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The DePuy Synthes CMF Distraction System is indicated for correction of congenital deficiencies or post-traumatic defects of the cranium, where gradual bone distraction is required in adults and pediatric patients.

Cranium

. The 1.5 mm and 2.0 mm mesh and cloverleaf footplates and screws are intended for infants, children, adolescents, and adults.

Device Description

DePuy Synthes Craniomaxillofacial (CMF) Distraction System is a modular distractor system intended for correction and reconstruction of the cranium in adults, adolescents, children, and infants. The distractor construct consists of the distractor body, footplates, extension arms, and bone screws, all of which are available in multiple configurations to meet patient and surgeon needs as detailed in the table below.

AI/ML Overview

Acceptance Criteria and Study for Craniomaxillofacial Distraction System (CMFD)

The provided document describes the Craniomaxillofacial Distraction System (CMFD) and its demonstration of substantial equivalence to predicate devices. The "acceptance criteria" here refers to the performance benchmarks demonstrated through non-clinical testing to ensure the device is safe and effective and comparable to existing devices, especially given some technological differences.

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (Implicit from Test Method/Predicate Comparison)	Reported Device Performance
Reversing Prevention	The device should not reverse unintentionally under conditions where the previous design of CMFD reversed.	The subject device does not reverse unintentionally under the same conditions where the previous design of CMFD reversed.
Construct Bending Strength	The CMFD construct should be at least as strong as the predicate KLS Arnaud distractor, and design changes should not weaken it.	The CMFD construct is stronger than the predicate KLS Arnaud distractor, and the design changes relative to the previous design in K060138 do not affect the strength of the distractor construct.
Torque Input/Force Output and Construct Torsional Strength	The device must be capable of outputting the force required to distract bone in the cranium without failing.	The device is capable of outputting the force required to distract bone in the cranium without failing.
Extension Arm Interface Tensile Strength	The interface between the distractor and extension arm must withstand a tensile force based on a human factors benchmark applicable to the previous CMFD design.	The redesigned CMFD meets the same human factors benchmark as the previous design of CMFD.
Biocompatibility	Materials should be biocompatible, either by using previously cleared materials or demonstrating biocompatibility for new materials.	For modified distractor bodies (new material, Cobalt Chromium), a risk-based assessment per ISO 10993-1 was conducted with supporting biocompatibility testing. Results demonstrated that the material change does not raise new questions of safety or efficacy with respect to biocompatibility. Other components use materials cleared in predicate K060138.
Steam Sterilization Validation	Must achieve a Sterility Assurance Level (SAL) of 10^-6 via steam sterilization using previously validated parameters.	The devices may be effectively steam sterilized by the proposed parameters, which are the same parameters as the previous design of CMFD. The sterilization parameters were validated using the "overkill" method as referenced in Annex D of ANSI/AAMI/ISO 17665-1 to assure an SAL of 10^-6.
Endotoxin Testing	Maximum endotoxin levels for finished devices must be met (e.g., 2.15 EU/device).	The subject devices meet the maximum endotoxin testing limit of 2.15 EU/device (quantified using a Kinetic Turbidimetric method).

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

The document does not specify sample sizes for the individual non-clinical tests (e.g., how many constructs were tested for bending strength, how many devices for reversing prevention). The tests are described generally, without providing specific numbers of units or repetitions.

The provenance of the data for these non-clinical tests would be the device manufacturer's (DePuy Synthes) internal testing laboratories or contracted labs, likely in the US (where the company is based). These are prospective tests performed specifically to support this regulatory submission.

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

This section is not applicable to the type of study presented. The studies described are non-clinical (mechanical, materials, sterilization, endotoxin) which rely on objective measurements and engineering standards, not expert interpretation of results to establish ground truth in the way a clinical study with image interpretation would.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation or subjective assessments, where disagreements among experts need a resolution process. The tests performed here are objective engineering and laboratory tests.

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

No, an MRMC comparative effectiveness study was not done. This submission focuses on demonstrating substantial equivalence through non-clinical performance testing and comparison to predicate devices, along with a literature review of the previous device. There is no mention of human readers or AI assistance.

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

This is not applicable as the device is a mechanical surgical implant (Craniomaxillofacial Distraction System), not an algorithm or AI software, so there is no standalone algorithm performance to evaluate.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is established by:

Engineering Standards and Specifications: For mechanical tests like bending strength, torsional strength, and tensile strength, the ground truth is defined by established engineering principles, material properties, and predetermined performance thresholds derived from predicate devices or clinical requirements.
Biocompatibility Standards: ISO 10993-1 provides the framework for biocompatibility assessment.
Sterilization Standards: ANSI/AAMI/ISO 17665-1 defines the "overkill" method for sterilization validation, setting the SAL of 10^-6 as the ground truth for sterility.
Endotoxin Limits: Established limits (e.g., 2.15 EU/device) are the ground truth for endotoxin testing.
Predicate Device Performance: Performance of the predicate devices implicitly sets a benchmark for acceptable "ground truth" performance for comparison.

8. The Sample Size for the Training Set

This section is not applicable. This is a submission for a mechanical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set" in the context of device development or testing mentioned here.

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

This section is not applicable for the same reasons as #8.

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