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

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

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

1. Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. Type of Ground Truth Used:

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

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

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

8. Sample Size for the Training Set:

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

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

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

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The Delphos Implants Rigid Fixation System is intended for fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.

The Delphos Implants Rigid Fixation System implants are intended for single use only.

The plates are manufactured in commercially pure titanium (ASTM F67 and ISO 5832-2) and the bone screws are manufactured from titanium alloy Ti-4Al-6V ELI (ASTM F136 and ISO 5832-3) and are available on different sizes, according with the site of the implantation and the extension of the fracture.

The devices are for single use, provided non-sterile, must be properly cleaned, disinfected and sterilized before use, according the recommendations provided on the Instructions for Use provided by Delphos Implants.

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

The provided text describes a 510(k) summary for the "Delphos Implants Rigid Fixation System," a bone plate device. This summary focuses on establishing substantial equivalence to predicate devices rather than proving a medical device's performance through clinical studies or AI-driven acceptance criteria.

The information you're requesting (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) is typically found in submissions for novel devices or AI/machine learning-based medical devices that require rigorous performance evaluation against established clinical endpoints or human performance.

This document does NOT contain the information needed to answer your questions about acceptance criteria performance, study design (sample size, provenance, experts, adjudication, MRMC, standalone), or training set details.

The document details:

• Device Name: Delphos Implants Rigid Fixation System
• Regulation Number: 21 CFR 872.4760 (Bone Plate)
• Regulatory Class: Class II
• Product Code: JEY
• Indications for Use: Fracture fixation in maxillofacial trauma reconstruction, mandibular reconstruction, and orthognathic reconstruction.
• Key Comparison: Substantial equivalence to predicate devices (Osteomed Modular Locking Fixation System, LeForte System Bone Plate & Screw, Biomet Microfixation Facial Plating System, CranioMaxillofacial Fixation (CMF) System - CMF Visionare).
• Performance Data: Primarily mechanical testing (ASTM F382 for plates, ASTM F543 for screws) to demonstrate comparable physical properties to predicate devices. Biocompatibility testing was also conducted according to ISO standards.
• Clinical Data: Explicitly states, "No clinical data were included in this submission."

Therefore, I cannot provide the requested information from this document. The provided text is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with performance metrics against acceptance criteria for a novel device or an AI/ML algorithm.

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Optimus CMF System is implantable bone plates and bone screws for maxillofacial and mandible surgery procedures including:

1. Fractures
2. Osteotomies
3. Reconstructive procedures
4. Revision procedures where other treatments or devices have failed.

The system is comprised of plate and screw. The range of subject device plate's sizes is from 0.6 to 1.5mm thick. It is made of unalloyed Titanium (ASTM F67) and anodized in 4 colors (silver, blue, green and gold). The range of screw's diameters is from 1.3 to 2.0mm in lengths of 6.0 to 12mm. The screws are made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and anodized in 3 colors (light blue, silver and gold).

The device is packed separately in a PE bag.The plate and screw aresingle use only, nonsterile products. The devices must be sterilized before use.

The screws are anodized in different colors to prevent confusion. The colors are selected for each model by diameter and so on. The devices are used as a pair (O-plate & O-screw, Fplate & F-screw) but sold individually (Not a kit or a set).

The IMF screw is for maxillomandibular fixation. The head has a relief groove in which wire or elastic bands can be wrapped around the screws which are temporarily implanted in the maxilla and mandible. It is intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla and/or the mandible. It is used independently, not with the plates.

This document is a 510(k) premarket notification for a medical device called the "Optimus CMF System," which consists of implantable bone plates and bone screws for maxillofacial and mandible surgery. As such, it primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific clinical performance acceptance criteria in the way an AI/ML device would.

Therefore, the requested information elements related to AI/ML device studies (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission. This document describes a physical medical implant, not a diagnostic or interpretative AI/ML system.

However, I can extract information related to the device's performance testing as a substitute for "acceptance criteria and reported performance" in the context of this device type.

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

The document describes non-clinical tests performed to evaluate the performance of the Optimus CMF System compared to predicate devices. The "acceptance criteria" here implicitly refer to demonstrating comparable or superior mechanical strength to legally marketed predicate devices, thereby establishing substantial equivalence.

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: The document does not explicitly state the number of samples (plates/screws) used for each mechanical test. Standard ASTM testing methods usually specify a minimum number of samples, but this information is not detailed in this summary.
• Data Provenance: The tests were performed to support a submission by Osteonic Co., Ltd. (located in Seoul, Korea) to the FDA in the USA. The specific location where the testing was physically conducted is not mentioned. These are prospective engineering tests performed on the manufactured devices.

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, as this is a non-AI physical device. Ground truth, in the context of these mechanical tests, is established by measurement instruments according to standardized ASTM protocols.

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

Not applicable, as this is a non-AI physical device.

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

Not applicable, as this is a non-AI physical device.

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

Not applicable, as this is a non-AI physical device.

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

The "ground truth" for the mechanical tests consists of objective measurements (e.g., force, displacement) obtained from standardized engineering tests (ASTM F382-14, ASTM F543-13) using calibrated equipment. For biocompatibility and sterilization, the ground truth is established by adherence to recognized standards and validated reports, often involving laboratory analyses.

8. The sample size for the training set

Not applicable, as this is a non-AI physical device and does not involve a training set.

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

Not applicable, as this is a non-AI physical device and does not involve a training set.

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The ARIX Foot System is intended for use in internal fixation, reconstruction, or arthrodesis of small bones including the fore, mid- and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.

The ARIX Foot System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Foot System is made of Unalloyed Titanium and Titanium Alloy (Ti-6AL-4V), which meet ASTM F67 and ASTM F136. The plates vary essentially through different lengths and number of plate holes. The screws are self-tapping with various diameters. The Cortical Screws & locking screws are provided with diameter 2.8 mm to 3.5 mm and lengths from 8 mm to 50 mm, lag screws (Cannulated and Cannulated Headless Types) with diameters of 1.5 mm to 6.0 mm and lengths of 8 mm to 80 mm. It also includes various manual surgical instruments, such as guide pins, drill guides, drill bits and driver shafts, washers, drill sleeve, depth gauge, bender, cleaning stylet and handbody. The ARIX Foot System not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery.

The provided 510(k) summary describes the ARIX Foot System, a medical device for bone fixation. However, it does not contain the kind of detailed information about acceptance criteria, study design, and performance metrics as typically expected for evaluating AI/algorithm-based devices with standalone performance or human-in-the-loop improvements. This summary pertains to a traditional medical implant, and the assessment is based on demonstrating substantial equivalence to predicate devices through non-clinical bench testing.

Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and study presented.

Here's a breakdown of the available information based on the prompt's requirements:

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)

This information is not provided in the document. For bench testing, "sample size" would refer to the number of plates and screws tested per standard. Data provenance is not applicable as this involves non-clinical 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)

This information is not applicable as this device relies on objective engineering standards (ASTM) for performance, not expert-derived ground truth from patient data.

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

This information is not applicable as this device relies on objective engineering standards (ASTM) for performance, not expert-derived ground truth from patient data requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a bone fixation system, not an AI or imaging diagnostic tool that would typically involve human readers.

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

No, this information is not applicable. This is a physical medical implant, not a software algorithm.

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

For the non-clinical tests, the "ground truth" or reference standard used was the specifications and test methods defined by ASTM F 382-99 (for plates) and ASTM F 543-07 (for screws).

8. The sample size for the training set

This information is not applicable. This device is a physical product, not a machine learning model that requires a "training set."

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

This information is not applicable for the reasons stated above.

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