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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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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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