detachable Feet is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
Neuro: The DePuy Synthes Single Vector Distractor with Detachable Feet can be used for stabilization and advancement of the mid-face, in which a deficiency of mid-facial bone requires gradual bone distraction. Such deficiencies include, but are not limited to Plagiocephaly, Trigonocephaly, Scaphocephaly, and Brachycephaly.

The DePuy Synthes Cranial Tube Clamp is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.

Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Dental: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes 1.3 & 1.5 mm Contourable Titanium (Ti.) Mesh Plates are intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

Dental: The DePuy Synthes External Midface Distractor is intended for use in maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla. Specifically, it is intended for distraction of the maxilla utilizing a LeFort I osteotomy, the midface utilizing a LeFort II or III osteotomy in adult and pediations where gradual bone distraction is required.
Neuro: The DePuy Synthes External Midface Distractor is intended for use in craniofacial surgery and reconstructive procedures. Specifically, it is intended for distraction of the cranium utilizing a monobloc osteotomy in adult and pediativ populations where gradual bone distration is required.

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are intended for use as follows: Neuro:
• Nasoethmoidal fractures

• Infraorbital area fractures
• Frontal sinus wall fractures ●
• Infant craniofacial surgery
  Dental:
• Maxillofacial surgery

Dental: DePuy Synthes Neuro Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: DePuy Synthes Neuro Plate and Screw System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

Dental: The DePuy Synthes Low Profile Neuro System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Low Profile Neuro System is intended for cranial closure and/or bone fixation, craniotomies, cranial trauma repair and reconstruction.

Dental: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

The DePuy Synthes CMF Distraction System is intended for use as a bone stabilizer and lengthening (and/or transport) device.
The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.

Dental: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the midface and maxillofacial skeleton; maxillofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Neuro: The DePuy Synthes Craniofacial Plate and Screw System is intended for use in selective trauma of the craniofacial skeleton and craniofacial surgery.

The DePuy Synthes MatrixNEURO Cranial Plating System is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

The DePuy Synthes MatrixNEURO Preformed Mesh is intended for use in fixation of the cranial bones in procedures such as reconstruction, fracture repair, craniotomies, and osteotomies.

The DePuy Synthes Maxillofacial Titanium Micro set consists of titanium bone plates (shapes include L,Y,H,T, Double-Y, Mesh and Straight) and self-tapping screws.

The DePuy Synthes Mandibular Modular Fixation System is a plate and screw system manufactured from titanium. The plates are available in a variety of shapes and sizes, and attach to bone via 2.0 mm, 2.4 mm or 2.7 mm screws.

The DePuy Synthes Single Vector Distractor with Detachable Feet is a subcutaneous bone distractor activated by a drive component. It features two telescoping components activated by a jack screw, fixed to the bone with bone screws. Bone lengthening and distraction are achieved by gradually activating the device. Upon removal, the telescoping components and jack screw are disengaged and removed, leaving the subcutaneous foot plates in the patient.

The DePuy Synthes Cranial Flap Tube Clamp consists of two clamp discs with a clamp shaft in between the discs. The clamp shaft consists of a 1.6 mm tube which is secured to the bottom disc. The top disc has a thickness of 0.4 mm and the plate diameters range from 8.0 to 20. mm.

The DePuy Synthes Low Profile Neuro System consists of titaniurn plates, and screws in a variety of shapes and sizes designed for various cranio-facial procedures.

Synthes ø1.6 mm Low Profile Neuro System self-drilling, self·tapping, and ø1.9 mm emergency self-tapping screws in 3 mm lengths are to be added to the system.

The DePuy Synthes 1.3 & 1.5 mm Contourable Ti. Mesh Plates come in a variety of shapes and sizes to meet the anatomical need of the patient. The plates are sterile and for single use only.

The DePuy Synthes External Midface Distractor is an external distraction osteogenesis device that attaches to the cranium and midface and is used to gradually lengthen the midface at the LeFort I, II, and III levels (including monobloc). The device consists of an external headframe, a central adjustment mechanism, a veridical central rod, horizontal crosspieces containing distraction screws, and separate footplates assemblies that attach to the zygoma and maxilla.

The DePuy Synthes 1.0/1.2 mm Craniofacial Screws are either self-drilling or self tapping, have a flat head profile with rounded edges with a cruciform recess, and are available in various lengths.

DePuy Synthes Neuro Plate and Screw System consists of plates, burr hole covers, and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium alloy and are intended for single use only.

