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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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KLS Martin IPS Distraction 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, and symphysis) and mid-face bones that require gradual distraction in adults, adolescents, children and infants weighing more than 2.5 kg.

KLS Martin IPS Distraction System is comprised of patient-specific models, guides and distraction footplates used in conjunction with previously cleared distractor bodies and metallic bone screws for internal fixation and reconstruction 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 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 personnel during the planning session. For each design iteration, verification is performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure its dimensional properties allow an adequate fit.

Implants are provided sterile or non-sterile, range in thickness from 0.6 - 10 mm, and are manufactured using additive or traditional (subtractive) methods from either CP Titanium (ASTM F67) or Ti-6A1-4V (ASTM F136) materials. These patient-specific devices are fixated with previously cleared KLS Martin screws.

This document describes the 510(k) summary for the KLS Martin IPS Distraction device. It provides information regarding the device's indications for use, technological characteristics, and a comparison to predicate and reference devices to support a claim of substantial equivalence.

Based on the provided text, the device in question is a medical implant (bone plates) designed for cranial and facial bone distraction. Therefore, the acceptance criteria and study proving its performance will relate to its mechanical properties, biocompatibility, sterilization, software validation, and clinical safety and effectiveness for its intended patient population.

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it describes various tests performed and their outcomes in narrative form to demonstrate substantial equivalence. I will infer the "acceptance criteria" from the types of tests conducted and the "reported device performance" from the stated results.

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

• Mechanical Testing (Weld Strength): The document does not specify the exact sample size for the weld strength test. It states "A direct comparison weld strength test was performed," implying sufficient samples for a comparative analysis, but no number is given.
• Biocompatibility, Sterilization, Pyrogenicity: These tests leveraged data from a previously cleared device (K191028). No new sample sizes are explicitly mentioned for these, as the substantial equivalence hinges on the similarity to the already-tested reference device. If new samples were tested for verification, their numbers are not stated.
• Software V&V: No specific sample size (e.g., number of cases or simulations) is mentioned for software testing. It refers to "all software requirements and specifications" and "on-site user acceptance testing."
• Clinical Performance (Pediatric): 5 clinical studies were analyzed to support the pediatric indications. The document lists the studies, but does not state how many patients were in the "test set" for the KLS Martin device specifically. These appear to be literature reviews, not new clinical trials conducted for this device clearance.
  • Data Provenance: The provenance of the data for the 5 analyzed clinical studies is implied to be from published literature ("Based on published literature findings"). Specific country of origin is not mentioned, nor is whether the studies were retrospective or prospective, though typical clinical trials are prospective, and reviews can be of either.

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

• Mechanical, Biocompatibility, Sterilization, Pyrogenicity, Software V&V: The document does not mention the use of external "experts" to establish ground truth for these non-clinical performance tests. These are typically assessed against pre-defined engineering and biological standards by internal or contract testing labs.
• Clinical Performance (Pediatric): The "ground truth" for the pediatric clinical performance is based on "published literature findings" and risk assessments performed based on FDA guidance. There is no mention of a specific number of experts used to establish a new ground truth for this 510(k) submission's test set. The experts are implicitly the authors of the peer-reviewed clinical literature analyzed and the regulatory/clinical affairs personnel conducting the risk assessment. Qualifications of these implied experts are not detailed in this document.

4. Adjudication Method for the Test Set

• No adjudication method (e.g., 2+1, 3+1) is described for any of the tests, as these are technical performance tests or literature reviews, not studies involving human interpretation of medical images or data requiring reader consensus.

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 MRMC comparative effectiveness study was mentioned or performed. This device is a passive implantable device, not an AI-assisted diagnostic tool.

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

• This question is not applicable. The device is a surgical implant, not a software algorithm. The software mentioned (for planning and design) is a tool for manufacturing patient-specific implants, not a diagnostic algorithm in itself that would have standalone performance.

7. The Type of Ground Truth Used

• Mechanical Testing: Ground truth is implicitly defined by engineering standards for tensile strength and material properties.
• Biocompatibility: Ground truth is established by the accepted international standard ISO 10993 series.
• Sterilization: Ground truth is defined by the accepted international standard ISO 17665-1:2006 and a target SAL of 10^-6.
• Pyrogenicity: Ground truth is defined by AAMI ANSI ST72:2019 and USP allowed limits for endotoxins.
• Software V&V: Ground truth is established by pre-defined software requirements, specifications, and risk assessment outcomes.
• Clinical Performance (Pediatric): Ground truth for the safety and effectiveness in pediatric applications is based on peer-reviewed clinical literature and FDA guidance on pediatric medical devices, interpreted through a risk assessment. This is a form of outcomes data and expert consensus derived from previous studies, rather than a new "ground truth" adjudicated for this submission.

