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Craniomaxillofacial Implants: The Universal CMF System is a Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

Mandible Implants: The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.

The subject device (combination of Universal CMF System (K022185) and NewGen/Universal Mandibular System (K014263)) consists of multiple modules including fracture and reconstruction modules. The modules consist of straight, angled, hemi/full mandible bridging, curved, and pre-bent plates. The screws in the modules include 1.2-2.7mm self-tapping, self-drilling, and locking screws that vary from 3mm-42mm in length. The plates and screws are made of commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98).

It appears there's a misunderstanding of the provided FDA document. The document, K221855 for the "Universal CMF System," is a 510(k) premarket notification for a bone plate and screw system, which is a physical medical device used for fixing craniomaxillofacial fractures.

It is NOT an AI/ML-driven medical device. Therefore, the document does not contain information about:

• Acceptance criteria for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC).
• A "study" proving device performance in the context of an AI/ML algorithm (e.g., clinical trials for AI diagnostic accuracy).
• Test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The "performance data" section (VIII) refers to:

• Sterilization validation: Ensuring the device can be properly sterilized by the end-user.
• Performance bench testing: Mechanical tests to ensure the physical plates and screws meet engineering standards (e.g., biocompatibility, insertion/removal torque, failure strength). These are standard tests for physical implants, not AI algorithm performance metrics.
• Animal and Clinical Testing: Explicitly states "not required as a basis for substantial equivalence" for this physical device.

In summary, there is no AI/ML component described in this document, and therefore, it's impossible to extract the requested information about AI/ML acceptance criteria and performance studies from it.

The request asks for specific details relevant to the validation of an AI/ML device. Since this document pertains to a physical implantable device, those details simply do not exist within this filing.

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MCI - CMF System is intended for use in selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin.

The bone plates are made from commercially pure titanium (ASTM F67) and the bone screws are manufactured from titanium alloy - Ti-6AI-4V (ASTM F136) and are available in different sizes and shapes, according the site of the implantation and the extension of the fracture. The surface of plates and screws are colored-anodized. MCI - CMF System implant devices are for single use. The devices are provided non-sterile and must be properly cleaned, disinfected and sterilized before use, according the recommendations provided in the Instructions for Use.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called the "MCI - CMF System," which consists of bone plates and screws. This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through comparison of design, materials, indications for use, and a limited set of mechanical and biocompatibility tests.

There is no mention of an AI/algorithm-driven device, nor are there any acceptance criteria or studies related to AI model performance, accuracy, or human-in-the-loop studies involving expert readers.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves a device meets acceptance criteria in the context of an AI/algorithm. The provided text simply does not contain this information.

To elaborate on why I cannot answer based on the provided text:

• No AI/Algorithm: The "MCI - CMF System" is a physical medical implant (bone plates and screws). It is not software, an algorithm, or an AI system.
• No Diagnostic Claims: The device is for "selective trauma of the midface, maxillofacial surgery, reconstructive procedures, and selective orthognathic surgery of the maxilla, mandible and chin." These are surgical indications, not diagnostic. There's no AI that would be "reading" images or assisting in diagnosis.
• No Acceptance Criteria for AI Performance: Since it's a physical implant, the "performance" data refers to mechanical testing (e.g., bending fatigue of plates, pullout strength of screws) and biocompatibility, not AI metrics like sensitivity, specificity, AUC, or reader studies.
• No Test Set Details: There's no test set of patient data, as there's no AI to evaluate on such data.
• No Expert Ground Truth or Adjudication: These concepts are relevant for evaluating AI in diagnostic imaging or clinical decision support, which is not the function of this device.
• No MRMC or Standalone AI Study: These are types of studies specifically for AI performance evaluation.
• No Training Set Information: Again, training sets are for machine learning models, which are not described in this document.

The 510(k) summary concludes that the device is substantially equivalent based on engineering principles, material science, and the stated indications for use, compared to predicate devices already on the market.

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

Specific Indications for Use:

-Orthognathic surgery

-Reconstructive maxillofacial surgery

-Mandible and maxillofacial trauma surgery.

The Stryker Facial iD Plating 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 orthognathic surgery, reconstructive maxillofacial surgery, and mandible and maxillofacial trauma surgery.