The DePuy Synthes 1.6 mm burr hole covers come in various sizes to accommodate various fracture and osteotomy sites, have a low plate/screw head profile and use existing (previously cleared) 1.6 mm or 1.9 mm emergency self-tapping and self-drilling screws. The DePuy Synthes 1.6 mm Burr Hole Covers have 5 lobes to accommodate a shunt/drain and are available in 12, 15, 17, and 24 mm diameters with a plate thickness of 0.5 mm.

The DePuy Synthes Craniofacial Plate and Screw System consist of plates and meshes that come in a variety of shapes and sizes to meet the anatomical needs of the patient. This system is designed for use with 1.8 mm screws and 2.1 mm emergency screws. The screws will be used with Synthes 1.8 mm hexagonal screwdriver blades. System components are manufactured in either titanium or titanium alloy and are intended for single use only.

DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, infants, and neonates. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs. The distractor body is first assembled with the desired footplates, and then the footplates are secured to bone using the bone screws. After implantation the distractor is activated through the rotation of an advancement/lead screw with an activation instrument percutaneously.

The DePuy Synthes Orbital Plates, components of the Synthes Craniofacial Plate and Screw System, consist of anatomically shaped orbital plates that come in various sizes and configurations to fit the patient anatomy. These devices are designed for use with DePuy Synthes craniofacial bone screws commercially available in the U.S. System components are manufactured in titanium and are intended for single use only.

The DePuy Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The reconstruction meshes are manufactured from titanium, are designed for use with DePuy Synthes MatrixNEURO Cranial Plating System screws, are offered sterile, and are intended for single use only.
The screws are manufactured from titanium alloy, are designed for use with DePuy Synthes MatrixNEURO plates, burr hole covers, and meshes, maybe be offered sterile or non-sterile, and are intended for single use only.

The DePuy Synthes MatrixNEURO Cranial Plating System consists of bone fixation implants offered in a variety of shapes and sizes to meet the anatomical needs of the patient.
The DePuy Synthes MatrixNEURO Preformed Meshes are precontoured to cover common cranial defects manufactured from grade 2 titanium that are designed for use with MatrixNEURO Cranial Plating System screws. The Preformed Meshes are offered sterile packed and are intended for single use only.

The provided text is a 510(k) Premarket Notification from the U.S. Food & Drug Administration (FDA) regarding several DePuy Synthes Craniomaxillofacial Neuro Devices. It describes changes to the labeling of these devices to indicate "MR Conditional" use.

The document consistently states that the purpose of the submission is to add MR Conditional information to the device labeling. It explicitly mentions that the intended use and technological characteristics of the devices remain unchanged. This implies that the devices are already cleared for their stated indications and the current submission is concerned with demonstrating their safety in an MR environment.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to support the MR Conditional safety of the devices. This is not a study proving clinical effectiveness or diagnostic accuracy of an AI/algorithm-based device, but rather a set of engineering tests to confirm a physical device's compatibility with an MR environment.

Based on the provided text, here's how to address your request:

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

The document repeatedly cites the ASTM standards as the basis for performance testing, which inherently contain acceptance criteria within them. The document does not provide specific quantitative performance results for each device against these criteria, but rather states that "Non-clinical testing is provided to support the conditional safety." This implies that the devices met the acceptance criteria defined by these ASTM standards.

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

• Sample Size: The document does not specify the number of individual devices or prototypes tested for each type of assessment (displacement, torque, heating, artifacts). These are engineering tests typically performed on representative samples.
• Data Provenance: The data provenance is "non-clinical testing" conducted by the manufacturer, DePuy Synthes. The "DUKE model" for RF heating is mentioned, which is a widely accepted phantom model for electromagnetic simulations in medical device testing. There's no information about the country of origin of the data beyond it being part of a US FDA submission. It is a prospective test in the sense that the testing was conducted to support the MR Conditional labeling.

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

This question is not applicable in the context of this submission. The "ground truth" for MR Conditional safety is established by engineering tests against recognized consensus standards (ASTM), not by human expert review of clinical cases. The tests directly measure physical properties like temperature increase or magnetic force, and these measurements are compared to the limits specified in the standards.

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

Not applicable. This is not a human reader study requiring adjudication. The assessment is based on objective physical measurements and adherence to ASTM standards.

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 submission is for physical medical devices (implants), not an AI/algorithm-based diagnostic or assistive software. No MRMC study was performed because the device is not an AI reading tool.

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

Not applicable. This is not an algorithm, so standalone performance is irrelevant. The tests are for the physical properties of the implants.

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

The "ground truth" for these tests is defined by the physical laws and empirically derived thresholds outlined in the ASTM standards for MR compatibility. For example, a certain temperature rise in a standard phantom model is deemed acceptable if it remains below a specified limit.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning or AI model.

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

Not applicable, as there is no training set.

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