8. The Sample Size for the Training Set

• This question is not applicable to an implantable device like KLS Martin IPS Distraction. "Training set" usually refers to data used to train a machine learning algorithm.
• For the patient-specific design, the "training" data is the individual patient's CT scan. Each device's design is unique to the patient's anatomy. The "training" for the process comes from accumulated experience, validated software, and adherence to design specifications described in the section about patient-specific manufacturing.

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

• This question is not applicable for the reasons stated above. For the individual patient design process, the "ground truth" (the patient's anatomy for which the device is being designed) is established directly from the patient's CT scan data. The "virtual planning" involves interactions between the physician and trained KLS Martin personnel to refine the design, with "verification" performed by virtually fitting the generated device model over a 3D model of the patient's anatomy to ensure adequate fit.

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The KLS Martin IPS Preprosthetic Implant is a subperiosteal implant composed of titanium intended to construct patient specific prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for multi-unit prostheses, such as dentures.

The KLS Martin Individual Patient Solutions (IPS) Preprosthetic system is comprised of patient-specific models and metallic bone plates with integrated pillars used in conjunction with metallic bone screws for internal fixation of the implant to maxillofacial / midface and mandibular bones. The integrated pillars will serve as the base for temporary dentures as well as a permanent prosthesis. 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.

The KLS Martin IPS Planning System is utilized to plan and design the IPS Preprosthetic implant. The IPS Planning System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support reconstructive and orthognathic surgeries. The system uses electronic medical images of the patients' anatomy (CT data) with input from the physician, to manipulate original patient images for planning and executing surgery. The system processes the medical images and produces a variety of patient specific physical and/or digital output devices which include anatomical models, implants, and case reports.

Implants are provided non-sterile, range in thickness from 1.2 - 10.0 mm, and are manufactured using additive methods from Ti-6Al-4V (ASTM F136). These patient-specific devices are fixated with previously cleared KLS Martin screws.

Implants have a minimum of two (2) transgingival pillars for the attachment of dental prostheses. The straight pillars (0° to the occlusal plane) have a diameter of 4 mm and are provided at lengths up to 20 mm.

The provided document is a 510(k) summary for the KLS Martin IPS Preprosthetic device and does not contain information about acceptance criteria for an AI/CADe device, nor does it detail a study proving such a device meets those criteria. The device described, the KLS Martin IPS Preprosthetic, is a patient-specific subperiosteal dental implant, not an AI or CADe system.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/CADe system.
• Sample size used for the test set and data provenance for an AI/CADe system.
• Number of experts and their qualifications used to establish ground truth for an AI/CADe system.
• Adjudication method for the test set of an AI/CADe system.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study for an AI/CADe system.
• Standalone performance for an AI/CADe system.
• Type of ground truth used for an AI/CADe system.
• Sample size for and establishment of ground truth for the training set of an AI/CADe system.

The document does mention "Software Verification and Validation" on page 10, stating:
"Software verification and validation was performed on individual software applications that are used in the planning and design of the implant based on the patient's images (CT). Quality and on-site user acceptance testing provide objective evidence that all software requirements and specifications were implemented correctly and completely and are traceable to system requirements. Testing required as a result of risk analysis and impact assessments showed conformity with pre-defined specifications and acceptance criteria. Software documentation demonstrates all appropriate steps have been taken to ensure mitigation of any potential risks and performs as intended based on the user requirements and specifications."

This section indicates that there was software used in the planning and design of the implant, which is based on CT images. This software underwent verification and validation, including "user acceptance testing" and conformity with "pre-defined specifications and acceptance criteria." However, it does not provide the specifics of these acceptance criteria, the study design, or any performance metrics in the format requested for an AI/CADe system. It is a general statement about software V&V, not a study proving the performance of an AI-driven diagnostic or CADe device in a clinical context.

The "Performance Testing - Clinical" section (page 11) discusses the clinical outcomes of the implant device itself (implant loosening, reduced post, exposed/removed screws, infections/abscesses, partial exposure of underlying framework), not the performance of any AI or CADe software used in its design.

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