The Subject Device plate(s) are additively manufactured patient-specific plates, and the patientspecific design of the plates allows certain features to be configured to meet the individual needs of each patient. The Subject Device plate(s) are provided with a printed version of the surgeonapproved Design Proposal, an electronic Instruction for Use (IFU) and an optional Anatomical Model. Additionally, the Subject Device is compatible with a separately provided Marking / Cutting Guide accessory.

The provided document describes the Stryker Facial iD Plating System, a custom-designed maxillofacial plating system. The following information is extracted regarding its acceptance criteria and the studies performed:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:
   The document focuses on bench testing and validation studies, not clinical studies involving patient data. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as typically applied to AI/diagnostic device studies using patient data are not directly applicable here. The "test sets" refer to physical samples (e.g., plates, accessory models) used in engineering and biocompatibility tests. The number of samples for each specific test is not detailed, but it is implied that sufficient samples were tested to meet the respective standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable as the studies described are bench tests and validation studies for a medical device (bone plate system), not a diagnostic AI device requiring expert-established ground truth from patient data. The "ground truth" for these tests are the established standards and specifications (e.g., ISO, ASTM).

4. Adjudication method for the test set:
   Not applicable, as no human expert adjudication of patient cases or images is described. The results of the tests were evaluated against predefined standards and criteria.

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, an MRMC comparative effectiveness study was not performed. This document describes the clearance of a physical medical device (bone plating system), not an AI/diagnostic software.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   While "Software output validation" was conducted for the design and manufacturing workflow, this is not a standalone performance evaluation of a diagnostic or assistive AI algorithm in the typical sense. It validates the output of the design software, ensuring it accurately translates digital models to manufacturing data. There's no performance metric comparing the algorithm's output to a ground truth established by humans for diagnostic purposes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For bench testing and validation, the ground truth is based on:

   • Established engineering standards: e.g., ASTM F382 for metallic bone plates, ASTM STP 731 for fatigue limits, ASTM D642 for compressive resistance, ASTM F1886M for seal integrity, ASTM E2314 for cleaning effectiveness.
   • Biocompatibility standards: e.g., ISO 10993 series and FDA guidance.
   • Sterilization standards: e.g., ISO 17665-1, ISO 14937.
   • Internal design specifications and user requirements: For software output validation and compatibility testing.

8. The sample size for the training set:
   Not applicable. This device is a physical bone plating system, not an AI model that requires a training set of data. The "patient-specific design" does involve software to design the plates for individual patients, but this is a design workflow, not a machine learning model that learns from a training set in the conventional sense.

9. How the ground truth for the training set was established:
   Not applicable, as there is no mention of a "training set" for an AI model in this 510(k) submission.

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The Stryker Universal CMF System is a Cranio-maxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

The predicate Universal CMF System, which was cleared in K022185, is intended for osteotomy, stabilization, and rigid fixation of CMF fractures and reconstruction. The Universal CMF System consists of an implant module for the respective anatomical and indicated areas with each containing various screw and plate versions and shapes. The Subject Device of this submission are the Upper-Face AXS screws and Mid-Face AXS (Subject Device) screws. This special 510(k) is submitted due to modifications made to the Subject Device. There have been no modifications to the plates, or meshes of the Predicate Device.

This document describes a 510(k) premarket notification for the Stryker Upper-Face AXS screws and Mid-Face AXS screws, which are part of the Stryker Universal CMF System. This is a Class II medical device (Bone Plate, 21 CFR 872.4760, Product Code JEY).

The submission is a special 510(k), indicating modifications were made to the subject device, but the overall indications for use remain the same as the predicate device (Stryker Universal CMF System – K022185).

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

• Same operating principle
• Same mode of fixation (plate fixation with screws)
• Same area of contact and contact duration (screws have contact to tissue/bone for >30 days)
• Same material | The document states under "B. Technological Characteristics" that "Even with the modification to the Subject Device... the technological characteristics remain the same as the Predicate Device," enumerating these points. |

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

The document does not specify the exact sample sizes (number of screws or tests) used for the bench testing. It only generally refers to "Verification and Validation (V&V) testing" being performed.

Data Provenance: The testing was "Performance Bench Testing," implying laboratory-based, in-vitro testing. No country of origin for the data is specified, but the submitter is based in Germany (Stryker Leibinger GmbH& Co. KG) and the contact person is in Portage, Michigan, USA. The testing is retrospective in the sense that it's performed on manufactured devices for regulatory submission, rather than prospective clinical trials.

