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The ACUTE Innovations® Sternal Fixation System is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Device Description

The ACUTE Innovations® Sternal Fixation System consists of plates and accessories as well as a cerclage-based device to provide fixation for sternotomies and sternal fractures. The plate designs for the Sternal Fixation System match the general anatomy of the sternum. The components of the ACUTE Innovations® Sternal Fixation System are made of commercially pure titanium, titanium alloy or stainless steel.

AI/ML Overview

The provided text is a 510(k) summary for the ACUTE Innovations® Sternal Fixation System, a medical device for sternal fixation. It details the device's indications for use, description, and comparison to predicate devices to demonstrate substantial equivalence.

However, the document does not describe an acceptance criteria table, device performance report, or a study (e.g., clinical, standalone, or comparative effectiveness) that would typically involve statistical analysis of a test set, expert ground truth, or MRMC studies. The "study" mentioned consists of non-clinical mechanical tests.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is the information that can be extracted or deduced, along with explanations for what cannot be found:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Bending strength of sternum plate: Not explicitly stated as a separate acceptance criterion, but implied to be comparable to predicate devices.	Non-clinical tests included "an analysis of bending strength of the ACUTE Innovations® sternum plate." The results "demonstrate that the ACUTE® Innovations Sternal Fixation System is substantially equivalent to legally marketed predicate devices."
Tensile strength of cerclage-based device: Not explicitly stated as a separate acceptance criterion, but implied to be comparable to predicate devices.	Non-clinical tests included "tensile testing of the cerclage-based device." The results "demonstrate that the ACUTE® Innovations Sternal Fixation System is substantially equivalent to legally marketed predicate devices."
Material compatibility: Implied to be comparable to predicate devices.	"The ACUTE Innovations® Sternal Fixation System and the predicate sternal fixation systems are made of the same materials (commercially pure titanium, titanium alloy or stainless steel)."
Fixation methods: Implied to be comparable to predicate devices.	"The methods of fixation for the subject device are the same as for the predicate devices."
Screws performance: Implied to be comparable to predicate devices.	"Based on comparability to the predicate screws, no additional testing was performed on the stainless steel screws."

Explanation: The document states that the device's performance was evaluated through non-clinical tests (bending strength and tensile testing) to demonstrate substantial equivalence to predicate devices. However, it does not explicitly list specific numerical acceptance criteria for these tests nor provide quantitative performance results. The acceptance criterion is generally framed as "substantially equivalent" to the predicate devices.

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 for test set: Not applicable. The "tests" mentioned are non-clinical mechanical tests on the device components, not tests involving patient data or a "test set" in the context of AI/diagnostic device evaluation.
Data provenance: Not applicable. These were laboratory mechanical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As this was a non-clinical device for physical fixation, no human experts were used to establish ground truth in the context of interpretation of images or patient outcomes.

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

Not applicable. There was no clinical or interpretive test set requiring adjudication.

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 done. This type of study is relevant for diagnostic devices involving human interpretation, which is not the case for a sternal fixation system.

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

Not applicable. This device is a physical implant, not a standalone algorithm or a device requiring human-in-the-loop performance evaluation in the context of AI or diagnostic imaging. The "standalone" performance here refers to the device's physical and mechanical properties tested in a lab setting.

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

Ground Truth Type: For the non-clinical tests, the "ground truth" was established by engineering standards and direct measurement of physical properties (bending strength, tensile strength) to compare against the known properties or performance of predicate devices. The concept of "expert consensus," "pathology," or "outcomes data" for ground truth is not applicable here as it refers to a physical, non-diagnostic device.

8. The sample size for the training set

Not applicable. The device is a physical implant, not an AI or machine learning model. There is no concept of a "training set" in this context.

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

Not applicable, as there is no training set for this type of device.

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