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Superior Lateral Plates are provided in 12-hole and 14-hole designs for the left and right clavicle, with pre-bent flaps that allow for additional anteroposterior screw fixation. The Superior Lateral Plates include an oblong hole in the plate for an optional plate insert that is provided in two (2) designs: one insert design is for suture fixation of the coracoclavicular ligament, and one insert design is for placement of an additional cortical screw. The Superior Lateral Plates have a curved shape, a maximum thickness of 3.4 mm. and an overall length between approximately 78 mm and 100 mm.

Superior Lateral Shaft Plates are provided in an 11-hole design for the left and right clavicle. The Superior Lateral Shaft Plates are designed for stable fixation of fractures on the lateral third of the midshaft without compromising the capsule and the acromioclavicular (AC) joint. The Superior Lateral Shaft Plates have a curved shape, a maximum thickness of 3.4 mm, and an overall length of approximately 94 mm.

Superior Midshaft Plates are provided in 6-hole, 10-hole, and 12-hole designs for the left and right clavicle. The 8-hole plates are provided with three (3) different S-shaped curvatures. The plates have a maximum thickness of 3.4 mm and an overall length between approximately 84 mm and approximately 141 mm.

Anterior Midshaft Plates are provided in 6-hole, 8-hole, and 10-hole designs for midshaft fractures of the clavicle. The Anterior Midshaft plates are designed for use on either the left or right clavicle. The plates have a maximum thickness of 3.4 mm, and an overall length between approximately 8 mm and approximately 118 mm.

The Anterior Lateral Plate is provided in a 6-hole design for lateral fractures of the left or right clavicle. The plate has a maximum thickness of 3.4 mm, and an overall length of approximately 80 mm.

All of the subject device plates and the plate inserts for the Superior Lateral Plates are manufactured from titanium alloy conforming to ASTM F136.

The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS® System. The compatible screws are 2.8 mm in diameter and were previously cleared in K091479 and K103332. The subject device plates also are compatible with 1.6 mm diameter Medartis APTUS® K-Wires previously cleared in K092038.

AI/ML Overview

The provided document is a 510(k) summary for the Medartis APTUS Clavicle System. It details the device's substantial equivalence to predicate devices, focusing on design, intended use, and technological characteristics. However, it explicitly states that clinical data were not provided in this submission. The performance data consists solely of non-clinical testing.

Therefore, the document does not contain information about acceptance criteria for device performance based on clinical outcomes or studies that typically involve human subjects or expert assessment.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly stated as not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance (Summary from Non-Clinical Testing)
Biocompatibility	Conformance to established standards	Referenced from K191848 and K181425 (previously cleared Medartis devices using identical materials and processes).
Sterilization	Conformance to established standards	Referenced from K191848 and K181425 (previously cleared Medartis devices using identical materials and processes).
Engineering Analysis	Not explicitly detailed	Performed to assess device design and characteristics.
Static Tensile Strength	Suture-suture insert-plate constructs significantly greater than suture-simulated clavicle bone constructs	Static testing demonstrated that the tensile strength of suture suture insert-plate constructs was significantly greater than the tensile strength of suture-simulated clavicle bone constructs.
Dynamic Mechanical Testing (Fatigue)	Performance of subject device comparable to predicate device in a simulated fracture model	For three groups of the subject device plates, the mechanically weakest plate was selected and compared to a predicate device plate under the same conditions. Performance was judged to be substantially equivalent to predicates K111540, K073186, and K101536.

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable for clinical test sets as "Clinical data were not provided in this submission." For non-clinical mechanical testing, the mechanically weakest subject device plate was selected for three groups of the subject device plates. Specific numbers of plates tested are not provided.
Data provenance: Non-clinical (laboratory testing). No country of origin for non-clinical test data is specified. The study is not retrospective or prospective in a clinical sense as it is entirely non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical ground truth was established by medical experts for this submission as "Clinical data were not provided in this submission." The ground truth for non-clinical testing is based on engineering principles and material science.

4. Adjudication method for the test set:

Not applicable. No clinical test set or adjudication by experts was performed.

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. This is a medical device (bone fixation system), not an AI diagnostic or assistive device. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or is relevant.

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

No. This is a medical device (bone fixation system), not an algorithm or software. No standalone algorithm performance was assessed.

7. The type of ground truth used:

Non-clinical: Engineering measurements and material property standards (e.g., ASTM F136 for titanium alloy, ASTM F67 for unalloyed titanium, ASTM F138/F139 for stainless steel). The "ground truth" for substantial equivalence was based on comparisons of design, materials, intended use, and mechanical performance to predicate devices already on the market.

8. The sample size for the training set:

Not applicable. This is a traditional medical device submission, not an AI/machine learning device that would typically have a "training set."

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

Not applicable. No training set or associated ground truth was established as this is not an AI/machine learning device.

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