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The subject device plate has an anatomical design appropriate for both the left and right wrist. The plate has a uniform thickness of 1.3 mm and has overall dimensions of approximately 35 mm x 13 mm, before bending to conform to the hand anatomy. The screw holes of the plate are designed to accommodate appropriately sized bone screws presently marketed as part of the APTUS® System and previously cleared under K051567. The subject device plate is compatible with 2.0 mm diameter screws, and is used with TriLock locking screws and cortical (nonlocking) screws. The subject device plate is made of unalloyed titanium conforming to ASTM F67.

AI/ML Overview

This document (K181009) is a 510(k) premarket notification for the Medartis AG APTUS® CMC-I Fusion Plate System. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative sense as might be found for software performance (e.g., specific sensitivity/specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices through various tests.

The performance data primarily focuses on mechanical equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility: Device material is safe for implantation.	Referenced from K051567 (APTUS® Titanium System). The final finished subject device is manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared reference predicate device components cleared in K051567.
Mechanical Strength (Static): The plate can withstand loads.	Mechanical testing according to ASTM F382 (four-point bend testing) was performed. The document states "Performance data demonstrated the subject device plates to be substantially equivalent to K062498."
Mechanical Strength (Dynamic/Fatigue): The plate can withstand repetitive loads without failure.	Comparative dynamic testing in a simulated fracture model was performed. The document states "Performance data demonstrated the subject device plates to be substantially equivalent to K062498."
Equivalent Intended Use: The device is for the same purpose as predicates.	The APTUS® CMC-I Fusion Plate System is intended to be used for fusion of the trapezium with the first metacarpal. This is deemed similar to the predicate device's use for internal fixation of bones of hand and wrist, with a focus on specific fusion.
Equivalent Technological Characteristics: Similar materials, design, and screw compatibility.	The subject device and predicate devices are made of unalloyed titanium (ASTM F67 for subject, grade 2 for primary predicate). Similar design characteristics including screw holes for locking/non-locking screws. Subject device compatible with screws from reference predicate K051567.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: The document does not specify the number of physical samples used for the mechanical tests (e.g., number of plates tested for four-point bend or dynamic testing). ASTM F382 and similar standards typically require a certain number of replicates, but this detail is not provided.
Data Provenance: The tests are non-clinical, laboratory-based mechanical and biocompatibility tests. Product development and potentially the testing itself occurred in Switzerland (Medartis AG is based in Basel, Switzerland). The document does not specify if the testing was performed retrospectively or prospectively, although in a verification/validation context they are typically conducted prospectively.

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 submission is for a physical medical device (bone plate) and relies on non-clinical engineering and material science testing, not on clinical data, image interpretation, or expert consensus on patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable for the reasons stated above (non-clinical, non-human-reader dependent testing).

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:

This information is not applicable. This is a submission for a physical medical implant, not an AI/software device that assists human readers.

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

This information is not applicable. This refers to AI/software performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" in this context refers to the established standards and specifications for material properties and mechanical performance.

For Biocompatibility: The "ground truth" is that the material (unalloyed titanium, ASTM F67) and manufacturing processes are identical to a previously cleared device (K051567), and thus are known to be biocompatible.
For Mechanical Performance: The "ground truth" for mechanical testing is established by recognized standards such as ASTM F382 and by comparative performance against a legally marketed predicate device (K062498) known to be safe and effective for its intended use. The device's performance measurements (e.g., load to failure, fatigue life) are compared against the predicate's performance in similar test setups.

8. The sample size for the training set:

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. This device is a physical implant.

9. How the ground truth for the training set was established:

This information is not applicable for the reasons stated above.

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