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

Not applicable. This device is a bone plate and screw system, and the studies performed are bench performance testing, not studies requiring expert interpretation of diagnostic images or clinical outcomes that would necessitate establishing a "ground truth" by medical experts. The acceptance criteria are based on engineering and performance specifications.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is bench performance testing, not a study involving human interpretation or clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a physical implant device, and its regulatory clearance is based on engineering performance tests and substantial equivalence to a predicate device, not on diagnostic accuracy or reader improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense, the "Performance Bench Testing" can be considered a standalone performance evaluation of the device itself (the screws) against predefined engineering criteria, without human interaction during the test execution beyond setting up the experiment. This report focuses on the physical device's performance, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing would be the engineering specifications, established mechanical properties (e.g., strength, stiffness, fatigue life), and functional performance requirements derived from the intended use and comparison to the predicate device. These are objective, measurable parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth established for one.

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The OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.

The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only.

The OSTEOMED Modular Locking Fixation System is comprised of plates, screws and instrumentation utilized in the fixation of craniofacial, maxillofacial and mandibular fractures. The locking screw and plate interface allows up to 20 degrees of angulation within screw placement. The plating system allows for the use of locking standard screws, locking Auto-Drive™ screws, standard nonlocking screws, safety screws and Auto-Drive™ screws, as needed. The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). Drill bits, plate bending pliers, plate holding forceps, plate cutters, drill guides, cannulae, taps, countersinks, and screwdrivers to facilitate the placement of screws and modification of plates will also be a part of the system.

This looks like a 510(k) summary for a medical device that has achieved substantial equivalence, not a study evaluating whether a device meets specific acceptance criteria through performance.

The provided text, K080694, describes the OsteoMed Modular Locking Fixation System, indicated for fracture fixation in cranio-maxillofacial trauma, mandibular reconstruction, and orthognathic reconstruction. However, it is a document seeking clearance for a medical device by demonstrating substantial equivalence to predicate devices already on the market, rather than a clinical study with acceptance criteria and reported device performance metrics.

Therefore, many of the requested categories for a study that proves a device meets acceptance criteria cannot be extracted because this document is not a performance study in that sense.

Here's a breakdown based on the provided text, Highlighting why certain information is not available from this type of document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. This document does not describe a performance study with a test set.
• Data Provenance: Not applicable. This document relies on comparisons to predicate devices and their established safety and effectiveness.

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

• Not applicable. No test set or ground truth establishment by experts is described in this document.

4. Adjudication Method for the Test Set

• Not applicable. No test set adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this document. This submission uses a substantial equivalence pathway.

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

• Not applicable. This is a physical medical device (plates, screws, instrumentation), not an algorithm or AI system.

7. The Type of Ground Truth Used

• Not applicable. No ground truth is established or used in this submission. The basis for clearance is substantial equivalence to legally marketed predicate devices, meaning that the device is shown to be as safe and effective as existing devices.

8. The Sample Size for the Training Set

• Not applicable. There is no concept of a "training set" for this type of physical, non-AI medical device submission.

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

• Not applicable. (See #8)

Summary Explanation:

The document provided (K080694) is a 510(k) premarket notification. The primary goal of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device (or devices). This means the device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, it does not raise new questions of safety and effectiveness and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.

This clearance pathway typically involves:

• Comparison to Predicate Devices: Identifying existing devices with similar indications for use, materials, and design.
• Performance Testing (Non-Clinical): Often involves bench testing (e.g., mechanical strength, fatigue, biocompatibility) to ensure the device meets specified engineering standards and performs comparably to the predicates. These tests are usually against internal company specifications or recognized standards, not necessarily "acceptance criteria" for a clinical performance study.
• Material Equivalence: Demonstrating that materials used are equivalent to those in predicate devices or have established safe use.

The text explicitly states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Synthes K063790, Stryker K022185, KLS K032442, OsteoMed (K911936/Addendum K924138 and K030448), and Lorenz (K063052)." and "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Modular Locking Fixation System does not raise any new safety or effectiveness issues."

Therefore, this document does not contain the information requested about a clinical study involving acceptance criteria, test sets, expert adjudication, or AI performance metrics because it is a regulatory clearance document based on substantial equivalence, not a clinical trial report.

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