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Materialise Personalized Guides for Craniomaxillofacial Surgery are intended to guide the marking of bone and or guide surgical instruments in facial surgery.

CMF Titanium Guides are used during bone repositioning/reconstruction surgical operations for orthognathic and reconstruction (including bone harvesting) indications.

CMF Titanium Guides are intended for children, adolescents and adults.

CMF Titanium Guides are intended for single use only.

CMF Titanium Guides are to be used by a physician trained in the performance of maxillofacial surgery.

Materialise Personalized Models for Craniomaxillofacial Surgery are intended for visualization of the patient's anatomy, preparation of surgical interventions and fitting or adjustment of implants or other medical devices such as osteosynthesis plates or distractors, in mandibular and maxillofacial surgical procedures.

CMF Plastic Models are intended for infants, children, adolescents and adults.

CMF Plastic Models are intended for single use only.

CMF Plastic Models are to be used by a physician trained in the performance of maxillofacial surgery.

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery combines the use of 3D preoperative planning software with patient-matched guides and models to improve and simplify the performance of surgical interventions by transferring the pre-operative plan to surgery. Materialise Personalized Guides and Models for Craniomaxillofacial Surgery are used in the facial skeleton or in maxillofacial surgeries.

The surgical planning is based on medical images of the patient that are segmented in order to create a 3D representation of the patient's anatomy. The surgical treatment of the patient is simulated based on instructions provided by the surgeon and the patient-matched devices are tailored to the treatment and the patient's needs. The patient-matched devices are manufactured from commercially pure Titanium, polyamide, or clear acrylic by means of additive manufacturing technologies. The patient-matched devices are provided non-sterile.

Materialise Personalized Guides and Models for Craniomaxillofacial Surgery include CMF Titanium Guides and CMF Plastic Models.

The provided text is a 510(k) summary for the device "Materialise Personalized Guides and Models for Craniomaxillofacial Surgery." It details the device's indications for use, description, comparison to predicate and reference devices, and non-clinical performance data. However, it does not include information about AI/algorithm performance, acceptance criteria for such an algorithm, or a clinical study for proving the device meets those criteria. The document lists "non-clinical testing" and states that "no guide specific mechanical testing is performed but this is covered by mechanical analysis of CMF Titanium Plates."

Therefore, I cannot extract the information required for an AI device acceptance criteria and study from this document. The document primarily focuses on the substantial equivalence of the physical, patient-matched guides and models to existing devices, covering aspects like material compatibility, mechanical properties, biocompatibility, and sterilization.

To answer your request, the ideal information would be present in a document describing an AI/ML medical device, which would typically contain details regarding the algorithm's performance metrics (acceptance criteria), the dataset used for testing, ground truth establishment, and potential MRMC studies. This document does not describe such a device.

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The Stryker Facial iD System is intended for osteotomy, stabilization of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher).

Specific Indications for Use:

• Orbital reconstructive/ trauma surgery

The Stryker Facial iD System (Subject Device) is intended for osteotomy, stabilization and rigid fixation of maxillofacial fractures and reconstruction in adults and adolescents (age 12 and higher), with the specific Indications for Use in orbital reconstructive and/or trauma surgery. The Subject Device is not intended for use in the orbital roof and can only be used if no exposure of the intracranial compartment is presented, and not intended for cranial use.

The Subject Device implants are additively manufactured patient-specific implants, and the patient-specific design of the implants allows certain features to be configured to meet the individual needs of each patient. The Subject Device implants are provided with a Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Additionally, the Subject Device is compatible with a separately provided Model. Customized Surgical Guides, Templates and Anatomical Models.

Here's a breakdown of the acceptance criteria and study information for the Stryker Facial iD System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal table of "acceptance criteria" with quantitative targets for each test, followed by the measured "device performance." Instead, it describes various performance tests and states that the "acceptance criteria were met" or that the device "met all pre-defined acceptance criteria."

I'll synthesize the information into a table format based on the tests performed and the outcomes mentioned:

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

• Mechanical Bench Testing: The document states that "All tests have been performed with the corresponding worst-case design considering the entire design envelope and all design features." It does not specify a numerical sample size (e.g., number of implants tested).
  • Data Provenance: Not explicitly stated, but it's in vitro bench testing.
• Biocompatibility Testing: Not specified.
  • Data Provenance: Not explicitly stated, but it's in vitro laboratory testing.
• Cleaning & Sterilization: Not specified.
  • Data Provenance: Not explicitly stated, but it's in vitro laboratory testing.
• End-User Testing: Not specified.
  • Data Provenance: Not explicitly stated, but it implies internal testing or simulation scenarios.

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

This information is not provided in the document. The studies described are primarily laboratory and bench testing, not clinical studies involving expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are technical performance tests (mechanical, biocompatibility, sterilization) and not clinical studies requiring human interpretation and adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document states "Clinical testing was not required as a basis for substantial equivalence." The studies focused on technical performance and comparison to predicate and reference devices.

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

This concept is not directly applicable to the Stryker Facial iD System as described. The "system" involves the design and manufacturing of patient-specific implants. While there's likely software involved in generating the designs from CT scans (similar to the predicate KLS Martin IPS software), the document focuses on the implant's performance rather than the standalone performance of a diagnostic algorithm or AI for interpretation. The device itself is an implant, not an AI software intended for standalone diagnostic use.

7. The Type of Ground Truth Used

• Mechanical Bench Testing: The ground truth is established by the performance characteristics of the Reference Device (K221855), against which the Subject Device's mechanical stability was compared for "substantial equivalence."
• Biocompatibility Testing: The ground truth is established by the international standards (ISO 10993-1, DIN EN ISO 10993-5, DIN EN ISO 10993-12) for biocompatibility.
• Cleaning & Sterilization: The ground truth is established by international standards (DIN EN ISO 17665-1, ISO 17665-2, ISO 14937) for sterilization and sterility assurance levels.
• End-User Testing: The ground truth is the "intended performance" under specified use conditions.

8. The Sample Size for the Training Set

This information is not applicable. The Stryker Facial iD System is a patient-specific implant system, not an AI model that requires a "training set" in the context of machine learning. The design of each implant is based on individual patient CT data.

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

This information is not applicable for the reasons stated above (not an AI model with a training set). The patient-specific designs are generated from individual patient CT scans based on established engineering principles and medical design specifications, informed by the capabilities proven by the predicate and reference devices.

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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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