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Inion CPS Orbital Plates are intended for use in trauma and reconstructive procedures of the orbital cavity as part of the Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System.

The Inion CPS® Orbital Plate fixation plates made of resorbable polylactic acid/trimethylcarbonate copolymer: This copolymer degrades in vivo by hydrolysis into L-lactic, D-lactic and TMC monomers which are then metabolised by the body.

Inion CPS® Orbital Plates are of dimensions: length: 25-40 mm, width: 24-40 mm, thickness: 0.5 mm. The fixation of the plates with Inion CPS® ø1.5 mm screws. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption takes place within two to four years. The implants are provided sterile to the user and are not to be resterilized.

The Inion CPS® Orbital Plates provide fixation and are not intended to replace healthy bone or withstand the stress of full load bearing.

The Inion CPS® Orbital Plates are designed to be used with customized instrumentation consisting of template, drill bits, bone taps, screw driver, plate benders and a heating device.

The provided text describes a 510(k) summary for the Inion CPS® Orbital Plate, focusing on the device description, indications for use, and performance testing for substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in discussions of AI/ML device performance.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, AI performance, ground truth, or study details.

The document primarily discusses:

• Device Description: Resorbable polylactic acid/trimethylcarbonate copolymer plates for orbital cavity trauma.
• Indications for Use: Trauma and reconstructive procedures of the orbital cavity as part of the Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System.
• Performance Testing: Mechanical shear test, biomechanical fixation test, in vitro degradation testing, functional and handling test, and simulated clinical use test were performed to demonstrate substantial equivalence to a predicate device (Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System K010352). These tests verified strength, fixation, degradation profile, and functionality.

No information regarding the performance of an AI/ML device, its acceptance criteria, or a study to demonstrate its performance against such criteria is present in the provided text.

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The Inion CPS™ 2.0 Orthognathic Plate is intended for use in trauma and reconstructive procedures in the craniofacial skeleton, midface, maxilla and mandible (in conjunction with appropriate maxillomandibular fixation) as a part of the Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System.
a) Fractures of the cranium, midface, maxilla and mandible.
b) Infant craniofacial surgery (i.e. craniosynostosis, congenital malformations.
c) LeFort (I, II, III) osteotomies.
d) Pediatric reconstructive procedures.
e) Orthognathic or reconstructive procedures of the cranium, midface, maxilla or mandible.
f) Craniotomy flap fixation.

The Inion CPS" 2.0 Orthognathic Plates are provided in different shapes similar to predicate device. The Inion CPS™ 2.0 Orthognathic Plate is made of resorbable polylactic acid/trimethylenecarbonate copolymer.

This is a medical device premarket notification (510(k)) for the Inion CPS™ 2.0 Orthognathic Plate. This type of submission is for demonstrating that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials.

Therefore, the document does not contain the detailed information requested about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies, as these are typically part of a full Premarket Approval (PMA) application or a de novo submission for novel devices.

Here's what can be inferred from the provided text, and what is missing because it's a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable for a 510(k) submission focused on substantial equivalence.
A 510(k) asserts that the device is "substantially equivalent" to a predicate device, meaning it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. There are no explicit "acceptance criteria" presented in the document in the sense of performance metrics with thresholds that the new device must meet, nor is there "reported device performance" from a study specifically designed to establish such performance.

The document states: "Both the plates have the same intended use and principles of operation and there is no change in safety or efficacy." This is the core claim of substantial equivalence.

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

Not applicable in this context.
No "test set" in the context of a performance study is described. The 510(k) process relies on demonstrating equivalence through comparison of design, materials, and intended use with a predicate device, sometimes supported by basic biocompatibility or mechanical testing if there are material or design changes, but not typically a clinical "test set" of patients to evaluate performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable.
No ground truth establishment process for a test set is described, as there isn't a performance study in the way requested.

4. Adjudication Method

Not applicable.
No adjudication method is described, as there isn't a performance study with expert assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable.
This device is a physical bone plate, not an AI-assisted diagnostic tool. An MRMC study would not be relevant.

6. Standalone (Algorithm Only) Performance Study

Not applicable.
This device is a physical bone plate, not a software algorithm.

7. Type of Ground Truth Used

Not applicable.
No ground truth is used in the context of a performance study for this submission. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate device.

8. Sample Size for the Training Set

Not applicable.
This is not an AI/ML device requiring a training set.

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

Not applicable.
Not an AI/ML device.

Summary of what the document focuses on, instead of the requested information:

• Predicate Device: Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System (K010352)
• Claim of Equivalence: The Inion CPS™ 2.0 Orthognathic Plate is a "line extension" of the predicate, sharing "the same technological characteristics," "same materials," "same packaging and sterility options," "same intended use and principles of operation," and "no change in safety or efficacy."
• Intended Use & Indications/Contraindications: Clearly defined for both the new device and implicitly compared to the predicate.
• Materials: Resorbable polylactic acid/trimethylenecarbonate copolymer (same as predicate).

The 510(k) process is a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed one, relying heavily on comparative analysis rather than new clinical data demonstrating "acceptance criteria" through a performance study.

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